"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.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
DEFERASIROX TABLET - FOR ORAL SUSPENSION
COMMON BRAND NAME(S): Exjade
WARNING: Deferasirox may rarely cause serious (even fatal) kidney disease, liver disease, and stomach/intestinal bleeding (see also Side Effects section). Kidney disease may be more likely to occur in people with kidney problems and in people with serious blood diseases. Liver disease may be more likely to occur in people with liver problems (such as cirrhosis) and in older adults. Stomach/intestinal bleeding may be more likely to occur in older adults with serious blood diseases (including blood cancers). Consult your doctor for more details.
Your doctor will monitor you closely while you are taking this medication. Keep all regular medical and laboratory appointments.
USES: This medication is used to treat ongoing high levels of iron in the body caused by multiple blood transfusions. It is also used to treat high levels of iron in people with a certain blood disorder who do not require blood transfusions (non-transfusion-dependent thalassemia). It works by binding to iron, allowing the body to pass extra iron out in the stool. Deferasirox belongs to a class of drugs known as iron-chelating agents.
Frequent blood transfusions are often needed in certain types of blood diseases (such as sickle cell disease, anemia). Blood transfusions have very helpful benefits, but they can cause the body to hold on to too much iron. The extra iron can build up in the body and cause problems such as heart failure, liver disease, and diabetes. Getting rid of extra iron can decrease the risk of these diseases.
HOW TO USE: Stir the tablet(s) into water, orange juice or apple juice until the tablets have completely broken apart and are well mixed into the liquid. If your dose is less than 1 gram, stir the tablets into about 1/2 cup (3.5 ounces/100 milliliters) of liquid. If your dose is more than 1 gram, use about 1 cup (7 ounces/200 milliliters) of liquid. Drink all of the mixture right away, then add more liquid to the empty container and stir to get any drug that may remain. Drink all of this rinsing liquid right away.
Take this medication by mouth on an empty stomach at least 30 minutes before food as directed by your doctor, usually once daily. Do not chew the tablets or swallow them whole. Always mix this medication into liquid as directed.
Antacids that contain aluminum can bind with deferasirox which may affect how deferasirox works. Avoid taking this medication with antacids that contain aluminum.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.
The dosage is based on your medical condition, weight, laboratory tests, and response to treatment. Your dosage may need to be lowered or your treatment may need to be stopped if you get certain side effects. Follow your doctor's instructions carefully.
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