Fact Sheet - TASIGNA

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Contact: BMORS Enquiries

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Authorization with Conditions of ^PrTASIGNA* (nilotinib Capsules) for the Treatment of Accelerated Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia (cml) in Adult Patients Resistant to or Intolerant of at Least One Prior Therapy, Including Imatinib

Fact Sheet

What is TASIGNA*?

TASIGNA* is a capsule containing 200 mg of nilotinib (as nilotinib hydrochloride monohydrate). TASIGNA* belongs to a class of anti-cancer agents called Protein-tyrosine kinase inhibitors.

Health Canada has authorized TASIGNA* with conditions, under the Notice of Compliance with Conditions (NOC/c) Policy for the treatment of accelerated phase Philadelphia chromosome positive chronic myeloid leukemia (CML) in adult patients resistant to or intolerant of at least one prior therapy, including imatinib. This authorization reflects the promising nature of the clinical evidence and safety which must be confirmed and/or extended with further studies. Products, approved under Health Canada's NOC/c Policy, have demonstrated promising benefit, are of high quality, and possess an acceptable safety profile based on a benefit/risk assessment.

What is TASIGNA* used for?

TASIGNA* (nilotinib capsules) is used for the treatment of accelerated phase Philadelphia chromosome positive chronic myeloid leukemia (CML) in adult patients resistant to or intolerant of at least one prior therapy, including imatinib.

What is Chronic Myeloid Leukemia (CML)?

Chronic Myeloid Leukemia is a type of leukemia where the bone marrow produces an excessive number of abnormal white blood cells named myeloid cells. These abnormal cells suppress the production of normal white blood cells, which act to protect the body against infection.

How does TASIGNA* work?

TASIGNA* specifically targets the activity of certain enzymes called tyrosine kinases that play an important role within certain cancer cells. In patients with accelerated phase Ph+ CML, TASIGNA* works by inhibiting the growth of the abnormal white blood cells.

What do patients need to know about using TASIGNA*?

TASIGNA* should be given under the supervision of a doctor experienced in the use of anti-cancer drugs. Serious side effects with TASIGNA* include:

• Myelosuppression (decrease of production of blood cells),
• Prolongation of the QT interval (abnormal electrical signal of the heart),
• Sudden deaths,
• Liver toxicity (increase of liver enzymes),
• Pancreatitis (inflammation of the pancreas),

TASIGNA* should not be used in patients with low levels of potassium or magnesium.

BEFORE taking ^PrTASIGNA*, patients should talk to their doctor or pharmacist if any of the following apply to them now or even in the past:

• have a heart disorder, or a heart rhythm disorder such as an irregular heartbeat or an abnormal electrical signal of the heart called "prolongation of the QT interval",
• are being treated with medicines that affect the heart beat (antiarrhythmics) or medicines that may have an unwanted effect on the function of the heart (QT prolongation),
• are being treated with medicines that affect the liver,
• suffer from low level of potassium or magnesium,
• have been treated with a type of medicine called anthracyclines (frequently used in cancer therapy, including leukemia therapy),
• have liver problems,
• have had pancreatitis (inflammation of the pancreas),
• have intolerance to lactose (milk sugar). TASIGNA* contains lactose,
• are pregnant or plan to get pregnant. TASIGNA* is not recommended during pregnancy. Women who can get pregnant must use effective birth control during treatment with TASIGNA*,
• breast feeding or plan to breast feed. Women should not breast feed while taking TASIGNA*.

TASIGNA* can cause a possible heart problem called QT prolongation which may uncommonly (0.1 to 1%) lead to sudden death.

Can TASIGNA* be taken with other drugs?

TASIGNA* may interact with other medications, including over-the-counter medications (medications that can be purchased without a prescription) or herbal products (e.g. St-John's Wort (also known as Hypericum Perforatum). Patients should inform their doctor or pharmacist about all drugs including medicines obtained without a prescription that they are taking or have recently taken. TASIGNA* may increase or decrease blood levels of certain drugs, which may increase side effects or decrease the effectiveness of treatment.

During treatment with TASIGNA*, patients should not start taking a new medicine including medicines obtained without a prescription before talking with their doctor or pharmacist.

What are the side effects and how serious are they?

Most patients taking TASIGNA* can have some side effects which are usually mild to moderate. Most side effects can be managed through additional medications, dose adjustment, or other measures. Very common side effects of TASIGNA* are nausea, constipation, diarrhea, headache, tiredness, itching, and rash. Bone pain, pain in joints, muscle spasms were commonly observed.

Rapid weight gain, swelling of hands, ankles, feet or face (signs of peripheral edema and fluid retention), heart disorders (congestive heart failure), abdominal pain, vomiting of blood, black stools, constipation, swollen abdomen (signs of gastrointestinal hemorrhage) and cerebral hemorrhage were observed during treatment with TASIGNA*. Low levels of white blood cells, red blood cells or platelets were observed during treatment with TASIGNA*.

Who should not be treated with TASIGNA*?

TASIGNA* should not be taken by patients with a known allergy (hypersensitivity) to the active ingredient (nilotinib) or to any of the other ingredients of TASIGNA* or by patients who have an abnormal electrical signal of the heart (prolongation of QT interval).

How is TASIGNA* taken?

The usual starting dose 400 mg twice a day (approximately every 12 hours). The capsules should be taken orally on an empty stomach, at least two hours after any food and wait at least 1 hour before eating again. The capsules should be swallowed whole with water and should not be opened. Avoid grapefruit and grapefruit juice while being treated with TASIGNA*.

Taking TASIGNA* at the same time each day will help you to remember when to take your capsules.

What else should patients know about taking TASIGNA*?

Store TASIGNA* at room temperature (15- 30°C).

Where can I learn more about TASIGNA*?

If you have any questions concerning TASIGNA*, kindly contact our Medical Information Department at 1-800-363-8883.

Please consult your doctor or pharmacist with any questions or concerns you may have regarding your individual condition.

This document including the TASIGNA* Prescribing Information and Patient Information can be found on Novartis' Website (http://www.novartis.ca).

^PrTASIGNA* (nilotinib) is a registered trademark.