


*From a randomized, crossover study of the pharmacokinetic properties of ADVATE and RECOMBINATE in 30 PTPs (>150 exposure days) infused with 50+5 IU/kg of therapy.2, 3
Indications:
ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method] is indicated in hemophilia A (classical hemophilia) for the prevention and control of bleeding episodes and for perioperative management of patients 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.
The most common related adverse reactions observed during the ADVATE clinical studies include: strange taste in mouth, headache, dizziness, and redness in the face.
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. If you experience any of these symptoms, stop the infusion immediately and promptly contact your doctor.
Contact your doctor if you are not able to prevent or control bleeding episodes with your regular doses of factor VIII therapy.
Indications:
RECOMBINATE [Antihemophilic Factor (Recombinant)] is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes and for the perioperative management of patients with hemophilia A.
RECOMBINATE is not indicated for von Willebrand’s disease.
Important Safety Information:
RECOMBINATE may be contraindicated in patients with known hypersensitivity to mouse, hamster, or bovine proteins.
Certain components used in the packaging of RECOMBINATE contain natural rubber latex.
Adverse events related to the administration of RECOMBINATE observed during the clinical studies included flushing, nausea, fatigue, and nose bleeds.
RECOMBINATE is stabilized with Albumin (Human). Reactions associated with albumin are rare, although nausea, fever, chills, or urticaria have been reported.
Contact your doctor if you are not able to prevent or control bleeding episodes with your regular doses of prescribed factor VIII therapy.
References:
1. RECOMBINATE Prescribing Information. Westlake Village, CA: Baxter Healthcare Corporation; October 2007.
2. ADVATE Prescribing Information. Westlake Village, CA: Baxter Healthcare Corporation; July 2007.
3. 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;10:1-10.
4. Shapiro AD. Anti-hemophilic factor (recombinant), plasma/albumin-free method (octocog-alpha; ADVATEĀ®) in the management of hemophilia A. Vasc Health Risk Manag. 2007;3(5):555-565.
