us agents (e.g., viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent (5.4).
ADVERSE REACTIONS
Most common adverse reactions observed by >5% of subjects after receiving Humate-P are allergic-anaphylactic reactions (e.g., urticaria, chest tightness, rash, pruritus, edema) and, in patients undergoing surgery, postoperative wound and injection-site bleeding, and epistaxis (6).
To report SUSPECTED ADVERSE REACTIONS, contact CSL Behring Pharmacovigilance at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Pregnancy: No human or animal data. Use only if clearly needed (8.1).
The hemostatic efficacy of Humate-P has been studied in 34 pediatric subjects with VWD (8.4). Based on the data from a subset of these subjects, age had no effect on the pharmacokinetics of VWF:RCo (12.3).
See 17 for PATIENT COUNSELING INFORMATION
Revised: 01/2010
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Back to Highlights and TabsFULL PRESCRIBING INFORMATION: CONTENTS*
*Sections or subsections omitted from the full prescribing information are not listed
1INDICATIONS AND USAGE
1.1Hemophilia A
1.2Von Willebrand Disease (VWD)
2DOSAGE AND ADMINISTRATION
2.1Therapy for Hemophilia A
2.2Treatment of Bleeding Episodes in VWD
2.3Prevention of Excessive Bleeding During and After Surgery in VWD
2.4Reconstitution and Administration
3DOSAGE FORMS AND STRENGTHS
4CONTRAINDICATIONS
5WARNINGS AND PRECAUTIONS
5.1Thromboembolic Events (VWD Patients)
5.2Monitoring for Intravascular Hemolysis
5.3Monitoring VWF:RCo and FVIII Levels
5.4Transmission of Infectious Agents
6ADVERSE REACTIONS
6.1Clinical Studies Experience
6.2Postmarketing Experience
7DRUG INTERACTIONS
8USE IN SPECIFIC POPULATIONS
8.1Pregnancy
8.2Labor and Delivery
8.3Nursing Mothers
8.4Pediatric Use
8.5Geriatric Use
11DESCRIPTION
11.1Virus Reduction Capacity
12CLINICAL PHARMACOLOGY
12.1Mechanism of Action
12.3Pharmacokinetics
14CLINICAL STUDIES
14.1Treatment of Bleeding Episodes in VWD
14.2Prevention of Excessive Bleeding During and After Surgery in VWD
14.3Virus Transmission Studies
15REFERENCES
16HOW SUPPLIED/STORAGE AND HANDLING
17PATIENT COUNSELING INFORMATION
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FULL PRESCRIBING INFORMATION
1INDICATIONS AND USAGE
1.1Hemophilia 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).
1.2Von 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 eva luate 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]).
2DOSAGE AND ADMINISTRATION
2.1Therapy for |
