HUMATE-P®

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Product Information

Hemophilia A – Treatment and prevention of bleeding in adults.
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 desmopressin is known or suspected to be inadequate. HUMATE-P is not indicated for the prophylaxis of spontaneous bleeding episodes in VWD.

Anaphylactic or severe systemic reaction to antihemophilic factor or VWF preparations.

Hemophilia A

One International Unit (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 (2.1).

VWD

Treatment of bleeding episodes – 40-80 IU VWF:Ristocetin Cofactor (RCo) per kg body weight (BW) every 8-12 hours.
Prevention of excessive bleeding during and after surgery for all types of VWD

Type of Surgery (see Full Prescribing Information for monitoring recommendations)	Calculation of Loading Dose Initial maintenance dose should be half the loading dose (see Full Prescribing Information for monitoring recommendations)
Major Surgery (2,3)	Δ * VWF:RCo x BW (kg) = IU VWF:RCo required IVR†
Minor/Oral Surgery^‡ (2,3)	Δ * VWF:RCo x BW (kg) = IU VWF:RCo required IVR
Emergency Surgery (2,3)	Administer a dose of 50-60 IU VWF:RCo/kg BW

^{* 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}

HUMATE-P is for intravenous use only.
HUMATE-P is available as a lyophilized powder in single-dose vials that contain the labeled amount of VWF:RCo and FVIII activity expressed in IU. The average ratio of VWF:RCo to FVIII is 2.4:1.
Do not refrigerate HUMATE-P after reconstitution. Administer within 3 hours after reconstitution.
Slowly infuse the solution (maximally 4 mL/minute) with a suitable intravenous administration set.