Recombinate

Recombinate is a prescription medication used to prevent bleeding episodes in children and adults with hemophilia A (cogenital factor VIII deficiency). 

Recombinate belongs to a group of drugs called clotting factors. It works by replacing a protein in the blood that is needed to control bleeding that people with hemophilia A are missing.

This medication comes in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects of Recombinate chills, flushing, rash, and nose bleeds.

Recombinate is a prescription medication used to prevent and control bleeding in adults and children with hemophilia A, a genetic disorder that increases bleeding and is caused by a missing or defective protein called factor VIII clotting factor. Recombinate may also be used to prevent bleeding during surgery.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Baxter Healthcare Bioscience Division

• Baxter Healthcare Corporation

Serious side effects have been reported with Recombinate. See the "Recombinate Precautions" section.

Common side effects of Recombinate include the following:

• chills
• flushing
• rash
• nose bleeding

This is not a complete list of Recombinate side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

No drug interactions have been evaluated by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Recombinate including the following:

Hypersensitivity Reactions. Recombinate can cause serious allergic reactions. Tell your healthcare provider immediately about any signs or symptoms of an allergic reaction, which include the following:

• rash
• hives
• itching
• difficulty breathing or swallowing
• chest pain
• chest tightness
• lightheadedness
• dizziness
• fainting

Neutralizing antibodies. Your body may form inhibitors to factor VIII, known as antibodies. Antibodies are proteins made by the body as a natural part of the immune system in response to something it recognizes as foreign. If your form these inhibitors, Recombinate may not work properly. Your healthcare provider will monitor you for development of these inhibitors with blood tests.

Do not take Recombinate if you:

• are allergic to Recombinate or to any of its ingredients
• are allergic to mice or hamsters

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Recombinate, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Recombinate, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Recombinate or to any of its ingredients
• are allergic to mice, hamsters, or cows
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed
• have been told you have inhibitors to factor VIII

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Recombinate falls into category C. No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Recombinate should be given to a pregnant woman only if clearly needed.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Recombinate comes in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Recombinate may be infused at a hemophilia treatment center or in your doctor's office. You may also be trained to do infusions at home. Do not attempt to do an infusion at home by yourself unless you have been taught how to do this by your doctor or hemophilia center. Always follow your healthcare provider's specific instructions on how to mix and administer Recombinate.

If you miss a dose or miss an appointment to receive a dose of Recombinate, contact your healthcare provider for instructions on when to receive your next dose.

The dose and duration of treatment of Recombinate your doctor recommends will be based on the following:

• your weight
• the severity of factor VIII deficiency
• the location of the bleeding
• your overall clinical condition
• how you respond to this medication

The recommended dose of Recombinate when being used for control and prevention of bleeding episodes will be determined by your doctor, depending on the severity and location of the bleed, as well as your factor VIII level. This dose is given every 12 to 24 hours as determined by your doctor until the bleeding is resolved.

The recommended dose of Recombinate when being given during surgery to prevent bleeding is one dose (dose determined by your doctor) given one hour before surgery. The dose may be repeated every 8 to 24 hours until bleeding is resolved or you are healed as determined by your doctor.

Your doctor will perform blood tests to measure your level of factor VIII and may adjust your dose or frequency based on the results.

If you take too much Recombinate, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Recombinate is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Keep all appointments with your doctor and laboratory. Your doctor will order lab tests to check your levels of factor VIII to determine your dose and frequency of Recombinate.
• If you are infusing Recombinate at home, store vials containing powdered product (unmixed) in the refrigerator at 2° to 8°C (36° to 46°F) or at room temperature (up to 30°C or 86°F). If you choose to store Recombinate at room temperature, do not put the product back in the refrigerator.
• Store vials in the original box and protect them from extreme exposure to light.
• Do not freeze Recombinate vials.
• Keep this and all medications out of the reach of children.