Approved Uses
JADENU® (deferasirox) tablets for oral use and JADENU® Sprinkle (deferasirox) granules are prescription medicines that are 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 JADENU or JADENU Sprinkle is safe and effective when used with other medicines to treat an increased amount of iron in the blood. It is not known if JADENU or JADENU Sprinkle 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 JADENU or JADENU Sprinkle 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 are not receiving regular blood transfusions.
Important Safety Information
What is the most important information I should know about JADENU and JADENU Sprinkle?
JADENU and JADENU Sprinkle can cause serious side effects, including:
Kidney problems: JADENU and JADENU Sprinkle 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 JADENU or JADENU Sprinkle 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 JADENU or JADENU Sprinkle.
Your health care provider should do blood and urine tests to check kidney function before and during treatment with JADENU or JADENU Sprinkle. Call your health care provider right away if:
- you or your child becomes sick with fever, vomiting, or diarrhea and cannot drink fluids normally during treatment with JADENU or JADENU Sprinkle. This may cause dehydration. Your health care provider may need to temporarily stop treatment with JADENU or JADENU Sprinkle and treat for dehydration to help prevent kidney problems. Your health care provider may monitor you or your child’s kidney function more closely
- you or your child are passing less urine than usual during treatment with JADENU or JADENU Sprinkle
Liver problems: JADENU and JADENU Sprinkle can cause liver problems, including liver failure that can sometimes cause death. Liver problems with JADENU or JADENU Sprinkle 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 JADENU or JADENU Sprinkle. 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 JADENU or JADENU Sprinkle, especially in elderly people with 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 JADENU, 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 JADENU or JADENU Sprinkle 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 JADENU or JADENU Sprinkle, 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 JADENU or JADENU Sprinkle.
Elderly people may be at a higher risk of developing serious side effects and death due to serious side effects with JADENU or JADENU Sprinkle. Your health care provider may need to monitor you more closely during treatment with JADENU or JADENU Sprinkle.
- Tell your health care provider if you get heartburn during treatment with JADENU or JADENU Sprinkle
- 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 JADENU or JADENU Sprinkle
Effects on your bone marrow: JADENU and JADENU Sprinkle 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: JADENU and JADENU Sprinkle 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 JADENU and JADENU Sprinkle. If you get a more severe rash, your health care provider may temporarily stop JADENU and JADENU Sprinkle.
Severe skin reactions can also occur with JADENU and JADENU Sprinkle 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. JADENU or JADENU Sprinkle 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 JADENU or JADENU Sprinkle if you develop hearing or vision problems.
Do not take JADENU or JADENU Sprinkle 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 JADENU or JADENU Sprinkle
Ask your health care provider if you are not sure if you have any of the medical conditions listed above.
Most common side effects: 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 JADENU and JADENU Sprinkle. Call your health care provider for medical advice about side effects.
Before taking JADENU or JADENU Sprinkle, 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 JADENU or JADENU Sprinkle can harm your unborn baby. Hormonal forms of birth control may not be as effective if used during treatment with JADENU or JADENU Sprinkle. 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 JADENU or JADENU Sprinkle
- are breastfeeding or plan to breastfeed. It is not known if JADENU or JADENU SPRINKLE passes into your breast milk and can harm your baby. You and your health care provider should decide if you will take JADENU or JADENU SPRINKLE 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 JADENU or JADENU Sprinkle works, and JADENU or JADENU Sprinkle may affect how other medicines work. Also, your risk of sudden kidney problems or severe bleeding may be increased if you take JADENU or JADENU Sprinkle with certain medicines.
- Avoid taking the following medicines during treatment with JADENU and JADENU Sprinkle:
- 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.
What should I avoid while taking JADENU or JADENU Sprinkle?
- JADENU or JADENU Sprinkle may cause dizziness. Avoid driving or operating machinery until you know how JADENU or JADENU Sprinkle affects you. Do not drive or operate machinery if JADENU or JADENU Sprinkle makes you dizzy
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 JADENU and JADENU Sprinkle.
