Antihemophilic Factor (Recombinant), Porcine Sequence

Antihemophilic Factor (Recombinant), Porcine Sequence is a prescription medication used to treat bleeding episodes in adults with acquired hemophilia A (acquired Factor VIII [FVIII] deficiency).

Antihemophilic Factor (Recombinant), Porcine Sequence is an antihemophilic factor that temporarily replaced substances naturally produced by the body to control bleeding.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

The most common side effect of Antihemophilic Factor (Recombinant), Porcine Sequence is the development of inhibitors to the active ingredient of Antihemophilic Factor (Recombinant)

Antihemophilic Factor (Recombinant), Porcine Sequence may be found in some form under the following brand names:

• Obizur

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Antihemophilic Factor (Recombinant), Porcine Sequence falls into category C. No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Antihemophilic Factor (Recombinant), Porcine Sequence should be given to a pregnant woman only if clearly needed.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight

The dose and frequency of Antihemophilic Factor (Recombinant), Porcine Sequence will be adjusted on the basis of the severity and location of acute bleeding episodes and patient’s clinical condition.

• Store Antihemophilic Factor (Recombinant), Porcine Sequence at refrigeration temperature of 2° to 8°C [36° to 46°F]. Do not freeze.
• Store vials in the original package to protect from light.
• Do not use beyond the expiration date printed on the carton or vial.
• Use Antihemophilic Factor (Recombinant), Porcine Sequence within 3 hours after reconstitution. Discard any unused reconstituted product if not used within 3 hours after reconstitution.
• Do not use Antihemophilic Factor (Recombinant), Porcine Sequence if the reconstituted solution is cloudy or has particulate matter.

Acquired Hemophilia A

Treatment and prevention of bleeding episodes in patients with acquired hemophilia A, a condition caused by the development of autoantibodies (inhibitors) to antihemophilic factor (blood coagulation factor VIII).1 2 3 4

Because of reduced cross-reactivity (about 5–10%) with human factor VIII inhibitors, may be useful in situations where human antihemophilic factor concentrates are ineffective.6 7 8 14 15

Designated an orphan drug by FDA for treatment and prevention of bleeding in patients with inhibitor antibodies to human coagulation factor VIII.2

Manufacturer states that safety and efficacy not established in patients with baseline anti-porcine factor VIII inhibitor titers >20 Bethesda Units.1

Manufacturer states that drug not indicated for treatment of patients with congenital hemophilia A or von Willebrand disease.1

Formal pharmacokinetic studies not conducted.3

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.