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Factor VIII, human plasma derived (Rx)Brand and Other Names:Monoclate-P, Hemofil M, more...Koate DVI, Antihemophilic Factor (Human)

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

solution reconstituted

  • 250 IU
  • 500 IU
  • 1000 IU
  • 1500 IU
more...

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

Dosage Forms & Strengths

solution reconstituted

  • 250 IU
  • 500 IU
  • 1000 IU
  • 1500 IU
more...

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

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Adverse Effects

Frequency Not Defined

Headache

Somnolence

Lethargy

Fever

Blurred vision

Chills

Tachycardia

Nausea

Vomiting

Anaphylaxis

Stinging at infusion site

Urticaria

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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

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Pregnancy & 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.

more...
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Pharmacology

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

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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

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Images

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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