"The U.S. Food and Drug Administration yesterday approved Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A (acquired Factor VIII [FVII] deficiency).
Exjade Consumer (continued)
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: trouble sleeping, hearing loss, unusual feelings of restlessness/high energy (hyperactivity), vision changes.
This drug may rarely cause serious (even fatal) liver disease. If you notice any of the following unlikely but serious side effects, tell your doctor immediately: persistent nausea/vomiting, severe stomach/abdominal pain, dark urine, yellowing of eyes/skin.
This drug may rarely cause serious (even fatal) stomach/intestinal bleeding and ulcers. Tell your doctor immediately if you have any of the following rare but serious symptoms: severe stomach/abdominal pain, black/tarry/bloody stools, vomit that looks like coffee grounds.
This drug may rarely cause serious (even fatal) kidney or blood problems. Tell your doctor immediately if you notice any of the following symptoms: change in amount of urine, easy bleeding/bruising, signs of infection (e.g., fever, persistent sore throat), unusual tiredness.
Deferasirox can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Therefore, tell your doctor immediately if you develop any rash.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Exjade (deferasirox) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking deferasirox, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems, low platelet counts, advanced cancer, certain bone marrow disorders involving damaged blood-forming cells (high-risk myelodysplastic syndromes).
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
If you have diarrhea or vomiting, drink plenty of fluids to replace lost body water and minerals. Ask your doctor or pharmacist for more details.
Older adults may be more sensitive to the side effects of this drug, especially liver problems and stomach/intestinal bleeding and ulcers.
This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.
It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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