Daily Medication Pearl: Humate-P

Medication Pearl of the Day: Humate-P

Indication: Humate-P is a stable, purified, sterile, lyophilized concentrate of an Antihemophilic Factor (Human) and von Willebrand Factor (VWF) (Human) complex indicated for the treatment of adult patients with classical hemophilia (hemophilia A) and von Willebrand disease (VWD). Purified from the cold insoluble fraction of pooled human fresh-frozen plasma, Humate-P contains highly purified and concentrated Antihemophilic Factor/von Willebrand Factor Complex (Human).

Furthermore, Humate-P contains a high degree of purity and a low quantity of non-factor proteins, with fibrinogen at less than or equal to 0.2 mg/mL. Additionally, Humate-P has a potency that is a higher factor than cryoprecipitate preparations.

Humate-P can also be used for pediatric patients with VWD in the treatment of spontaneous and trauma-induced bleeding episodes, and the prevention of excessive bleeding during and after surgery.

Insight:

• Dosing: Individualize dosage based on the patient’s weight, type, and severity of hemorrhage, factor VIII (FVIII) level, and the presence of inhibitors.
• Dosage forms: Humate-P is available as a lyophilized powder in single-dose vials that contain the labeled amount of VWF:Ristocetin Cofactor (RCo) and FVIII activity expressed in IU. The average ratio of VWF:RCo to FVIII is 2.4:1.
  • VWF: RCo/vial FVIII/vial Diluent
  • 600 IU, 250 IU, 5 mL
  • 1200 IU, 500 IU, 10 mL
  • 2400 IU, 1000 IU, 15 mL
• Adverse events (AEs): Most common AEs from Humate-P observed by more than 5% of subjects include allergic-anaphylactic reactions (eg, urticaria, chest tightness, rash, pruritus, edema) and, in patients undergoing surgery, postoperative wound and injection-site bleeding, and epistaxis.
• Mechanism of action: The active components of Humate-P consist of 2 different noncovalently bound proteins (FVIII and VWF). FVIII is an essential cofactor in activation of factor X, leading ultimately to the formation of thrombin and, subsequently, fibrin. VWF promotes platelet aggregation and platelet adhesion on damaged vascular endothelium; activated platelets interact with clotting proteins to form a clot. VWF also serves as a stabilizing carrier protein for the procoagulant protein FVIII. The activity of VWF is measured as VWF:RCo.

Reference: Humate-P-Prescribing-Information.pdf (cslbehring.com)