BEBULIN [Factor IX Complex] Nanofiltered and Vapor Heated

The information contained in this page is intended for Singapore healthcare professionals only.

Indications

BEBULIN is indicated for the prevention and control of hemorrhagic episodes in hemophilia B patients.
BEBULIN is not indicated for use in the treatment of factor VII deficiency. No clinical studies have been conducted to show benefit from this product for treating deficiencies other than Factor IX deficiency.1

Important Risk Information for BEBULIN

The risk of thromboembolic complications including disseminated intravascular coagulation (DIC) and hyperfibrinolysis is present with the administration of Factor IX Complex, particularly in the postoperative period and in patients with risk factors predisposing to thrombosis.

BEBULIN is made from human plasma. It may carry a risk of transmitting infectious agents, e.g. viruses and theoretically the Creutzfeldt‐Jakob disease (CJD) agent.

Severe hypotensive reactions, such as anaphylactic shock, require immediate intervention using current principles of shock therapy. Have epinephrine available for immediate administration, if appropriate, in the event of an anaphylactic reaction to BEBULIN.

In patients with risk factors predisposing to thrombosis, do not raise the Factor IX level to more than approximately 60% of normal and monitor for the possible development of DIC and/or thrombosis.

Anaphylactoid or anaphylactic reactions may occur following infusion of BEBULIN. The occurrence of these reactions (e.g. fever, urticarial rashes, nausea, retching, dyspnea, anaphylactic shock) necessitates the interruption of replacement therapy.

Disposal and Recycling

After using BEBULIN, dispose of the empty vial, reconstitution device and syringe in a Sharps container.

References

1. BEBULIN Prescribing Information. Westlake Village, CA; Baxter Healthcare Corporation. April 2011.

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