Only ADVATE therapy offers this comprehensive array of benefits:
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Eliminates Potential Risk of Viral Transmission
The first recombinant factor VIII therapy to eliminate the potential risk of viruses that may be carried by blood-based additives,* because no plasma proteins are added at any stage of processing.2-4
*There have been no confirmed reports of viral transmissions with recombinant factor VIII therapies.
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Efficacy and Safety
In a clinical study in previously treated patients (PTPs), the majority of bleeds were resolved with a single infusion and 93% of bleeds were resolved with 1-2 infusions.4,5 In clinical studies, less than 1% of previously treated patients developed an inhibitor.6†‡
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Proven Experience
Backed by extensive clinical studies and significant real-world experience, with more than four billion IUs distributed to date.6,7§
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Fit for Active Lives
Offers short infusion time, 6-month room temperature storage,¤ and the broadest range of dosage strengths available, including 3000 IU.4
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There for You
Through therapies, participation, and progress, Baxter is there for you with an ongoing commitment to the hemophilia community.
†The rate [95% confidence interval] for developing an inhibitor in PTPs (≤2% factor VIII) was 0.51% [0.03%-2.91%] based on completed study analysis.6
‡The formation of inhibitors has been observed with all factor VIII products, including ADVATE.
§Worldwide, as of May 2008.
¤Up to 86°F, not to exceed printed expiration date. After storage at room temperature, ADVATE must not be returned to the refrigerator.
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Indications:
ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method] is indicated in hemophilia A (classical hemophilia) for the control and prevention of bleeding episodes and for perioperative management of adults and children with hemophilia A.
ADVATE is not indicated for the treatment of von Willebrand’s disease.
Important Safety Information:
Let your doctor know if you have had any previous allergic reactions to other factor VIII products or mouse or hamster proteins.
There is a possibility that you can have an allergic reaction to ADVATE. Symptoms of an allergic reaction may include rash, hives, itching, tightness in throat or chest, difficulty breathing, feeling dizzy or light-headed, or a weak pulse. Anaphylaxis, a severe and potentially life-threatening allergic reaction, is possible. If you experience any of these symptoms, stop the infusion immediately and promptly contact your doctor.
The formation of inhibitors has been observed with all factor VIII products, including ADVATE. Contact your doctor if you are not able to prevent or control bleeding episodes with your regular doses of factor VIII therapy.
The most serious adverse reactions seen with ADVATE are chest pain and fever. The most common adverse reactions observed include nausea and vomiting, upper respiratory-type infection, fever, accident and injury, joint pain and swelling, headache, limb pain, and cough.
ADVATE Full Prescribing Information (PDF).
References: 1. Industry, financial, and research reports on file. Westlake Village, CA: Baxter Healthcare Corporation. 2. The National Hemophilia Foundation. MASAC Recommendations Concerning the Treatment of Hemophilia and Other Bleeding Disorders. MASAC Document #187, November 2008. 3. McCormack PL, Plosker GL. Octocog alpha, plasma/albumin-free method. Drugs. 2005;65:2613-2620. 4. ADVATE Prescribing Information. Westlake Village, CA: Baxter Healthcare Corporation; December 2008. 5. Tarantino MD, Collins PW, Hay CRM, et al, and the 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;10:428-437. 6. Shapiro AD. Anti-hemophilic factor (recombinant), plasma/albumin-free method (octocog-alpha; ADVATE) in the management of hemophilia A. Vasc Health Risk Manag. 2007;3(5):555-565. 7. Data on File. Westlake Village, CA: Baxter Healthcare Corporation.

