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. 

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. 

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

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

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

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.

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).

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.

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. 

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 

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. 

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 Assurance^SM 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.

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.

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

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

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.

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.

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.