Indication: ADVATE is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia A (congenital factor VIII deficiency) for: Control and prevention of bleeding episodes. Perioperative management; Routine prophylaxis to prevent or reduce the frequency of bleeding episodes. ADVATE is not indicated for the treatment of von Willebrand disease.

On-demand bleed control in clinical studies

Access to an on-demand treatment is critical for patients with hemophilia A.1 ADVATE is indicated as an on-demand factor VIII replacement therapy with an established safety profile for adult and pediatric patients.2

On-demand study design2

The efficacy and safety of ADVATE was studied in 111 previously treated patients (PTPs) aged ≥10 years with moderate to severe hemophilia A (FVIII ≤2% of normal) and having an estimated ≥150 factor VIII exposure days, for which ADVATE was used to treat 510 new bleeding episodes. The primary endpoint was to demonstrate safety and the ability to treat bleeding episodes.

SELECTED IMPORTANT RISK INFORMATION

WARNINGS & PRECAUTIONS

Hypersensitivity reactions: Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with ADVATE. Symptoms include dizziness, paresthesia, rash, flushing, facial swelling, urticaria, dyspnea, pruritus, and vomiting. Discontinue ADVATE if hypersensitivity symptoms occur and administer appropriate emergency treatment.

Please see additional detailed important risk information below.

Taken on-demand, ADVATE has been shown to control most bleeding episodes with 1 or 2 infusions2

93% of bleeding episodes were controlled with 1 or 2 infusions.

93% of 510 bleeding episodes

were controlled with 1 or 2 infusions.2
86% of responses to treatment were rated as excellent or good.

Response to treatment in 86%

of 510 bleeding episodes was rated as excellent or good.†2,3

Excellent is defined as abrupt pain relief and/or unequivocal improvement in objective signs of bleeding within approximately 8 hours after a single infusion; good defined as definite pain relief and/or improvement in signs of bleeding within approximately 8 hours after an infusion, but possibly requiring more than one infusion for complete resolution.

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  1. World Federation of Hemophilia. Guidelines for the Management of Hemophilia. 2nd ed. World Federation of Hemophilia; 2012. Accessed October 1, 2019. http://www1.wfh.org/publications/files/pdf-1472.pdf
  2. Advate. Prescribing information. Baxalta US Inc; 2018.
  3. Tarantino MD, Collins PW, Hay CRM, et al; and rAHF-PFM Clinical Study Group. Clinical evaluation of an advanced category antihaemophilic factor prepared using a plasma/albumin-free method: pharmacokinetics, efficacy, and safety in previously treated patients with haemophilia A. Haemophilia. 2004;10(5):428-437. doi:10.1111/j.1365-2516.2004.00932.x