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Monoclate-P ®

Antihemophilic Factor (Human) Factor VIII:C Pasteurized Monoclonal Antibody Purified
Full Prescribing Information for Monoclate-P®        Important Safety Information

Monoclate-P is indicated for the treatment of classical hemophilia (hemophilia A).

  • Over a decade of clinical experience and efficacy supported by over 1 billion international units (IU) of use
  • The manufacturing process combines nature's own design - the human factor VIII molecule - with innovations in laboratory engineering: monoclonal antibody purification and pasteurization designed to remove and inactivate lipid-enveloped and certain non-lipid-enveloped viruses
  • A demonstrated level of consistent potency
  • Potency ranges, diluent volumes, and peel-off labels designed for patient convenience

Diagnostic Codes (ICD-10-CM)

Billing Codes (HCPCS, NDC, CPT)

Medicare Part B ASP Pricing Limits

Authorized Distributors

Important Safety Information for Monoclate-P

Monoclate-P®, Antihemophilic Factor (Human) Factor VIII: C Pasteurized Monoclonal Antibody Purified, is indicated for treatment of classical hemophilia (Hemophilia A). Affected individuals frequently require therapy following minor accidents. Surgery, when required in such individuals, must be preceded by temporary corrections of the clotting abnormality. Monoclate-P is not effective in controlling the bleeding of patients with von Willebrand's disease.

Monoclate-P is contraindicated in individuals with a known hypersensitivity to mouse protein. Products of this type are known to have caused allergic reactions, mild chills, nausea, or stinging at the infusion site. In some cases, inhibitors of Factor VIII may occur.

Monoclate-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.

Please see full prescribing information for Monoclate-P.

CRP16-05-0001 05/2016
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