What is Obizur, and how does it work?

Generic drug: antihemophilic factor (recombinant), porcine sequence

Brand name: Obizur

Obizur [antihemophilic factor (recombinant), porcine sequence] is a recombinant DNA derived, antihemophilic factor indicated for the treatment of bleeding episodes in adults with acquired hemophilia A.

What are the side effects of Obizur?

Common side effects of Obizur include: 

  • development of inhibitors to porcine factor VIII,
  • flushing of the face,
  • headache,
  • nausea,
  • fast heartbeat, and injection site reactions (burning, redness, or irritation),
  • fever, and
  • chills.

What is the dosage for Obizur?

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.

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.

Table 1 Dosing for On-Demand Treatment and Control of Bleeding Episodes

Type of BleedingFactor VIII Level Required (Units per dL or % of normal)Initial Dose (Units per kg)Subsequent DoseFrequency and Duration of Subsequent Dosing
Minor and Moderate
Superficial muscle/no neurovascular compromise, and joint
50 to100200Titrate subsequent doses to maintain recommended factor VIII trough levels and individual clinical responseDose every 4 to 12 hours, frequency may be adjusted based on clinical response and measured factor VIII levels
Major
Moderate to severe intramuscular bleeding, retroperitoneal, gastrointestinal, intracranial
100 to 200 (To treat an acute bleed) 50 to100 (After acute bleed is controlled, if required)200Titrate subsequent doses to maintain recommended factor VIII trough levels and individual clinical responseDose every 4 to 12 hours, frequency may be adjusted based on clinical response and measured factor VIII levels

What drugs interact with Obizur?

No Information Provided

Is Obizur safe to use while pregnant or breastfeeding?

  • There are no data with Obizur use in pregnant women to inform a drug-associated risk.
  • There are no adequate and well-controlled studies in pregnant women.
  • There is no information regarding the presence of Obizur in human milk, the effect on the breastfed child, or the effects on milk production.
  • The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Obizur and any potential adverse effects on the breastfed child from Obizur or from the underlying maternal condition.

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Summary

Obizur [antihemophilic factor (recombinant), porcine sequence] is a recombinant DNA derived, antihemophilic factor indicated for the treatment of bleeding episodes in adults with acquired hemophilia A. Common side effects of Obizur include development of inhibitors to porcine factor VIII, flushing of the face, headache, nausea, fast heartbeat, and injection site reactions (burning, redness, or irritation), fever, and chills.

Treatment & Diagnosis

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Medically Reviewed on 2/22/2021
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All sections courtesy of the U.S. Food and Drug Administration