• your child becomes sick with fever, vomiting, or diarrhea and cannot drink fluids normally during treatment with JADENU or JADENU Sprinkle. Your child may be dehydrated. Your healthcare provider may need to temporarily stop treatment with JADENU or JADENU Sprinkle and treat your child for dehydration to help prevent kidney problems. Your healthcare 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 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 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 JADENU or JADENU Sprinkle. Call your healthcare provider right away, if you develop any of the following signs and symptoms:

• 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 who 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 who are not receiving regular blood transfusions.

• 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. See the end of this medication guide for a list of the ingredients in JADENU and JADENU Sprinkle.

Ask your healthcare provider if you are not sure if you have any of the medical conditions listed above.

• have kidney problems
• have liver problems
• have advanced cancer. See “Do not take JADENU or JADENU Sprinkle if you?”
• 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 healthcare provider about other birth control options that you can use during this time. Tell your healthcare 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 healthcare provider should decide if you will take JADENU or JADENU SPRINKLE or breastfeed. You should not do both.

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 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. See “What is the most important information I should know about JADENU and JADENU Sprinkle?”

• 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 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.

• Take JADENU exactly as your healthcare provider tells you.
• Do not change your dose of JADENU or stop taking unless your healthcare provider tells you to.
• JADENU comes as tablets or Sprinkle granules.
  • You may take JADENU tablets or JADENU Sprinkle granules on an empty stomach or with a light meal. Examples of a light meal include:
    • 1 whole wheat English muffin, 1 packet of jelly (0.5 ounce), and skim milk (8 fluid ounces), or
    • A turkey sandwich (2 ounces of turkey on whole wheat bread with lettuce, tomato, and 1 packet of mustard)

Taking JADENU tablets:

• Take JADENU tablets by mouth with water or other liquids 1 time every day, preferably at the same time every day.
• If you have trouble swallowing the tablets whole, you may crush JADENU tablets and mix them with soft foods such as yogurt or applesauce right before taking your dose.
• Take the dose right away. Do not save any of the JADENU and soft food mixture for later use.
• Do not use store-bought pill crushers with serrated surfaces for crushing JADENU 90 mg tablets.

Taking JADENU Sprinkle granules:

• Sprinkle the prescribed dose of granules onto soft food such as yogurt or applesauce right before taking your dose.
• Take the sprinkles and soft food by mouth.

• Do not take JADENU or JADENU Sprinkle with aluminum-containing antacid products. See “Before taking JADENU or JADENU Sprinkle”.
• Tell your healthcare provider if you or your child gain or lose any weight. Your or your child’s dose of JADENU or JADENU Sprinkle may need to be adjusted.
• If you take the diabetes medicine repaglinide during treatment with JADENU, you may need to test your blood sugar (glucose) levels more often. Follow your healthcare provider’s instructions about how often to test your blood sugar during this time.
• Your healthcare provider should do blood and urine tests before, and during treatment to check how you respond to JADENU, and to monitor you for side effects. Your healthcare provider may change your dose, or temporarily or permanently stop JADENU if you have certain side effects.
• In people who have thalassemia, your healthcare provider will check the amount of iron in your liver before and during treatment with JADENU.
• If you or your child take too much JADENU or JADENU Sprinkle, call your healthcare provider right away or go to the nearest hospital emergency room. Symptoms that can happen if you take too much JADENU include: stomach-area (abdominal) pain, diarrhea, nausea and vomiting.

• 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.

• See "What is the most important information I should know about JADENU and JADENU Sprinkle?"
• Effects on your bone marrow. JADENU and JADENU Sprinkle can affect your bone marrow and cause you to have 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 healthcare 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:

• Store JADENU or JADENU Sprinkle at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep the bottle closed tightly and away from moisture.

Keep JADENU or JADENU Sprinkle and all medicines out of the reach of children.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use JADENU or JADENU Sprinkle 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 JADENU or JADENU Sprinkle.