Antihemophilic Factor (Recombinant [Pegylated])

• It is used to treat hemophilia.
• It is used to treat or prevent bleeding.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Allergic side effects may rarely happen.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Call the doctor right away if the normal dose does not work as well.
• Talk with the doctor before you travel. You will need to bring enough of antihemophilic factor for use during travel.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Use antihemophilic factor as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a vein.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• Follow how to use as you have been told by the doctor or read the package insert.
• Wash hands before and after use.
• If stored in a refrigerator, let this medicine come to room temperature before mixing. Do not heat antihemophilic factor.
• This medicine needs to be mixed before use. Follow how to mix as you were told by the doctor.
• Do not shake.
• After mixing, do not refrigerate.
• Use within 3 hours of making.
• Do not use if the solution is cloudy, leaking, or has particles.
• Do not use if solution changes color.
• Throw away any part of opened vial not used after use.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

• Store unopened vials in a refrigerator. Do not freeze.
• Store in original container.
• Protect from light.
• May also store unopened vials at room temperature. If stored at room temperature, throw away any unused vials after 3 months.
• If stored at room temperature, make a note of the date it was placed at room temperature.
• Do not put this medicine back in the refrigerator after it has been stored at room temperature.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• AHF (Recombinant [Pegylated])
• Factor VIII (Recombinant [Pegylated])

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous:

Adynovate: 250 units (1 ea); 500 units (1 ea); 750 units (1 ea); 1000 units (1 ea); 1500 units (1 ea); 2000 units (1 ea) [contains mouse (murine) and/or hamster protein, polysorbate 80]

Adynovate: 3000 units (1 ea) [contains polysorbate 80]

• Antihemophilic Agent

Hypersensitivity reactions, heart rate and blood pressure (before and during IV administration); plasma factor VIII activity prior to and during treatment using a one-stage clotting assay to confirm adequate factor VIII levels have been achieved and maintained); development of factor VIII inhibitors using the Bethesda inhibitor assay; signs of bleeding; hemoglobin, hematocrit.

Animal reproduction studies have not been conducted. Factor VIII concentrations may increase in pregnant women with coagulation disorders. Pregnant women should have clotting factors monitored, particularly at 28 and 34 weeks gestation and prior to invasive procedures. Prophylaxis may be needed if concentrations are <50 units/mL at term and treatment should continue for 3 to 5 days postpartum depending on route of delivery. The neonate may also be at an increased risk of bleeding following delivery and should be tested for the coagulation disorder (Kadir 2009; Lee 2006). Although recombinant products are generally preferred when therapy in pregnancy is needed, initial studies conducted with the pegylated product were done only in males (Konkle 2015).