Antihemophilic factor (Recombinant) Pegylated-aucl (By injection)

Antihemophilic Factor (Recombinant) Pegylated-aucl (an-tye-hee-moe-FIL-ik FAK-tor ree-KOM-bin-ant PEG-il-ay-ted - aucl)

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

Brand Name(s):

Jivi

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.
• Vial:
  • Allow the vial and diluent syringe to warm up to room temperature.
  • Remove the cap from the vial. Clean the rubber stopper with an alcohol swab.
  • Peel off the paper cover on the vial adapter plastic housing. Do not remove the adapter from the plastic housing. Place over the vial and firmly press down. The adapter will snap over the vial cap. Do not remove the adapter housing.
  • Attach the prefilled syringe to the vial adapter. Hold the plunger rod by the top plate. Do not touch the sides and thread of the plunger rod. Attach the plunger rod by turning it clockwise. Inject the diluent slowly by pushing down on the plunger rod.
  • Swirl the vial gently to dissolve the medicine. Do not shake. Do not use it if the mixture is cloudy or has particles in it.
  • While holding the plunger down, turn the vial upside down. Tilt the vial to the side and back to make sure all mixture has been drawn toward the opening. Detach the syringe by turning it counter-clockwise.
  • Give the injection as directed by your doctor. Follow instructions for the infusion set provided.
  • If you are using more than one bottle of medicine for your dose, prepare the second bottle the same way. Add the mixture from the second bottle to the same syringe.
• 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.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. You may store the medicine at room temperature for up to 6 months. Do not put it back in the refrigerator. Throw the medicine away after 6 months.

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 von Willebrand disease.
• 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
• Unexplained bleeding

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

• Fever, cough, headache
• Pain, itching, burning, redness, swelling, or a lump under your skin where the needle is placed
• Stomach pain

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

Last Updated: 7/10/2025