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BAXTER INTRODUCES 2 mL DILUENT VOLUME FOR ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method]

Providing Less Volume to Infuse

 

ADVATE is now available with a 2 mL diluent (sterile water for infusion) volume for dosage strengths ranging from 250 IU to 1700 IU. This represents a reduction in diluent volume from 5 mL to 2 mL.  The new 2 mL diluent is another benefit offered by ADVATE for infusing smaller volumes.  ADVATE is now also approved for prophylaxis in both adults and children (0 – 16 years old).1

 

ADVATE is a medicine used to replace clotting factor VIII that is missing in people with hemophilia A (also called “classic” hemophilia). ADVATE is used to prevent and control bleeding in people with hemophilia A. Your healthcare provider may give you ADVATE when you have surgery.

 

ADVATE is not used to treat von Willebrand Disease.

 

You should not use ADVATE if you are allergic to mice or hamsters or any ingredients in ADVATE.

 

Having seven potencies available with 2 mL diluent volume and three additional potencies available with 5 mL diluent volume, ADVATE offers a broad selection of doses and offers the opportunity for a single-vial option.1

 

“Baxter is committed to people with hemophilia and their families across all life stages, from first diagnosis through adulthood,” said Ashish Sagrolikar, vice president, sales & marketing, Hemophilia Therapies, Baxter Healthcare Corporation. “We developed the 2 mL diluent vials in response to the community’s desire for a decreased volume to infuse.”

New color-coded packaging

ADVATE with a 2 mL diluent vial will be available in nominal dosage strengths of 250 IU, 500 IU, 1000 IU & 1500 IU, and in intermediate dosage strengths of 375 IU, 750 IU & 1700 IU.  The color of the unit carton and the label on the 2 mL diluent vials will be purple.

 

ADVATE with a 5 mL diluent vial will be available in nominal dosage strengths of 2000 IU & 3000 IU and in the intermediate dosage strength 2500 IU. The color of the unit carton for the 5 mL diluent configuration will remain yellow/orange.

 

All dosage strengths of ADVATE come with the BAXJECT II mixing device. Each unit carton of ADVATE with a 2 mL diluent vial also will include a 25-gauge (Terumo microbore) butterfly infusion set to help accommodate the smaller infusion volume.

 

You should be trained on how to do infusions by your hemophilia treatment center or your healthcare provider. A dose of ADVATE should be administered over a period of ≤ 5 minutes, up to a maximum infusion rate of 10 mL/min, regardless of the diluent volume.

 

Clinical Study

Baxter performed an open-label, multi-center, randomized, crossover study to compare the pharmacokinetics of ADVATE reconstituted in 2 mL vs. 5 mL diluent in previously treated adult and adolescent patients with severe hemophilia A. The study demonstrated that the same dose of ADVATE reconstituted in either diluent volume resulted in similar factor eight (VIII) levels in the body.

Please see below for Detailed Important Risk Information for ADVATE and the attached ADVATE full Prescribing Information.

For more information, visit advate.com or call 888-4-ADVATE.

DETAILED IMPORTANT RISK INFORMATION FOR ADVATE

You should not use ADVATE if you are allergic to mice or hamsters or any ingredients in ADVATE.

You should tell your healthcare provider if you have or have had any medical problems, take any medicines, including prescription and non-prescription medicines and dietary supplements, have any allergies, including allergies to mice or hamsters, are nursing, are pregnant, or have been told that you have inhibitors to factor VIII.

You can have an allergic reaction to ADVATE. Call your healthcare provider right away and stop treatment if you get a rash or hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, nausea, or fainting.

Your body may form inhibitors to factor VIII. An inhibitor is part of the body’s normal defense system. If you form inhibitors, it may stop ADVATE from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to factor VIII.

Side effects that have been reported with ADVATE include: cough, sore throat, unusual taste, abdominal pain, diarrhea, nausea/vomiting, headache, fever, dizziness, hot flashes, chills, sweating, joint swelling/ aching, itching, hematoma, swelling of legs, runny nose/congestion, and rash.

Call your healthcare provider right away about any side effects that bother you or if your bleeding does not stop after taking ADVATE.

Please visit advate.com for full ADVATE Prescribing Information.

1. ADVATE prescribing information. Westlake Village, CA: Baxter Healthcare Corporation; December, 2011.

Baxter, Advate and Baxject are registered trademarks of Baxter International Inc. All other products or trademarks appearing herein are the property of their respective owners.

 

 

 

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