Adult and pediatric patients (≥ 1 year old) with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).
Adult patients with CP and accelerated phase (AP) Ph+ CML resistant or intolerant to prior therapy that included imatinib.
Pediatric patients (≥ 1 year old) of age with CP and AP Ph+ CML with resistance or intolerance to prior tyrosine kinase inhibitor (TKI) therapy.
NILOTINIB is a prescription medicine used to treat:
- Adults and children 1 year old or older with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).
- Adults with CP and accelerated phase (AP) Ph+ CML resistant or intolerant to prior therapy that included imatinib.
- Children 1 year old or older with CP and AP Ph+ CML with resistance or intolerance to prior tyrosine kinase inhibitor (TKI) therapy.
It is not known if NILOTINIB is safe and effective in children younger than 1 year of age with newly diagnosed, resistant, or intolerant Ph+ CML in chronic phase.
The long-term effects of treating children with NILOTINIB for a long period of time are not known.
QTc Prolongation and Sudden Death: NILOTINIB can cause QTc prolongation, a possibly life-threatening heart problem. QTc prolongation causes an irregular heartbeat, which may lead to sudden death. Call your doctor right away if you feel lightheaded, faint, or have an irregular heartbeat while taking NILOTINIB. These can be symptoms of QTc prolongation.
NILOTINIB is a prescription medicine used to treat:
- Adults and children 1 year old or older with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).
- Adults with CP and accelerated phase (AP) Ph+ CML resistant or intolerant to prior therapy that included imatinib.
- Children 1 year old or older with CP and AP Ph+ CML with resistance or intolerance to prior tyrosine kinase inhibitor (TKI) therapy.
It is not known if NILOTINIB is safe and effective in children younger than 1 year of age with newly diagnosed, resistant, or intolerant Ph+ CML in chronic phase.
The long-term effects of treating children with NILOTINIB for a long period of time are not known.
QTc Prolongation and Sudden Death: NILOTINIB can cause QTc prolongation, a possibly life-threatening heart problem. QTc prolongation causes an irregular heartbeat, which may lead to sudden death. Call your doctor right away if you feel lightheaded, faint, or have an irregular heartbeat while taking NILOTINIB. These can be symptoms of QTc prolongation.
Your doctor should check your heart with a test called an electrocardiogram (ECG).
Do not take NILOTINIB if you have long QTc syndrome or low levels of potassium or magnesium in your blood.
NILOTINIB can interact with many medicines and supplements. This may increase your chances for serious and life-threatening side effects. Do not take any other medicine while taking NILOTINIB unless your doctor tells you it is okay to do so.
Food and grapefruit products increase the amount of NILOTINIB in your body. This may increase your chances for serious and life-threatening side effects. Take NILOTINIB on an empty stomach.
Avoid eating food for at least 2 hours before the dose is taken, and avoid eating food for at least 1 hour after the dose is taken.
Avoid grapefruit, grapefruit juice, and any supplement containing grapefruit extract while taking NILOTINIB.
NILOTINIB can cause serious side effects that can even lead to death. During treatment with NILOTINIB your doctor will do tests to check for side effects. These tests will check your heart, blood cells (white blood cells, red blood cells, and platelets), electrolytes (potassium, magnesium), cholesterol, blood sugar, and pancreas and liver function. Your doctor may have you stop NILOTINIB for some time or lower your dose if you have side effects. You should follow your doctor's instructions. Serious side effects include:
Low Blood Counts:
Low blood counts are common with NILOTINIB but can also be severe. Your doctor will check your blood counts regularly during treatment with NILOTINIB. Call your doctor right away if you have symptoms of low blood counts including:
Decreased Blood Flow to the Legs, Heart, or Brain:
People who have recently been diagnosed with Ph+ CML and take NILOTINIB may develop decreased blood flow to the legs, heart, or brain. Get medical help right away if you suddenly develop any of the following symptoms:
Pancreas Inflammation (Pancreatitis):
Call your doctor if you have symptoms including sudden stomach area pain with nausea and vomiting.
Liver Problems:
NILOTINIB can increase your risk of liver problems. People who have had liver problems in the past may be at risk for getting liver problems with NILOTINIB. Call your doctor, or get medical help right away if you develop any symptoms of liver problems including stomach area (abdominal) pain, yellow skin/eyes, and dark-colored urine.
Tumor Lysis Syndrome (TLS):
TLS is caused by a fast breakdown of cancer cells. Your doctor may do blood tests to check you for TLS. TLS can cause you to have kidney failure (with the need for dialysis treatment) and/or an abnormal heartbeat.
Bleeding Problems:
Serious bleeding problems and death have happened during treatment with NILOTINIB. Call your doctor right away if you develop signs and symptoms of bleeding such as uncontrolled bleeding, changes in eyesight, unconsciousness, sudden headache, or sudden confusion about your surroundings.
Total Gastrectomy:
Tell your doctor if you have had a surgical procedure involving the removal of the entire stomach (total gastrectomy). Your doctor may need to change your dose.
Lactose:
Tell your doctor if you have a severe problem with lactose (milk sugar) or other sugars. NILOTINIB capsules contain lactose. Most people who have mild or moderate lactose intolerance can take NILOTINIB.
Fluid Retention:
Your body may hold too much fluid (fluid retention). Symptoms of fluid retention include shortness of breath, rapid weight gain, and swelling.
Abnormal Growth or Development in Children:
Effects on growth and development have happened in children with chronic phase Ph+ CML during treatment with NILOTINIB. Some children and adolescents who take NILOTINIB may have slower than normal growth.
Pregnancy and Breastfeeding:
NILOTINIB should not be used during pregnancy since it may harm an unborn baby. If you become pregnant, think you may be pregnant, or are planning to become pregnant, tell your doctor right away. If you are able to become pregnant, your doctor should perform a pregnancy test before you start NILOTINIB. Effective birth control should be used during treatment and for at least 14 days after your last NILOTINIB dose. Do not breastfeed during treatment with NILOTINIB and for at least 14 days after the final dose.
Treatment-Free Remission in Adults:
Your doctor will monitor your CML during treatment with NILOTINIB to see if you are in remission. After at least 3 years of treatment with NILOTINIB, your doctor may do certain tests to determine if you continue to be in remission. Based on your test results, your doctor will decide if you are eligible to try stopping treatment with NILOTINIB. This is called treatment-free remission (TFR). Your doctor will carefully monitor your CML during and after you stop taking NILOTINIB. If your test results show your CML is no longer in remission, your doctor will restart NILOTINIB treatment. It is important that your doctor does frequent monitoring to find out if you need to restart your NILOTINIB treatment. Follow your doctor's instructions about restarting NILOTINIB if you are no longer in TFR.
Drug Interactions:
NILOTINIB can interact with many medicines and supplements. This may increase your chances for serious and life-threatening side effects. Tell your doctor about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements.
If you need to take antacids (medicines to treat heartburn) do not take them at the same time that you take NILOTINIB. If you take:
A medicine to block the amount of acid produced in the stomach (H2 blocker): Take these medicines about 10 hours before you take NILOTINIB or about 2 hours after you take NILOTINIB
An antacid that contains aluminum hydroxide, magnesium hydroxide, and simethicone to reduce the amount of acid in the stomach: Take these medicines about 2 hours before or about 2 hours after you take NILOTINIB
Common Side Effects in Adults and Children Include:
Side Effects in Adults Attempting TFR: If you and your doctor decide that you can stop taking NILOTINIB and try TFR, you may have more muscle and bone (musculoskeletal) symptoms than before you stopped treatment. Symptoms may include muscle pain, bone pain, arm and leg pain, spinal pain, and joint pain
Tell your doctor if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of NILOTINIB. For more information, ask your doctor or pharmacist.
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 click here for the full Prescribing Information, including the Boxed WARNING, and the NILOTINIB Medication Guide.
