BEBULIN Rx

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BEBULIN

Bleeding disorders
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Generic Name and Formulations:

Coagulation Factor IX Complex (human) 500–700 IU; per vial; freeze-dried concentrate for IV infusion after reconstitution; contains Factors II, VII, X and heparin.

Company:

Baxalta

Select therapeutic use:

Indications for BEBULIN:

Prevention and control of bleeding in Hemophilia B.

Adults and Children:

Dosage Required (IU) = Body Weight (kg) × Desired Factor IX increase × 1.2 IU/kg. Max infusion rate: 2mL/min. Bleeding: minor: 20% increase (25–35 IU/kg) for 1 dose. Moderate: 40% increase ( 40–55 IU/kg) once, give 2nd dose after 24hrs (continue until resolved). Major: ≥60% increase (60–70 IU/kg) once daily for 2–3 days or until healed. Surgery: Give loading dose 1hr prior to surgery. May repeat dose every 12hrs initially then every 24hrs in late post-op period. Minor: Initially 40–60% (50–60 IU/kg), then 20–40% (25–55 IU/kg) for 1–2 weeks. Major: Initially ≥60% increase (70–95 IU/kg) then 20–60% (35–75 IU/kg) for 1–2 weeks, then 20% (25–35 IU/kg) until healed. Prophylaxis: 20–30 IU/kg 1–2 times weekly.

Warnings/Precautions:

Not for treating factor deficiencies other than Factor IX deficiency. Contains human plasma; monitor for possible infection transmission. Thromboembolic disorders; risk increased during post-op period; avoid FIX increases >60%; monitor for thrombosis, disseminated intravascular coagulation (DIC). Surgery. Pregnancy (Cat.C).

Pharmacological Class:

Clotting factor.

Adverse Reactions:

Hypersensitivity reactions, thrombosis, DIC.

Note:

Report all infections suspected to be transmitted by Bebulin to (866) 424-6724. Formerly known under the brand name Bebulin VH.

How Supplied:

Single-use vials—1 (w. diluent, needles)

BEBULIN single dose of 700iu kits (Qty:1)

appx. price $747.00