Hemofil M

— THERAPEUTIC CATEGORIES —
  • Bleeding disorders

Hemofil M Generic Name & Formulations

General Description

Antihemophilic Factor VIII (human) 220–400 IU, 401–800 IU, 801–1700 IU, 1701–2000 IU; per bottle; dried concentrate for IV infusion after reconstitution; contains albumin.

Pharmacological Class

Clotting factor.

How Supplied

Single-dose bottle—1 (w. diluent, needles)

Hemofil M Indications

Indications

Prevention and control of hemorrhagic episodes in Hemophilia A.

Hemofil M Dosage and Administration

Adults and Children

Dosage Required (IU) = Body Weight (kg) × Desired % Factor VIII Increase × 0.5. Individualize. Infuse at rate of up to 10mL/min. Monitor pulse rate; if increased significantly, reduce infusion rate or hold. Hemorrhage: Mild: obtain 20–40% FVIII increase; give every 12–24hrs for 1–3 days until resolved. Moderate: obtain 30–60% FVIII increase; give every 12–24hrs for 3 days or until pain or disability resolved. Life-threatening: obtain 60–100% FVIII increase; give every 8–24hrs until resolved. Surgery: Minor: obtain 60–80% FVIII increase; give single infusion plus oral antifibrinolytic therapy within 1 hour; Major: pre- and post-op: obtain 80–100% FVIII increase; repeat every 8–24hrs based on healing.

Hemofil M Contraindications

Contraindications

Mouse protein sensitivity.

Hemofil M Boxed Warnings

Not Applicable

Hemofil M Warnings/Precautions

Warnings/Precautions

Not for von Willebrand's disease. Confirm Factor VIII deficiency prior to treatment. Contains human plasma; monitor for possible infection transmission. Monitor for development of Factor VIII inhibitors. Latex allergy. Pregnancy (Cat.C).

Hemofil M Pharmacokinetics

See Literature

Hemofil M Interactions

Not Applicable

Hemofil M Adverse Reactions

Adverse Reactions

Allergic reactions, nausea, fever, chills, urticaria, antibody formation.

Hemofil M Clinical Trials

See Literature

Hemofil M Note

Notes

Report all infections suspected to be transmitted by Hemofil M to (800) 423-2862.

Hemofil M Patient Counseling

See Literature