Profilnine SD (Factor IX Complex): Uses, Dosage, Side Effects, and Warnings

Published on by Dr. Christine Leduc, PharmD

Profilnine SD (Factor IX complex) is a replacement therapy used to prevent and control bleeding in people with factor IX deficiency due to hemophilia B. Hemophilia B is an inherited bleeding disorder in which the body does not produce enough functional factor IX, a protein needed for normal blood clotting.

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Profilnine SD is made from pooled human plasma and is administered intravenously (into a vein). It temporarily increases factor IX levels to help the blood clot properly and prevent or control excessive bleeding.

Profilnine SD is manufactured by Grifols Biologicals LLC and was originally approved by the FDA on July 20, 1981. In this article, we’ll discuss important information about Profilnine SD, including its uses, dosage, administration, side effects, warnings, and precautions.

Profilnine SD: Approved Uses 

Profilnine SD is FDA-approved for the prevention and control of bleeding in people with factor IX deficiency due to hemophilia B.

Hemophilia B, sometimes called Christmas disease, is an inherited bleeding disorder caused by a deficiency or dysfunction of clotting factor IX. Without enough functional factor IX, the blood does not clot properly, which can cause prolonged or excessive bleeding.

Profilnine SD temporarily replaces deficient factor IX to help prevent or control bleeding.

Mode of Action

Profilnine SD contains clotting factor IX along with factors II and X and low levels of factor VII. In people with hemophilia B, Profilnine SD temporarily replaces deficient factor IX, increasing factor IX activity in the blood and helping the normal blood-clotting process occur.

The effects of factor IX replacement therapies are temporary, so additional doses may be necessary depending on the severity and location of bleeding, the desired factor IX level, and the patient’s response to treatment.

Profilnine SD: Drug Form

Profilnine SD is supplied as a sterile, freeze-dried (lyophilized) powder in single-dose vials containing approximately 500 IU, 1,000 IU, or 1,500 IU of factor IX. The medication must be reconstituted before intravenous administration.

Each vial is labeled with the actual factor IX potency expressed in International Units (IU). Follow the instructions provided with the medication and your healthcare provider’s directions when preparing and administering Profilnine SD.

Dosage and Administration

Profilnine SD is administered intravenously after reconstitution. The infusion rate should not exceed 10 ml per minute because administering the medication too rapidly may cause vasomotor reactions. The appropriate dose varies from person to person and should be determined by a healthcare provider.

The dose may depend on factors such as:

  • Body weight
  • Baseline factor IX level
  • Desired factor IX level
  • Location and severity of bleeding
  • Individual response to treatment
  • Whether treatment is needed around a surgical procedure

How Is the Profilnine SD Dose Calculated?

According to the prescribing information, approximately 1 unit of factor IX per kilogram of body weight can be expected to increase circulating factor IX levels by about 1%. However, individual responses may vary.

A healthcare provider may estimate the required dose using the following formula:

Body weight (kg) × desired increase in factor IX (%) × 1 unit/kg = factor IX units required

Factor IX levels should be monitored to help determine whether the desired level has been achieved and maintained.

Typical Dose of Profilnine SD for Hemophilia B

Factor IX dosing depends on bleeding severity. For minor to moderate bleeding, levels are raised to 20–30% every 16–24 hours, with treatment lasting 1–2 days for minor bleeds and 2–7 days for moderate ones. 

For major bleeding, levels are first raised to 30–50%, then maintained at 20% until healing, typically over 3–10 days. 

For surgery, levels are raised to 30–50% beforehand (up to 50% for dental extractions) and maintained until healing, usually 7–10 days, with doses given every 16–24 hours throughout. In short, more severe bleeding requires higher factor IX levels and longer treatment.

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Possible Side Effects

Like other medications, Profilnine SD can cause side effects. Possible adverse reactions include:

Boy with a headache, which is a common symptom of taking Profilnine SD
  • Headache
  • Fever
  • Chills
  • Flushing
  • Nausea
  • Vomiting
  • Tingling
  • Lethargy (lack of energy)
  • Hives

Serious adverse reactions have also been reported with Profilnine SD. These may include:

  • Severe allergic or hypersensitivity reactions, including anaphylaxis 
  • Abnormal blood clot formation (thrombosis), including deep vein thrombosis (DVT) and pulmonary embolism (PE)
  • Disseminated intravascular coagulation (DIC), a serious condition that causes abnormal clotting throughout the body’s blood vessels
  • Development of factor IX inhibitors, which can make factor IX replacement therapy less effective

Seek immediate medical attention if you develop symptoms of a severe allergic reaction or blood clot after receiving Profilnine SD.

Precautionary Measures

Before receiving Profilnine SD, tell your healthcare provider about your medical history and any medications you take. In particular, tell your healthcare provider if you:

  • Have liver disease
  • Have a history of blood clots
  • Have recently had surgery or are scheduled to have surgery
  • Are pregnant or planning to become pregnant
  • Are breastfeeding

It is not known whether Profilnine SD can cause fetal harm when administered during pregnancy. Talk with your healthcare provider about the potential benefits and risks of treatment if you are pregnant or breastfeeding.

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Warnings

Profilnine SD may increase the risk of thromboembolic complications (blood clots). The risk may be greater in certain people, including those undergoing or recovering from surgery and those with liver disease or other conditions that increase the risk of abnormal blood clotting. 

Because Profilnine SD is made from human plasma, it carries a potential risk of transmitting infectious agents. Manufacturing processes, donor screening, and testing are used to substantially reduce this risk, but the possibility of transmitting infectious agents cannot be completely eliminated.  

Some people may develop neutralizing antibodies, known as inhibitors, against factor IX. These inhibitors can make factor IX replacement therapy less effective. If Profilnine SD does not produce the expected factor IX levels or adequately control bleeding, your healthcare provider may perform blood tests to check for inhibitors. 

Estimated Cost

Profilnine SD is a branded medication and can be relatively expensive. In the U.S., the estimated cash price can range from approximately $770 to $2,300 per vial, depending on the strength. These figures are estimates rather than fixed manufacturer prices, and you may pay less with insurance or eligible discount programs. Contact us if you are interested in financial assistance or copay assistance for Profilnine SD.

Short Bowel Syndrome and Malnutrition: Nutrition Strategies, TPN, and Long-Term Management

Published on by Neil Marshall, DACM, BSN, LAc, RN, CRNI, NCCAOM®

What Is Short Bowel Syndrome?

Short bowel syndrome (also called short gut syndrome) is a rare but serious malabsorption disorder. It occurs when the small intestine is too short or cannot absorb enough nutrients from food. 

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In most cases, short bowel syndrome occurs when a portion of the small intestine is surgically removed to treat another medical condition. It can also occur in infants born with a shorter-than-typical small intestine. 

According to the American Gastroenterological Association (AGA), short bowel syndrome commonly occurs when less than about 200 cm of small intestine remains. However, the amount of intestine needed to maintain adequate nutrition varies depending on which sections remain and whether the colon is intact [1]. For reference, the average length of the adult small intestine is about 600 cm [2]. 

Treatment for short bowel syndrome aims to control diarrhea and fluid losses, improve intestinal absorption, and maintain adequate nutrition and hydration. The treatment can include [3]:

  • Certain medications 
  • Hormonal therapy
  • Dietary changes
  • Enteral nutrition 
  • Total parenteral nutrition (TPN)
  • Surgery 

Short Bowel Syndrome and Malnutrition: What to Know

In short bowel syndrome, malnutrition can occur when the body cannot absorb enough calories, protein, vitamins, minerals, or other nutrients to meet its needs. This can lead to weight loss, vitamin and mineral deficiencies, dehydration, and other health complications.  

Malnutrition is a common complication of short bowel syndrome. Because much of the absorption of nutrients and fluids occurs in the small intestine, having short bowel syndrome can lead to malabsorption, dehydration, nutritional deficiencies, and other metabolic complications. 

Signs and symptoms can include: 

  • Diarrhea with or without foul-smelling stools
  • Excessive tiredness
  • Poor appetite
  • Weight loss
  • Dehydration 
  • Slowed growth in infants and children 

Specific symptoms may occur due to vitamin and mineral deficiencies, such as:

  • Night blindness and dry eyes due to vitamin A deficiency
  • Muscle weakness or bone pain due to vitamin D deficiency
  • Anemia due to iron, folate, or vitamin B12 deficiency
  • Loss of appetite and impaired wound healing due to zinc deficiency
  • Muscle cramps or weakness due to calcium or magnesium deficiency
  • Easy bruising or bleeding due to vitamin K deficiency

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Understanding the Nutrition Strategy

Each case of short bowel syndrome is different, and so is the treatment. 

A team of healthcare professionals works together to determine which treatment or combination of treatments is best for you. The healthcare team can include dietitians, pharmacists, nurses, surgeons, gastroenterologists, and social workers. 

Treatment typically starts with a comprehensive nutrition assessment by a dietitian experienced in short bowel syndrome. They may review your medical history, medications, usual diet, fluid intake and losses, weight changes, and a food diary, if available. 

They may also assess you for:

  • Other medical conditions that may affect nutrient absorption, food intake, or fluid loss
  • Signs and symptoms of malnutrition and dehydration
  • Vitamin and mineral deficiencies that can occur with short bowel syndrome

You will also need regular tests for liver and kidney function, micronutrient levels, bone density, fluid balance, and weight changes. 

Then, they will recommend a diet tailored to your needs, along with appropriate dietary counseling. 

Dietary recommendations for short bowel syndrome vary considerably depending on how much and which portions of the intestine remain, whether the colon is intact, and the amount of fluid lost through diarrhea or an ostomy. The following strategies may be recommended for some patients, but your healthcare provider or an SBS-experienced dietitian can help determine which are appropriate for you [4]:

  • Eat smaller meals more frequently, such as 5 to 6 meals throughout the day.
  • Limit foods and beverages high in added sugars, which may worsen diarrhea in some people.
  • Take small bites and chew food thoroughly.
  • Follow your healthcare provider’s recommendations about when and how much to drink with meals.
  • Limit or avoid alcohol and excessive caffeine if they worsen fluid losses or symptoms.
  • If recommended by your healthcare team, use an oral rehydration solution (ORS) to help replace fluids and electrolytes.

Short Bowel Syndrome and Malnutrition: When Do You Need TPN?

Nurse helping patient with short bowel syndrome prepare for TPN at home

Total parenteral nutrition (TPN) is a life-saving treatment for patients with short bowel syndrome. It is essential for nearly all patients with short bowel syndrome during the initial period after surgery. TPN helps prevent malnutrition. 

During the initial phase of short bowel syndrome, your healthcare provider may use TPN with another feeding method called enteral or tube feeding. 

TPN may also be administered at home in the subsequent periods. Also called home PN, it offers long-term care in the comfort of your home. However, you will need regular monitoring and supplementation to reduce the risk of micronutrient deficiencies. 

Will You Need TPN Forever?

Whether you will need TPN forever depends primarily on the length of the remaining small intestine. You will likely need TPN for a lifetime if your remaining small intestine is less than 100 cm and you have excessive fluid losses. 

The risk of having to use lifetime TPN may also be higher in people who have:

  • Lost the large intestine (colon)
  • Lost the valve between the end of the small intestine and the colon 
  • Narrowing of a portion of the small intestine 

Conversely, you may be able to wean off TPN if the remaining small intestine adapts to changing demands after surgery. Certain medications and supplemented diets may help intestinal adaptation. 

According to the American Gastroenterological Association (AGA), more than half of adults with short bowel syndrome will be able to live without TPN within 5 years of diagnosis [1]. 

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What Are the Risks of TPN for Short Bowel Syndrome?

While TPN can be life-saving, it is not free of risks. Some of them can include:

  • Central venous catheter infections, which can sometimes lead to bloodstream infection or sepsis
  • Blood clots associated with the central venous catheter
  • Loss of usable central venous access after repeated catheter complications
  • Fluid, electrolyte, or blood glucose abnormalities
  • Metabolic bone disease
  • Liver and gallbladder complications

Additionally, long-term TPN use can increase the risk of complications called parenteral nutrition-associated liver disease (PNALD). Liver complications are one of the most common causes of death in people with short bowel syndrome. 

Moreover, early evidence suggests that patients who need to be on TPN for survival are at a greater risk of developing complications requiring intestinal transplant. 

Long-Term Management of Short Bowel Syndrome-Associated Malnutrition

Long-term management of short bowel syndrome focuses on appropriate medications, individualized nutrition, fluid management, and other supportive measures to maintain adequate nutrition and hydration and, when possible, reduce dependence on parenteral nutrition. 

Your healthcare team may also consider surgery to help increase the intestine’s ability to absorb nutrients. Surgery is usually reserved for cases where other treatment options have failed or when life-threatening complications occur. 

Living with short bowel syndrome can be challenging. Dietary changes, frequent bowel movements, fatigue, and ongoing medical care can affect everyday life. In addition to medical and nutritional treatment, several strategies may help you manage these challenges. 

  • Consider joining a support group where you can connect with others living with short bowel syndrome and share experiences and practical strategies. 
  • Stay active. It can be challenging, but small efforts add up. Start slow and gradually increase the duration or intensity of the activity. Ask your healthcare provider about the activities appropriate to your condition. 
  • If you need to use a restroom frequently, find out if there are local facilities when you are traveling or are out and about. Plan ahead!

Frequently Asked Questions

What is the life expectancy of a child with short bowel syndrome?

Life expectancy varies considerably among children with short bowel syndrome. Outcomes depend on factors such as the amount and type of intestine remaining, the underlying cause of SBS, the child’s ability to achieve intestinal adaptation, dependence on parenteral nutrition, and whether serious complications develop. Advances in nutrition support, intestinal rehabilitation, and medical and surgical treatment have substantially improved outcomes for children with short bowel syndrome. 

What causes short bowel syndrome in adults? 

Short bowel syndrome in adults usually develops after extensive surgical removal of the small intestine. Conditions that may lead to this surgery include: 

  • Crohn’s disease
  • Trauma 
  • Recurrent intestinal obstruction 
  • Damage to the small intestine by radiation therapy 
  • Loss of blood flow to the intestine (mesenteric ischemia) 

What is the best diet for short bowel syndrome and malnutrition?

There is no single diet that is best for everyone with short bowel syndrome. Your nutritional needs depend on factors such as which portions of your intestine remain, whether your colon is intact, your stool or ostomy output, and your ability to absorb fluids and nutrients.

Depending on your individual needs, your healthcare team may recommend eating smaller, more frequent meals; getting adequate protein and calories; limiting concentrated sugars; and using an oral rehydration solution when appropriate. Some people may also need specific adjustments to fat, fiber, oxalate, or fluid intake.

Because dietary recommendations can vary substantially, work with a dietitian experienced in short bowel syndrome to develop an individualized nutrition plan.

Tolvaptan (Jynarque/Samsca): Uses, Warnings, Doses, and Side Effects

Published on by Dr. Samantha Kaeberlein, PharmD

Jynarque and Samsca are brand-name prescription medications. Both contain the same active ingredient, tolvaptan. However, these products treat different conditions and should not be used interchangeably. 

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Jynarque

Jynarque is used to slow kidney function decline in adults who are at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). 

ADPKD is an inherited kidney disease in which fluid-filled sacs (cysts) form in the kidneys. These cysts gradually impair kidney function as they grow and may lead to kidney failure. There’s no cure for this condition. 

Samsca 

Samsca is used to treat clinically significant low blood sodium levels (hyponatremia) in certain adults, including some people with heart failure or Syndrome of Inappropriate Antidiuretic Hormone (SIADH). 

Jynarque vs. Samsca

BrandsJynarqueSamsca
Manufacturer Otsuka Pharmaceutical Co., Ltd.Otsuka Pharmaceutical Co., Ltd.
FDA approval20182009
Drug classVasopressin V2 receptor antagonistsVasopressin V2 receptor antagonists
Dosage formOral tabletsOral tablets
Available strengths 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg15 mg and 30 mg
Duration of treatment for the indicated condition Years, decades, or until kidney failure occursNo longer than 30 days
AvailabilityAvailable only through the Tolvaptan for ADPKD Shared System REMS*Not restricted by REMS* for hyponatremia. Should be initiated or reinitiated in a hospital

*REMS (Risk Evaluation and Mitigation Strategies) is a drug safety program. The FDA requires REMS for certain medicines that have serious risks. 

Important Tolvaptan (Jynarque/Samsca) Information and Warnings

Jynarque

This medication can cause serious liver problems, which can be fatal or require you to have a liver transplant. That’s why it is available only through the Tolvaptan for ADPKD Shared System REMS. 

Stop taking this medication and call your healthcare provider immediately if you have:

  • Unusual tiredness
  • Loss of appetite
  • Nausea
  • Pain in the right upper stomach 
  • Vomiting
  • Fever
  • Rash
  • Itching
  • Yellowing of the skin and eyes (jaundice)
  • Dark urine
  • Pale feces

Your healthcare provider will order blood tests to check your liver before you start Jynarque, 2 weeks and 4 weeks after starting treatment, monthly for the first 18 months, and every 3 months thereafter. 

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Samsca

This medication may cause blood sodium levels to rise too quickly, potentially leading to osmotic demyelination syndrome (ODS). ODS is a serious neurological condition that can occur when severely low sodium levels are corrected too rapidly. It can cause serious neurological problems, coma, or death. 

Call your healthcare provider immediately if you have:

  • Difficulty speaking or swallowing
  • Drowsiness
  • Confusion
  • Mood changes
  • Weakness or difficulty controlling movements in the arms or legs 
  • Seizures

The following factors may increase the risk of ODS. Inform your healthcare provider if you have any of them. 

  • Liver disease
  • Malnutrition 
  • Extremely low blood levels of sodium
  • Chronic alcoholism

To lower the risk of ODS, your healthcare provider will start and restart treatment with Samsca in a hospital, where you can be monitored closely. You should drink water when you are thirsty. Also, you should keep water readily available at all times during treatment. 

Samsca may cause potentially fatal liver problems. Call your healthcare provider immediately if you have: 

  • Unusual tiredness
  • Loss of appetite
  • Nausea
  • Pain in the right upper stomach 
  • Vomiting
  • Fever
  • Rash
  • Itching
  • Yellowing of the skin and eyes (jaundice)
  • Dark urine
  • Pale feces

Samsca should not be taken for more than 30 days because of the risk of liver injury. It should generally be avoided in people with underlying liver disease, including cirrhosis. 

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Before Taking Tolvaptan (Jynarque/Samsca)

Jynarque

Before you receive your first dose of Jynarque, inform your provider if you:

  • Are allergic to this product or any product component
  • Have a history of extremely low sodium levels
  • Are pregnant or plan to get pregnant
  • Are breastfeeding or plan to breastfeed (Avoid breastfeeding during treatment)

Taking Jynarque with certain medicines may raise blood levels of tolvaptan. Ask your healthcare provider which medicines you can take with Jynarque. Your dose of Jynarque may need to be reduced. Talk to your healthcare provider before starting a new medication. 

Don’t take Jynarque if you:

  • Have a history, signs, or symptoms of significant liver impairment or injury, other than uncomplicated polycystic liver disease
  • Take certain medications that are strong CYP3A inhibitors
  • Have an abnormal blood sodium level that has not been corrected
  • Are unable to sense or appropriately respond to thirst
  • Are dehydrated
  • Have hypovolemia (abnormally low fluid volume in the body)
  • Have a urinary tract obstruction that has not been corrected
  • Are unable to produce urine

Samsca

Before you receive your first dose of Samsca, inform your provider if you:

  • Are allergic to this product or any product component
  • Have kidney or liver problems
  • Cannot make urine
  • Are unable to feel that you are thirsty
  • Are pregnant or plan to get pregnant
  • Are breastfeeding or plan to breastfeed
  • Take desmopressin (dDAVP) 

Don’t take Samsca if you:

  • Are allergic to tolvaptan or any of the ingredients in Samsca
  • Need an urgent increase in your blood sodium level
  • Are unable to sense or appropriately respond to thirst
  • Have hypovolemic hyponatremia (low blood sodium associated with low fluid volume)
  • Take certain medications called strong CYP3A inhibitors
  • Are unable to produce urine

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Tolvaptan (Jynarque/Samsca) Mechanism of Action 

Tolvaptan belongs to a class of medications called vasopressin V2 receptor antagonists. It works by blocking the effects of vasopressin, a hormone that normally causes the kidneys to retain water.

In people with ADPKD, blocking vasopressin V2 receptors helps reduce processes involved in kidney cyst growth and slows the decline in kidney function.

Tolvaptan also causes the kidneys to remove more water through urine without proportionally increasing sodium loss. In people with certain types of hyponatremia, this loss of excess water can help increase the concentration of sodium in the blood.

Tolvaptan (Jynarque/Samsca) Dosing

Jynarque

The starting total dose is 60 mg orally per day, which is divided into: 45 mg upon waking and 15 mg 8 hours later. If tolerated, the dose may be increased to 90 mg orally per day (60 mg upon waking and 30 mg 8 hours later).

The highest dose is 120 mg orally per day (90 mg upon waking and 30 mg 8 hours later). 

Samsca

The usual starting dose is 15 mg orally with or without food. The dose may be increased to 30 mg orally once daily after at least 24 hours. The maximum dose is 60 mg orally once daily. Don’t take this medication for longer than 30 days in order to reduce the risk of liver injury. 

Tolvaptan (Jynarque/Samsca) Proper Use and Storage

  • Take your doses exactly as directed. Take your medicine around the same time each day.
  • You may take this medication with or without food.
  • Avoid drinking grapefruit juice while on treatment with this medication. 
  • Drink enough water to prevent dehydration. 
  • Call your healthcare provider if you have vomiting or diarrhea. 
  • If you miss a dose, don’t double the dose. Continue your schedule as usual. 
  • If you think you have overdosed, call your healthcare provider immediately. 
  • If you need to stop taking Samsca because your healthcare provider told you to, ask them how much fluid you can take safely. 
  • Keep all medications out of reach of children and pets. 
  • Store Jynarque at77°F (25°C).
  • Store Samsca between 68°F and 77°F (20°C and 25°C).

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Tolvaptan (Jynarque/Samsca) Side Effects

Common Side Effects of Jynarque

Woman drinking water after experiencing thirst, a common side effect of tolvaptan
  • Thirst 
  • Drinking more fluid than normal
  • Frequent urination
  • Increased urine output
  • Urinating at night

Severe Side Effects of Jynarque

  • Hypernatremia (elevated blood sodium levels)
  • Dehydration and hypovolemia (loss of too much fluid from the body)

Jynarque increases water loss through urination and can cause dehydration and hypovolemia (abnormally low fluid volume). Drink enough water throughout the day and night to avoid becoming thirsty or dehydrated. If you cannot drink enough water for any reason, stop taking Jynarque and contact your healthcare provider. 

Call your healthcare provider if you experience any of the following:

  • Dizziness
  • Fainting
  • Weight loss
  • Changes in heart rhythm 
  • Confusion
  • Extreme weakness

Common Side Effects of Samsca

  • Thirst
  • Dry mouth
  • Weakness
  • Constipation
  • Frequent urination
  • Increased urine output
  • Elevated blood glucose levels

Severe Side Effects of Samsca

Call your healthcare provider immediately if you have signs of dehydration, such as dizziness or feeling like you are going to pass out. Tell your healthcare provider if you have vomiting or diarrhea and difficulty drinking fluids.

Tolvaptan (Jynarque/Samsca) Cost

Cost can vary depending on your insurance plan, location, and pharmacy. Ask your insurance provider if your plan covers this medication or if you need prior authorization. 

Otsuka offers copay assistance for eligible patients who have been prescribed Jynarque. Contact us if you are interested in getting copay assistance for tolvaptan.

Recombinate: Uses, Dosing, Side Effects, Storage, and Administration

Published on by Dr. Robert Hakim, PharmD

Recombinate is an FDA-approved intravenous (IV) factor VIII replacement therapy used to control bleeding episodes in people with hemophilia A. It is also used to manage bleeding before, during, and after surgery in people with hemophilia A. 

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Recombinate Introduction and Uses

Recombinate is a brand-name prescription product. The active ingredient is a lab-made form of factor VIII, also known as antihemophilic factor, a natural clotting protein found in blood. Recombinate does not contain any human blood products. 

Recombinate belongs to the drug class called coagulation factors or hemostatics. 

A healthcare provider may prescribe Recombinate for people with hemophilia A to control bleeding episodes or manage bleeding around surgery. 

Recombinate is not indicated for the treatment of von Willebrand disease (VWD).  

Availability note: Takeda has announced the global discontinuation of Recombinate and previously stated that it intended to continue supplying the medication to existing patients until inventory was depleted or expired in mid-2026. Patients currently using Recombinate should speak with their healthcare provider about product availability and whether a transition to another factor VIII therapy is needed. 

Recombinate Mechanism of Action

People with hemophilia A have deficient or dysfunctional clotting factor VIII. Factor VIII is necessary for the blood-clotting process, and a deficiency can cause prolonged or spontaneous bleeding into the joints, muscles, or internal organs.

Recombinate works by temporarily replacing the missing clotting factor VIII in the blood, helping the blood form clots and control bleeding.

Recombinate Dosing

Your healthcare provider will calculate your dose based on your body weight, desired increase in factor VIII activity, clinical response, and treatment needs. Always use the dose prescribed specifically for you.

Recombinate comes as an off-white to faint yellow powder in single-dose vials. It is available in nominal dosage strengths of approximately 250, 500, 1,000, 1,500, and 2,000 International Units (IU) per vial. The powder must be mixed with an appropriate volume of Sterile Water for Injection before intravenous (IV) infusion. Your provider will use a vial size that is appropriate for your calculated dose.

Dosing for Treatment of Bleeding Episodes 

Mild bleeding: The dose is individualized to achieve a post-infusion factor VIII activity level of approximately 20% to 40% of normal. It is administered every 12 to 24 hours for 1 to 3 days until healing is achieved or the bleeding is adequately resolved. 

Moderate bleeding: The dose is individualized to achieve a post-infusion factor VIII activity level of approximately 30% to 60% of normal. Treatment may be repeated every 12 to 24 hours for 3 days or more until pain or disability is resolved. 

Life-threatening bleeding: The dose is individualized to achieve a post-infusion factor VIII activity level of approximately 60% to 100% of normal. Treatment may be repeated every 8 to 24 hours until the threat no longer exists. 

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Dosing for Surgery

Minor surgery: The dose is individualized to achieve a post-infusion factor VIII activity level of approximately 60% to 80% of normal. According to the prescribing information, a single infusion plus oral antifibrinolytic therapy within 1 hour is sufficient in approximately 70% of cases. 

Major surgery: The dose is individualized to achieve a factor VIII activity level of 80% to 100% of normal (pre- and post-operative). Treatment may be repeated every 8 to 24 hours. 

Recombinate Side Effects

Common Side Effects

Recombinate patient suffering from a nosebleed, which is a common side effect of using this medication

In clinical studies, the most commonly reported side effects included:

  • Chills
  • Flushing
  • Rash
  • Nosebleeds

Other side effects reported during clinical trials included nausea, fatigue, fever, dizziness, itching, pain in an extremity, and low blood pressure.

Serious risks include severe allergic reactions and the development of factor VIII inhibitors. Contact your healthcare provider right away if bleeding does not stop after using Recombinate, as this may be a sign that the medication is not working as expected. Seek immediate medical care if you develop symptoms of a severe allergic reaction. 

Recombinate Important Information and Warnings

Never attempt to inject this medication on your own unless you know how to safely administer it. Carefully follow your healthcare provider’s instructions about the dose and schedule for administering Recombinate. 

Severe Allergic Reactions

Recombinate may cause serious allergic reactions, including anaphylaxis. Anaphylaxis is a potentially life-threatening allergic reaction that can cause difficulty breathing, swelling, chest tightness, wheezing, or low blood pressure.

Stop using Recombinate and seek immediate medical care if you develop symptoms of a severe allergic reaction, such as:

  • Rash and itching
  • Hoarseness
  • Breathing difficulty
  • Trouble swallowing
  • Swelling of your hands, face, or mouth
  • Chest tightness
  • Low blood pressure

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Inhibitor (Antibody) Production

In some cases, your body can develop proteins called inhibitors (antibodies) against factor VIII, which can prevent Recombinate from working well to treat or prevent bleeding. Inhibitor development is an important concern, particularly in previously untreated patients. 

Your healthcare provider will likely order tests to measure factor VIII inhibitors in your blood if:

  • Factor VIII level doesn’t increase as expected after starting treatment
  • Bleeding doesn’t stop with an appropriate dose

Before Taking Recombinate

Before using Recombinate, tell your healthcare provider if you:

  • Are allergic to Recombinate, any of its ingredients, or mouse, hamster, or bovine proteins
  • Have or have previously developed factor VIII inhibitors
  • Are pregnant or planning to become pregnant
  • Are breastfeeding or planning to breastfeed 

Don’t use Recombinate if you have a known hypersensitivity to Recombinate, any of its ingredients, or mouse, hamster, or bovine proteins. 

Proper Use

Use this or any medication exactly as directed. You may receive your first dose in a hospital, clinic, or treatment center. If home treatment is appropriate, your healthcare provider will teach you how to prepare and administer the medication safely.

  • Read and follow the Instructions for Use included with the product
  • Wash your hands and work on a clean surface
  • Allow the kit to reach room temperature
  • Administer Recombinate at room temperature and follow your healthcare provider’s instructions for the infusion rate. Do not infuse faster than instructed. 
  • Use only the supplies provided or specifically recommended by your healthcare provider
  • You may need blood tests after receiving Recombinate to help determine if the blood level of factor VIII is enough for clot formation. 
  • Check the reconstituted solution before infusion. It should be colorless to faint yellow and substantially free of visible particles.
  • Do not use the solution if it is discolored or contains visible particles.
  • If you miss a scheduled dose, contact your healthcare provider for instructions. Do not change your dose or treatment schedule unless instructed to do so. 

Contact your healthcare provider immediately if:

  • Bleeding is not controlled after treatment
  • You administer more than your prescribed dose
  • You have difficulty preparing or infusing the medication

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Recombinate Storage and Handling

  • Store unopened Recombinate in a refrigerator at 2°C to 8°C (36°F to 46°F) or at room temperature up to 30°C (86°F). Keep the vials in their original box and protect them from extreme exposure to light. 
  • Don’t freeze. 
  • If you choose to store this medication at room temperature, keep it at room temperature until infusion and never put it back in the refrigerator. 
  • Use the reconstituted solution within 3 hours. Don’t store or refrigerate the reconstituted solution. 
  • Safely throw away any drug left in the vial at the end of the infusion. 

Recombinate Cost and Financial Assistance

Cost can vary depending on your insurance plan, location, and pharmacy. Contact your insurance provider to find out if your plan covers this medication or if you need prior authorization. If cost is a concern, contact us to explore financial assistance and copay assistance for Recombinate.

Xyntha: Uses, Dosing, Side Effects, Storage, and Administration

Published on by Dr. Mark Alfonso, PharmD, BCMTMS

Xyntha is an FDA-approved prescription medication for adults and children with hemophilia A that replaces clotting factor VIII to help prevent and control bleeding. Hemophilia A (classic hemophilia) is an inherited bleeding disorder caused by a deficiency or dysfunction of clotting factor VIII.

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Xyntha Introduction and Uses

Xyntha is a brand-name prescription product. The active ingredient in this product is recombinant antihemophilic factor (rAHF), which is also known as coagulation factor VIII or moroctocog alfa.

Xyntha belongs to a drug class called coagulation factors. 

A healthcare provider may prescribe this medication for children and adults with hemophilia A to:

  • Treat and control bleeding episodes as they occur
  • Manage bleeding before, during, and after surgery
  • Reduce the frequency of bleeding episodes through routine preventive treatment

Xyntha is not indicated for the treatment of von Willebrand disease (VWD).  

Xyntha comes as a white to off-white powder in single-use vials. Each vial contains 250, 500, 1,000, or 2,000 International Units (IU) of the active drug. 

Each Xyntha vial kit contains:

  • 4 ml 0.9% Sodium Chloride with plunger rod for assembly
  • One vial adapter
  • One sterile infusion set
  • Two alcohol swabs
  • One bandage
  • One gauze pad
  • One package insert

The powder must be mixed with the sodium chloride solution before intravenous (IV) infusion.

Mechanism of Action

People with hemophilia A have deficient or dysfunctional clotting factor VIII. Factor VIII plays an important role in the blood-clotting process, and a deficiency can lead to prolonged or spontaneous bleeding, including bleeding into the joints and muscles. 

Xyntha works by temporarily replacing the missing clotting factor VIII in the blood, helping the blood form clots and control bleeding.

Before Using Xyntha 

Before you receive your first dose of Xyntha, inform your healthcare provider if you are:

  • Allergic to Xyntha, any of its ingredients, or hamster proteins, which may be present in trace amounts
  • Pregnant or planning to become pregnant
  • Breastfeeding or planning to breastfeed

Important Xyntha Warnings

Allergic Reactions

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis is a potentially life-threatening allergic reaction that can cause breathing problems, swelling, a rapid heartbeat, faintness, or low blood pressure. 

Stop using this medication and seek immediate medical care if you develop the following symptoms after receiving Xyntha:

  • Rash and itching
  • Hoarseness
  • Breathing difficulty
  • Trouble swallowing
  • Swelling of your hands, face, or mouth
  • Chest tightness
  • Low blood pressure

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Factor VIII Inhibitor Development 

Some people can develop antibodies called factor VIII inhibitors, which may reduce or prevent Xyntha from working effectively. 

Your healthcare provider may order blood tests to check for factor VIII inhibitors if: 

  • Your factor VIII levels do not increase as expected after treatment
  • Bleeding is not controlled with an appropriate dose

Dosing

Your healthcare provider will calculate your dose based on your body weight, desired increase in factor VIII activity, clinical response, and treatment needs. Always use the dose prescribed specifically for you.

The dose and duration of treatment depend on:

  • The severity of the factor VIII deficiency
  • The location and extent of bleeding
  • The type of bleeding episode or surgery
  • Your clinical condition and response to treatment

Dosing for On-Demand Treatment and Control of Bleeding Episodes

Minor bleeding: The dose is individualized to achieve a factor VIII activity level of approximately 20% to 40% of normal. Treatment may be repeated every 12 to 24 hours for at least 1 day, depending on the severity of bleeding.

Moderate bleeding: The dose is individualized to achieve a factor VIII activity level of approximately 30% to 60% of normal. Treatment may be repeated every 12 to 24 hours for 3 to 4 days or until bleeding is adequately controlled. 

Major bleeding: The dose is individualized to achieve a factor VIII activity level of approximately 60% to 100% of normal. Treatment may be repeated every 8 to 24 hours until the bleeding is controlled. 

Dosing for Preventing Bleeding During Surgery

Minor surgery: The dose is individualized to achieve a factor VIII activity level of approximately 30% to 60% of normal. Treatment may be repeated every 12 to 24 hours as directed by the healthcare provider.

Major surgery: The dose is individualized to achieve a factor VIII activity level of approximately 60% to 100% of normal. Treatment may be repeated every 8 to 14 hours until adequate wound healing is achieved. 

Dosing for Routine Prevention of Bleeding Episodes 

Recommended starting regimens include:

  • Adults and adolescents 12 years or older: 30 IU/kg IV three times weekly
  • Children younger than 12 years: 25 IU/kg IV every other day

Children younger than 12 may require higher or more frequent doses because the medication may be cleared from their bodies more quickly.

Your healthcare provider will adjust the dose or frequency based on your bleeding pattern, factor VIII levels, and clinical response.

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Side Effects

Common side effects reported with Xyntha include:

Boy suffering from headaches, a side effect of taking Xyntha
  • Nausea, vomiting, diarrhea
  • Headache
  • Dizziness
  • Joint pain
  • Rash
  • Sore throat
  • Cough
  • Stuffy nose
  • Weakness
  • Tiredness
  • Fever
  • Pain, swelling, or itching at the injection site

Serious risks of Xyntha include severe allergic reactions and the development of factor VIII inhibitors. Contact your healthcare provider if bleeding is not adequately controlled after receiving Xyntha or if you experience an increase in bleeding episodes. These may be signs that factor VIII inhibitors have developed.

Seek immediate medical attention if you experience symptoms of a serious allergic reaction, such as difficulty breathing, chest tightness, swelling of the face or mouth, or severe dizziness or fainting.

Xyntha Administration and Proper Use 

Use Xyntha exactly as prescribed by your healthcare provider. You may receive your first dose in a hospital, clinic, or treatment center. If home treatment is appropriate, your healthcare provider will teach you how to prepare and administer the medication safely.

  • Read and follow the Instructions for Use included with the product
  • Wash your hands and work on a clean surface
  • Allow the kit to reach room temperature
  • Use only the supplies provided with Xyntha or recommended by your healthcare provider 
  • Inspect the reconstituted solution before infusion; it should be clear to slightly opalescent and colorless 
  • Do not use the solution if it contains particles or appears discolored

Contact your healthcare provider immediately if:

  • Bleeding is not controlled after treatment
  • You administer more than your prescribed dose
  • You have difficulty preparing or infusing the medication

Before traveling, speak with your healthcare provider and bring enough medication and infusion supplies for the entire trip.

Xyntha Storage and Handling

  • Store unopened Xyntha in a refrigerator at 2°C to 8°C (36°F to 46°F) for up to 36 months from the date of manufacture, but not beyond the labeled expiration date. 
  • Within the labeled expiration period, the medication may be stored at room temperature no higher than 25°C (77°F) for up to 3 months.
  • Record the date room-temperature storage begins in the space provided on the carton.
  • After 3 months at room temperature, use the medication immediately or discard it.
  • Do not return the medication to the refrigerator after it has been stored at room temperature.
  • Do not use the medication after its labeled expiration date or after 3 months at room temperature, whichever occurs first.
  • Do not freeze Xyntha.
  • Protect it from prolonged exposure to light.
  • After reconstitution, keep the syringe upright at room temperature until use.
  • Infuse the reconstituted solution within 3 hours after reconstitution or after removing the gray rubber tip cap.
  • Discard the reconstituted solution if it has not been used within 3 hours.

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Cost and Financial Assistance

Cost can vary depending on your insurance plan, location, and pharmacy. Contact your insurance provider to find out if your plan covers this medication or if you need prior authorization. If cost is a concern, contact us to learn more about financial or copay assistance for Xyntha.

Vonvendi for Von Willebrand Disease: Uses, Dosage, and Side Effects

Published on by Dr. Saba Rassouli, PharmD

Vonvendi is a prescription medicine used to treat and control bleeding episodes in people with von Willebrand disease (VWD). It is also used to manage bleeding around surgery, and in adults, it can be used routinely to reduce the frequency of bleeding episodes.  VWD is an inherited bleeding disorder in which the blood does not clot properly.  As a result, people with VWD experience bleeding for longer than normal after injuries, surgeries, dental procedures, or other situations. VWD is the most common inherited bleeding disorder and affects about 1% of the U.S. population [1]. 

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If you or someone you care for is living with von Willebrand disease (VWD), treatments are available to help manage bleeding. Vonvendi is one treatment option that can help control bleeding episodes and, in certain situations, help prevent excessive bleeding. In this article, we’ll discuss Vonvendi, including its uses, side effects, dosage, precautions, and cost. 

What Is Vonvendi?

Vonvendi is an FDA-approved recombinant von Willebrand factor (VWF) medicine. In adults and children with von Willebrand disease (VWD), it is used for on-demand treatment and control of bleeding episodes and for perioperative management of bleeding. In adults, Vonvendi is also approved for routine preventive treatment (prophylaxis) to reduce the frequency of bleeding episodes [3]. 

The FDA first approved Vonvendi in the United States in 2015 [2]. Unlike plasma-derived VWF products, such as Humate-P, Vonvendi contains recombinant VWF and is not derived from human plasma [3]. 

Vonvendi comes as a powder that is mixed with sterile water before it is given as an intravenous (IV) injection. 

What Is Vonvendi Used For?

Vonvendi is FDA-approved for certain uses in adults and children with von Willebrand disease (VWD), although not all approved uses apply to both age groups [3]. Vonvendi contains a recombinant version of VWF, a protein that plays an important role in blood clotting. It temporarily replaces deficient or dysfunctional VWF in people with VWD. Vonvendi is FDA-approved for [3]:

On-Demand Treatment and Control of Bleeding Episodes: People with VWD can use Vonvendi when they experience bleeding that requires replacement of von Willebrand factor (VWF). Depending on the severity and location of the bleeding, you may need several doses.

Management of Bleeding Around Surgery:  Vonvendi can be used before, during, and after surgery to help manage bleeding. 

Routine Preventive Treatment of Bleeding: Adults with VWD can receive Vonvendi regularly as routine prophylaxis to reduce the frequency of bleeding episodes [3]. 

Please note that Vonvendi does not cure von Willebrand disease (VWD). Instead, it temporarily replaces the missing or defective VWF and helps your body control bleeding.

How Does Vonvendi Work?

People with von Willebrand disease (VWD) either have too little von Willebrand factor (VWF) in their blood or have VWF that does not work properly. Vonvendi contains a man-made version of VWF. It works by temporarily replacing the missing or ineffective VWF.

VWF has two important roles in forming a blood clot. First, VWF helps platelets attach to sites where blood vessels have been damaged, an important step in forming a blood clot. Second, VWF binds to factor VIII and protects it from being broken down too quickly in the bloodstream. 

By providing recombinant VWF, Vonvendi increases VWF activity in the blood and can also help stabilize the patient’s own factor VIII. If a patient’s baseline factor VIII activity (FVIII:C) is below 40% or is unknown and an immediate increase in FVIII:C is needed, the first dose of Vonvendi should be administered with an approved recombinant factor VIII (rFVIII) product. If an immediate increase in FVIII:C is not necessary, Vonvendi may be administered without rFVIII. Treatment decisions should be based on the patient’s factor levels and clinical situation [3]. 

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Vonvendi Side Effects

Like other medicines, Vonvendi can cause side effects. Some side effects may require medical attention. Here are some common and serious side effects of Vonvendi [3][4]:

Common Side Effects

Woman experiencing nausea as a side effect of taking Vonvendi
  • Headache
  • Vomiting
  • Nausea
  • Dizziness
  • Itching

Talk with your healthcare provider if you experience side effects that persist, worsen, or concern you. 

Serious Side Effects 

Vonvendi can cause serious adverse reactions. Important risks and warnings include hypersensitivity reactions, thromboembolic events, and the development of neutralizing antibodies (inhibitors) [3].  

Hypersensitivity Reactions: Severe allergic reactions, including anaphylaxis, can occur with Vonvendi. Signs and symptoms may include hives, generalized itching, swelling, difficulty breathing, rapid heartbeat, chest tightness, dizziness, or low blood pressure. Stop the infusion and seek immediate medical attention if signs of a severe allergic reaction occur [3]. 

Blood Clots (Thromboembolic Events): Blood clots in arteries or veins have occurred in patients receiving Vonvendi, particularly in people with risk factors for thrombosis. Your healthcare provider may monitor you for signs of blood clots and may also monitor factor VIII levels when Vonvendi is given with recombinant factor VIII. Seek prompt medical attention for symptoms such as chest pain, shortness of breath, or pain or swelling in an arm or leg [3]. 

Development of Inhibitors: Neutralizing antibodies (inhibitors) against VWF and/or factor VIII can develop during treatment. If expected VWF activity or factor VIII levels are not achieved, or if bleeding is not controlled with an appropriate dose, your healthcare provider may perform tests for inhibitors [3]. 

Please note that this is not a complete list of all possible side effects. Contact your doctor immediately if you experience any severe side effects of Vonvendi.

Vonvendi Dosage 

Vonvendi comes as a powder that is reconstituted before administration and is given intravenously. Dosing is individualized according to factors such as body weight, the type and severity of bleeding, the clinical situation, and VWF and factor VIII levels. Your healthcare provider will determine the appropriate dose and treatment schedule. The following summarizes dosing recommendations from the prescribing information [3]: 

For On-Demand Treatment and Control of Bleeding Episodes: For minor bleeding, such as a nosebleed or oral bleeding, the recommended initial dose is 40–50 IU/kg. Subsequent doses of 40–50 IU/kg may be administered every 8–24 hours as clinically required.

For major bleeding, the recommended initial dose is 50–80 IU/kg. Subsequent doses of 40–60 IU/kg may be administered every 8–24 hours for approximately 2–3 days, or as clinically required [3].

For Surgery: Perioperative dosing is individualized according to the type of surgery and the patient’s VWF and factor VIII levels. For elective surgery, a preoperative dose of Vonvendi may be given 12–24 hours before surgery when needed to allow the patient’s factor VIII level to increase. VWF and factor VIII levels are assessed before surgery, and an additional dose may be administered within 1 hour before the procedure to achieve appropriate target levels. Emergency surgery and postoperative dosing require individualized management based on factor levels and clinical response [3]. 

For Routine Preventive Treatment: The recommended dose for adults is 40–60 IU/kg twice weekly [3]. 

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Before Starting Vonvendi

Before you start Vonvendi, tell your doctor your complete medical history, including if you [4]:

  • Have previously had an allergic reaction to Vonvendi or any of its ingredients
  • Have a history of blood clots or other risk factors for thrombosis 
  • Have heart or blood vessel problems
  • Have previously developed inhibitors or antibodies against VWF or factor VIII 
  • Are pregnant, planning to become pregnant, or breastfeeding
  • Take any medicines, vitamins, or herbal supplements
  • Have previously received other VWF or factor VIII products

Your doctor may monitor your VWF and factor VIII blood levels during treatment to make sure the medicine is working and to reduce the risk of excessive clotting.

Vonvendi Cost

The cost of Vonvendi can vary considerably depending on the prescribed dose, body weight, number and strength of vials required, frequency and duration of treatment, insurance coverage, and where treatment is received.

Because Vonvendi dosing is weight-based and treatment requirements differ among patients, the cost of an individual treatment episode can also vary substantially. For example, patients being treated for a major bleeding episode may require different doses and a different number of infusions than patients receiving treatment for a minor bleed or routine prophylaxis.

The amount a patient pays out of pocket may differ from the medicine’s list or acquisition price because of insurance benefits, deductibles, copayments, and financial assistance programs. Patients should contact their insurance provider, specialty pharmacy, treatment center, or the manufacturer’s patient-support program for current information about coverage and potential out-of-pocket costs. If costs are a concern, contact us to explore financial or copay assistance for Vonvendi.

Rixubis for Hemophilia B: Uses, Dosage, and Side Effects

Published on by Dr. Christine Leduc, PharmD

Rixubis is an FDA-approved prescription medicine used to prevent and control bleeding episodes in people with hemophilia B. Hemophilia B is an inherited bleeding disorder in which the body does not produce enough functional clotting factor IX, a protein needed for normal blood clotting. As a result, bleeding can last longer than normal. People with more severe hemophilia B may also experience spontaneous bleeding, including bleeding into the joints and muscles. 

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For people with hemophilia B, factor IX replacement therapies such as Rixubis can help prevent or control bleeding by replacing the deficient clotting factor IX. In this article, we’ll cover important information about Rixubis, including its uses, side effects, dosing, precautions, and more. 

What Is Rixubis?

Rixubis is a recombinant factor IX replacement medicine used to replace deficient factor IX in people with hemophilia B. It contains recombinant (laboratory-produced) coagulation factor IX. Rixubis comes as a lyophilized powder that is mixed with sterile water before use. You will receive it by intravenous infusion (into a vein).

Rixubis was initially approved by the FDA in 2013 for adults with hemophilia B. Later in 2014, its approval was expanded to include children [1][2]. Rixubis is available in several strengths, including 250 IU, 500 IU, 1,000 IU, 2,000 IU, and 3,000 IU [3].

What Is Rixubis Used For?

Rixubis is FDA-approved for adults and children with hemophilia B. It is FDA-approved for [3]:

On-Demand Treatment and Control of Bleeding: A person with hemophilia B can use Rixubis when a bleeding episode occurs. Replacing factor IX increases the amount of clotting factor available in the bloodstream. This helps your body stop the bleeding.

Routine Prophylaxis: You can use Rixubis regularly as a preventive treatment. Regular use of Rixubis increases factor IX activity and helps reduce the frequency of bleeding episodes. 

Perioperative Management: Rixubis can be used around the time of surgery to maintain adequate factor IX activity and reduce the risk of excessive bleeding.

Please note that Rixubis does not cure hemophilia B. Instead, it temporarily replaces the missing clotting factor and helps prevent or control bleeding.

How Does Rixubis Work?

Factor IX is a protein that plays an important role in blood clotting. It participates in a series of reactions known as the coagulation cascade. These reactions eventually produce thrombin, which helps convert fibrinogen into fibrin. Fibrin forms a strong mesh that stabilizes the blood clot.

People with hemophilia B have insufficient factor IX, so this clotting process does not work properly. As a result, they experience bleeding for an unusually long time.

Rixubis contains recombinant factor IX. When infused into a vein, it temporarily increases factor IX activity in the blood, supporting the coagulation cascade and helping the body form stable blood clots to prevent or control bleeding. 

Rixubis Side Effects

Like any medicine, Rixubis can cause side effects. Some are mild, and others are serious enough to need immediate medical attention. Here are some of the common and serious side effects of Rixubis [3][4]:

Common Side Effects

Patient holding arm due to pain, a common side effect of Rixubis
  • Unusual or altered taste in the mouth
  • Pain in the arms or legs
  • A positive test for furin antibodies

Tell your healthcare provider if you experience side effects that are persistent, bothersome, or concerning. 

Serious Side Effects 

Serious side effects from Rixubis are rare, but they can happen. Serious side effects associated with Rixubis include: 

Serious Allergic Reactions: Rixubis can cause serious allergic reactions, including anaphylaxis. Patients should be monitored for signs and symptoms of hypersensitivity. Get emergency care if you develop hives, swelling, chest tightness, trouble breathing, wheezing, dizziness, or fainting.

Factor IX Inhibitors: Some patients can develop neutralizing antibodies, called inhibitors, against factor IX. These inhibitors can reduce the effectiveness of factor IX replacement therapy. Your doctor may test your blood for inhibitors, especially if bleeding doesn’t stop as expected or your factor IX levels don’t rise enough.

Blood Clots: Factor IX medicines have been linked to abnormal blood clot formation inside blood vessels. Your doctor may watch you more closely if you have liver disease, are having surgery, show signs of abnormal clotting, or have other risk factors.

Please note that this is not a list of all possible side effects. Contact your healthcare provider if you experience concerning side effects. Seek emergency medical care for symptoms of a severe allergic reaction, such as difficulty breathing, wheezing, chest tightness, dizziness, fainting, or swelling of the face or throat. 

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Dosing of Rixubis

Rixubis is given as an IV infusion after the powder is mixed with sterile water. Your dose and treatment schedule depend on your age, weight, factor IX activity, the location and severity of bleeding, and how you respond to treatment. Your healthcare provider will individualize the dose based on your clinical response and may measure factor IX activity to make sure the desired level is achieved. 

For patients 12 and older, 1 IU/kg of Rixubis raises factor IX activity by about 0.9 IU/dl. For children younger than 12, the increase is about 0.7 IU/dl [3]. Here is the usual recommended dosage [3]:

For Routine Prophylaxis: The recommended dose for adults and children 12 years of age and older is 40 to 60 international units per kg twice weekly. For children younger than 12, the recommended dose is 60–80 IU/kg twice weekly.

For Bleeding Episodes: The dose and treatment duration depend on the location and severity of bleeding and your individual response.

For minor bleeding, the desired factor IX activity is generally 20–30 IU/dl. Treatment is generally given every 12–24 hours for at least 1 day, until healing is achieved.

For moderate bleeding, the desired factor IX activity is generally 25–50 IU/dl. Treatment is generally given every 12–24 hours for 2–7 days, until bleeding stops and healing is achieved.

For major bleeding, the desired factor IX activity is generally 50–100 IU/dl. Treatment is generally given every 12–24 hours for 7–10 days, until bleeding stops and healing is achieved.

For Surgery: Rixubis can be used before, during, and after surgery to maintain adequate factor IX activity and reduce the risk of excessive bleeding. For minor surgery, the target factor IX activity is generally 30–60 IU/dl, with treatment generally given every 24 hours for at least 1 day, until healing is achieved. For major surgery, the target is generally 80–100 IU/dl, with treatment generally given every 8–24 hours for 7–10 days, until healing is achieved. Dosing should be individualized based on factor IX activity and clinical response. 

Before Starting Rixubis

Before you start Rixubis, tell your doctor your full medical history. Let them know if you [4]:

  • Have had an allergic reaction to Rixubis or any of its ingredients
  • Are allergic to hamster proteins
  • Have or have had factor IX inhibitors
  • Have liver disease or problems with blood clotting
  • Are pregnant, planning to become pregnant, or breastfeeding
  • Take prescription medicines, over-the-counter medicines, vitamins, or herbal supplements

A few other things to keep in mind before you start:

  • Rixubis is contraindicated in patients with known hypersensitivity to Rixubis or its components, including hamster protein. 
  • Tell your doctor about any signs of an allergic reaction during or after your infusion.
  • Your doctor may monitor your factor IX levels and check for inhibitors during treatment.
  • Don’t use Rixubis to induce immune tolerance. Its safety and effectiveness for that haven’t been established.

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Rixubis Cost

The cost of Rixubis can vary considerably depending on the prescribed dose, body weight, frequency of treatment, insurance coverage, specialty pharmacy or distributor, and other factors. Because Rixubis dosing is based partly on body weight and treatment needs, the amount of medication required can differ substantially from one patient to another.

The amount you pay out of pocket may also differ from the medication’s listed or pharmacy price. Patients and caregivers can contact their insurance provider or specialty pharmacy for an estimate based on their prescribed dose and coverage. If cost is a concern, contact us to explore financial and copay assistance for Rixubis.

Humate-P: Uses, Side Effects, Dosage, and More

Published on by Dr. Robert Hakim, PharmD

Humate-P is a prescription medication made from purified human plasma. It contains two clotting proteins — antihemophilic factor (Factor VIII [FVIII]) and von Willebrand factor (VWF) — that help control bleeding in people with hemophilia A or von Willebrand Disease (VWD).

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Humate-P Introduction and Uses

Humate-P is a brand-name product. It belongs to a drug class called coagulation factors or hemostatics. Humate-P contains two factors:

  • Antihemophilic factor (Factor VIII [FVIII])
  • von Willebrand factor (VWF)

Together, these proteins help replace clotting factors that are missing or deficient, allowing blood to clot more effectively and reducing bleeding.

This medication is FDA-approved to:

  • Prevent or treat bleeding in adults with hemophilia A
  • Treat bleeding episodes and prevent excessive blood loss during or after surgery in patients of all ages with von Willebrand disease. This medication may be used for all types of VWD. 

Humate-P comes as a powder for reconstitution (preparing a solution by mixing with the provided liquid) in a single-dose vial. 

The following strengths are available in the US:

  • VWF/vial: 600 IU, FVIII/vial: 250 IU (with a 5 ml vial of Sterile Water for Injection)
  • VWF/vial: 1,200 IU, FVIII/vial: 500 IU (with a 10 ml vial of Sterile Water for Injection)
  • VWF/vial: 2,400 IU, FVIII/vial: 1,000 IU (with a 15 ml vial of Sterile Water for Injection)

Humate-P Mechanism of Action

Humate-P temporarily replaces deficient or missing von Willebrand factor and factor VIII. VWF helps platelets stick to damaged blood vessels to form a clot, while FVIII works with other clotting proteins to stabilize the clot and stop bleeding. 

Humate-P Dosing

Hemophilia A

Your healthcare provider will determine your dose based on:

  • Your body weight 
  • Type and severity of hemorrhage
  • FVIII level
  • Presence of inhibitors (antibodies that can make this medication less effective)

Minor bleeding: Loading dose is 15 IU/kg IV; should achieve FVIII:C plasma level ~30% of normal; may repeat using 50% of loading dose once or twice daily for 1-2 days.

Moderate bleeding: Loading dose is 25 IU/kg IV; should achieve FVIII:C plasma level ~50% of normal, followed by 15 IU/kg every 8 to 12 hours for 1 to 2 days to maintain FVIII:C levels at 30% normal, and then the same dose once or twice daily for up to 7 days or until adequate wound healing.

Life-threatening bleeding: 40-50 IU/kg IV initially, followed by 20-25 IU/kg every 8 to 12 hours to maintain FVIII:C level at 80% to 100% of normal for 7 days, then continue the same dose once or twice daily for another 7 days to maintain FVIII:C level at 30% to 50% of normal.

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Von Willebrand disease

For the treatment of bleeding episodes, your healthcare provider will determine the dosage based on the extent and location of bleeding. The typical dose is 40 to 80 International Units (IU) VWF:RCo per kg body weight every 8 to 12 hours. Doses may be repeated as long as needed based on laboratory findings. 

For preventing excessive bleeding during and after surgery, your healthcare provider will use a specific formula to calculate the dose. The loading dose for an emergency surgery is 50 to 60 International Units VWF:RCo/kg body weight. 

Before Taking Humate-P

Don’t take this medication if you have a history of severe allergic reactions to antihemophilic factor.

Before you receive the first dose of this medication, inform your healthcare provider if you are:

  • Pregnant or plan to get pregnant 
  • Breastfeeding or plan to breastfeed 

Also tell your healthcare provider if you:

  • Have a history of blood clots.
  • Have heart disease or other cardiovascular risk factors.
  • Have any known allergies to plasma-derived products.
  • Are taking medications that increase the risk of blood clots.

Important Humate-P Warnings

  • This medication may increase the risk of potentially serious blood clots in patients with von Willebrand disease. 
  • Your healthcare provider will monitor you for signs of red blood cell destruction if you have blood group A, B, or AB. The risk of red blood cell destruction may be higher if you are using large or frequent doses of this medication. 
  • Patients with von Willebrand disease may need certain blood tests, especially if they are undergoing surgery. 
  • Because Humate-P is made from human plasma, there is a very small theoretical risk of transmitting infectious agents. Plasma donors are carefully screened, and the product undergoes multiple manufacturing steps designed to reduce this risk. Your healthcare provider may recommend hepatitis A and hepatitis B vaccination before treatment. 
  • Call your healthcare provider immediately if you have low-grade fever, rash, joint pain, loss of appetite, nausea, vomiting, fatigue, and jaundice. 

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Humate-P Proper Use and Storage

  • Humate-P is given by injection into your vein. 
  • Use Humate-P exactly as prescribed by your healthcare provider. Do not change your dose or stop treatment unless instructed to do so.  
  • You will likely receive your first dose in a hospital or clinic setting. 
  • Ask your healthcare provider or pharmacist for instructions about injecting this medication at home. 
  • After reconstitution, keep the solution at room temperature and use it within 3 hours. Do not refrigerate or freeze the mixed solution, and do not shake the vial.
  • A single-dose vial is meant for one use only. 
  • Don’t use this medication if you see particles in it or if the product has changed colors. 
  • Use a disposable needle and syringe only once.
  • Keep the medicine and mixing liquid at room temperature. Protect them from moisture and heat. 
  • Ask your pharmacist for instructions about proper disposal of unused or expired medicines. 

Humate-P Side Effects 

Man scratching itch on arm

Common Side Effects

  • Mild allergic reactions (rash, itching, or swelling)
  • Injection-site bleeding
  • Nosebleeds

Contact your healthcare provider if any side effect becomes severe or does not go away.

Severe Side Effects

Allergic reactions

This medicine may cause allergic reactions, including anaphylaxis. Anaphylaxis is a potentially fatal allergic reaction that causes difficulty breathing and low blood pressure. 

Seek immediate medical care if you develop the following symptoms after receiving this medication:

  • Rash and itching
  • Hoarseness
  • Breathing difficulty
  • Trouble swallowing
  • Swelling of your hands, face, or mouth
  • Chest tightness
  • Low blood pressure

Blood clots

Using Humate-P may increase the risk of potentially serious blood clots in patients with von Willebrand disease. Patients with known risk factors for blood clots and those undergoing surgery may be at a higher risk of developing blood clots. 

Seek immediate medical attention if you develop symptoms of a blood clot, such as:

  • Sudden chest pain
  • Shortness of breath
  • Swelling or pain in one leg
  • Sudden weakness or numbness
  • Difficulty speaking

Risks of infection transmission

See the Important Humate-P Warnings section above for more information about the small theoretical risk of transmitting infectious agents from plasma-derived products. 

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Humate-P Cost 

Cost can vary depending on your insurance plan, location, and pharmacy. Contact your insurance provider to find out whether your plan covers this medication or requires prior authorization.

CSL Behring GmbH, the manufacturer of Humate-P, offers financial support and helpful resources through its Co-Pay Assistance Program, CSL Behring AssuranceSM Program, and CSL Behring Patient Assistance Program. 

Contact us if you are interested in financial or copay assistance for Humate-P.

Humate-P vs DDAVP

Although both Humate-P and DDAVP (desmopressin) are used to treat certain bleeding disorders, they work differently.

Humate-P replaces missing von Willebrand factor and factor VIII, making it appropriate for many patients with hemophilia A and all types of von Willebrand disease.

DDAVP works by stimulating the release of stored VWF and FVIII from the lining of blood vessels. It is commonly used for some patients with mild hemophilia A and certain types of von Willebrand disease but is not effective or appropriate for everyone. Your healthcare provider will determine which treatment is best based on your specific condition.

Xyntha Solofuse: Uses, Dosing, Side Effects, Storage, and Administration

Published on by Dr. Robert Hakim, PharmD

Hemophilia A is an inherited bleeding disorder caused by a deficiency or dysfunction of clotting factor VIII. Xyntha Solofuse is an FDA-approved prescription medication used in adults and children with hemophilia A to replace clotting factor VIII to prevent bleeding.

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Xyntha Solofuse Introduction and Uses

Xyntha Solofuse is a brand-name prescription medication. The active ingredient in this product is recombinant antihemophilic factor (rAHF), which is also known as coagulation factor VIII or moroctocog alfa.

Xyntha Solofuse belongs to a drug class called coagulation factors. 

A healthcare provider may prescribe Xyntha Solofuse for adults and children with hemophilia A to:

  • Treat and control bleeding episodes as they occur
  • Manage bleeding before, during, and after surgery
  • Reduce the frequency of bleeding episodes through routine preventive treatment

Xyntha Solofuse does not contain von Willebrand factor and is not indicated for the treatment of von Willebrand disease.

Xyntha Solofuse comes in a single-use, prefilled dual-chamber syringe. One chamber contains a white to off-white freeze-dried powder, and the other contains 4 ml of 0.9% sodium chloride solution. The powder must be mixed with the sodium chloride solution before intravenous (IV) infusion. 

Xyntha Solofuse is available in nominal strengths of 250, 500, 1,000, 2,000, and 3,000 International Units. The actual factor VIII potency is printed on the product label. 

Each Xyntha Solofuse kit contains:

  • One plunger rod for assembly
  • One sterile infusion set
  • Two alcohol swabs
  • One bandage
  • One gauze pad
  • One vented sterile cap
  • One package insert

Xyntha Solofuse Mechanism of Action

People with hemophilia A have deficient or dysfunctional clotting factor VIII. Factor VIII is necessary for the blood-clotting process, and a deficiency can cause prolonged or spontaneous bleeding into the joints, muscles, or internal organs.

Xyntha Solofuse temporarily replaces the missing factor VIII, helping the blood form clots and control bleeding.

Xyntha Solofuse Dosing 

Your healthcare provider will calculate your dose based on your body weight, desired increase in factor VIII activity, clinical response, and treatment needs. Always use the dose prescribed specifically for you.

The dose and duration of treatment depend on:

  • The severity of the factor VIII deficiency
  • The location and extent of bleeding
  • The type of bleeding episode or surgery
  • Your clinical condition and response to treatment

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Dosing for the treatment and control of bleeding episodes 

Minor bleeding: The dose is individualized to achieve a factor VIII activity level of approximately 20% to 40% of normal. Treatment may be repeated every 12 to 24 hours for at least 1 day, depending on the bleeding episode.

Moderate bleeding: The dose is individualized to achieve a factor VIII activity level of approximately 30% to 60% of normal. Treatment may be repeated every 12 to 24 hours for 3 to 4 days or until bleeding is adequately controlled.

Major bleeding: The dose is individualized to achieve a factor VIII activity level of approximately 60% to 100% of normal. Treatment may be repeated every 8 to 24 hours until the bleeding is controlled.

Dosing for perioperative bleeding management 

Minor surgery: The dose is individualized to achieve a factor VIII activity level of approximately 30% to 60% of normal. Treatment may be repeated every 12 to 24 hours as directed by the healthcare provider.

Major surgery: The dose is individualized to achieve a factor VIII activity level of approximately 60% to 100% of normal. Treatment may be repeated every 8 to 24 hours until adequate wound healing is achieved. Treatment may then continue for at least another 7 days to maintain an appropriate factor VIII activity level, as directed by the healthcare provider.

Dosing for routine prevention of bleeding episodes 

Recommended starting regimens include:

  • Adults and adolescents 12 years or older: 30 IU/kg IV three times weekly
  • Children younger than 12 years: 25 IU/kg IV every other day

Children younger than 12 may require higher or more frequent doses because the medication may be cleared from their bodies more quickly.

Your healthcare provider will adjust the dose or frequency based on your bleeding pattern, factor VIII levels, and clinical response.

Xyntha Solofuse Side Effects

Boy holding elbow, experiencing joint paint, a side effect of Xyntha Solofuse

Xyntha Solofuse can cause side effects that can range from mild to serious.

Common side effects reported with Xyntha include:

  • Headache
  • Joint pain
  • Fever
  • Cough
  • Vomiting
  • Diarrhea
  • Weakness

Serious risks include severe allergic reactions and the development of factor VIII inhibitors.

Contact your healthcare provider about any side effect that concerns you or does not go away. Additionally, seek emergency medical care for signs of a serious allergic reaction.

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Before Using Xyntha Solofuse

Before using Xyntha Solofuse for the first time, tell your healthcare provider if you:

  • Have had a severe allergic reaction to Xyntha Solofuse, any of its ingredients, or hamster proteins, which may be present in trace amounts
  • Are pregnant or planning to become pregnant
  • Are breastfeeding or planning to breastfeed

Important Xyntha Solofuse Warnings

Severe allergic reactions 

Xyntha Solofuse can cause severe allergic reactions, including anaphylaxis. Anaphylaxis is a potentially life-threatening reaction that may cause breathing problems, swelling, a rapid heartbeat, faintness, or low blood pressure. 

Stop using Xyntha Solofuse and seek emergency medical care immediately if you experience:

  • Rash, hives, or itching
  • Wheezing or difficulty breathing
  • Chest tightness
  • Swelling of the face, mouth, or throat
  • A rapid heartbeat
  • Faintness or dizziness
  • Blue-colored lips or gums

Development of inhibitors 

Your body may develop neutralizing antibodies, called inhibitors, against factor VIII. These inhibitors can reduce or prevent Xyntha Solofuse from working properly.

Your healthcare provider may order blood tests to check for inhibitors if:

  • Your factor VIII activity does not increase as expected after treatment
  • Bleeding is not controlled with an appropriate dose

How To Use Xyntha Solofuse

Use Xyntha Solofuse exactly as prescribed by your healthcare provider.

You may receive your first dose in a hospital, clinic, or treatment center. If home treatment is appropriate, your healthcare provider will teach you how to prepare and administer the medication safely.

Before using the medication:

  • Read and follow the Instructions for Use included with the product
  • Wash your hands and work on a clean surface
  • Allow the kit to reach room temperature
  • Use only the supplies provided or specifically recommended by your healthcare provider
  • Check the reconstituted solution before infusion; it should be clear to slightly opalescent and colorless
  • Do not use the solution if it contains particles or appears discolored

Contact your healthcare provider immediately if:

  • Bleeding is not controlled after treatment
  • You administer more than your prescribed dose
  • You have difficulty preparing or infusing the medication

Before traveling, speak with your healthcare provider and bring enough medication and infusion supplies for the entire trip.

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Xyntha Solofuse Storage and Handling

  • Store unopened Xyntha Solofuse in a refrigerator at 2°C to 8°C (36°F to 46°F) until the expiration date, for up to 36 months from the date of manufacture.
  • Within the labeled expiration period, the medication may be stored at room temperature no higher than 25°C (77°F) for up to 3 months.
  • Record the date room-temperature storage begins in the space provided on the carton.
  • After 3 months at room temperature, use the medication immediately or discard it.
  • Do not return the medication to the refrigerator after it has been stored at room temperature.
  • Do not use the medication after its labeled expiration date or after 3 months at room temperature, whichever occurs first.
  • Do not freeze Xyntha Solofuse.
  • Protect it from prolonged exposure to light.
  • After reconstitution, keep the syringe upright at room temperature until use.
  • Infuse the reconstituted solution within 3 hours after reconstitution or after removing the gray rubber tip cap.
  • Discard the solution if it has not been used within 3 hours.

Xyntha Solofuse Cost and Financial Assistance

The cost of Xyntha Solofuse depends on factors such as the prescribed dose, insurance coverage, pharmacy or treatment provider, location, and prior-authorization requirements.

Contact your insurance provider to determine:

  • Whether Xyntha Solofuse is covered
  • Whether prior authorization is required
  • Your expected copayment or coinsurance
  • Whether a specialty pharmacy must dispense the medication

Eligible patients may qualify for manufacturer copay assistance or other support programs. Program benefits, eligibility requirements, and annual limits can change. Contact us if you are interested in financial assistance or copay assistance for Xyntha Solofuse.

Xyntha Solofuse vs. Xyntha

Xyntha and Xyntha Solofuse contain the same active ingredient: recombinant antihemophilic factor, also called recombinant factor VIII or moroctocog alfa.

The main difference is the product presentation:

  • Xyntha: Supplied as freeze-dried powder in a single-use vial, with a separate prefilled diluent syringe
  • Xyntha Solofuse: Supplied in a prefilled dual-chamber syringe containing both the freeze-dried powder and the sodium chloride diluent

Both products must be reconstituted before intravenous administration. Patients should use the presentation prescribed by their healthcare provider and follow the instructions supplied with that specific product.

Lomustine (Gleostine): Uses, How It Works, and Side Effects

Published on by Dr. Robert Hakim, PharmD

Lomustine (Gleostine) is an oral chemotherapy medication used to treat certain brain tumors as well as Hodgkin’s lymphoma. Unlike many other chemotherapy medications that are given by an intravenous (IV) infusion, lomustine is taken by mouth as a single dose every 6 weeks because its effects on the bone marrow can last for several weeks. Read on to learn how lomustine works, its approved uses, recommended dosage, possible side effects, and cost. 

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What Is Lomustine? 

Lomustine is a type of chemotherapy medication. It belongs to a drug class called alkylating agents. This medication is FDA-approved to treat:

  • Brain tumors (both primary and metastatic) in people who’ve previously received surgery or radiation
  • Hodgkin’s Lymphoma (a type of cancer that affects white blood cells called B lymphocytes) that has progressed in people who’ve received chemotherapy

Lomustine is available as oral capsules in the following strengths in the United States: 

  • 10 mg (white cap and body)
  • 40 mg (white cap and a moss green body)
  • 100 mg (moss green cap and body)

Lomustine Mechanism of Action

Lomustine is an alkylating agent. It works by damaging the DNA of cancer cells by forming abnormal chemical bonds. This prevents cancer cells from growing and dividing normally, ultimately causing them to die. 

Lomustine can also cross the blood-brain barrier, allowing it to reach brain tumors more effectively than many other chemotherapy drugs. This makes it especially useful for treating certain cancers of the brain. 

Lomustine Dosing

The recommended starting dose for adults and pediatric patients is 130 mg/m² taken by mouth once every 6 weeks. Your healthcare provider will calculate your dose based on your body surface area and may adjust it depending on your blood cell counts, liver or kidney function, and other cancer treatments you are receiving. 

Important Lomustine Warnings

Risk of Bone Marrow Suppression

Bone marrow suppression occurs when your bone marrow doesn’t produce enough blood cells. This can increase your risk of serious infections, anemia, and bleeding. Unlike many chemotherapy drugs, lomustine causes delayed bone marrow suppression, meaning your blood cell counts may not reach their lowest levels until 4 to 6 weeks after treatment. Severe and potentially fatal infections may occur 4 to 6 weeks after you have received lomustine. 

Call your healthcare provider immediately if you experience:

  • Fever, sore throat, hoarseness, ongoing cough, chills, or other signs of infection
  • Abnormal bleeding or bruising
  • Bloody or tarry stools
  • Bloody vomit
  • Vomiting blood or brown material that looks like coffee grounds

Risk of Overdosage

Overdosing on lomustine can be fatal. Take only one dose of lomustine every 6 weeks. 

Because lomustine can affect your body for prolonged periods, your healthcare provider will order a weekly blood test for at least 6 weeks after each dose. 

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Before Taking Lomustine 

Before you receive your first dose of lomustine, inform your provider if you:

  • Are allergic to this product or any product component
  • Ever had liver, kidney, or lung disease
  • Are pregnant or plan to get pregnant 
  • Are breastfeeding or plan to breastfeed 

Females who can get pregnant should use birth control during treatment and for at least 14 days after the last dose. Males with female partners who can get pregnant should use birth control during treatment and for at least 14 weeks after the last dose. 

Contact your healthcare provider immediately if you or your partner becomes pregnant during treatment with this medication. 

Avoid breastfeeding during treatment and for at least 14 days after the last dose. 

Lomustine Side Effects

Woman lying on couch, suffering nausea as a result of taking lomustine

Like most chemotherapy medications, lomustine can cause both common and serious side effects. Your healthcare provider will monitor you closely throughout treatment with regular blood tests and follow-up appointments. 

Common Side Effects

  • Nausea
  • Vomiting
  • Increased risk of infection 
  • Mouth sores
  • Hair loss

Talk to your healthcare provider or pharmacist if any side effects worsen or persist. 

Severe Side Effects

Call your healthcare provider immediately or seek emergency care if you have:

  • Signs of an allergic reaction, such as hives, difficult breathing, and swelling of the face, lips, tongue, or throat
  • Jaundice (yellowing of the skin or eyes)
  • Easy bruising
  • Abnormal bleeding or purple/red pinpoint spots under the skin
  • Signs of kidney problems, such as little to no urination, swelling in the feet or ankles, tiredness, and breathing difficulty
  • Signs of infection, such as fever, chills, sore throat, blisters in the mouth, red or swollen gums, and difficulty swallowing
  • Signs of delayed lung damage, such as new or worsening cough, chest pain, shortness of breath (these symptoms may appear within 6 months or even longer after you take lomustine)
  • Sudden change or loss of vision

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Proper Use, Handling, and Storage

  • Take your doses exactly as directed: a single dose once every 6 weeks. 
  • To take your full dose, you may need to take 2 or more capsules of different strengths and colors. 
  • If you miss a dose, call your healthcare provider immediately. 
  • If you think you have overdosed, seek emergency medical care or call the Poison Help line at 1-800-222-1222. Signs of an overdose can include stomach pain, diarrhea, vomiting, loss of appetite, lethargy, dizziness, cough, and shortness of breath.
  • Because lomustine is a chemotherapy medication, wear disposable gloves when handling the capsules whenever possible, especially if someone other than the patient is handling the medication. Never reuse the gloves. Throw them away after single use. 
  • Don’t open the capsule or use a broken one. If the medicine from a broken capsule comes in contact with your skin, wash immediately with soap and water. 
  • Ask your healthcare provider or pharmacist to learn more about safe handling and disposal of broken capsules. 
  • Store lomustine capsules at room temperature (25°C/77°F). Short-term storage between 15°C and 30°C (59°F to 86°F) is permitted. Avoid exposing the medication to temperatures above 40°C (104°F). 

Lomustine Cost

Lomustine is a specialty chemotherapy medication, and its cost can vary significantly depending on your insurance coverage, pharmacy, and whether you receive the brand-name or generic version. Ask your insurance provider whether your plan covers this medication or requires prior authorization. 

According to Drugs.com, 

  • A supply of five 10 mg Gleostine capsules costs about $601
  • A supply of five 40 mg capsules starts from $2,381
  • A supply of five 100 mg capsules starts from $6,559

Note: Prices quoted above apply only when you pay in cash

You may be able to get the generic version of Gleostine at a lower cost. If you’re concerned about the cost of treatment, contact us to learn whether you may qualify for financial assistance or copay assistance for lomustine. 

Conclusion

Lomustine is an oral chemotherapy medication used to treat certain brain tumors and Hodgkin’s lymphoma. Because it can cause delayed but serious side effects, including bone marrow suppression, it should be taken exactly as prescribed and requires regular blood test monitoring. If you have questions about your treatment, side effects, or medication costs, speak with your healthcare provider or pharmacist.