"The US Food and Drug Administration (FDA) has approved Bayer AG's unmodified, full-length recombinant antihemophilic factor VIII product, Kovaltry, for the treatment of hemophilia A in children and adults, the company said.
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 right away if you have any serious side effects, including: hearing loss, vision changes (such as blurred vision).
This medication decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can worsen anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. Tell your doctor right away if you develop any of the following unlikely symptoms: unusual tiredness, pale skin, signs of infection (such as fever, chills, persistent sore throat), easy bruising/bleeding.
This drug may rarely cause serious stomach/intestinal problems (such as stomach/intestinal bleeding and ulcers). If you notice any of the following unlikely but serious side effects, stop taking deferasirox and consult your doctor or pharmacist right away: black/bloody stools, vomit that looks like coffee grounds, persistent stomach/abdominal pain.
Deferasirox may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: persistent nausea/vomiting, loss of appetite, stomach/abdominal pain, yellowing of eyes/skin, dark urine.
Deferasirox has rarely caused very serious (possibly fatal) kidney disease. Get medical help right away if you develop symptoms of kidney disease, including: change in the amount of urine, frothy urine.
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 right away if you develop any rash.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 disease, liver disease, low platelet counts, advanced cancer, certain bone marrow disorders involving damaged blood-forming cells (high-risk myelodysplastic syndromes).
This drug may make you dizzy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Older adults may be more sensitive to the side effects of this drug, especially liver problems, stomach/intestinal bleeding, and ulcers.
This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details.
It is unknown if this medication 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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