y, four were infants (1 month to under 2 years of age), 23 were children (2 through 12 years), and seven were adolescents (13 through 15 years).
As in adults, pediatric patients should be dosed based on body weight (kg) (see Dosage and Administration [2.2, 2.3]).
8.5Geriatric Use
Clinical studies of Humate-P did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger subjects. As for all patients, dosing for geriatric patients should be appropriate to their overall situation.
11DESCRIPTION
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) to be administered by the intravenous route 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 and contains purified and concentrated FVIII/VWF Complex (Human). Fibrinogen content is less than or equal to 0.2 mg/mL.
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]). An International Unit (IU) is 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.
When reconstituted with the volume of diluent (sterile water) provided, each mL of Humate-P contains 72 to 224 International Units (IU) VWF:RCo activity2, 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.
Humate-P has been demonstrated in several studies to contain the high molecular weight multimers of VWF. This component is considered to be important for correcting the coagulation defect in patients with VWD.5 When administered to patients with VWD (types 1, 2, or 3), bleeding time decreased. This outcome was correlated with the presence of a multimeric composition of VWF similar to that found in normal plasma.6
Humate-P contains anti-A and anti-B blood group isoagglutinins (see Warnings and Precautions [5.2]).
The pooled human plasma used to produce Humate-P is collected from licensed facilities in the 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) and human immunodeficiency virus-1 (HIV-1) and found to be nonreactive (negative). The source plasma is also tested by an investigational NAT for hepatitis B virus (HBV) and found to be nonreactive (negative). The purpose of the HBV test is to detect low levels of viral material; however, the significance of a nonreactive (negative) result has not been established.
--------------------------------------------------------------------------------
2
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.
11.1Virus Reduction Capacity
The manufacturing procedure for Humate |
