Antihemophilic Factor (an-tee-hee-moe-FIL-ik FAK-tor)

Treats, controls, prevents, and decreases the frequency of bleeding episodes, and prevents bleeding during surgery in patients with hemophilia A.

Brand Name(s):

Advate, Adynovate, Afstyla, Altuviiio, Eloctate, Esperoct, Hemofil M, Jivi, Koate, Koate-DVI, Kogenate FS, Kovaltry, Novoeight, Nuwiq, Obizur

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• Adynovate®:
  • To prepare the medicine using 2 vials:
    • Take the vials out of the refrigerator and let them warm to room temperature.
    • Peel the lid of the vial adapter. Keep the vial on a flat surface. Hold the vial with one hand and using the other hand, press down firmly on the diluent vial until the diluent flows down into the other vial. Do not remove the blue cap.
    • Swirl the mixture gently and continuous until completely dissolved. Do not shake.
    • Check the mixture to make sure it is clear and colorless. Do not use the medicine if you can see particles in it.
    • Remove the blue cap from the housing and connect the syringe.
    • Turn over the vial containing the mixture. Slowly pull back the plunger of the syringe to draw the mixture.
    • Give the injection as directed by your doctor.
    • Use the mixed liquid within 3 hours. Do not store or refrigerate it. Throw away any unused medicine after 3 hours.
• Obizur®:
  • To prepare the medicine using 1 vial and 1 prefilled syringe:
    • Take the vial and prefilled syringe out of the refrigerator and warm them to room temperature.
    • Wipe the rubber stopper with an alcohol swab and allow them to dry.
    • Peel the lid of the vial adapter. Keep the vial on a flat surface. Hold the vial with one hand and using the other hand, connect the syringe into the vial by pushing the tip onto the luer lock (tip) in the center of the vial, turn it clockwise until secured.
    • On a flat surface, place the vial adapter over the vial and push the filter spike of the adapter into the center of the vial's rubber until the clear plastic cap snaps into the vial.
    • Slowly push down on the plunger to inject all liquid from the syringe into the vial. Swirl the bottle gently to dissolve the medicine.
    • Check the mixture to make sure it is clear and colorless. Do not use the medicine if you can see particles in it.
    • Gently unscrew the syringe from the vial by turning it counter clockwise.
    • Give the injection as directed by your doctor.
• Use a new needle and syringe each time you inject your medicine.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Call your doctor or pharmacist for instructions.
• Each brand of medicine has different storage instructions. Follow the directions for your brand. Most brands need to be stored in the refrigerator. Some brands can be stored at room temperature for 3 to 12 months. Ask your doctor or pharmacist if you are not sure how to store your brand. Do not use this medicine after the expiration date.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. Keep it in its original container. Protect from light. Do not place it back in the refrigerator if you store it at room temperature.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have heart or blood vessel disease or von Willebrand disease.
• AHF may be made from donated human blood. Some human blood products have transmitted viruses, although the risk is low because donors and blood are both tested for viruses. AHF products that are not taken from human blood are also available. Talk with your doctor if you have concerns.
• Tell your doctor if this medicine does not prevent or stop bleeding as expected.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Fever

If you notice these less serious side effects, talk with your doctor:

• Headache, dizziness
• Nausea, diarrhea
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed

If you notice other side effects that you think are caused by this medicine, tell your doctor

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