Patient information: uses, side effects, how to take - Nilotinib

What are the ingredients in Nilotinib Capsules?

Active ingredient: nilotinib d-tartrate

Inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium aluminometasilicate, magnesium stearate and polysorbate 80.

The empty capsules contain gelatin, iron oxide (black), iron oxide (red), iron oxide (yellow), and titanium dioxide. The black ink contains iron oxide (black), potassium hydroxide, propylene glycol, shellac, and strong ammonia solution.

Manufactured by:

Cipla Ltd.,

Verna- 403722, Goa, India.

Cipla Ltd.

At M/s Genvion Corporation,

Winnipeg, Manitoba R2J 4K2,

Canada (CAN)

Manufactured for:

Cipla USA, Inc.

10 Independence Boulevard, Suite 300

Warren, NJ 07059

For more information, go to https://usa.cipla.com or call 1-866-604-3268.

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.

What is the most important information I should know about Nilotinib Capsules?

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.
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 “How should I take Nilotinib Capsules?”

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 “What are the possible side effects of Nilotinib Capsules?” 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. See “What is the most important information I should know about Nilotinib Capsules?”

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 swallow Nilotinib Capsules whole, tell your healthcare provider.
Do not drink grapefruit juice, eat grapefruit, or take supplements containing grapefruit extract at any time during treatment. See “What is the most important information I should know about Nilotinib Capsules?”
If you miss a dose, just take your next dose at your regular time. Do not take 2 doses at the same time to make up for a missed dose.
If you take too much Nilotinib Capsules, call your healthcare provider or go to the nearest hospital emergency room right away. Symptoms may include vomiting and drowsiness.
During treatment with Nilotinib Capsules your healthcare provider will do tests to check for side effects and to see how well Nilotinib Capsules is working for you. The tests will check your:
heart
blood cells (white blood cells, red blood cells, and platelets). Your blood cells should be checked every 2 weeks for the first 2 months and then monthly.
electrolytes (potassium, magnesium)
pancreas and liver function
bone marrow samples

Your healthcare provider may change your dose. Your healthcare provider may have you stop Nilotinib Capsules for some time or lower your dose if you have side effects with it.

Your healthcare provider will monitor your CML during treatment with Nilotinib Capsules to see if you are in a remission. After at least 3 years of treatment with Nilotinib Capsules, your healthcare provider may do certain tests to determine if you continue to be in remission. Based on your test results, your healthcare provider may decide if you may be eligible to try stopping treatment with Nilotinib Capsules. This is called Treatment Free Remission (TFR).
Your healthcare provider will carefully monitor your CML during and after you stop taking Nilotinib Capsules. Based on your test results, your healthcare provider may need to re-start your Nilotinib Capsules if your CML is no longer in remission.
It is important that you are followed by your healthcare provider and undergo frequent monitoring to find out if you need to re-start your Nilotinib Capsules treatment because you are no longer in TFR. Follow your healthcare provider’s instructions about re-starting Nilotinib Capsules if you are no longer in TFR.

What are the possible side effects of Nilotinib Capsules?

Nilotinib Capsules may cause serious side effects, including:

See “What is the most important information I should know about Nilotinib Capsules?”
Low blood cell counts. Low blood cell counts (red blood cells, white blood cells, and platelets) are common with Nilotinib Capsules, but can also be severe. Your healthcare provider will check your blood counts regularly during treatment with Nilotinib Capsules. Call your healthcare provider or get medical help right away if you develop any signs or symptoms of low blood counts, including:

fever
chills or other signs of infection
unexplained bleeding or bruising
unexplained weakness
shortness of breath

Decreased blood flow to the leg, heart, or brain. People who have recently been diagnosed with Ph+ CML and take Nilotinib Capsules may develop decreased blood flow to the leg, the heart, or brain.

Get medical help right away if you suddenly develop any of the following symptoms:

chest pain or discomfort
numbness or weakness
problems walking or speaking
leg pain
your leg feels cold
change in the skin color of your leg

Pancreas inflammation (pancreatitis). Tell your healthcare provider right away if you develop any symptoms of pancreatitis, including sudden stomach area pain with nausea and vomiting.
Liver problems. Nilotinib Capsules 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 Capsules. Call your healthcare provider or get medical help right away if you develop any symptoms of liver problems, including:

stomach area (abdominal) pain

yellow skin and eyes

dark-colored urine

Tumor Lysis Syndrome (TLS). TLS is caused by a fast breakdown of cancer cells. Your healthcare provider may do blood tests to check you for TLS. TLS can cause you to have:

kidney failure and the need for dialysis treatment
an abnormal heart beat

Bleeding problems. Serious bleeding problems and death have happened during treatment with Nilotinib Capsules. Tell your healthcare provider right away if you develop any signs and symptoms of bleeding during treatment with Nilotinib Capsules.
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 may have slower than normal growth during treatment with nilotinib.

The most common side effects of Nilotinib Capsules in adults include:

nausea
rash
headache
tiredness
itching
vomiting

diarrhea
cough
constipation
muscle and joint pain
runny or stuffy nose, sneezing, sore throat
fever
night sweat

Side effects in adults attempting treatment free remission:

If you and your healthcare provider decide that you can stop taking Nilotinib Capsules and try treatment free remission (TFR), you may have more muscle and bone (musculoskeletal) symptoms than before you stopped treatment. Symptoms may include:

muscle pain
arm and leg pain
joint pain

bone pain
spine pain

Tell your healthcare provider 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 Capsules.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Nilotinib Capsules?

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.

General information about the safe and effective use of Nilotinib Capsules.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Nilotinib Capsules for a condition for which it was not prescribed. Do not give Nilotinib Capsules to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Nilotinib Capsules that is written for health professionals.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Issued: 1/2025

Nilotinib (Cavhanza, Danziten): Uses, Side Effects and Dosage