Factor VIII, Human Plasma Derived

Factor VIII, human plasma derived is used to treat hemorrhage due to hemophilia A.

Factor VIII, human plasma derived is available under the following different brand names: Monoclate-P, Hemofil M, Koate DVI, and Antihemophilic Factor (Human).

Dosages of Factor VIII, Human Plasma Derived:

Dosage Forms and Strengths

Solution Reconstituted

• 250 IU
• 500 IU
• 1000 IU
• 1500 IU

Dosage Considerations – Should be Given as Follows:

Hemophilia A

• Minor hemorrhage: 15 IU/kg loading dose to achieve FVIII:C plasma level approximately 30% of normal; THEN may administer half of loading dose once daily or every 12 hours for 1-2 days if a second infusion necessary
• Moderate hemorrhage/minor surgery: 25 IU/kg loading dose to achieve FVIII:C plasma level approximately 50% of normal; THEN administer FVIII:C 15 IU/kg intravenously (IV) every 8-12 hours for 1-2 days to maintain plasma levels of FVIII:C at 30% of normal; repeat dose once daily or every 12 hours 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 IV every 8-12 hours to maintain plasma levels of FVIII:C at 80-100% of normal for 7 days; continue dose once daily or every 12 hours for up to 7 days to maintain FVIII: C levels at 30% to 50% normal
• Administration
• Administer at 2 mL/minute, with maximum rate of 10 mL/minute
• Monitor for tachycardia
• Monitor Factor VIII levels

Dosage Forms and Strengths

Solution Reconstituted

• 250 IU
• 500 IU
• 1000 IU
• 1500 IU

Dosage Considerations – Should be Given as Follows:

Hemophilia A

• Minor hemorrhage: 15 IU/kg loading dose to achieve FVIII: C plasma level approximately 30% of normal; THEN may administer half of the loading dose once daily or every 12 hours for 1-2 days if a second infusion is necessary
• Moderate hemorrhage/minor surgery: 25 IU/kg loading dose to achieve FVIII: C plasma level approximately 50% of normal; THEN administer FVIII: C 15 IU/kg intravenously (IV) every 8-12 hours for 1-2 days to maintain plasma levels of FVIII: C at 30% of normal; repeat dose once daily or every 12 hours for up to 7 days or until adequate wound healing achieved
• Severe hemorrhage/major surgery: 40-50 IU/kg loading dose THEN administer FVIII: C 20-25 IU/kg IV every 8-12 hours to maintain plasma levels of FVIII: C at 80-100% of normal for 7 days; continue dose once daily or every 12 hours for up to 7 days to maintain FVIII: C levels at 30% to 50% normal
• Administration
• Administer at 2 mL/minute, with a maximum rate of 10 mL/minute
• Monitor for tachycardia
• Monitor Factor VIII levels

Side effects of factor VIII, human plasma-derived include:

• Headache
• Drowsiness
• Lethargy
• Fever
• Blurred vision
• Chills
• Fast heart rate
• Nausea
• Vomiting
• Anaphylaxis
• Stinging at the infusion site
• Hives

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Factor VIII, human plasma-derived has no listed severe interactions with other drugs.
• Factor VIII, human plasma-derived has no listed serious interactions with other drugs.
• Factor VIII, human plasma-derived has no listed moderate interactions with other drugs.
• Factor VIII, human plasma-derived has no listed mild interactions with other drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

• This medication contains factor VIII, human plasma-derived. Do not take Monoclate-P, Hemofil M, Koate DVI, or Antihemophilic Factor (Human) if you are allergic to factor VIII, human plasma-derived, or any ingredients contained in this drug.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity

Effects of Drug Abuse

• No information available

Short-Term Effects

• See "What Are Side Effects Associated with Using Factor VIII, Human Plasma Derived?”

Long-Term Effects

• See "What Are Side Effects Associated with Using Factor VIII, Human Plasma Derived?”

Cautions

• Administer at a rate less than 10 mL/minute
• The theoretical possibility of pathogen transmission
• The risk of thromboembolic event increased with each use
• The patient may develop neutralizing antibodies to factor VIII
• Dose requirements will vary in patients with factor VIII inhibitors

Pregnancy and Lactation

• Use factor VIII, human plasma-derived with caution during pregnancy if benefits outweigh risks. Animal studies show risk and human studies are not available or neither animal nor human studies were done.
• It is unknown if factor VIII, human plasma-derived is excreted into breast milk. Use caution while breastfeeding.