DEFERASIROX ORAL GRANULES- deferasirox granule
EPIC PHARMA, LLC
Dispense with Medication Guide available at: www.epic-pharma.com/medguide/Deferasirox-Oral-Granules.pdf.
Deferasirox (dee-fer’a-si-rox) Oral Granules
What is the most important information I should know about deferasirox oral granules? Deferasirox oral granules can cause serious side effects, including:
Kidney problems: Deferasirox oral granules can cause sudden (acute) kidney problems, including kidney failure that may require treatment with dialysis, and may cause death. Deaths have happened mostly in people who also have other health problems and had a blood disorder that was in an advanced stage. Adults and children who already have kidney problems and are taking certain medicines with deferasirox oral granules may also have an increased risk of sudden kidney problems. Be sure to tell your healthcare provider about all the medicines you take during treatment with deferasirox oral granules.
Your healthcare provider should do blood and urine tests to check your or your child’s kidney function before and during treatment with deferasirox oral granules. Call your healthcare provider right away if:
Liver problems. Deferasirox oral granules can cause liver problems, including liver failure that can sometimes cause death. Liver problems with deferasirox oral granules may be more common in people who are over 55 years of age but can also happen in children. Liver failure has happened more often in people with cirrhosis of the liver and failure of other organs. Liver failure has also happened along with kidney problems in certain children who become dehydrated. See “Kidney problems” above.
Your healthcare provider should do blood tests to check your liver function before you start and regularly during treatment with deferasirox oral granules. Call your healthcare provider right away, if you develop any of the following signs and symptoms:
Bleeding, ulcers, and tears of the stomach or intestine. Severe stomach and intestine bleeding (hemorrhage) that have caused death have happened in some people treated with deferasirox oral granules, especially in elderly people who have advanced blood cancers or low platelet counts. Some people have also had ulcers of the stomach or intestine, sometimes with tears (perforation) that have caused death. In some people who have taken deferasirox oral granules, including children and adolescents, irritation of the upper gastrointestinal tract, ulcers, and bleeding have happened, but did not cause death.
Your risk of severe bleeding (hemorrhage) may be increased if you take deferasirox oral granules along with other medicines that can cause ulcers or bleeding, such as:
Before you start taking deferasirox oral granules, tell your healthcare provider if you are taking one of these medicines. Ask your healthcare provider if you are not sure. If you develop an ulcer of the stomach or intestine, or severe bleeding, your healthcare provider may stop deferasirox oral granules.
Elderly people may be at a higher risk of developing serious side effects and death due to serious side effects with deferasirox oral granules Your healthcare provider may need to monitor you more closely during treatment with deferasirox oral granules.
See "What are the possible side effects of deferasirox oral granules?" for more information about side effects.
What are deferasirox oral granules?
Deferasirox oral granules are prescription medicines that are used to treat:
It is not known if deferasirox oral granules is safe and effective when used with other medicines to treat an increased amount of iron in the blood.
It is not known if deferasirox oral granules is safe and effective for treating children under 2 years of age who have an increased amount of iron in their blood for a long period of time (chronic) caused by repeated blood transfusions.
It is not known if deferasirox oral granules is safe and effective for treating children under 10 years of age with thalassemia who have an increased amount of iron in their blood, but who are not receiving regular blood transfusions.
Do not take deferasirox oral granules if you:
Ask your healthcare provider if you are not sure if you have any of the medical conditions listed above.
Before taking deferasirox oral granules tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. Some medicines may affect how deferasirox oral granules works, and deferasirox oral granules may affect how other medicines work. Also, your risk of sudden kidney problems or severe bleeding may be increased if you take deferasirox oral granules with certain medicines. See “What is the most important information I should know about deferasirox oral granules?”
Ask your healthcare provider if you are not sure if you take one of these medicines. Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.
How should I take deferasirox oral granules?
Taking deferasirox oral granules:
What should I avoid while taking deferasirox oral granules?
What are the possible side effects of deferasirox oral granules?
Deferasirox oral granules can cause serious side effects, including:
The most common side effects in anyone who takes deferasirox oral granules include: diarrhea and nausea.
Other common side effects in people with too much iron in their blood due to repeated blood transfusions include: vomiting, stomach-area (abdomen) pain, and an abnormal kidney function blood test.
These are not all the possible side effects of deferasirox oral granules. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800- FDA-1088.
How should I store deferasirox oral granules?
Keep deferasirox oral granules and all medicines out of the reach of children.
General information about the safe and effective use of deferasirox oral granules
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use deferasirox oral granules for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for more information about deferasirox oral granules.
What are the ingredients in deferasirox oral granules?
Active ingredient: deferasirox
Inactive ingredients: crospovidone; magnesium stearate, microcrystalline cellulose, poloxamer, povidone, and silicon dioxide.
Epic Pharma, LLC
Laurelton, NY 11413
This Medication Guide has been approved by the U.S. Food and Drug Administration.