RECOMBINATE [Antihemophilic Factor (Recombinant)] Important Information
Indications for RECOMBINATE
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.
Detailed Important Risk Information for RECOMBINATE
You should not use RECOMBINATE if you are allergic to mouse, hamster, or bovine proteins or if you are allergic to any ingredients in RECOMBINATE.
RECOMBINATE is for treating patients with Factor VIII deficiency (hemophilia A), and it is essential that you are diagnosed before using RECOMBINATE.
You should tell your doctor if you have or have had any medical problems; take any medicines, including prescription and non-prescription medicines, dietary supplements and herbal remedies; have any allergies, including allergies to mouse, hamster, or bovine proteins; are nursing; are pregnant; or have been told that you have inhibitors to Factor VIII (because Factor VIII may not work for you).
You could have an allergic reaction to RECOMBINATE. Symptoms of an allergic reaction may include rash or hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, or fainting. If you have an allergic reaction, call your doctor right away and stop treatment.
Your body may form inhibitors to Factor VIII. Inhibitors are part of your body’s normal defense system. If you form inhibitors, it may stop RECOMBINATE from working properly. Consult with your doctor to make sure you are carefully monitored with blood tests for the development of inhibitors to Factor VIII.
The most common side effects are chills, flushing, rash, and nose bleed.
Post marketing adverse reactions have been reported and include the following: inhibitors, rapid heartbeat, bluish coloration of the skin, vomiting, stomach pain, body discomfort, injection site reactions, chest pain, chest discomfort, anaphylactic reaction, hypersensitivity, loss of consciousness, headache, tingling sensation, difficulty breathing, cough, airway swelling, localized swelling, hives, and redness of the skin.
Call your doctor right away about any side effects that bother you or if your bleeding does not stop after taking RECOMBINATE.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Click here for RECOMBINATE full Prescribing Information.