Humate-p

Humate-p

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Uses

1.1 Hemophilia A

Humate-P, Antihemophilic Factor/von Willebrand Factor Complex (Human), is indicated for treatment and prevention of bleeding in adults with hemophilia A (classical hemophilia).

1.2 Von Willebrand Disease (VWD)

Humate-P is also indicated in adult and pediatric patients with von Willebrand disease (VWD) for:

(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 use of desmopressin (DDAVP) is known or suspected to be inadequate.
Controlled clinical trials to evaluate the safety and efficacy of prophylactic dosing with Humate-P to prevent spontaneous bleeding have not been conducted in VWD subjects [see Clinical Studies (14)].

History

There is currently no drug history available for this drug.

Other Information

Humate-P, Antihemophilic Factor/von Willebrand Factor Complex (Human), is a purified, sterile, lyophilized concentrate of Factor VIII (FVIII) and von Willebrand Factor (VWF) (Human) for intravenous administration in the treatment of patients with classical hemophilia (hemophilia A) and VWD [see Clinical Pharmacology (12)].

Humate-P is purified from the cold insoluble fraction of pooled human plasma. The pooled human plasma used to produce Humate-P is collected from licensed facilities in the United States (US). All source plasma used in the manufacture of Humate-P is tested by FDA-licensed Nucleic Acid Tests (NAT) for hepatitis C virus (HCV), human immunodeficiency virus-1 (HIV-1) and hepatitis B virus (HBV) and found to be nonreactive (negative).

Each vial of Humate-P contains the labeled amount of von Willebrand Factor:Ristocetin Cofactor (VWF:RCo) and FVIII activity expressed in International Units (IU) [see Dosage Forms and Strengths (3)], as defined by the current international standard established by the World Health Organization. One International Unit (IU) of VWF:RCo or FVIII is approximately equal to the amount of VWF:RCo or FVIII in 1.0 mL of fresh-pooled human plasma. The average ratio of VWF:RCo to FVIII is 2.4:1. Fibrinogen content in Humate-P is less than or equal to 0.2 mg/mL. Humate-P contains anti-A and anti-B blood group isoagglutinins [see Warnings and Precautions (5.2)].

When reconstituted with the volume of Sterile Water for Injection, USP provided, each mL of Humate-P contains 72 to 224 International Units (IU) VWF:RCo activity1, 40 to 80 International Units (IU) FVIII activity, 15 to 33 mg of glycine, 3.5 to 9.3 mg of sodium citrate, 2 to 5.3 mg of sodium chloride, 8 to 16 mg of Albumin (Human), 2 to 14 mg of other proteins, and 10 to 20 mg of total proteins. Humate-P contains no preservative.

The manufacturing procedure for Humate-P includes multiple processing steps that reduce the risk of virus transmission. The virus inactivation/removal capacity consists of four steps:

  • Cryoprecipitation
  • Al(OH)3 adsorption, glycine precipitation, and NaCl precipitation, studied in combination
  • Heat treatment at 60°C for 10 hours in aqueous solution
  • Lyophilization

The total cumulative virus reductions range from 6.0 to ≥11.7 log10 as shown in Table 7.

Table 7: Cumulative Virus Reduction Factors for Humate-P
Manufacturing Step Virus Reduction Factor (log10)
Enveloped Viruses Non-Enveloped Viruses
HIV-1 BVDV PRV WNV HAV CPV B19V
HIV-1, human immunodeficiency virus type 1, model for HIV-1 and HIV-2
BVDV, bovine viral diarrhea virus, model for HCV
PRV, pseudorabies virus, model for large enveloped DNA viruses
WNV, West Nile virus
HAV, hepatitis A virus
CPV, canine parvovirus, model for B19V
B19V, human parvovirus B19
ND, not determined
NA, not applicable
*
At 60°C for 10 hours in aqueous solution.
The virus evaluation studies for B19V employed a novel experimental infectivity assay using a clone of the cell line UT7 that contains erythropoietic progenitor cells; (residual) virus titer was determined using an immunofluorescence-based detection method.
Cryoprecipitation ND ND 1.6 ND ND 1.9 ND
Al(OH)3 Adsorption/
Glycine Precipitation/
NaCl Precipitation
3.8 2.8 3.9 ND 2.3 3.0 ND
Heat Treatment* ≥6.4 ≥8.9 4.7 ≥7.8 4.2 1.1 ≥3.9†
Lyophilization ND ND ND ND 1.3 ND ND
Cumulative Virus Reduction [log10] ≥10.2 ≥11.7 10.2 NA 7.8 6.0 NA
1
This correlates to a VWF:RCo to FVIII activity average ratio of 2.4:1, which is used to calculate the nominal values of VWF:RCo activity and is the average VWF:RCo activity.

Humate-p Manufacturers


  • Csl Behring Gmbh
    Humate-p (Antihemophilic Factor/von Willebrand Factor Complex (Human)) Kit [Csl Behring Gmbh]

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