Antihemophilic factor and von willebrand factor complex (human)
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Dosing in kidney impairment
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Preparation and administration
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International Units (IU)/dL rise per International Unit (IU)/kg VWF:RCo administered. The administration of 1 International Unit (IU) of FVIII per kg body weight can be expected to lead to a rise in circulating VWF:RCo of approximately 5 International Units (IU)/dL. Table 2 provides dosing recommendations for adult and pediatric patients ( see also Pediatric Use [8.4] ). 2 [See table below.] Type 2 VWD (all variants) and Type 3 VWD Minor (clinical indications above) 40-50 IU/kg (1 or 2 doses).
Major (clinical indications above) Loading dose 60-80 IU/kg. Then 40-60 IU/kg every 8-12 hours for 3 days to keep the trough level of VWF:RCo >50%. Then 40-60 IU/kg daily for up to 7 days.
Reconstitution and Administration Humate-P is for intravenous (IV) use only. Inspect visually for particulate matter and discoloration prior to administration. Use either the Mix2Vial ™ filter transfer set provided with Humate-P ( see How Supplied/Storage and Handling [16] ) or a commercially available double-ended needle and vented filter spike.
Plastic disposable syringes are recommended for use with Humate-P. Protein solutions of this type tend to adhere to the ground glass surface of all-glass syringes. [See table below.] When the reconstitution procedure is followed precisely, it is not uncommon for a few small flakes or particles to remain. The Mix2Vial should remove those particles.
Do not refrigerate Humate-P after reconstitution. Administer within 3 hours after reconstitution. Slowly infuse the solution (maximally 4 mL/minute) with a suitable IV administration set. Discard the administration equipment and any unused Humate-P after use. Figure Figure Figure Figure Figure Figure Figure Figure
| Hemorrhagic Event | Dosage (IU FVIII:C/kg Body Weight) |
|---|---|
| IU = International Units. | |
| Minor hemorrhage: Early joint or muscle bleed Severe epistaxis | Loading dose 15 IU FVIII:C/kg to achieve a FVIII:C plasma level of approximately 30% of normal; one infusion may be sufficient. If needed, half of the loading dose may be given once or twice daily for 1-2 days. |
| Moderate hemorrhage: Advanced joint or muscle bleed Neck, tongue, or pharyngeal hematoma (without airway compromise) Tooth extraction Severe abdominal pain | Loading dose 25 IU FVIII:C/kg to achieve a FVIII:C plasma level of approximately 50% of normal, followed by 15 IU FVIII:C/kg every 8-12 hours for the first 1-2 days to maintain the FVIII:C plasma level at 30% of normal. Continue the same dose once or twice daily for up to 7 days or until adequate wound healing is achieved. |
| Life-threatening hemorrhage: Major surgery Gastrointestinal bleeding Neck, tongue, or pharyngeal hematoma (with potential for airway compromise) Intracranial, intraabdominal, or intrathoracic bleeding Fractures | Initially 40-50 IU FVIII:C/kg, followed by 20-25 IU FVIII:C/kg every 8 hours to maintain the FVIII:C plasma level at 80-100% of normal for 7 days. Continue the same dose once or twice daily for another 7 days to maintain the FVIII:C level at 30-50% of normal. |
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- Antihemophilic factor and von willebrand factor complex (human)
Label text (1 paragraph)
None reported.
Contraindications
Humate-P is contraindicated in individuals who have had an anaphylactic or severe systemic reaction to antihemophilic factor or von Willebrand factor preparations. Anaphylactic or severe systemic reaction to antihemophilic factor or VWF preparations ( 4 ).
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for antihemophilic factor and von willebrand factor complex (human). Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Pregnancy Category C. Animal reproduction studies have not been conducted with Humate-P. It is also not known whether Humate-P can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Humate-P should be given to a pregnant woman only if clearly needed.
Lactation
8.3 Nursing Mothers It is not know whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Humate-P is administered to a nursing woman.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
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