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ADVATE (antihemophilic factor- recombinant kit


Patient Information

  • Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
  • Advise patients to report any adverse reactions or problems following ADVATE administration to their physician or healthcare provider.
  • Allergic-type hypersensitivity reactions have been reported with ADVATE. Warn patients of the early signs of hypersensitivity reactions, including hives, pruritus, generalized urticaria, angioedema, hypotension, shock, anaphylaxis and acute respiratory distress. Advise patients to discontinue use of the product if these symptoms occur and seek immediate emergency treatment.
  • Inhibitor formation may occur with the treatment of a patient with hemophilia A. Advise patients to contact their physician or treatment center if they experience a lack of clinical response to factor VIII replacement therapy, as this may be a manifestation of an inhibitor.
  • Advise patients to consult with their physicians or healthcare provider prior to travel. While traveling, advise patients to bring an adequate supply of ADVATE based on their current regimen of treatment.

To enroll in the confidential, industry-wide Patient Notification System, call 1-888-873-2838.

BAXALTA, ADVATE, BAXJECTand RECOMBINATEare trademarks of Baxalta Incorporated, a wholly-owned, indirect subsidiary of Shire plc.

SHIRE and the Shire Logo are trademarks or registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affiliates.

Patented: see https://www.shire.com/legal-notice/product-patents

Baxalta US Inc.
Lexington, MA 02421 USA
U.S. License No. 2020



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