Antihemophilic Factor (Recombinant)

Antihemophilic Factor (Recombinant) is a prescription medication used to prevent, treat, and control bleeding episodes in children and adults with hemophilia A. 

Antihemophilic Factor (Recombinant) 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 as a dry powder to be mixed into a solution and injected into a vein (IV). 

Common side effects include fever and headache. 

Antihemophilic Factor (Recombinant) is a prescription medication used to prevent, treat, and control bleeding in adults and children with hemophilia A. This medication may also be used to prevent bleeding during surgery.

This medication is not used to treat von Willebrand Disease.

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

Antihemophilic Factor (Recombinant) may be found in some form under the following brand names:

• Advate

• Afstyla

• Kovaltry

Serious side effects have been reported with this medication. See the "Drug Precautions" section.

Common side effects include the following:

• fever
• headache
• cough
• joint pain
• sore throat
• stomach pain
• diarrhea
• chills
• runny nose or congestion
• nausea or vomiting
• itching
• sweating
• swelling of legs
• hot flashes

This is not a complete list of 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 reported 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 this medication including the following:

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

• dizziness
• numbness or tingling
• rash
• flushing
• swelling in the face
• hives
• itching
• trouble breathing
• vomiting

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, this medication may not work properly. Your healthcare provider will monitor you for development of these inhibitors with blood tests.

Do not receive this medication if you:

• are allergic to antihemophilic factor (recombinant)  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 this medication, there are no specific foods that you must exclude from your diet when receiving this medication.

Before receiving this medication, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to antihemophilic factor (recombinant) or to any of its ingredients
• have or have had any medical problems
• are allergic to mice or hamsters
• have been told that you have inhibitors to factor VIII
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

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.

No studies have been done in animals, and no well-controlled studies have been done in pregnant women. This medication should be given to a pregnant woman only if clearly needed.

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

It is not known if this medication crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using this medication.

Antihemophilic Factor (Recombinant) comes in an injectable form to be given directly into a vein. 

• Do not attempt to do an infusion to yourself unless you have been taught how by your healthcare provider or hemophilia center.
• If will administer this medication, always follow the specific instructions for using this medication given by your healthcare provider. If you are unsure of the procedures, please call your healthcare provider before using.

Call your healthcare provider right away if bleeding is not controlled after using this medication. Your healthcare provider will prescribe the dose that you should take.

Your healthcare provider may need to take blood tests from time to time.

Talk to your healthcare provider before traveling. You should plan to bring enough medication for your treatment during this time.

Reconstitute this medication as directed. Follow the specific infusion instruction leaflet included with the infusion set provided.

Carefully handle antihemophilic factor (recombinant). Dispose of all materials, including any leftover reconstituted product, in an appropriate container.

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

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

If you administer or receive too much of this medication, call your doctor or seek emergency medical treatment.

• Store and handle Antihemophilic Factor (Recombinant) according to the specific brand's recommendations
• Keep this medication and all medication away from children. 

Kovaltry

• Do not freeze Kovaltry.
• Store Kovaltry at +2°C to +8°C (36°F to 46°F) for up to 30 months from the date of manufacture. Within this period, Kovaltry may be stored for a period of up to 12 months at temperatures up to +25°C or 77°F.

Advate

• Do not freeze.
• Refrigerate in powder form at 2°– 8°C (36°– 46°F).
• Store at room temperature up to 30°C (86°F) for a period of up to 6 months not to exceed the expiration date.