HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Humate-P safely and effectively. See full prescribing information for Humate-P.
Humate-P
Antihemophilic Factor/von Willebrand Factor Complex (Human)
Lyophilized Powder for Reconstitution for Intravenous Use Only.
Initial U.S. Approval: 1986
INDICATIONS AND USAGE
Humate-P is an Antihemophilic Factor/von Willebrand Factor (VWF) Complex (Human) indicated for:
Hemophilia A – Treatment and prevention of bleeding in adults (1.1).
Von Willebrand disease (VWD) – in adults and pediatric patients in the
(1)
Treatment of spontaneous and trauma-induced bleeding episodes, and
(2)
Prevention of excessive bleeding during and after surgery.
This applies to patients with severe VWD as well as patients with mild to moderate VWD where the use of desmospressin is known or suspected to be inadequate (1.2). Humate-P is not indicated for the prophylaxis of spontaneous bleeding episodes in VWD.
DOSAGE AND ADMINISTRATION
For intravenous use only.
Hemophilia A
One IU of factor VIII (FVIII) activity per kg body weight increases the circulating FVIII level by approximately 2.0 IU/dL. Individualize dosage based on the patient's weight, type and severity of hemorrhage, FVIII level, and presence of inhibitors (see Table 1 for dosing recommendations) (2.1).
VWD
Treatment of bleeding episodes – Administer 40-80 IU VWF:Ristocetin Cofactor (RCo) per kg body weight every 8-12 hours (2.2).
Prevention of excessive bleeding during and after surgery for all types of VWD (2.3).
Type of Surgery
(see Table 3 for complete surgical dosing) Calculation of Loading Dose
Initial maintenance dose should be half the loading dose (see Table 4 for monitoring recommendations).
IU = International Units.
BW = body weight.
*
Δ = Target peak plasma VWF:RCo level – baseline plasma VWF:RCo level.
†
IVR = in vivo recovery as measured in the patient. If the IVR is unknown, use 2.0 IU/dL per IU/kg.
‡
Oral surgery is defined as extraction of fewer than three teeth, if the teeth are non-molars and have no bony involvement.
Major Surgery (2.3) Δ* VWF:RCo × BW (kg)
IVR† = IU VWF:RCo required
Minor/Oral Surgery‡ (2.3) Δ* VWF:RCo × BW (kg)
IVR = IU VWF:RCo required
Emergency Surgery (2.3) Administer a dose of 50-60 IU VWF:RCo/kg BW
DOSAGE FORMS AND STRENGTHS
Each vial of Humate-P lyophilized powder contains the labeled amount of VWF:RCo and FVIII activity expressed in IU1. The average ratio of VWF:RCo to FVIII is 2.4:1. Approximate potencies are shown below; check each carton/vial for the actual potency prior to reconstitution (3):
VWF:RCo/vial FVIII/vial Diluent
* IU = International Units.
600 IU 250 IU 5 mL
1200 IU 500 IU 10 mL
2400 IU 1000 IU 15 mL
CONTRAINDICATIONS
Anaphylactic or severe systemic reaction to antihemophilic factor or VWF preparations (4).
WARNINGS AND PRECAUTIONS
VWD patients receiving Humate-P may be at risk of developing thromboembolic events (5.1).
Monitor for intravascular hemolysis and decreasing hematocrit values in patients with A, B, and AB blood groups who are receiving large or frequent doses (5.2).
Monitor VWF:RCo and FVIII levels in VWD patients, especially those undergoing surgery (5.3).
Products made from human plasma may contain infectio