Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl (an-tee-hee-moe-FIL-ik FAK-tor (ree-KOM-bi-nant) Fc-VWF-XTEN FUE-zhun PROE-teen - ehtl)

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

Brand Name(s):

Altuviiio

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. This medicine must be given slowly, so the IV will need to stay in place for 1 to 10 minutes.
• 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.
• Use a new needle and syringe each time you inject your medicine.
• 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. Do not use other source of heat (including hot water).
  • Wipe the rubber surface of the bottles 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, place the vial adapter in its package over the vial.
  • Push the vial adapter straight down until the spike on the vial adapter punctures the center of the vial stopper. The spike should be placed directly above the center of the rubber stopper.
  • Lift the package cover away from the vial and throw away the cover.
  • Place the tip of the plunger rod into the end of the prefilled diluent syringe. Turn the rod to the right until firmly attached.
  • Hold the prefilled syringe directly under the cap with the cap pointing up. Bend the cap until it snaps off.
  • On a flat surface, insert the tip of the prefilled syringe into the vial. Turn the syringe to the right until it is firmly attached to 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. Do not shake.
  • Check the mixture to make sure it is clear and colorless to slightly yellowish. Do not use the medicine if you can see particles in it.
  • Turn the vial upside down. Slowly pull down on the plunger to draw all the mixture from the vial to the syringe.
  • Gently unscrew the syringe from the vial by turning it to the right. Do not touch the tip of the syringe or inside of the cap.
  • Give the injection as directed by your doctor.
• Missed dose: Call your doctor or pharmacist for instructions.
• Store the medicine in a closed container at room temperature or in the refrigerator, away from heat, moisture, and direct light. Keep from freezing. If stored at room temperature, the medicine will expire at 6 months or after the expiration date, whichever comes first.
• Do not return the room temperature medicine in the refrigerator.
• Use the mixture within 3 hours after it is prepared. Do not store in the refrigerator after mixing and use later.

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.
• 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

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

• Headache
• Joint pain
• 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