Monograph Details
|
|
Hematology
> Bleeding disorders
|
|
BEBULIN VH |
| Manufacturer |
|
Baxter |
| Legal Classification |
|
Rx
|
| Pharmacological Class |
|
Clotting factor. |
| Generic Name |
|
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. |
| Indications |
|
Prevention and control of bleeding in Hemophilia B. |
| Adults and Children |
|
See prescribing note for dosing equation. 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. |
| 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). |
| Adverse Reactions |
|
Hypersensitivity reactions, thrombosis, DIC. |
| Extra Text |
|
Note: Report all infections suspected to be transmitted by Bebulin VH to (800) 423-2862. |
| How Supplied |
|
Single-use vials—1 (w. diluent, needles) |
| Additional Resources |
|
• Related Prescribing Note |
|
|
|
|
