TASIGNA- nilotinib capsule 
Novartis Pharmaceuticals Corporation

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Medication Guide

TASIGNA® (ta-sig-na)

(nilotinib)

Capsules

Read this Medication Guide before you start taking TASIGNA and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment.

What is the most important information I should know about Tasigna?

Tasigna can cause a possible life-threatening heart problem called QTc prolongation. QTc prolongation causes an irregular heartbeat, which may lead to sudden death.

Your doctor should check the electrical activity of your heart with a test called an electrocardiogram (ECG):

You may lower your chances for having QTc prolongation with Tasigna if you:

Call your doctor right away if you feel lightheaded, faint, or have an irregular heartbeat while taking Tasigna. These can be symptoms of QTc prolongation.

What is Tasigna?

Tasigna is a prescription medicine used to treat a type of leukemia called Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in adults who:

It is not known if Tasigna is safe and effective in children.

Who should not take Tasigna?

Do not take if you have:

What should I tell my doctor before starting Tasigna?

Before taking Tasigna, tell your doctor about all of your medical conditions, including if you have:

Tell your doctor about all the medicines you take, including prescription and nonprescription 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 Tasigna. If you take:

Tasigna 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 Tasigna?”

Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.

How should I take Tasigna?

What are the possible side effects of Tasigna?

Tasigna may cause serious side effects including:

Your doctor may do blood tests to check you for TLS.

The most common side effects of Tasigna include:

  • low blood count
  • nausea
  • rash
  • headache
  • tiredness
  • itching
  • vomiting
  • diarrhea
  • cough
  • constipation
  • muscle and joint pain
  • runny or stuffy nose, sneezing, sore throat
  • fever
  • night sweats

 

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 Tasigna. For more information, ask your doctor or pharmacist.

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 Tasigna?

Keep Tasigna and all medicines out of the reach of children.

General information about Tasigna

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Tasigna for a condition for which it was not prescribed. Do not give Tasigna to other people, even if they have the same problem you have. It may harm them.

This Medication Guide summarizes the most important information about Tasigna. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Tasigna that is written for health professionals.

For more information, go to www.us.tasigna.com or call 1-866-411-8274.

What are the ingredients in Tasigna?

Active ingredient: nilotinib

Inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate and poloxamer 188.

The capsule shell contains gelatin, iron oxide (red), iron oxide (yellow), iron oxide (black), and titanium dioxide.

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

Manufactured by:
Novartis Pharma Stein AG
Stein, Switzerland

Distributed by:
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936

Revised: January 2014

© Novartis

T2014-03
January 2014

Revised: 01/2014
 
Novartis Pharmaceuticals Corporation