Obizur
Generic name:antihemophilic factor (recombinant), porcine sequence
Dosage form: injection
Drug class:Miscellaneous coagulation modifiers
Medically reviewed by Drugs.com. Last updated on Oct 1, 2021.
On This Page
- Indications and Usage
- Dosage and Administration
- Dosage Forms and Strengths
- Contraindications
- Warnings and Precautions
- Adverse Reactions/Side Effects
- Use In Specific Populations
- Description
- Clinical Pharmacology
- Nonclinical Toxicology
- Clinical Studies
- How Supplied/Storage and Handling
- Patient Counseling Information
Indications and Usage for Obizur
Obizur, Antihemophilic Factor (Recombinant), Porcine Sequence, is a recombinant DNA derived, antihemophilic factor indicated for the on-demand treatment and control of bleeding episodes in adults with acquired hemophilia A.
Limitations of Use:
- Safety and efficacy of Obizur has not been established in patients with baseline anti- porcine factor VIII inhibitor titer greater than 20 BU.
- Obizur is not indicated for the treatment of congenital hemophilia A or von Willebrand disease.
Obizur Dosage and Administration
For intravenous use after reconstitution only.
Dose
- Dose, dosing frequency, and duration of treatment with Obizur depend on the location and severity of bleeding episode, target factor VIII levels, and the patient's clinical condition. Monitor replacement therapy in cases of major surgery or life-threatening bleeding episodes.
- Each vial of Obizur has the recombinant porcine factor VIII potency in units stated on the vial.
- Patients may vary in their pharmacokinetic (e.g., half-life, in vivo recovery) and clinical responses. Titrate dose and frequency based on factor VIII recovery levels and individual clinical response.
- Initial dosing below the recommended 200 U/kg has been associated with lack of efficacy.
A guide for dosing Obizur for the on-demand treatment and control of bleeding episodes is provided in Table 1. Maintain the factor VIII activity within the target range. Plasma levels of factor VIII should not exceed 200% of normal or 200 units per dL.
