Approved Uses
EXJADE® (deferasirox) tablets for oral suspension is a prescription medicine that is used to treat:
- people 2 years of age and older who have an increased amount of iron in their blood for a long period of time (chronic), caused by repeated blood transfusions
- certain people 10 years of age or older, with thalassemia, who have an increased amount of iron in their blood but are not receiving regular blood transfusions
It is not known if EXJADE is safe and effective when used with other medicines to treat an increased amount of iron in the blood.
Important Safety Information
What is the most important information I should know about EXJADE?
EXJADE can cause serious side effects, including:
Kidney problems. EXJADE can cause sudden (acute) kidney problems, including kidney failure that may require treatment with dialysis, and may cause death. Deaths have occurred 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 EXJADE, may also have an increased risk of sudden kidney problems. Be sure to tell your health care provider about all the medicines you take during treatment with EXJADE.
Your health care provider should do blood and urine tests to check your or your child’s kidney function before and during treatment with EXJADE. Call your or your child’s health care provider right away if:
- your child becomes sick with fever, vomiting, or diarrhea and cannot drink fluids normally during treatment with EXJADE. Your child may be dehydrated. Your child’s health care provider may need to temporarily stop treatment with EXJADE and treat your child for dehydration to help prevent kidney problems. Your child’s health care provider may monitor your child’s kidney function more closely
- you notice that you or your child are passing less urine than usual during treatment with EXJADE
Liver problems. EXJADE can cause liver problems, including liver failure that can sometimes cause death. Liver problems with EXJADE may be more common in people who are over 55 years of age but can also occur in children. Liver failure has occurred more often in people with cirrhosis of the liver and failure of other organs. Liver failure has also occurred along with kidney problems in certain children who become dehydrated.
Your health care provider should do blood tests to check your liver function before you start, and regularly during, treatment with EXJADE. Call your health care provider right away, if you develop any of the following signs and symptoms:
- Drowsiness
- Upper right stomach-area (abdomen) pain
- Yellowing or increased yellowing of your skin or eyes
- Dark urine
Bleeding, ulcers, and tears of the stomach or intestine. Severe stomach or intestine bleeding (hemorrhage) that has caused death has occurred in some people treated with EXJADE, 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 EXJADE, including children and adolescents, irritation of the upper gastrointestinal tract, ulcers, and bleeding have occurred but did not cause death.
Your risk of severe bleeding (hemorrhage) may be increased if you take EXJADE along with other medicines that can cause ulcers or bleeding such as:
- Nonsteroidal anti-inflammatory drugs (NSAIDs)
- Corticosteroids
- Certain osteoporosis medicines called oral bisphosphonates
- Blood thinner medicines
Before you start taking EXJADE, tell your health care provider if you are taking one of these medicines. Ask your health care provider if you are not sure. If you develop an ulcer of the stomach or intestine, or severe bleeding, your health care provider may stop EXJADE.
Elderly people may be at a higher risk of developing serious side effects and death due to serious side effects with EXJADE. Your health care provider may need to monitor you more closely during treatment with EXJADE.
- Tell your health care provider if you get heartburn during treatment with EXJADE
- Get emergency medical help right away if you vomit blood or pass black or bloody stools, or if you have severe stomach-area (abdomen) pain during treatment with EXJADE
Effects on your bone marrow. EXJADE can affect your bone marrow and cause you to have a low white blood cell count which can be serious, decreased platelets, or worsening of your anemia, and may lead to death. Your risk for effects on your bone marrow may be increased if you already have other blood disorders. Your health care provider will do blood tests to monitor your blood cell counts for these problems.
Serious allergic reactions. EXJADE may cause serious allergic reactions, which usually start within the first month of treatment. Get medical help right away if you develop any of the following symptoms of a serious allergic reaction including:
- Difficulty breathing or swallowing
- Chest pain
- Rapid heartbeat
- Feeling faint
- Swelling of the face, lips, mouth, tongue, or throat
- Severe itching of the skin with a red rash or raised bumps
- Hives
Skin rash and severe skin reactions. Skin rashes are common with EXJADE. If you get a more severe rash, your health care provider may temporarily stop EXJADE.
Severe skin reactions can also occur with EXJADE and can be life-threatening or lead to death. Get medical help right away if you develop any one or more of the following signs and symptoms of a severe skin reaction, including:
- Rash or red skin
- Blisters on your lips, or around your mouth or eyes
- Mouth sores
- Skin peeling
- High fever or flu-like symptoms
- Enlarged lymph nodes
Hearing and vision problems. EXJADE can cause decreased hearing and changes in your vision, including cataracts, increased pressure in your eye, and problems with your retinas. Your health care provider should do hearing and vision tests before you start, and then regularly, during treatment. Your health care provider may decrease your dose or stop EXJADE if you develop hearing or vision problems.
Tell your health care provider if you develop any changes in your vision or hearing during treatment with EXJADE.
Do not take EXJADE if you:
- have certain kidney problems
- have high-risk myelodysplastic syndrome (MDS)
- have advanced cancer
- have a low platelet count
- are allergic to deferasirox or any of the ingredients in EXJADE
Ask your health care provider if you are not sure if you have any of the medical conditions listed above.
The most common side effects in anyone who takes EXJADE 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 EXJADE.
Before taking EXJADE, tell your health care provider about all of your medical conditions, including if you:
- have kidney problems
- have liver problems
- have advanced cancer
- have a blood disorder that may increase your risk for bleeding
- are pregnant or plan to become pregnant. It is not known if EXJADE can harm your unborn baby. Hormonal forms of birth control may not be as effective if used during treatment with EXJADE. You could become pregnant. Talk to your health care provider about other birth control options that you can use during this time. Tell your health care provider right away if you become pregnant during treatment with EXJADE
- are breastfeeding or plan to breastfeed. It is not known if EXJADE passes into your breast milk and can harm your baby. You and your health care provider should decide if you will take EXJADE or breastfeed. You should not do both.
Tell your health care provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. Some medicines may affect how EXJADE works, and EXJADE may affect how other medicines work. Also, your risk of sudden kidney problems or severe bleeding may be increased if you take EXJADE with certain medicines.
- Avoid taking the following medicines during treatment with EXJADE:
- Antacid products (medicines used to treat heartburn) that contain aluminum
- Theophylline
- Certain medicines to lower your cholesterol, called bile acid sequestrants
Ask your health care 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 health care provider or pharmacist when you get a new medicine.
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.
Please see full Prescribing Information, including Boxed WARNING and Medication Guide, for EXJADE.
