The True Cost of Moving Your IG Therapy to a Healthcare Provider’s Office

Published on by Dr. Robert Hakim, PharmD

Do you have an immunodeficiency disease or an autoimmune condition? If so, immunoglobulin (IG) therapy could be a life-saving treatment for you. This therapy can be administered either at home or in a healthcare provider’s office, depending on the specific brand and how it’s given. 

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If you currently receive IG therapy at home, you might consider switching where you receive your therapy to a healthcare provider’s office for many reasons. While this is possible, it is important to understand the potential challenges involved with switching. In this article, we will explore the true costs and challenges of moving your IG therapy to a healthcare provider’s office.

What Is IG Therapy?

Immunoglobulin (IG) therapy or IG replacement therapy is a treatment used to provide patients with antibodies that they need to fight infections. Immunoglobulins (antibodies) are collected from the blood of healthy donors. These immunoglobulins help prevent infections by fighting foreign pathogens like viruses and bacteria.

You might receive IG therapy if you have primary immunodeficiency disorders or other conditions that affect your immune system’s ability to produce antibodies. Immunoglobulin therapy is typically infused into the body, either by intravenous (IV) infusion or by subcutaneous (SC) injection. Immunoglobulin therapy given via an IV infusion is called IVIG, and when given via a SC injection, it is called SCIG. In both IVIG and SCIG, you receive the same immunoglobulin product. You can typically receive IVIG and SCIG at home or in a healthcare provider’s office. 

IG therapy only provides temporary protection from infections. A single dose of IVIG or SCIG will protect you for 1 to 4 weeks, depending on the specific product. Because of this, you have to receive IG therapy on a regular basis. If you have a primary immunodeficiency disorder, you have to take IG therapy for a lifetime [1][2].

Reasons for Moving Your IG Therapy From Home to a Healthcare Provider’s Office

There may be several reasons why you would want to move your IG therapy from home to a healthcare provider’s office. Some examples may include: 

Supervision and Support: You might feel more comfortable receiving treatment under the supervision of a medical professional. Also, some people may have specific conditions that need close monitoring.

Convenience: For some people, it is more convenient to receive IG therapy in a healthcare provider’s office. This is especially true if you have difficulty with self-infusion or you do not have a suitable home environment for infusion.

Access to Resources: Generally, a healthcare provider’s office has more resources than you have in your home. There are emergency equipment and professional staff who can handle any complications that you might have.

Ensuring Proper Administration: In a healthcare provider’s office, medical staff will ensure that the IG is administered at the correct dose and rate. Also, if any complications occur during the infusion, there will be trained staff who can manage these issues effectively.

The True Price of Moving Your IG Therapy to a Healthcare Provider’s Office

Man sitting on sofa in living room while receiving IVIG therapy

Before moving your IG therapy to a healthcare provider’s office, you must first consider the drawbacks, such as:

Higher Costs

Several studies have shown that both healthcare and pharmaceutical costs are significantly higher for healthcare provider’s office infusion than home infusion [4][5][6]. Another study showed that in 2010, taking IV therapy in a healthcare provider’s office was 31% more expensive than receiving the infusion at home [3]. Back then, patients had to spend an additional $18,876 to $26,136 per year if they received 13 to 18 infusions in a healthcare provider’s office.

Besides medical bills, there are other costs associated with receiving IG therapy in a healthcare provider’s office, such as:

  • Transportation costs. These costs can add up if you visit a doctor’s office frequently and live in a rural or remote area.
  • Lost wages if you take time off work for frequent healthcare provider’s office visits. 
  • Childcare arrangements during your appointment.
  • Overnight accommodations if you have to travel long distances to reach your healthcare provider’s office. This can increase your overall treatment cost significantly.

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Logistical Challenges

If you want to move your IG therapy to a healthcare provider’s office, you may also face some logistical challenges, such as:

Time and Convenience: Coordinating visits to your healthcare provider’s office can be difficult, especially if you have a busy schedule or family responsibilities. Unlike home therapy, receiving IG therapy in a healthcare provider’s office is less flexible. You may face situations where you must miss an appointment or rearrange personal commitments. This can cause additional stress and inconvenience. Additionally, if you live in a rural area or get stuck in heavy traffic, traveling to and from your healthcare provider’s office can take a lot of time. 

Comfort and Safety: Receiving IG therapy at a healthcare provider’s office can be less comfortable and safe compared to home therapy. At home, you have the comfort of familiar surroundings. But in a healthcare provider’s office, you may feel anxious and uncomfortable due to the intimidating environment. Several studies have shown that receiving IG therapy at a healthcare provider’s office can reduce your quality of life because of such reasons [3]. Additionally, a healthcare provider’s office can expose you to other sick people. This can increase your risk of getting infections [7].

The Bottom Line

You might think that moving your IG therapy to a healthcare provider’s office is a minor change. But the reality is different. This transition comes with a lot of hidden costs and logistical challenges. The treatment cost in a healthcare provider’s office is significantly higher, and there are other significant indirect costs like lost wages, childcare, and transportation costs. In addition, there are inconveniences related to time, travel, and treatment experience that must be considered when making the decision to switch where you receive your infusion.

If you are still considering this transition, you should conduct a cost-benefit analysis first. After that, consult your healthcare professional for further advice about the transition.

Home Infusion Therapy: Understanding Benefits, Challenges, and Eligibility

Published on by Dr. Saba Rassouli, PharmD

Home infusion therapy (HIT) is a safe and effective alternative that allows patients to receive medications and treatment in the comfort of their homes rather than in a hospital setting. In recent years, patient preference for home infusion therapy has increased tremendously because of the personalized, convenient, and high-quality care it provides. 

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In fact, studies have shown that patients who received infusions at home reported better health outcomes, including lower infection rates and faster recovery times.

Therefore, if you have a chronic illness that can be monitored and managed at home, you can switch to home infusion therapy by consulting your healthcare provider. 

In this article, we will take a closer look at home infusion therapy, its potential benefits, types, and some common challenges to consider before transitioning from hospital settings to home care. 

Home Infusion Therapy 

Patients with chronic illnesses or those recovering from surgery can receive medications (such as antibiotics, biologics, steroids, or clotting factors), fluids, or nutrition in the comfort of their homes.

A trained home infusion nurse or a caregiver administers the prescribed medication or fluids directly into the patient’s body either subcutaneously (under the skin) or intravenously (via IV catheter into the veins). 

Every year, over 1.2 million infusion courses are administered at home via peripherally inserted central catheters (PICCs), ports, or central catheters.

Potential Benefits of Home Infusion Therapy 

Home infusion therapy offers numerous benefits over hospital infusion settings, which makes this therapy an attractive option for patients. Some of the significant benefits of opting for home infusion therapy are as follows:

1. Convenience and Comfort

One of the major advantages of home infusion therapy is that it provides comfort to patients. With home infusion therapy, a patient can receive their daily prescribed doses or nutrition in the comfort of their home, surrounded by loved ones. In addition, this therapy reduces hospital visits. Patients who have mobility issues or who live far from medical centers can save time, energy, and travel expenses. 

In terms of convenience, home infusion therapy offers flexibility to patients who require regular or long-term infusions. This therapy allows them to easily incorporate treatments into their daily routine without disrupting their professional and personal activities. 

2. Personalized Care and Improved Patient Outcomes

Each patient requires personalized care according to their disease condition. Home infusion therapy offers personalized and patient-centered care, where you will work closely with your healthcare provider to develop treatment plans according to your specific medical needs and preferences. 

Also, this personalized care approach improves the patient’s overall health and allows healthcare providers to monitor the patient’s daily improvements and manage side effects (if they occur). 

3. Cost Effectiveness

Home infusion therapy is typically less expensive than inpatient infusion therapy, as it reduces the costs of hospital stays, room charges, and overhead expenses. However, the costs of home infusion and hospital infusion can differ depending on the type of disease being treated. 

According to the National Home Infusion Center, an anti-infective infusion at home may cost $122/day, as opposed to $798/day for inpatients. Similarly, a systematic review of 253 articles reported that the cost of home infusions was substantially less than infusions at a medical facility. For example, hemophilia patients can save anywhere from $1,928 to $2,974 for each course of treatment.

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4. Reduced Exposure to Infectious Environments

With home infusion therapy, you will have less exposure to infectious environments. It is therefore a better option for individuals who have compromised immune systems. Unlike hospital and clinical infusion settings, which are the hotspots for pathogens and infectious diseases, home infusion therapy provides a clean and safe environment with reduced exposure to infectious agents. 

In some cases, patients receiving infusions at home may get infections when proper aseptic techniques are not followed. However, the overall rate of infections among patients receiving infusions at home is generally lower compared to hospital infusion settings. 

Some common infections that may occur due to a poor hygienic environment are catheter-associated bacterial infections and central-line–associated bloodstream infections. 

5. Improved Quality of Life

Patients who receive infusion therapy at home are more likely to experience improved quality of life. With home therapy, patients feel more independent. In addition, spending time with loved ones improves their emotional health and gives them a more optimistic view of their therapeutic path.

Common Types of Home Infusion Therapies

Setup for home infusion, with IV stand, bottle and pump

There are several common types of home infusion therapies, which are given to patients according to their condition:

IV Antibiotic therapy

This therapy is typically used to treat resistant infections like osteomyelitis (inflammation in the bone), endocarditis, and certain skin infections. Home antibiotic infusion allows patients to avoid prolonged hospital stays. 

Pain Management

Individuals recovering from surgery or having chronic pain may receive pain management therapy at home, where analgesics or anesthetics are infused to control pain. 

Immunoglobulin (IVIG) therapy

IVIG therapy is typically recommended to treat immune-related conditions and can be administered at home to individuals who require regular infusions for a long period. 

Chemotherapy Treatment

Certain chemotherapy treatments can be given at home when the patient’s condition is stable, and they do not require intensive monitoring. 

Cardiac/Inotropic Therapies 

Patients with heart failure or cardiogenic shock receive medication through a continuous IV line infusion at home to make their heart muscles contract normally.

Hydration Therapy

This therapy provides vitamins, fluids, and medication directly into the patient’s bloodstream to provide rapid relief from hangovers, jet lag, fatigue, and dehydration.

Nutritional Support (TPN/EN)

Individuals with compromised gastrointestinal function receive IV infusions of essential nutrients (proteins, carbs, vitamins, electrolytes, etc.) at home to fulfill their body’s nutrient requirements and prevent malnutrition. 

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Eligibility Criteria for Home Infusion Therapy (HIT)

Not everyone is eligible for home infusion therapy. This option is only available to patients with stable conditions who can safely receive treatment at home. Home infusion therapy might be a good choice for:

  • Patients who require long-term IV treatment due to chronic illnesses like infectious diseases, immune deficiency, Crohn’s disease (gastrointestinal disease), rheumatologic disorders, autoimmune diseases, inflammatory conditions, and cancer.
  • Patients with nutritional deficiencies or malabsorption.
  • Patients who cannot access a healthcare facility due to mobility issues.

Challenges and Other Considerations

Although home infusion therapy offers several benefits, it also has some challenges that you must consider as a patient or caregiver to ensure the safety and effectiveness of this therapy. 

1. Patient and Caregiver Training

Improper training can result in adverse outcomes or complications, such as issues with the central venous catheters used for infusions, catheter blockages, central-line infections, or medication errors. Therefore, you must receive proper training in administering medication, managing side effects, and handling equipment and medications. 

2. Infection Risks

Poor hygiene can increase the risk of infection, including central line-associated bloodstream infections, venous thromboembolism, phlebitis, and occlusion. You can minimize or control the risks of infections by adhering to strict aseptic techniques. 

Also, make sure you have a safe and secure place to store the medication and medical equipment.

3. Insurance Coverage

Home infusion therapy can be expensive if your insurance does not fully cover your medication and infusion equipment costs. Therefore, you must check your insurance plan before switching from a hospital setting to home care. 

4. Psychological Stress and Burnout 

You may feel isolated or stressed while managing the treatment independently. Burnout is also common among caregivers. Seeking counseling or taking breaks can help mitigate patient stress and burnout among caregivers. 

Conclusion

Home infusion therapy is an effective and safe approach for patients who are stable and eligible to receive treatment in the comfort of their homes. Along with the benefits, there are also some challenges to consider before initiating therapy. 

If you or your loved one plans to switch to home infusion therapy, you should consult your healthcare provider to explore whether it is the right option for you. 

Why Continuing Your IG Treatment Is Vital for Long-Term Health

Published on by Dr. Samantha Kaeberlein, PharmD

If you’re diagnosed with immune conditions like antibody deficiency or autoimmune disorders, then immunoglobulin (IG) therapy may become a lifelong treatment to stabilize your long-term health. 

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Consistently receiving IG treatment as prescribed by the healthcare provider is important. It ensures that your immune system remains supported, reduces the risks of recurrent infections and symptom flare-ups, and prevents other disease-associated complications. 

However, when you discontinue your IG therapy early, your health may begin to deteriorate, and your body becomes more vulnerable to life-threatening complications. 

In this article, we will explore why continuing IG treatment is vital for long-term health and what potential risks you can experience if you discontinue it prematurely. You’ll also learn some practical tips to help you stay consistent so you can prioritize your health and live life to its fullest.

Importance of IG Treatment in Maintaining Long-Term Health

IG treatment plays a vital role in managing and treating immunodeficiencies, autoimmune disorders, and certain neurological conditions that compromise the patient’s immune system. 

When a concentrated solution of antibodies is administered in the patient’s body via intravenous (IVIG) or subcutaneous (SCIG) infusions, it strengthens the immune system and helps manage disease-associated symptoms. 

The following are some of the vital roles of IG therapy in maintaining long-term health: 

It Boosts Immune Function

The primary role of IG treatment is to boost immune function in patients who lack essential antibodies due to a disorder, such as primary or secondary immunodeficiency, making them more prone to infections. IG treatment provides the essential antibodies required to fight off infections. 

Also, regular IG infusions are vital for these patients to reduce the frequency and severity of infections and support long-term health. 

It Regulates Immune Responses

IG treatment also regulates the immune system in patients with autoimmune disorders like Guillain-Barre syndrome (GBS), multiple sclerosis (MS), or chronic inflammatory demyelinating polyneuropathy (CIDP). It does this by preventing the immune response from overreacting against healthy cells. As a result, patients experience significant improvement in their symptoms and regain control over their lives with their continuous regular infusions. 

It Prevents Complications

In some patients, IG treatment helps to prevent long-term complications such as organ damage caused by recurrent infections or uncontrolled immune activity. Regardless of the condition being treated, IG therapy maintains balance in the immune system and improves quality of life. 

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Benefits of Adhering to Prescribed IG Treatment 

Doctor preparing IVIG bottle for infusion

IG treatment offers long-term health benefits to patients who adhere to their prescribed therapy, including:

Reduced Infection Rates

If you adhere to your prescribed IG treatment, the antibody levels will remain steady in your body, and your risk of recurrent infections will be reduced significantly. Continuing your IG treatment may also reduce hospital visits and improve your overall quality of life.

Improved Disease-Associated Symptoms 

IG treatment also improves disease-associated symptoms if continued as prescribed by a doctor. The anti-inflammatory properties of IG therapy help manage the symptoms of autoimmune diseases (i.e., GBS or MS) by lowering inflammation, thereby decreasing discomfort. 

With time and continuous treatment, you will feel more resilient and energized. 

Enhanced Overall Health

By adhering to your IG treatment plan, your body can overcome challenges and live life to the fullest. Many individuals have shared their transformative journey where they experienced an improvement in their overall health when they stayed consistent with their IG treatment. 

Conversely, early discontinuation of IG therapy can lead to various consequences that may impact your long-term health. 

Risks Associated With Discontinuation of the IG Treatment Prematurely

Sometimes, when a patient notices improvements in their condition or faces challenges like high costs, side effects, and time demands, they discontinue their IG treatment prematurely without realizing the consequences on long-term health. 

If you stop or delay your IG therapy, even temporarily, you can experience several health-related risks, which are as follows:

Increased Risk of Infections

If you have a primary or secondary immune deficiency syndrome, you may experience more frequent and severe infections after discontinuing your prescribed IG infusions. Since the level of antibodies declines over time, it leaves your body more vulnerable to potentially serious infections. 

For example, common respiratory tract infections can progress into more serious and life-threatening complications like pneumonia if IG treatment is discontinued abruptly. 

Worsening of Autoimmune Conditions

If you have an autoimmune disorder, your condition may get worse if you stop your IG treatment without consulting your healthcare provider. Even a temporary pause in IG therapy can lead to relapses or progression of autoimmune symptoms, tissue damage, and a decline in overall health. This can make your recovery even more challenging.

Loss of Progress

Regular IG therapy stabilizes your condition. Conversely, if you miss doses frequently or stop therapy too soon, it might reverse a lot of your progress and force you to restart from a less stable starting point.

Reduced Efficacy of Treatment

The efficacy of the IG therapy is also reduced if restarted again. Since the immune system may become more difficult to control or stabilize, you may not find promising results if you resume IG therapy after a break.

Compromised Quality of Life

Your quality of life may also be compromised if you discontinue your IG treatment prematurely. You may experience anxiety or depression due to your untreated symptoms, recurring illnesses/infections, and deteriorating physical condition.

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Be Patient: IG Therapy May Take Time to Work for Neurological Conditions

For patients receiving IG therapy to manage neurological conditions such as CIDP, GBS, or MS, it’s important to understand that results may not be immediate. Unlike treatments for infections, where improvement can be seen relatively quickly, the benefits of IG therapy for neurological conditions may take several weeks — or even a few months — to become noticeable.

This is because IG works by gradually modulating the immune system, reducing inflammation, and allowing nerves to recover. Some individuals experience steady improvement, while others may notice subtle changes over time, such as less fatigue, reduced pain, or improved mobility. Staying consistent with treatment is essential to give your body the time it needs to respond and heal.

Tips for Staying Consistent With IG Treatment

You can stay consistent with IG treatment by following some practical tips:

  1. Schedule your regular infusions to make the treatment part of your routine.
  2. Set reminders using alarms, calendars, or apps, so you won’t miss your next IG infusion.
  3. Track your progress by noting symptoms and improvements in a journal.
  4. Regularly check in with your doctor or nurse, as they can help address concerns and keep your treatment on track.

Takeaway

IG therapy is a life-saving treatment for many patients, and continuing IG therapy is vital to maintain long-term health and regain control over your life. However, early discontinuation of IG treatment can lead to serious health consequences, ranging from recurrent infections, worsened symptoms, and reduced quality of life and overall well-being.

IVIG for Immune Checkpoint Inhibitor-Related Toxicity

Published on by Dr. Christine Leduc, PharmD

Immune checkpoint inhibitors (ICIs) are potent drug agents that stimulate long-lasting immune responses against cancer. ICI immunotherapy has revolutionized treatment procedures for cancer and now has become an effective option for patients with advanced or hard-to-treat (aggressive) cancers. 

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However, these anti-cancer agents can sometimes overstimulate the immune response and cause several adverse effects, also known as immune-related adverse events (irAEs) or immune checkpoint inhibitor-related toxicity. ICI-related toxicity can impact all organs, but the skin, digestive, and endocrine organs are more frequently affected. 

If you or someone you know are experiencing severe-to-moderate immune checkpoint-related toxicity, then IVIG therapy can be considered to manage these toxicities (or irAEs). This article briefly explains what immune checkpoint inhibitors are, the toxicities they cause, and how IVIG can help manage them. 

What Are Immune Checkpoint Inhibitors?

Normally, your immune system has immune checkpoints, which are the proteins that act like a brake to stop the immune cells from attacking normal healthy cells. However, some cancer cells can evade destruction by producing their own checkpoint proteins.

When a cancer cell’s checkpoint proteins bind to the T-cell’s checkpoint proteins, they turn off the T-cells — as a result, cancer cells continue to grow and spread. 

Immune checkpoint inhibitors (ICIs) block these proteins on the T-cell and cancer cells. This turns on the T-cells and allows them to kill the cancer cells effectively. 

Though ICIs have successfully treated certain cancers like myeloma, kidney, or lung cancer, they can sometimes overstimulate the immune system, leading to immune checkpoint inhibitor-related toxicity or immune-related adverse events. The toxicity occurs early and typically happens weeks to 3 months after starting immune checkpoint blockers. 

The type of ICIs you’ve received can affect and cause inflammation in any organ in the body. Some of the affected organs with side effects (toxicities) include:

  • Skin (Dermatitis, seen in 40% to 60% of cases)
  • Lungs (Pneumonitis, seen in 5% of cases)
  • Endocrine system (Hypothyroidism, seen in 6% of cases)
  • Gastrointestinal system (Severe colitis, seen in 2% to 7% of cases)
  • Liver (Hepatitis, seen in 5% to 10% of cases) 
  • Neurological complications (Meningoencephalitis, myasthenia gravis, and peripheral neuropathy, seen in 1% to 5% of cases)

Each patient responds to ICI immunotherapy differently. The toxicities of ICIs can vary among cancer patients and may range from mild to severely fatal. Therefore, a standard treatment is required to manage immune checkpoint inhibitor-related toxicity without completely shutting down its effect on fighting cancer. 

Healthcare providers treat immune checkpoint inhibitor-related toxicity depending on their severity. For instance, mild cases are usually managed with supportive care and careful monitoring. In most cases, corticosteroids (e.g., prednisone) are given to manage moderate to severe cases. 

In some cases, when the patients do not respond to steroids, then immunosuppressive drugs like mycophenolate mofetil or infliximab are used in the treatment plan for these patients. 

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IVIG therapy can be used as an additional treatment in some severe cases of immune checkpoint inhibitor-related toxicity. For instance, one case report demonstrated that high-dose steroid therapy and IVIG treatment resolved immune checkpoint inhibitor-related toxicity in a non-small cell lung cancer patient who experienced esophagitis, gastritis, and myocarditis after taking ICIs (e.g., pembrolizumab). 

IVIG modulates the overstimulated immune system in multiple ways: 

It Neutralizes Autoantibodies 

IVIG therapy neutralizes the autoantibodies that are produced by ICIs due to an overstimulated immune system. It counteracts the effects of these autoantibodies.

It Reduces Inflammation

Since IVIG has anti-inflammatory effects, it also helps to reduce inflammation caused by hyperactive immunological responses due to ICIs. 

It Prevents Tissue Damage

IVIG prevents tissue damage by stopping additional immunological attacks. 

In short, IVIG helps patients manage the harmful toxicities of immune checkpoint inhibitors (ICIs) while stabilizing the immune system. This allows patients to benefit from their cancer treatment with ICIs without affecting their immune response.

Patient receiving IVIG at home

IVIG is not a first-line treatment for immune checkpoint inhibitor-related toxicity and is only recommended under certain conditions:

IVIG is considered for immune checkpoint inhibitor-related toxicity for two main reasons: 

  • First, IVIG has a rapid response, which means it works quickly and can manage severe or refractory ICI-related toxicities. 
  • Second, IVIG targets specific parts of the immune system and does not interfere with the effectiveness of ICIs, unlike other immunosuppressive drugs. 

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The dose of IVIG can vary among patients and the type of toxicity they are experiencing. For instance, intravenous immunoglobulins can be given at a dose of 2 g/kg (0.4 g/kg/day over 5 days) to treat ICI-induced toxic epidermal necrolysis (a type of skin condition), pneumonitis (a type of lung condition), myasthenia gravis, and GBS. 

Patients who received IVIG treatment showed significant improvement in their condition. However, IVIG can cause some side effects, such as headache, fever, nausea, and allergic reactions. 

Conclusion

Though Immune checkpoint inhibitors (ICIs) are considered effective for treating aggressive cancers, they also cause toxicities (side effects) in some patients by overstimulating the immune system. 

If you or your loved one are experiencing any unusual symptoms or ICI-associated toxicity, IVIG therapy may help manage these toxicities. IVIG does this by modulating the overactive immune system without disrupting the working mechanism of ICI in fighting cancer. 

It is recommended to consult your healthcare provider to get a customized plan of IVIG according to your ICI-related toxicity.

IVIG for Neonatal Hemochromatosis (NH)

Published on by Dr. Mark Alfonso, PharmD, BCMTMS

Neonatal hemochromatosis (NH) is an extremely rare and life-threatening condition that causes damage to the liver of a developing fetus. Babies with neonatal hemochromatosis are often born prematurely (very early) or struggle to grow normally in the womb during pregnancy. 

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If left untreated, this condition can lead to stillbirth late in pregnancy or newborn death after birth due to severe liver injury and iron accumulation in the body. 

IVIG therapy has been successfully introduced to improve the outcomes of neonatal hemochromatosis and can be used as a prenatal (during pregnancy) and postnatal (after childbirth) treatment. 

This article reviews the basics of neonatal hemochromatosis, how it occurs, and how IVIG can be used as a novel therapy to treat newborns diagnosed with NH and improve the survival rate of the fetus in pregnant women with a history of NH in previous pregnancies.  

Neonatal Hemochromatosis: Brief Overview

Hemochromatosis is a condition that describes the excessive accumulation of iron in the body. In adults, it is usually genetic (known as hereditary hemochromatosis) and progresses slowly. However, neonatal hemochromatosis is an immune-mediated condition that occurs during pregnancy (typically in the fourth month).  

The fetus in the womb develops advanced liver injury due to maternal-fetal alloimmunity, which ultimately leads to the accumulation of iron in the body and other organs like the pancreas, heart, and endocrine glands.

To understand the role of IVIG in treating NH, let’s first briefly review what exactly causes neonatal hemochromatosis.

Causes of Neonatal Hemochromatosis

Numerous research evidence indicates that in 95% of cases, neonatal hemochromatosis is caused by maternal-fetal alloimmunity, a condition termed gestational alloimmune liver disease (GALD), in which the maternal antibodies attack the fetus’s liver cells during the pregnancy. 

In a healthy pregnancy, the mother’s immune system produces IgG antibodies (maternal antibodies) that travel through the placenta to protect the fetus from infection. 

In some cases, these maternal antibodies, instead of protecting the fetus (baby), mistakenly identify the fetus cells as “foreign” and start attacking them, causing fetal injury. This is referred to as “maternal-fetal alloimmunity.” 

In GALD (which is the underlying cause of NH), the maternal antibodies specifically target the fetus’s liver cells (hepatocytes) during pregnancy, ultimately causing liver injury or damage. This damage causes iron to build up in the fetus’s body, leading to symptoms of neonatal hemochromatosis. 

Simply put, NH results from the mother’s immune system attacking the baby’s liver during pregnancy because of GALD.

It is estimated that if your past pregnancy ends in NH or your first child is born with neonatal hemochromatosis, there is approximately a 90% chance that your next child will have the same condition.  

Therefore, prenatal and postnatal treatments are recommended to ensure the delivery of a healthy baby and to improve the survival rate of newborns with neonatal hemochromatosis (NH) without requiring liver transplants.  

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How Can IVIG Help Manage Neonatal Hemochromatosis?

IVIG therapy has proven to improve the outcome of NH when used as prenatal and postnatal treatment. 

1. Use of IVIG as a Prenatal Treatment (During Pregnancy)

Treatment with IVIG therapy can prevent the recurrence of NH during pregnancy. For instance, a case report of a 32-year-old woman with a history of NH in previous pregnancies delivered a healthy baby after receiving IVIG therapy (at a dose of 1 mg/kg) weekly in the third trimester until the end of pregnancy. 

Similarly, various other case studies reported that receiving IVIG therapy at 14 weeks, 16 weeks, and weekly from the 18th week until the end of pregnancy can prevent the recurrence of NH and increase the survival rate of the baby. 

Working Mechanism of IVIG as a Prenatal Treatment

IVIG therapy as a prenatal treatment can help to modulate the mother’s immune response during pregnancy. It does this by:

  • Neutralizing the effect of maternal antibodies that pass from the mother to the fetus and damage the liver cells 
  • Reducing the inflammation that damages the liver
  • Blocking the activation of the complement cascade (a component of the innate immune system) that attacks the fetal liver cells 

2. Use of IVIG as a Postnatal Treatment (After Childbirth)

Sleeping newborn baby in crib

For newborns diagnosed with NH, IVIG can be used as a part of their treatment plan to stop further liver damage and reduce the need for a liver transplant. Recent studies demonstrate that IVIG therapy can block the antibodies’ action and interfere with complement cascade activation to prevent severe liver failure in infants with NH.

According to research results, the outcome (survival rate without liver transplantation) improved from 17% to 75% in infants treated with exchange transfusion (ET) and four doses of IVIG. Similarly, in another case report of 50 infants with NH, when treated early with IVIG, their survival rate without liver transplantation increased by 80%. 

Working Mechanism of IVIG as a Postnatal Treatment

As a postnatal treatment, IVIG therapy works to prevent complications like multi-organ failure, stop ongoing liver damage, and improve the survival rates of infants. 

The rate of occurrence and deaths dramatically decreased among neonates with NH after the administration of IVIG as a preventive therapy. 

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What Is the Typical Dosage of IVIG for NH?

IVIG is administered intravenously in a hospital setting over a period of hours. According to some literature, IVIG can be given at a dose of 1g/kg to patients with neonatal hemochromatosis. However, depending on the patient’s health, the newborn’s weight, and the severity of the condition, the doses can be adjusted.  

Takeaway

In summary, neonatal hemochromatosis can be effectively managed with prenatal treatment and early postnatal IVIG injection as it decreases the severity of symptoms, averts liver failure, and avoids the need for a liver transplant. 

If you or someone you know has lost a baby prematurely due to neonatal hemochromatosis or is at higher risk of NH recurrence, IVIG treatment can help manage this condition. Early diagnosis of NH and administration of IVIG in newborns with NH can achieve positive outcomes for affected families.

Is Zepzelca Right for You? A Guide to Treatment, Cost, and Safety

Published on by Dr. Robert Hakim, PharmD

If you are living with small-cell lung cancer and chemotherapy has not been effective, a new treatment called Zepzelca may be an option for you.

Studies suggest Zepzelca can be more effective in treating small-cell lung cancer (SCLC) than other currently available medications in specific scenarios. In this article, we will explore everything you need to know about Zepzelca, including its dosing, side effects, cost, and more.

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What Is Zepzelca?

Zepzelca (lurbinectedin) is an FDA-approved chemotherapy medication used to treat small-cell lung cancer. The FDA first approved this medication on June 15, 2020 [1].

If your cancer has spread to other parts of your body and other medications (e.g., platinum-based chemotherapy) haven’t worked well, ask your oncologist if this treatment is right for you.

Zepzelca is a chemotherapy medication called an alkylating agent. It works by attaching to the DNA (genetic material) of the cancer cells to stop their ability to grow and multiply.

It is given through an infusion through the veins (intravenous or IV), which takes about 1 hour. Some common side effects include tiredness, diarrhea, nausea, and constipation.

What Is Zepzelca Used for?

You can use Zepzelca when your small-cell lung cancer has:

  • Spread to other parts of your body
  • Gotten worse after you had other treatments like platinum-based chemotherapy

Keep in mind that the FDA approved this medication quickly based on how well it worked and how long the benefits lasted. However, its continued approval depends on further studies.

How Does It Work?

Zepzelca is an alkylating agent. It attaches to a specific part of the DNA of cancer cells and stops them from replicating. As a result, the cancer cells aren’t able to multiply, and they eventually die [2].

Side Effects

A woman holding her chest and coughing

Like any other medication, Zepzelca can have some side effects [3].

Common Side Effects

Common side effects include:

  • Diarrhea
  • Trouble breathing
  • Nausea
  • Tiredness
  • Low levels of sodium and magnesium in the blood
  • Constipation
  • Low white and red blood cell counts
  • Low level of albumin in the blood
  • Decreased appetite
  • Increased kidney and liver function blood test
  • Increased blood sugar
  • Muscle and joint pain
  • Cough and vomiting

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Severe Side Effects

Severe side effects of Zepzelca include:

Severe Neutropenia: In this condition, your white blood cell levels become abnormally low. This raises your chance of getting life-threatening infections. During treatment, the provider will regularly monitor your white blood cell counts. If your white blood cells become too low, your provider may adjust your dose or delay treatment.

Liver Problems: Zepzelca chemotherapy medication can damage your liver. Symptoms of liver problems include loss of appetite, pain on the right side of your stomach, and nausea or vomiting. Liver function tests (LFTs) are blood results that can indicate how healthy your liver is. Your provider will regularly monitor your LFTs during Zepzelca treatment to ensure your liver is healthy.

Severe Muscle Problems: This medication can cause severe muscle pain or weakness. Inform your provider immediately if you encounter these symptoms.

Leakage of Zepzelca Out of Your Vein During the Infusion: If Zepzelca leaks out of your vein during the infusion, it can damage the surrounding tissue and cause tissue death. If this happens, you will need urgent treatment at a hospital. During the infusion, if you see any leakage out of your vein or feel sudden pain or burning around the infusion site, tell your provider immediately.

Please note that this is not a list of all possible side effects. If you encounter any severe side effects, consult your provider immediately.

What Are the Clinical Benefits of Zepzelca?

A clinical study was conducted on 105 patients with small-cell lung cancer (SCLC) whose cancer got worse after receiving platinum-based chemotherapy. All the patients in the study received Zepzelca. Researchers found that 35% of all patients receiving this drug saw a reduction in their tumor size, with a median response of 5.3 months [1]. Compared to traditional medications, Zepzelca was more effective.

Zepzelca Dosing Information

You can get Zepzelca as an intravenous infusion. Home infusion treatments take about an hour to complete. You may also receive some anti-nausea medications shortly before the infusion to help prevent nausea.

The dosage depends on your body’s surface area. The usual dose is 3.2 mg/m2 given once every 21 days. You will continue receiving this treatment until your cancer worsens or you experience bothersome or serious side effects [2].

Your provider will determine the right dosage for you based on your specific clinical situation. So, always follow your provider’s advice. Your prescriber will also regularly monitor you during treatment to manage any side effects you might be experiencing.

Before Receiving Zepzelca

Before you start your chemotherapy treatment with Zepzelca:

  • Tell your provider if you are allergic to lurbinectedin or any of the ingredients in lurbinectedin injection.
  • Inform your provider if you are pregnant or want to become pregnant. The medication may harm your unborn baby, so it shouldn’t be taken during pregnancy. If you are a female, able to become pregnant, and are receiving Zepzelca, you should use birth control during the treatment and for 6 months after the final dose. If you are a male recipient with a female partner who’s able to get pregnant, you should use birth control during the treatment and for 4 months after the final dose.
  • Tell your provider all of your medical history. Inform them about all the medications that you are currently taking, including over-the-counter and herbal medications.
  • Inform your provider if you are breastfeeding. You should not breastfeed during treatment and for at least 2 weeks after your final dose due to potential harm and side effects to your baby.

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Zepzelca Cost

Zepzelca is available as a powder for injection, with a strength of 4 mg per vial. The cost can vary significantly based on your location, treatment plan, insurance coverage, and the pharmacy you visit. However, on average, each vial of Zepzelca costs around $6,470 [4].

So, the overall treatment cost is very high. Before beginning your treatment, you should consult your provider and health insurance company about the cost. You should also explore various financial assistance programs.

FAQs

Here are some frequently asked questions about Zepzelca:

1. Does Zepzelca cause hair loss?

Yes. Hair loss is a side effect of chemotherapy treatment with Zepzelca. In clinical trials, about 1% of patients receiving the medication experienced hair loss [5]. Consult your prescriber for possible remedies if you experience hair loss during treatment.

2. Can I use Zepzelca if I have liver problems?

If you have mild liver problems, then you can use Zepzelca. There is no need for dosage adjustments. However, there is still no data on patients with moderate to severe liver problems [2]. In such cases, you should consult your provider for further information.

3. What should I avoid while taking Zepzelca?

While taking this medication, you should take some precautions and avoid certain things to minimize side effects:

  • It can weaken your immune system. This makes you more likely to get infections. So, to decrease your chance of getting infections, you should avoid close contact with people who are sick and practice good hygiene.
  • You should avoid drinking alcohol. Alcohol can interfere with your liver. Since Zepzelca is processed through the liver, avoiding alcohol can help prevent liver-related complications.
  • You should avoid eating or drinking anything that contains grapefruit or Seville oranges. These products can raise the levels of Zepzelca in your body, which can raise your risk for side effects after chemotherapy.

Exploring Xgeva and Its Role in Treating Bone-Related Issues

Published on by Dr. Saba Rassouli, PharmD

If you are suffering from advanced cancer that has spread to your bones, then Xgeva is an option that can help you prevent bone-related complications. The FDA first approved this drug on November 18, 2010 [1].

Several studies have shown that Xgeva injections are more effective in managing bone-related complications than other medications. In this article, we will explore everything you need to know about Xgeva, including its uses, dosing, side effects, cost, and more.

What Is Xgeva?

Xgeva (denosumab) is a brand-name prescription medication used to prevent bone-related complications in patients whose cancer has spread to the bones.

These complications can include bone fractures and pressure on the spinal cord. Xgeva can also be used to treat high blood levels of calcium caused by cancers when other medications are ineffective.

Xgeva is a monoclonal antibody. It helps you by reducing bone damage and increasing bone density. In clinical studies, researchers found that this medication was more effective than other drugs in preventing bone-related problems in cancer patients.

In patients with multiple myeloma, a type of blood cancer, Xgeva injections helped prevent bone-related complications for about 23 months [2].

What Is Xgeva Used To Treat?

Xgeva is FDA-approved for the following uses [2]:

Prevention of Bone Fractures: Doctors use Xgeva to prevent bone fractures in adult patients with multiple myeloma and bone metastasis from solid tumors. Multiple myeloma is a type of blood cancer that affects the bone marrow. It can cause fractures in your bones, resulting in symptoms like pain in the back, ribs, hips, chest, or skull. Bone metastasis is a condition where cancer cells spread from their original location to the bones. Symptoms include neck and back pain, muscle weakness, fever, and low platelet count.

Treatment of Giant Cell Tumors of Bones: Doctors use this medication to treat adults and adolescents with giant cell tumors of the bone when the tumor cannot be completely removed through surgery or when surgery poses significant risks.

Treatment of Hypercalcemia Caused by Cancers: Hypercalcemia is a condition where there is too much calcium in the blood. It can cause complications in the bones, kidneys, stomach, brain, and heart. Xgeva is approved to treat adults with hypercalcemia caused by cancer, but only after they have tried a type of drug called bisphosphonate.

How Do Xgeva Injections Work?

Xgeva (denosumab) is an FDA-approved medication used to prevent bone-related problems in patients whose cancer has spread to the bones.

In our bodies, there is a balance between bone-forming cells called osteoblasts and bone-destroying cells called osteoclasts. However, cancer that has spread to the bones breaks this balance. As a result, more and more bones start to break down.

The active ingredient is denosumab, which is a monoclonal antibody. It works by attaching and blocking the activity of a protein called RANKL.

RANKL is necessary to create and maintain osteoclasts (cells that break down bones). Xgeva works by blocking RANKL, which decreases bone loss and prevents bone-related problems like fractures [2].

Side Effects

A woman in bed holding her lower back in pain

Like any other medication, Xgeva can have side effects. Here are some mild to severe side effects [2][3]:

Mild Side Effects

Mild side effects include:

  • Back and joint pain
  • Nausea
  • Difficulty breathing
  • Tiredness and weakness
  • Cough
  • Headache
  • Low levels of phosphate
  • Appetite loss
  • Toothache
  • Swelling in your legs and arms

These mild side effects usually go away on their own within a few days to a few weeks. However, if they do not go away or become worse, consult your doctor.

Severe Side Effects

Anyone who uses Xgeva may experience severe side effects, such as:

Low Calcium Level in Blood: Xgeva can lower calcium levels in your blood. A low calcium level can cause symptoms like muscle spasms, stomach pain, extreme thirst, vomiting, and nausea.

Osteonecrosis of the Jaw: Xgeva injections can cause your jaw bones to die as it reduces blood supply to the jaw. As a result, patients can experience symptoms like jaw pain, numbness, swelling, and loose teeth. It is recommended that you maintain good oral hygiene and get regular dental check-ups while using this medication.

Allergic Reactions: Xgeva medication can cause severe allergic reactions in rare cases. Symptoms include rash, difficulty breathing, and itching.

Pneumonia: This is the most common severe side effect in multiple myeloma patients receiving Xgeva. Pneumonia is an infection of the lungs with symptoms like difficulty breathing, high fever, rapid breathing, cough, and rapid heart rate.

Please note that this is not a list of all possible side effects. Contact your provider immediately if you encounter any serious side effects after receiving Xgeva.

Xgeva Dosing Information

The dosage of Xgeva depends on several factors, such as your age, current condition, and medical history. Your doctor will determine the right dosage based on your situation. You will receive Xgeva as a subcutaneous injection in your upper arms, upper thighs, or abdomen. The usual recommended dose for different conditions is given below [2]:

Multiple Myeloma and Bone Metastasis From Solid Tumors: The recommended dose is 120 mg every 4 weeks. If calcium levels in your blood become too low, you may also be prescribed calcium and vitamin D supplements.

Giant Cell Tumor of Bone: The recommended dose is 120 mg every 4 weeks. In your first month of Xgeva treatment, you will receive two additional 120 mg doses on Day 8 and 15. You will also receive calcium and vitamin D supplements if the calcium levels in your blood become too low.

Hypercalcemia Caused by Cancers: The recommended dose is 120 mg every 4 weeks with additional two 120 mg doses on Day 8 and Day 15 of the first month of treatment.

Xgeva Cost

Xgeva medication is available as a 120 mg/1.7 ml solution in a single-dose vial. Each single-dose vial costs around $3,470 [4]. However, the actual cost of treatment will depend on your insurance coverage, location, treatment plan, and the pharmacy you visit. Contact us if you are interested in receiving financial assistance.

Before You Start

Before you start receiving Xgeva injections, there are some facts you need to be aware of to ensure that it is safe and appropriate for you:

  • Before starting your treatment, inform your doctor of your medical history. Also, tell them about all the medicines you are using, including over-the-counter drugs, vitamins, and herbal medicines.
  • Tell your doctor if you are pregnant or want to become pregnant. Xgeva can harm your unborn baby. You need to have a negative pregnancy test before starting treatment.
  • While receiving Xgeva medication, you should not take Prolia (another similar denosumab product).
  • Xgeva can damage your jaw bones. So, while taking the medication, you should have good dental hygiene and regular dental check-ups.
  • Xgeva injections are very expensive. Before starting the treatment, you need to discuss the cost with your doctor and insurance provider. You should also inquire about any financial assistance programs that can help you with the cost.

FAQs

Here are some frequently asked questions about Xgeva:

1. Can I take Prolia instead of Xgeva?

Xgeva and Prolia are brand-name medications containing the same active ingredient, denosumab. However, they are used to treat different conditions and have different administration routes. So, if your doctor prescribed Xgevia, you can NOT use Prolia.

2. For how long do I have to take this medication?

You have to receive Xgeva injections once every 4 weeks for a long time. However, you should stop using it if Xgeva is ineffective for you or if you encounter severe side effects.

3. Can I use Xgeva if I have kidney problems?

Yes. You can use Xgeva, but you need to be careful. Anyone with a kidney problem who uses Xgeva has a higher chance of developing hypocalcemia (low calcium level in blood) [2]. So, your calcium levels should be monitored regularly. Your doctor will prescribe calcium and vitamin D supplements if necessary.

Everything You Need to Know About Udenyca for Cancer Patients

Published on by Dr. Samantha Kaeberlein, PharmD

If you are undergoing chemotherapy treatment, you may face many side effects, including low white blood cell count. White blood cells fight against foreign pathogens, like viruses and bacteria, and protect you from diseases. Therefore, a low level of white blood cells increases your risk of having fever or infections.

To combat this side effect, drugs like Udenyca can help by increasing your white blood cell count. In this article, we will explore everything you need to know about Udenyca, including its dosing, side effects, injection costs, and more.

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What Is Udenyca?

Udenyca (pegfilgrastim-cbqv) is a medication used to reduce the risk of infection in people receiving chemotherapy for non-myeloid cancers.

Non-myeloid cancers are all cancers that do not affect your bone marrow. Some examples are carcinoma, sarcoma, melanoma, lymphomas, lymphocytic leukemias, and multiple myeloma. The FDA approved Udenyca on November 2, 2018 [1].

If you receive chemotherapy for non-myeloid cancers, your neutrophil (a type of white blood cell) level may decrease. This condition is called neutropenia. Neutrophils fight off infections. So, having a low level of neutrophils will increase your risk of infection.

If you have a fever with neutropenia, then the condition is known as febrile neutropenia. Udenyca injections help you by increasing the production of neutrophils.

What Is Udenyca Used To Treat?

Udenyca is an FDA-approved medicine used to prevent febrile neutropenia in patients receiving chemotherapy for non-myeloid cancers [2]. Symptoms of febrile neutropenia include fever, chills, shortness of breath, burning while urinating, rash, redness, and pain.

How Does Udenyca Work?

Chemotherapy lowers the levels of neutrophils in patients being treated for non-myeloid cancers.

Udenyca is a medication that contains the drug pegfilgrastim-cbqv. It works by helping you produce more neutrophils. It does this by binding to specific cell surface receptors on neutrophil precursors in the bone marrow.

After binding, it encourages the white blood cells to grow, mature, and become active.

Udenyca Side Effects

Like any other medicine, Udenyca can have some side effects. Below are some mild to severe adverse effects [3]:

Mild Side Effects

  • Pain in your arms and legs
  • Bone pain

These mild side effects usually go away within a few days. However, if they do not go away or become worse, consult your doctor.

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Severe Side Effects

A woman with her hands on her head and chest

Spleen Rupture: Udenyca can enlarge your spleen, and in some cases, it can cause a rupture. A ruptured spleen can lead to death. Symptoms include pain in the upper left abdomen and left shoulder. Consult your doctor right away if you encounter these symptoms.

Acute Respiratory Distress Syndrome (ARDS): ARDS is a lung condition that can be life-threatening. Symptoms include shortness of breath, rapid breathing, and difficulty breathing.

Serious Allergic Reactions: Udenyca injections can cause severe allergic reactions that can be deadly. Symptoms include rash, shortness of breath, dizziness, swelling of your mouth and eyes, and rapid heart rate. If you encounter these symptoms, stop using Udenyca and inform your doctor right away.

Kidney Problems: Symptoms of kidney problems include blood in your urine or dark-colored urine, less frequent urination, and swelling of your face and ankles.

Capillary Leak Syndrome (CLS): In this condition, fluids leak from your blood vessels into your body tissues. It can even cause death. Symptoms include difficulty breathing, tiredness, dizziness, swelling of your abdomen, and a feeling of fullness.

Aortitis: Udenyca medication can cause inflammation in your aorta (the large blood vessel that transports blood from the heart to the body). Symptoms include fever, stomach pain, tiredness, and back pain.

Please note that this is not a complete list of all possible side effects. Consult your doctor right away if you encounter any severe side effects of Udenyca.

Udenyca Dosing

The dosage of Udenyca differs from patient to patient. Your doctor will determine the right dosage for you. You will receive Udenyca as an injection under your skin. The usual recommended dosage is given below [2]:

For patients with cancer who are receiving chemotherapy: The recommended adult dose of Udenyca is 6 mg once per chemotherapy cycle. It’s typically given one day after chemotherapy. You should not receive this drug between 14 days before and 24 hours after receiving chemotherapy. For children who weigh less than 45 kg, a doctor will adjust the dose based on weight.

For patients exposed to harmful doses of radiation: The recommended adult dose of Udenyca is two 6 mg injections. After the radiation exposure, you will receive the first 6 mg injection as soon as possible. Then, after one week, you will receive another 6 mg injection. The dosage for children under 45 kg is adjusted based on their weight.

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Udenyca Injection Costs

Udenyca is available as a 6 mg/0.6 ml single-dose prefilled syringe. A single dose of the Udenyca medication costs around $4,400 [4]. However, the actual cost will depend on your insurance coverage, location, treatment plan, and the pharmacy you visit.

FAQs

Here are some common frequently asked questions about Udenyca:

1. Can Udenyca injections cause hair loss?

No. Hair loss is not a side effect of Udenyca. If you are experiencing hair loss, it could be due to chemotherapy.

2. Can I use Udenyca during pregnancy or breastfeeding?

There is still not enough data to recommend or prohibit the use of Udenyca during pregnancy or breastfeeding [2]. You may only use it during pregnancy or breastfeeding if your doctor thinks that the potential benefits outweigh the risks.

3. What are the clinical benefits?

Udenyca injections help you increase your neutrophil count. Neutrophils fight foreign objects like viruses or bacteria and prevent you from getting infections. In clinical studies, researchers found that Udenyca significantly reduced the risk of febrile neutropenia (fever and a low white blood cell count), hospitalizations, and the need for IV antibiotics [2].

4. Can elderly people use this medication?

Yes. Patients aged 65 or older can safely use Udenyca. It is just as effective and safe in older people as it is in younger people [2].

5. Does Udenyca interact with other medications?

The interactions of Udenyca with other medications are not known. The manufacturers do not mention any drug interactions of Udenyca [2]. Still, you should be careful. Before starting treatment, inform your doctor about all the medications that you are taking, including over-the-counter drugs and herbal medicines.

6. How long does it take for Udenyca to work?

Udenyca starts working soon after you take the injection. However, due to the way it works, you may not feel a difference in your body. Your doctor will monitor you during treatment to ensure the medication is working.

Trodelvy Explained: Benefits, Costs, and Side Effects of This Breast Cancer Treatment

Published on by Dr. Christine Leduc, PharmD

If you are undergoing treatment for breast cancer, then Trodelvy can be an option for specific breast cancers. According to studies, it is more effective in fighting certain types of breast cancers than other available medications and can increase your overall life expectancy.

In this article, we will explore everything you need to know about Trodelvy, including its uses, dosing, side effects, cost, and much more.

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What Is Trodelvy?

Trodelvy (sacituzumab govitecan-hziy) is a cancer medicine used to treat two types of breast cancer.

The FDA first approved this drug on April 22, 2020, to treat adults with triple-negative breast cancer. Later, on February 3, 2023, the FDA approved this drug to treat adults with HR-positive, HER2-negative breast cancer (HR+/HER2-) [1].

You can only receive Trodelvy infusions after receiving at least two other treatments. Several studies have shown that this drug can increase the time before your cancer progresses and increase your life expectancy.

This drug works by targeting and binding to a protein present on the surface of the cancer cells, delivering chemotherapy medication into the cancer cells and killing them. This targeted approach also minimizes side effects.

What Is Trodelvy Used To Treat?

Trodelvy is an FDA-approved brand-name cancer medicine. Trodelvy uses include the treatment of the following cancers that have spread locally (locally advanced) or in other parts of the body (metastatic) and cannot be removed by surgery [2]:

Triple-Negative Breast Cancer: Before using Trodelvy, you have to try at least two other treatments, one of which should be for metastatic cancer.

Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-negative (HR+/HER2-) Breast Cancer: Before using Trodelvy, you have to try endocrine-based therapy and at least two other treatments for the metastatic cancer.

How Does Trodelvy Work?

Trodelvy is a cancer medicine that contains an antibody and an anticancer drug called SN-38. It works differently than traditional chemotherapy drugs. Many breast cancer cells have a large amount of protein called Trop-2 on the outside.

The antibody part of Trodelvy infusions targets and attaches to this Trop-2 protein of cancer cells. Once attached, it delivers the anticancer drug SN-38 directly into the cancer cells.

This targeted approach allows this medication to effectively kill the cancer cells while minimizing damage to the normal, healthy cells to reduce side effects [2].

Side Effects

Like any other medication, Trodelvy has side effects, some of which can be severe. These are some common and severe side effects of this medication [3]:

Common Side Effects

Common side effects of Trodelvy include:

  • Low white blood cell count
  • Feeling tired or weak
  • Anemia
  • Loss of appetite
  • Changes in kidney function test
  • Hair loss
  • Increased sugar levels in the blood
  • Diarrhea
  • Decreased levels of potassium, magnesium, and sodium in the blood

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An infusion nurse touching a patient’s chest

Severe Side Effects

Trodelvy can also cause some severe side effects. Some of the severe side effects of using Trodelvy for breast cancer are:

Severe Neutropenia: In this condition, you have an abnormally low level of white blood cells, which can lead to life-threatening infections. During your Trodelvy treatment, your doctor will regularly monitor your white blood cell counts. If your white blood cell count is too low, your doctor might lower your Trodelvy dose. In some cases, your doctor might stop your treatment.

Severe Diarrhea: Diarrhea is common with Trodelvy treatment. Sometimes, it can be severe. Diarrhea can cause dehydration and kidney problems. Inform your doctor right away if you encounter diarrhea.

Allergic Reactions: This medicine can cause severe, life-threatening allergic reactions. These reactions typically occur within 24 hours of Trodelvy infusion. Symptoms include rash, itching, hives, fever, difficulty breathing, dizziness, chills, and swelling of your face, lips, tongue, or throat.

Nausea and Vomiting: Trodelvy can cause nausea and vomiting, which is common, and sometimes they can be severe. To help you manage nausea and vomiting, your doctor will prescribe you some medicines.

Please note that this is not a list of all possible side effects. Contact your doctor if you encounter any side effects after your Trodelvy infusion.

What Are the Clinical Benefits of Trodelvy?

Trodelvy offers significant benefits to certain types of breast cancer patients compared to standard treatment. In a clinical trial involving 529 patients with metastatic or locally advanced triple-negative breast cancer who received two or more prior treatments, Trodelvy was compared to standard chemotherapy treatment. Researchers found that patients who received infusions lived an average of 4.8 months without disease progression.

However, patients who received standard chemotherapy treatment only lived an average of 1.7 months without disease progression. Patients who took Trodelvy lived an average of 11.8 months longer compared to 6.9 months for those who took standard treatment [2].

In another study, Trodelvy was compared to standard chemotherapy treatment in 543 patients with HER2-negative, HR-positive breast cancer who previously had at least two treatments and an endocrine-based therapy.

According to research findings, Trodelvy users lived an average of 5.5 months before disease progression, compared to 4 months for those receiving standard chemotherapy. Those receiving infusions lived an average of 14.4 months longer, while those receiving standard chemotherapy lived 11.2 months longer [2].

Dosing

You can receive Trodelvy as an intravenous infusion. The typical dosage of Trodelvy for breast cancer treatment is 10 mg per kilogram of your body weight.

Your doctor will give you Trodelvy once each week, on day 1 and day 8 of a 21-day treatment cycle. This treatment will continue until your disease worsens or side effects become too severe [2].

The first infusion will take about 3 hours to complete, and home infusions after that will take about 1 to 2 hours. Before each treatment, your doctor may recommend additional medicines to prevent infusion reactions, nausea, and vomiting.

Your doctor will monitor you during the infusion and at least 30 minutes after it finishes. Your doctor might adjust your Trodelvy dose or stop the treatment to manage side effects.

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Trodelvy Cost

Trodelvy is available as a powder for injection, with a strength of 180 mg per vial. Each vial costs around $2,600 [4]. The typical dosage is 10 mg per kg of your body weight. So, if your weight is 72 kg, you will need 4 vials, and a single Trodelvy infusion can cost around $10,400.

However, the actual cost depends on your insurance coverage, location, treatment plan, and the pharmacy you visit. Contact us if you are interested in receiving financial assistance.

FAQs

1. Does Trodelvy cause hair loss?

Yes. Hair loss is a common side effect of Trodelvy. In clinical studies, researchers found that about 45% of patients who took this medication experienced hair loss [2]. If you experience significant hair loss, consult your doctor for advice.

2. Is Trodelvy safe during pregnancy or breastfeeding?

Trodelvy use can pose a risk to your unborn baby. So, you should not use it if you are pregnant. Also, you should use effective birth control during treatment and for 6 months after the last dose.

There is still no data on the safety of Trodelvy usage during breastfeeding. So, you should not breastfeed during treatment and for 1 month after your last dose [3].

3. Can I use this medication if I have liver problems?

You can safely use Trodelvy for breast cancer if you have mild liver problems. However, it is not known if it is safe and effective in people with moderate to severe liver problems [2]. You should consult your doctor if you have moderate to severe liver problems.

IVIG for Churg-Strauss Syndrome: How This Therapy Helps When Standard Treatments Fall Short

Published on by Dr. Mark Alfonso, PharmD, BCMTMS

Various case reports have shown that IVIG therapy can be used as a second-line treatment in patients with severe Churg-Strauss syndrome. 

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Churg-Strauss syndrome, or CSS, is a rare autoimmune and inflammatory disorder that causes inflammation in the small blood vessels (vasculitis), particularly affecting those in the respiratory system. The inflamed or swollen blood vessels restrict blood flow to the lungs, often leading to asthma, sinusitis, and permanent organ damage in severe cases.

Standard treatments like corticosteroids or surgery are used to treat Churg-Strauss syndrome. However, in some cases, IVIG therapy is recommended as a second-line treatment when the conventional therapies are not sufficient. 

This article discusses the basics of Churg-Strauss syndrome, how IVIG can help, and what to expect if you or your loved one are considering IVIG for CSS. 

Churg-Strauss Syndrome: A Brief Overview

In 2010, medical experts renamed Churg-Strauss syndrome to eosinophilic granulomatosis with polyangiitis (EGPA) to reflect the three main features of the disease:

  • Eosinophilic: Excessive buildup of eosinophils (a type of white blood cell) that leads to inflammation and tissue damage
  • Granulomatosis: Formation of granulomas (clusters of immune cells) in affected tissues as a response to inflammation
  • Polyangiitis: Inflammation affecting multiple blood vessels throughout the body

Therefore, EGPA is a condition characterized by an excessive buildup of eosinophils, granuloma formation, and inflammation of multiple blood vessels. These factors together lead to symptoms and tissue damage in affected organs, including the lungs, skin, and nerves.

EGPA is more common in people who have asthma or a history of allergies. 

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How Can IVIG Help Patients With Churg-Strauss Syndrome (CSS)?

Various case reports have shown that IVIG therapy can effectively treat patients with CSS when other standard treatments do not yield promising results. Since CSS is part of a group of autoimmune diseases in which the overactive immune system mistakenly targets the body, IVIG can help to modulate the immune system and prevent it from attacking the body.

While the exact working mechanism of IVIG is not clear, researchers believe that IVIG treatment exerts a wide array of effects to improve the quality of life in CSS patients. For instance, IVIG can:

1. Suppress Inflammation

IVIG therapy is known to have anti-inflammatory properties. It can help reduce the inflammation in the blood vessels and eventually reduce the risk of severe organ damage. 

2. Neutralize Autoantibodies

IVIG also helps to neutralize or block the activity of autoantibodies. Autoantibodies are abnormal proteins that attack healthy cells. One of these antibodies, called ANCA, is present in some people with EGPA, though not all. Only about 40% of EGPA patients have it.

3. Reduce Blood Eosinophil Levels

Eosinophils are a type of immune cell that is involved in an allergic response or infection. In CSS patients, the level of eosinophils is often double that of normal levels. This leads to the buildup of these cells in the tissues such as the lungs, skin, heart, or nerves, causing inflammation and tissue damage. 

In CSS patients, IVIG helps reduce the eosinophil level in the blood. It does this by blocking the activity of eosinophils. This prevents the excessive buildup of eosinophils in the tissues. 

How Is IVIG Administered to Patients With Churg-Strauss Syndrome?

Man receiving IVIG in a chair at home

IVIG is administered through an intravenous (IV) infusion in a hospital setting or at home. This process takes several hours and may require multiple sessions, depending on the CSS patient’s response and the severity of the symptoms. 

After IVIG treatment, you may experience headaches, fatigue, flu-like symptoms, or allergic reactions. 

Who Can Receive IVIG Therapy?

Not all CSS patients can receive IVIG therapy. It is generally considered for:

  • Patients who showed poor response to standard treatments of CSS
  • Patients with compromised immune function (who are at higher risk of developing secondary infections from standard immune-suppressing drugs)
  • Patients with relapses or severe organ involvement

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How Effective Is IVIG for Patients With Churg-Strauss Syndrome (CSS)?

Currently, only a few studies have reported the beneficial effects of IVIG in CSS patients. Based on these studies’ results, IVIG is considered an effective second-line treatment for CSS when conventional therapies are insufficient. 

For example, a double-blind, placebo-controlled study demonstrated that IVIG therapy improved vasculitis symptoms and normalized eosinophil count in patients with severe CSS. 

Similarly, another case report showed that IVIG therapy improves blood flow to nerves when given in combination with cyclophosphamide to a CSS patient with severe neuropathy. The three sessions of IVIG therapy reduced the eosinophil level, and serum anti-myeloperoxidase ANCA levels decreased to within the normal range. Hence, IVIG therapy can be considered a second-line treatmentfor CSS patients when standard treatments do not give promising results.