12/4/2017 Humate-P®

United States

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Antihemophilic Factor/ Complex (Human) Full Prescribing Information for Humate-P® Important Safety Information

Humate-P is an Antihemophilic Factor/von Willebrand Factor (VWF) Complex (Human) indicated for:

Hemophilia A — Treatment and prevention of bleeding in adults (1.1). 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 desmospressin is known or suspected to be inadequate (1.2). Humate-P is not indicated for the prophylaxis of spontaneous bleeding episodes in VWD.

Visit www.humate-p.com to learn more.

Diagnostic Codes (ICD-10-CM)

ICD-10-CM Codes Used to identify patient medical conditions (for claims with a date of service on or after October 1, 2015)

Code Description

D66 Hereditary factor VIII deficiency

D68.0 von Willebrand's Disease

30233V1 Transfusion of Nonautologous Antihemophilic factors into peripheral vein, percutaneous approach

30243V1 Transfusion of Nonautologous antihemophilic factors into central vein, percutaneous approach

Billing Codes (HCPCS, NDC, CPT)

HCPCS Codes The following HCPCS codes describe supplies (including drugs) rendered by the billing provider. CMS publishes and maintains the HCPCS code set. These codes are entered to paper claim form CMS-1500 in Field 24; or, to electronic claim form ASC 837P in Loop 2400, Segment SV101-2, with the Qualifier "HC" entered to Segment SV101-1, unless otherwise directed by the payor.

Code Description

J7187 INJECTION, VON WILLEBRAND FACTOR COMPLEX (HUMATE P), PER IU VWF:RCO

NDC Codes Certain payors may require the entry of NDC information to the claim form, as directed by the payor.

VWF:RCO/vial NDC Number

600 IU RcoF 63833-0615-02

1200 IU RcoF 63833-0616-02

2400 IU RcoF 63833-0617-02

CPT Codes If the billing provider performs administration services in conjunction with a patient's infusion, the following administration codes may be used to bill for this service if the service meets the requirements of the code description.

Code Description

96365 Intravenous infusion for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour

96366 Each additional hour

96374 Intravenous push, single or initial substance/drug

96376 Each additional sequential intravenous push of the same substance/drug provided in a facility

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Authorized Distributors

Companies

Atlantic Biologics Corp

BCA

BDI Pharma

BioCare

Cardinal Health Specialty Pharmaceutical Distribution

CT International

FFF Enterprises

Health Coalition

HMPG Pharmacy LLC

Lifeline Pharmaceuticals LLC

McKesson Plasma & Biologicals LLC

National Hospital Specialties

New York Blood Center

Prodigy Health Provider

Smith Medical Partners

Safety Data Sheets

Safety Data Sheets (SDS) for Humate-P.

Important Safety Information for Humate-P

Antihemophilic Factor/von Willebrand Factor Complex (Human), Humate-P® is indicated for treatment and prevention of bleeding in adult patients with hemophilia A (classical hemophilia). 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, and patients with mild and moderate VWD for whom use of is known or suspected to be inadequate. Humate-P is not indicated for the prophylaxis of spontaneous bleeding episodes.

Humate-P is contraindicated in individuals with a history of anaphylactic or severe systemic response to antihemophilic factor or von Willebrand factor preparations. Monitor for intravascular hemolysis and decreasing hematocrit values in patients with A, B, and AB blood groups who are receiving large or frequent doses. Also monitor VWF:RCo and FVIII levels in VWD patients, especially those undergoing surgery.

Thromboembolic events have been reported in VWD patients receiving factor replacement. Caution should be exercised and antithrombotic measures considered, particularly in patients with risk factors for thrombosis.

Humate-P is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

In patients receiving Humate-P in clinical studies for treatment of VWD, the most commonly reported adverse reactions (reported by >5% of subjects) were allergic-anaphylactic reactions, including urticaria, chest tightness, rash, pruritus, and edema. For patients undergoing surgery, the most common adverse reactions are postoperative wound or injection-site bleeding, and epistaxis.

Please see full prescribing information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA- 1088.

The information provided here is primarily intended for use by physicians and other healthcare professionals in the United States. The CSL Behring product listed may not have been approved in other countries and may not be available everywhere.

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