Antihemophilic Factor (Recombinant [Porcine Sequence])

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• 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.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take antihemophilic factor or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to antihemophilic factor. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

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

Solution Reconstituted, Intravenous:

Obizur: 500 units (1 ea) [contains mouse (murine) and/or hamster protein, polysorbate 80]

Acquired hemophilia A: IV: Note: Dose, dosing frequency, and duration based on location and severity of bleeding, target factor VIII levels, and clinical condition of the patient. Plasma levels of factor VIII should not exceed 200% of normal or 200 units/dL.

Minor to moderate hemorrhage: 200 units/kg initially to achieve factor VIII plasma level 50% to 100% of normal; titrate subsequent doses to maintain recommended factor VIII trough levels and individual clinical response; dose every 4 to 12 hours (frequency may be adjusted based on clinical response/factor VIII levels).

Major hemorrhage: 200 units/kg initially to achieve factor VIII plasma level 100% to 200% (for acute bleed) or 50% to 100% (after acute bleed is controlled, if required) of normal; titrate subsequent doses to maintain recommended factor VIII trough levels and individual clinical response; dose every 4 to 12 hours (frequency may be adjusted based on clinical response/factor VIII levels).

There are no dosage adjustments provided in the manufacturer’s labeling.

Heart rate and blood pressure (before and during IV administration); plasma factor VIII activity prior to and during treatment (30 minutes and 3 hours after initial dose; 30 minutes after subsequent doses); development of factor VIII inhibitors; signs of bleeding; hemoglobin, hematocrit.