Nilotinib

What it is used for

Nilotinib capsules are a kinase inhibitor indicated for the treatment of: Adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib.

Pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy. 1.1 Adult and Pediatric Patients With Newly Diagnosed Ph+ CML-CP Nilotinib capsules are indicated for the treatment of adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.

1.2 Adult Patients With Resistant or Intolerant Ph+ CML-CP and CML-AP Nilotinib capsules are indicated for the treatment of adult patients with chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) resistant or intolerant to prior therapy that included imatinib. 1.3 Pediatric Patients With Resistant or Intolerant Ph+ CML-CP Nilotinib capsules are indicated for the treatment of pediatric patients greater than or equal to 1 year of age with chronic phase Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) with resistance or intolerance to prior tyrosine-kinase inhibitor (TKI) therapy.

Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation’s TASIGNA (nilotinib) capsules. However, due to Novartis Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

The most important thing to know

Nilotinib Capsules can cause a possible life-threatening heart problem called QTc prolongation. QTc prolongation causes an irregular heartbeat, which may lead to sudden death. Your healthcare provider should check the electrical activity of your heart with a test called an electrocardiogram (ECG): before starting Nilotinib Capsules 7 days after starting Nilotinib Capsules with any dose changes regularly during Nilotinib Capsules treatment You may lower your chances for having QTc prolongation with Nilotinib Capsules if you: Take Nilotinib Capsules 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.

Do not drink grapefruit juice, eat grapefruit, or take supplements containing grapefruit extract during treatment with Nilotinib Capsules. Grapefruit products increase the amount of Nilotinib Capsules in your body. Avoid taking other medicines or supplements with Nilotinib Capsules that can also cause QTc prolongation. Nilotinib can interact with many medicines and supplements and increase your chance for serious and life-threatening side effects.

How to take it

” Call your healthcare provider right away if you feel lightheaded, faint, or have an irregular heartbeat during treatment with Nilotinib Capsules. These can be symptoms of QTc prolongation. See “

Side effects, and when to stop

” for more information about side effects. What is Nilotinib Capsules? Nilotinib Capsule is a prescription medicine used to treat: adults who have been newly diagnosed with a certain type of leukemia called Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. adults with chronic phase Ph+ CML or accelerated phase Ph+ CML who: are no longer benefiting from other treatments, including imatinib (Gleevec), or have taken other treatments, including imatinib (Gleevec), and cannot tolerate them.

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. Who should not take Nilotinib Capsules? Do not take if you have: low levels of potassium or magnesium in your blood long QTc syndrome Before taking Nilotinib Capsules, tell your healthcare provider about all of your medical conditions, including if you: have heart problems have had a stroke or other problems due to decreased blood flow to the brain have problems with decreased blood flow to your legs have irregular heartbeat have QTc prolongation or a family history of it have liver problems have had pancreatitis have low blood levels of potassium or magnesium in your blood 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 Capsules. have bleeding problems had a surgical procedure involving the removal of the entire stomach (total gastrectomy) are pregnant or plan to become pregnant. Nilotinib can harm your unborn baby. Tell your healthcare provider right away if you are pregnant, or if you become pregnant during treatment with Nilotinib Capsules.

In females who are able to become pregnant: Your healthcare provider should do a pregnancy test before you start treatment with Nilotinib Capsules. Use effective birth control (contraception) during treatment with Nilotinib Capsules and for 14 days after the last dose. are breastfeeding or plan to breastfeed. It is not known if nilotinib passes into your breast milk.

Do not breastfeed during treatment and for 14 days after your last dose of Nilotinib Capsules. Tell your healthcare provider 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 Capsules.

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 Capsules, or about 2 hours after you take Nilotinib Capsules. 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 Capsules.

Nilotinib can interact with many medicines and supplements and increase your chance for serious and life-threatening side effects. How should I take Nilotinib Capsules? Take Nilotinib Capsules exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking Nilotinib Capsules unless your healthcare provider tells you.

Nilotinib Capsules is a long-term treatment. Take your prescribed dose of Nilotinib Capsules 2 times a day, about 12 hours apart. Your healthcare provider will tell you how many Nilotinib Capsules to take and when to take them. Nilotinib Capsules must be taken 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.

Swallow Nilotinib Capsules whole with water. Do not open Nilotinib Capsules. If you cannot

Who should not take it

Do not take any other medicine during treatment with Nilotinib Capsules unless your healthcare provider tells you it is okay to do so. For more information, see “

Storing it

Store Nilotinib Capsules at room temperature between 68°F to 77°F (20°C to 25°C). Safely throw away medicine that is out of date or no longer needed. Keep Nilotinib Capsules and all medicines out of the reach of children.