Antihemophilic Factor-von Willebrand Factor Complex

Antihemophilic Factor-von Willebrand Factor Complex is a prescription medication used for the treatment of hemophilia A and Von Willebrand disease. 

• Antihemophilic Factor-von Willebrand Factor Complex is available under various brand names: Alphanate, Humate P, Wilate

Common side effects of the Antihemophilic Factor-von Willebrand Factor Complex include:

• nosebleeds,
• rash,
• itching,
• numbness,
• tingling,
• headache,
• dizziness, and
• back pain

Serious side effects of Antihemophilic Factor-von Willebrand Factor Complex include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• chest pain,
• wheezing,
• lightheadedness,
• hot flashes when the injection is given,
• sudden numbness or weakness,
• slurred speech,
• problems with vision or balance,
• sudden cough,
• coughing up blood,
• pain, swelling, warmth, or redness in one or both legs,
• pale or yellowed skin,
• dark-colored urine,
• fever,
• confusion,
• weakness,
• bleeding from a wound or where the medicine was injected, and
• bleeding that is not controlled

Rare side effects of Antihemophilic Factor-von Willebrand Factor Complex include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

IV solution (lyophilized powder for reconstitution)

• 250 IU (Alphanate, Humate P)
• 450 IU FVIII/450 VWF:RCo (Wilate)
• 500 IU (Alphanate, Humate P)
• 900 IU FVIII/900 VWF:RCo (Wilate)
• 1000 IU (Alphanate, Humate P)
• 1500 IU (Alphanate)

Hemophilia A

Adult and pediatric dosage

• Wilate
  • On-demand hemorrhage treatment
  • Minor: 30-40 IU/kg IV every 12- 24 hours for at least 1 day until hemorrhage resolved
  • Moderate: 30-40 IU/kg IV every 12 to 24 hours for at least 3-4 days until hemorrhage resolved
  • Major: 35-50 IU/kg IV every 12 to 24 hours for at least 3-4 days until hemorrhage resolved
  • Life-threatening: 35-50 IU/kg IV every 8 to 12 hours until the threat has resolved
  • Routine prophylaxis
  • 20-40 IU/kg IV every 2-3 days
• Alphanate
  • Bleeding episode control
    • Minor: 15 IU/kg IV every 12 hours for 1-2 days until hemorrhage stops and healing achieved
    • Moderate: 25 IU/kg IV every 12 hours for 2-7 days (average) until healing achieved
    • Major: 40-50 IU/kg IV every 12 hours for at least 3-5 days until healing is achieved for up to 10 days; intracranial hemorrhage may require prophylaxis therapy for up to 6 months
• Surgery
  • Before surgery: 40-50 IU/kg IV once
  • After surgery: 30-50 IU/kg IV every 12 hours for the next 7-10 days, or until healing has been achieved
• Humate P
  • Minor hemorrhage: Loading dose is 15 IU/kg IV should achieve FVIII: C plasma level ~30% of normal; may repeat using 50% of loading dose once or twice daily for 1-2 days
  • Moderate hemorrhage: Loading dose is 25 IU/kg IV should achieve FVIII: C plasma level ~50% of normal, followed by 15 IU/kg q8-12hr for 1-2 days to maintain FVIII: C levels at 30% normal, and then the same dose once or twice daily for up to 7 days or until adequate wound healing
  • Life-threatening hemorrhage: 40-50 IU/kg IV initially, followed by 2-25 IU q8-12hr to maintain FVIII: C level at 80-100% of normal for 7 days, then continue the same dose once or twice daily for another 7 days to maintain FVIII: C level at 30-50% of normal
  • Infants and children: Safety and efficacy not established
• Adolescents
  • Below 84 kg: 50 IU/kg infused over 5 minutes; not to exceed 4200 IU/dose
  • Above 84 kg: 4200 IU IV infused over 5 min
  • If the attack symptoms persist, may administer a second dose at the recommended dose level (not to exceed 4200 IU/dose)
  • Not to exceed 2 doses/24 hr

Von Willebrand Disease

Adult and pediatric dosage

• Alphanate
  • Preoperative dose of 60 IU VWF: RCo/kg IV; maintenance dose is 40-60 IU VWF: RCo/kg IV at 8-12 hr intervals postoperative as clinically needed
  • Minor surgery/bleeding: 1-3 days; target FVIII activity is 40-50 IU/dL
  • Major surgery/bleeding: 3-7 days; target FVIII activity is 100 IU/dL
• Humate P
  • VWD type 1, mild (major hemorrhage): Loading dose of 40-60 IU/kg IV, then 40-50 IU/kg every 8 to 12 hours for 3 days to keep trough level of VWF: RCo above 50%; then 40-50 IU/kg/day for up to 7 days
  • VWD type 1, moderate or severe (minor hemorrhage): 40-50 IU/kg IV x1-2 doses
  • VWD type 1, moderate or severe (major hemorrhage): Loading dose of 50-75 IU/kg IV, then 40-60 IU/kg q8-12hr for 3 days to keep trough level of VWF: RCo >50%; then 40-60 IU/kg/day for up to 7 days
  • VWD type 2 and 3 (minor hemorrhage): 40-50 IU/kg IV x1-2 doses
  • VWD type 2 and 3 (major hemorrhage): Loading dose of 60-80 IU/kg IV, then 40-60 IU/kg every 8 to 12 hours for 3 days to keep trough level of VWF: RCo above 50%; then 40-60 IU/kg/day for up to 7 days
  • Major surgery: IU = Target peak plasma (100 IU/dL) – baseline plasma VWF: RCo x kg / incremental recovery
  • Minor/oral surgery: IU = Target peak plasma (50-60 IU/dL) – baseline plasma VWF: RCo x kg / incremental recovery
• Wilate
  • Minor hemorrhage: Loading dose is 20-40 IU/kg IV, then 20-30 IU/kg every 12 to 24 hours; VWF: RCo and FVIII trough level of above 30% normal, may continue for up to 3 days
  • Major hemorrhage: Loading dose is 40-60 IU/kg IV, then 20-40 IU/kg every 12 to 24 hours; VWF: RCo and FVIII trough level of above 50% normal, may continue for 5-7 days
  • Minor surgeries: Loading dose is 30-60 IU/kg IV, then 15-30 IU/kg every 12 to 24 hours VWF: RCo and FVIII trough level of above 30% normal, may continue until wound healing achieved for up to 3 days
  • Major surgeries: Loading dose is 40-60 IU/kg IV, then 20-40 IU/kg every 12 to 24 hours; VWF: RCo and FVIII trough level of above 50% normal, may continue until wound healing achieved for up to 6 days or more

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, 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.

• Antihemophilic Factor-von Willebrand Factor Complex has no noted severe interactions with any other drugs.
• Antihemophilic Factor-von Willebrand Factor Complex has no noted serious interactions with any other drugs.
• Antihemophilic Factor-von Willebrand Factor Complex has no noted moderate interactions with any other drugs.
• Antihemophilic Factor-von Willebrand Factor Complex has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Antihemophilic Factor-von Willebrand Factor Complex?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Antihemophilic Factor-von Willebrand Factor Complex?”

Cautions

• May cause hypersensitivity reactions, including anaphylaxis
• Procoagulant activity-neutralizing antibodies have been detected; suspect this if FVIII activity levels are not attained, or if bleeding is not controlled
• Thromboembolic events reported in patients with VWD receiving AHF-vWF Complex
• Massive doses may result in acute hemolytic anemia
• Made from pooled human plasma; risk of transmitting infectious agents (e.g., viruses, CJD)

Pregnancy & Lactation

• Data are limited regarding the use in pregnant women to inform a drug-associated risk
• Animal reproduction studies have not been conducted
• Do not administer to pregnant women unless needed
• Lactation
  • No human or animal data are available; use only if needed