Factor VIII, human plasma derived (Monoclate-P, Hemofil M, Koate DVI, Antihemophilic Factor (Human))
Classes: Hemostatics; Coagulation Factors
Dosing and uses of Monoclate-P, Hemofil M (Factor VIII, human plasma derived)
Adult dosage forms and strengths
solution reconstituted
- 250 IU
- 500 IU
- 1000 IU
- 1500 IU
Hemophilia a
Minor hemorrhage: 15 IU/kg loading dose to achieve FVIII:C plasma level ~30% of normal; THEN may administer half of loading dose qDay or q12hr for 1-2 days if a second infusion necessary
Moderate hemorrhage/minor surgery: 25 IU/kg loading dose to achieve FVIII:C plasma level ~50% of normal; THEN administer FVIII:C 15 IU/kg IVq8-12hr for 1-2 days to maintain plasma levels of FVIII:C at 30% of normal; repeat dose qDay or q12hr for up to 7 days or until adequate would healing achieved
Severe hemorrhage/major surgery: 40-50 IU/kg loading dose THEN administer FVIII:C 20-25 IU/kg IVq8-12hr to maintain plasma levels of FVIII:C at 80-100% of normal for 7 days; continue dose qDay or q12hr for up to 7 days to maintain FVIII: C levels at 30% to 50% normaL
Administration
Administer at 2 mL/min, with maximum rate of 10 mL/min
Monitor for tachycardia
Monitor Factor VIII levels
Pediatric dosage forms and strengths
solution reconstituted
- 250 IU
- 500 IU
- 1000 IU
- 1500 IU
Hemophilia a
Minor hemorrhage: 15 IU/kg loading dose to achieve FVIII:C plasma level ~30% of normal; THEN may administer half of loading dose qDay or q12hr for 1-2 days if a second infusion necessary
Moderate hemorrhage/minor surgery: 25 IU/kg loading dose to achieve FVIII:C plasma level ~50% of normal; THEN administer FVIII:C 15 IU/kg IVq8-12hr for 1-2 days to maintain plasma levels of FVIII:C at 30% of normal; repeat dose qDay or q12hr for up to 7 days or until adequate would healing achieved
Severe hemorrhage/major surgery: 40-50 IU/kg loading dose THEN administer FVIII:C 20-25 IU/kg IVq8-12hr to maintain plasma levels of FVIII:C at 80-100% of normal for 7 days; continue dose qDay or q12hr for up to 7 days to maintain FVIII: C levels at 30% to 50% normaL
Administration
Administer at 2 mL/min, with maximum rate of 10 mL/min
Monitor for tachycardia
Monitor Factor VIII levels
Monoclate-P, Hemofil M (Factor VIII, human plasma derived) adverse (side) effects
Frequency not defined
Headache
Somnolence
Lethargy
Fever
Blurred vision
Chills
Tachycardia
Nausea
Vomiting
Anaphylaxis
Stinging at infusion site
Urticaria
Warnings
Contraindications
Hypersensitivity t
Cautions
Administer at a rate <10 mL/min
Theoretical possibility of pathogen transmission
Risk of thromboembolic event increased with each use
Patient may develop neutralizing antibodies to factor VIII
Dose requirements will vary in patients with factor VIII inhibitors
Pregnancy and lactation
Pregnancy category: C
Lactation: Excretion in milk unknown; use with caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Monoclate-P, Hemofil M (Factor VIII, human plasma derived)
Mechanism of action
Factor VIII derived from pooled human plasma, temporarily replaces missing clotting factor VIII which corrects and/or prevents bleeding in patients with hemophilia A
Pharmacokinetics
Onset: Immediated (shortening of bleeding time)
Half-life: 8-28 hr
Administration
IV Preparation
Reconstitute with the supplied sodium chloride diluent
Prevent excessive foaming
Gently rotate the vial to dissolve the powder
IV Administration
Administer using a single sterile disposable plastic syringe
Attach the syringe to the luer end of the infusion set tubing and perform venipuncture
Rate of administration should be determined by the pt's comfort leveL
Storage
Refrigerate (Humate-P can be stored at room temp for up to 2 yr)
Protect from freezing
Protect from light
