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Antihemophilic Factor (Recombinant), Porcine Sequence

Class: Hemostatics
Brands: Obizur

Introduction

Antihemophilic factor (recombinant), porcine sequence is a hemostatic agent.

Uses for Antihemophilic Factor (Recombinant), Porcine Sequence

Antihemophilic factor (recombinant), porcine sequence has the following uses:

Antihemophilic factor (recombinant), porcine sequence is an antihemophilic factor indicated for the treatment of bleeding episodes in adults with acquired hemophilia A.1

Antihemophilic factor (recombinant), porcine sequence has the following limitations of use:

Safety and efficacy of antihemophilic factor (recombinant), porcine sequence have not been established in patients with a baseline anti-porcine factor VIII inhibitor titer of greater than 20 Bethesda Units (BU).1

Antihemophilic factor (recombinant), porcine sequence is not indicated for the treatment of congenital hemophilia A or von Willebrand disease.1

Antihemophilic Factor (Recombinant), Porcine Sequence Dosage and Administration

General

Antihemophilic factor (recombinant), porcine sequence is available in the following dosage form(s) and strength(s):

Lyophilized powder for solution in single-use vials containing nominally 500 units per vial.1

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

For intravenous use after reconstitution only1

  • Initial dose of antihemophilic factor (recombinant), porcine sequence is 200 units per kg.1

  • Titrate dose and frequency of administration based on factor VIII recovery levels and individual clinical response.1

Cautions for Antihemophilic Factor (Recombinant), Porcine Sequence

Contraindications

Do not use in patients who have had life-threatening hypersensitivity reactions to antihemophilic factor (recombinant), porcine sequence or its components, including hamster protein.1

Warnings/Precautions

Hypersensitivity Reactions

Hypersensitivity reactions can occur with antihemophilic factor (recombinant), porcine sequence. The drug contains trace amounts of hamster proteins. Early signs of allergic reactions, which can progress to anaphylaxis, include angioedema, chest-tightness, dyspnea, hypotension, wheezing, urticaria, and pruritus. Immediately discontinue administration and initiate appropriate treatment if allergic or anaphylactic-type reactions occur.1

Inhibitory Antibodies

Inhibitory antibodies to antihemophilic factor (recombinant), porcine sequence have occurred. Monitor patients for the development of antibodies to antihemophilic factor (recombinant), porcine sequence with appropriate assays. If the plasma factor VIII level fails to increase as expected, or if bleeding is not controlled after antihemophilic factor (recombinant), porcine sequence administration, suspect the presence of an anti-porcine factor VIII antibody. If such inhibitory antibodies to anti-porcine factor VIII are suspected and there is a lack of clinical response, consider other therapeutic options.1

Monitoring Laboratory Tests

  • Perform one-stage clotting assay to confirm that adequate factor VIII levels have been achieved and maintained. Monitor factor VIII activity 30 minutes and 3 hours after initial dose. Monitor factor VIII activity 30 minutes after subsequent doses.1

  • Monitor the development of inhibitory antibodies to antihemophilic factor (recombinant), porcine sequence. Perform a Nijmegen Bethesda inhibitor assay if expected plasma factor VIII activity levels are not attained or if bleeding is not controlled with the expected dose of antihemophilic factor (recombinant), porcine sequence. Use Bethesda Units (BU) to report inhibitor levels.1

Specific Populations

Pregnancy

Pregnancy category C.1

Animal reproduction studies have not been conducted with antihemophilic factor (recombinant), porcine sequence. It is also not known whether the drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Antihemophilic factor (recombinant), porcine sequence should be given to a pregnant woman only if clearly needed.1

Nursing Mothers

It is not known whether this drug is excreted into human milk. Because many drugs are excreted into human milk, caution should be exercised if antihemophilic factor (recombinant), porcine sequence is administered to nursing mothers.1

Pediatric Use

The safety and efficacy of antihemophilic factor (recombinant), porcine sequence have not been established in pediatric patients.1

Geriatric Use

Of the 29 subjects within the clinical trial evaluating antihemophilic factor (recombinant), porcine sequence, the average age was 70 years of age. Nineteen subjects were 65 years of age or older. Clinical studies suggest that antihemophilic factor (recombinant), porcine sequence is safe and effective in the adult population. While no differences were observed between geriatric and adult responses to the drug, these findings are inconclusive given the small number of subjects enrolled in either group.1

Dose adjustments in the geriatric population have not been studied. Specific hazards associated with the concomitant use of antihemophilic factor (recombinant), porcine sequence with other drugs in the elderly population have not been studied in the clinical trial.1

Common Adverse Effects

Common adverse reactions observed in greater than 5% of subjects in the clinical trial were development of inhibitors to porcine factor VIII.1

Drug Interactions

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Please see product labeling for drug interaction information.

Actions

Mechanism of Action

Antihemophilic factor (recombinant), porcine sequence temporarily replaces the inhibited endogenous factor VIII that is needed for effective hemostasis in patients with acquired hemophilia A.1

Advice to Patients

Patient Counseling Information

Advise patients to report any adverse reactions or problems following antihemophilic factor (recombinant), porcine sequence to their physician or healthcare provider.1

Additional Information

AHFS First Release. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

Preparations

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.

Antihemophilic Factor (Recombinant), Porcine Sequence

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

For Injection, for IV use only

Nominally 500 units

Obizur

Baxter Healthcare Corporation

AHFS Drug Information. © Copyright 2016, Selected Revisions September 13, 2016. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Baxter Healthcare Corporation. OBIZUR (ANTIHEMOPHILIC FACTOR PORCINE, B-DOMAIN TRUNCATED RECOMBINANT) prescribing information. 2014 Oct.

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