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Recombinate

recombinant FVIII
Used for Hemophilia
Used for Hemophilia

Recombinate (factor VIII) is a clotting factor replacement used to prevent and control bleeding in people with hemophilia A (also known factor VIII deficiency). It's given through the vein (intravenously, or IV) as an infusion. This medication is made in a lab using recombinant technology and not a human blood product like some other clotting factor replacements.

Reviewed by:
reviewer
Robert Chad Hakim, PharmD, BCCCP
reviewer
Kristianne Hannemann, PharmD
Last reviewed on August 23, 2022
BasicsSide effectsPros & consPharmacist tipsFAQsWarningsDosageInteractionsContraindicationsAlternativesPricesMedicare
basics-icon

What is Recombinate (factor VIII)?

What is Recombinate (factor VIII) used for?

  • To prevent or treat bleeding in people with hemophilia A

How Recombinate (factor VIII) works

Recombinate (factor VIII) is a coagulation (clotting) factor replacement used for people who are missing a protein called factor VIII. This protein is one of many clotting factors that work in your blood to form blood clots, which help control bleeding. Recombinate (factor VIII) replaces the missing factor VIII in the blood to help prevent and treat bleeding in people with hemophilia A.

Are you looking for information on Advate (recombinant factor VIII) or Hemofil M (factor VIII human plasma) instead?

Drug Facts

Common BrandsRecombinate
Drug ClassCoagulation replacement factor
Controlled Substance ClassificationNot a controlled medication
Generic StatusNo lower-cost generic available
AvailabilityPrescription only
basics-icon

What are the side effects of Recombinate (factor VIII)?

The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.

Common Side Effects

  • Chills
  • Flushing (feeling warm all of a sudden)
  • Rash
  • Bloody nose

Other Side Effects

  • Nausea
  • Fatigue
  • Fever
  • Dizziness
  • Sweating
  • Itching
  • Low blood pressure

Serious Side Effects

Contact your healthcare provider immediately if you experience any of the following.
  • Serious allergic reaction: difficulty breathing, hives, fast heartbeat, nausea, dizziness, swelling in the face or tongue

Source: DailyMed

The following side effects have also been reported

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Fever

Less common or rare

Changes in facial skin color

chills

fast or irregular breathing

nausea

puffiness or swelling of the eyelids or around the eyes

sensation of burning, warmth, heat, numbness, tightness, or tingling

skin rash, hives, or itching

tightness in the chest

trouble breathing

unusual tiredness or weakness

Incidence not known

Bluish color of the fingernails, lips, skin, palms, or nail beds

blurred vision

chest pain or discomfort

confusion

cough

deep or fast breathing with dizziness

difficult or labored breathing

difficulty with swallowing

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fast, pounding, or irregular heartbeat or pulse

noisy breathing

numbness of the feet, hands, and around the mouth

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

slow or irregular heartbeat

sweating

swelling of the face, throat, or tongue

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Headache

Less common

Burning, stinging, or swelling at the injection site

diarrhea

dizziness or lightheadedness

dry mouth or bad taste in the mouth

lack or loss of strength

nosebleed

redness of the face

vomiting

Rare

Change in taste

loss of taste

Incidence not known

Feeling of warmth

increased sweating

irritability

muscle or bone pain

redness of the eye

redness of the face, neck, arms, and occasionally, upper chest

redness of the skin

stomach pain

trouble seeing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

pros-and-cons

Pros and cons of Recombinate (factor VIII)

thumbs-up

Pros

Works well to prevent and treat bleeding in people with hemophilia A

Can be given at home, if approved by your provider

A lab-made product, so it doesn't have a risk of infection like other clotting factor products made from human plasma

thumbs-down

Cons

Given as an IV injection

Available as a brand name only, which can be expensive

Not approved for routine prevention of bleeding (only approved to prevent bleeding during surgeries)

pharmacist-tips

Pharmacist tips for Recombinate (factor VIII)

pharmacist

  • Depending on your medical condition and level of comfort with self-infusions, your provider might train you to prepare and give Recombinate (factor VIII) infusions to yourself at home. Learning to use Recombinate (factor VIII) correctly will help avoid accidental injuries or medication waste. Carefully read the instructions on how to give the injection. Contact your provider if you have any questions on how to use Recombinate (factor VIII).

    • Recombinate (factor VIII) comes in color-coded vials that contain different amounts of medication (e.g., light-blue, pink, green, purple, orange). Make sure you have the correct vial strength for your prescribed dose so you receive the correct amount of medication.

      • Store Recombinate (factor VIII) at room temperature or in the refrigerator. Keep the vials in the original carton and away from light.

        • After you prepare Recombinate (factor VIII) for your infusion, use the medication within 3 hours. Don't put the prepared medication in the refrigerator at any time.

          • Throw away any used syringes and needles in a sharps container or something made of heavy-duty plastic (e.g., empty milk carton, laundry detergent bottle) to lower the risk of needle-stick injuries. Don't throw them away in your trash can. When your sharps container is almost full, close it tightly with the cap. For more information on how to throw away your sharps container safely and guidance for your specific state, visit the FDA's website.

            faqs

            Frequently asked questions about Recombinate (factor VIII)

            What is hemophilia A?
            Hemophilia A is a rare, genetic blood condition that makes it difficult for your blood to clot. People with hemophilia A are missing factor VIII in their blood, which is one of the proteins (called clotting factors) responsible for making clots to stop bleeding from injuries. Symptoms of hemophilia A include bleeding for a longer time than other people, excessive bleeding from small cuts or injuries, or even bleeding inside the body. Recombinate (factor VIII) helps your blood clot by replacing factor VIII.
            How long do I need to be treated with Recombinate (factor VIII)?
            Recombinate (factor VIII) is typically used when it's needed (on an "as-needed" basis). This means you'll only receive treatment when you experience a bleed or to prevent bleeds during surgery. Your length of treatment is typically a few days, but it could also be longer because it depends on how severe your bleed is and how well your body responds to this medication. Some people with severe hemophilia A need to have regular factor VIII replacements to prevent future bleeds. Talk with your provider if you have any questions about how long you need Recombinate (factor VIII) treatment.
            Can I give myself Recombinate (factor VIII) infusions at home?
            Ask your provider if it's okay for you to give yourself Recombinate (factor VIII) infusions at home. When this product is used during an active bleed or for surgery, you'll probably receive the medication under the care of a healthcare provider. But sometimes, it might be possible for you to receive Recombinate (factor VIII) at home. Ask your provider if or when home infusions might be appropriate for you.
            What's the difference between Recombinate (factor VIII) and Hemofil M (factor VIII)?
            Both Recombinate (factor VIII) and Hemofil M (factor VIII) are clotting factor replacements used to treat hemophilia A. The main difference between them is how they're made. Recombinate (factor VIII) is made in a lab using recombinant DNA technology, while Hemofil M (factor VIII) is made from donated human plasma (the liquid portion of blood). When using human blood products, there's a very small chance that they can contain viruses or other infectious material (though the manufacturer takes many steps to make sure it's safe). Recombinant products, such as Recombinate (factor VIII), are generally considered safer because they're made in the lab and don't carry the same risk of potential infections from receiving human-derived products. Currently, many providers typically prefer recombinant factor VIII products over those made from human plasma.
            Can I use Recombinate (factor VIII) if I'm pregnant?
            Recombinate (factor VIII) hasn't been studied in human pregnancy, so it's not known whether this medication is safe in pregnant females and their unborn baby. Recombinate (factor VIII) should only be used in pregnancy if it's clearly needed. If you're pregnant or thinking of becoming pregnant, talk with your provider about the risks and benefits of using Recombinate (factor VIII) before starting this medication.
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            What are the risks and warnings for Recombinate (factor VIII)?

            Recombinate (factor VIII) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.

            risk-warning

            Serious allergic reactions

            • Risk factors: Latex allergy | Cattle, mouse, or hamster allergy

              Serious allergic reactions to Recombinate (factor VIII) are possible, including life-threatening reactions like anaphylaxis (e.g., closing of the throat). This can happen anytime during or after an infusion. Tell your provider if you have an allergy to latex, since some components of the packaging contain natural rubber latex. Also tell your provider if you're allergic to cattle, mice, or hamsters; there's a very small amount of these animal proteins in the medication from the manufacturing process. If you notice difficulty breathing, dizziness, rash, nausea, or swelling of the face, lips, or tongue after using Recombinate (factor VIII), stop using the medication and get medical help right away.

              risk-warning

              Development of antibodies against factor VIII

              It's possible you could develop certain antibodies (also known as inhibitors) against Recombinate (factor VIII). These antibodies can block the medication from working, which can make Recombinate (factor VIII) less effective. Let your provider know if bleeding becomes difficult to control even after receiving Recombinate (factor VIII). Your provider might need to check whether or not you have antibodies and make changes to your treatment.

              dosage

              Recombinate (factor VIII) dosage forms

              Typical dosing for Recombinate (factor VIII)

              This medication is given as an infusion through your veins. Your provider will determine how much, how often, and how long you need Recombinate (factor VIII). This is based on your body weight, why you're using it, how severe your bleed is, and how well your body responds to the medication.

              interactions

              Interactions between Recombinate (factor VIII) and other drugs

              Recombinate (factor VIII) may interact with certain medications or supplements. Always let your doctor and pharmacist know about any other medications or supplements (including prescribed and over-the-counter medications, vitamins, and dietary or herbal supplements) that you are currently taking. The list below does not include all possible drug interactions with Recombinate (factor VIII). Please note that only the generic name of each medication is listed below.

              Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

              contraindications-icon

              Recombinate (factor VIII) contraindications

              Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Recombinate (factor VIII) will not be safe for you to take.

              • Allergy to bovine (cattle), mouse, or hamster proteins

              alternatives

              What are alternatives to Recombinate (factor VIII)?

              There are a number of medications that your doctor can prescribe in place of Recombinate (factor VIII). Compare a few possible alternatives below.
              Recombinate (factor VIII)
              Used for:

              • To prevent or treat bleeding in people with hemophilia A

              View Prices
              Hemofil M (factor VIII)
              Used for:

              • To prevent or treat bleeding in people with hemophilia A

              View Prices
              Advate (factor VIII)
              Used for:

              • To treat or prevent bleeds in people with hemophilia A

              $3696.78 Lowest GoodRx priceView Prices

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