Antihemophilic Factor (Recombinant), Porcine Sequence

Name: Antihemophilic Factor (Recombinant), Porcine Sequence

Antihemophilic Factor (Recombinant), Porcine Sequence Precautions

Serious side effects have been reported with Antihemophilic Factor (Recombinant), Porcine Sequence including the following:

  • Hypersensitivity reactions. Tell your healthcare provider right away if you have some or all of the following symptoms of hypersensitivity reactions.
    • swelling of the face, lips, or tongue
    • feeling of tightness in the chest
    • shortness of breath
    • decreased blood pressure
    • wheezing
    • rashes or hives
    • itching

Do not take Antihemophilic Factor (Recombinant), Porcine Sequence if you:

  • are allergic to Antihemophilic Factor (Recombinant), Porcine Sequence or to any of its ingredients, including hamster protein

Cautions for Antihemophilic Factor (Recombinant), Porcine Sequence

Contraindications

  • Life-threatening hypersensitivity reactions to antihemophilic factor (recombinant), porcine sequence or any of its components (e.g., hamster protein).1

Warnings/Precautions

Warnings

Development of Inhibitors to Porcine Factor VIII

Risk of development of inhibitory antibodies (inhibitors) to porcine factor VIII.1 Reported in approximately 26% of patients in principal efficacy study.1

Monitor patients for development of inhibitors with appropriate clinical observation and laboratory tests.1 (See Laboratory Monitoring under Cautions.) Suspect presence of inhibitors if patient fails to respond to adequate therapy.1 Consider other therapeutic options if inhibitors suspected and lack of response present.1

Laboratory Monitoring

Monitor factor VIII activity (with one-stage clotting assay) after each dose to confirm that adequate levels have been attained and maintained.1 Obtain plasma factor VIII level 30 minutes and 3 hours after initial dose, and 30 minutes after each subsequent dose.1

Monitor for development of inhibitors to porcine factor VIII.1 Perform appropriate laboratory test (i.e., modified version of Bethesda assay [Nijmegen]) to confirm presence of an inhibitor.1 (See Development of Inhibitors to Porcine Factor VIII under Cautions.)

Sensitivity Reactions

Hypersensitivity Reactions

Risk of hypersensitivity reactions.1

Contains trace amounts of baby hamster kidney (BHK) proteins, which may stimulate antibody production and cause hypersensitivity reactions; anti-BHK antibodies not detected in principal clinical study.1

Observe for manifestations of hypersensitivity (e.g., angioedema, chest tightness, dyspnea, hypotension, wheezing, urticaria, pruritus, anaphylaxis).1 If a hypersensitivity reaction occurs, immediately discontinue drug and initiate appropriate therapy.1

Specific Populations

Pregnancy

Category C.1

Lactation

Not known whether distributed into human milk; use with caution.1

Pediatric Use

Safety and efficacy not established in pediatric patients.1 Acquired hemophilia A occurs very rarely in children.10

Geriatric Use

No overall differences in efficacy and safety observed between geriatric patients ≥65 years of age and younger adults in principal clinical study; however, small number of patients in this age group precludes definitive conclusions.1

Common Adverse Effects

Development of inhibitors to porcine factor VIII.1

Actions

  • Biosynthetic (recombinant DNA origin) preparation of B domain-deleted porcine coagulation factor VIII.1 14 15 Structurally and functionally similar to endogenous human factor VIII.1 14 15

  • Patients with acquired hemophilia A have a functional deficiency of factor VIII due to the development of autoantibodies (inhibitors) against the coagulation factor, resulting in a hemorrhagic tendency.1 5 6 7 8 9 15 Typical bleeding pattern includes bleeding into skin, muscles, soft tissues, and/or mucous membranes; hemarthrosis occurs less frequently, unlike in patients with congenital hemophilia A.5 6 7 8

  • Antihemophilic factor (recombinant), porcine sequence therapy temporarily replaces the inhibited factor VIII required for effective hemostasis in patients with acquired hemophilia A.1 Reduced cross-reactivity (about 5–10%) to human factor VIII inhibitors enables the drug to function effectively in the presence of autoantibodies to factor VIII.3 6 7 8 14 15

  • Produced by recombinant DNA technology in a BHK cell line; undergoes a series of purification and viral inactivation/removal processes (e.g., solvent/detergent treatment, nanofiltration).1 3 15 Final preparation is free of additives of human or animal origin.1

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