Hemofil M Generic Name & Formulations
Legal Class
Rx
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)
Manufacturer
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