Recombinate
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.
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.
Drug facts
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
Less Common Side Effects
- Nausea
- Fatigue
- Fever
- Dizziness
- Sweating
- Itching
- Low blood pressure
Recombinate (factor VIII) 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
The following Recombinate (factor VIII) 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
Less common or rare
Changes in facial skin color
chills
fast or irregular breathing
puffiness or swelling of the eyelids or around the eyes
sensation of burning, warmth, heat, numbness, tightness, or tingling
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
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
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
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 of Recombinate (factor VIII)
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
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 for Recombinate (factor VIII)
- 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.
Common questions about Recombinate (factor VIII)
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.
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.
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.
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.
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.
How to save using GoodRx
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.
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.
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.
Recombinate (factor VIII) dosage
Typical dosage 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 between Recombinate (factor VIII) and other drugs
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.
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
