Tasigna (Novartis Pharmaceuticals Canada, 200 mg, 150 mg): Uses, Side Effects and Dosage

Serious warnings and precautions box

What Tasigna is used for:

Tasigna is used to treat adults with:

• newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase,
• chronic phase and accelerated phase Ph+ CML who are no longer benefiting from other therapies for CML including imatinib.

Tasigna is used to treat children and adolescents 2 years of age and older with:

• newly diagnosed Ph+ CML in chronic phase,
• chronic phase Ph+ CML who are no longer benefiting from other therapies for CML including

Tasigna should be given under the supervision of a doctor experienced in the use of anti-cancer drugs.

Serious side effects with Tasigna include:

• Sudden cardiac deaths,
• Prolongation of the QT interval (abnormal electrical signal of the heart),
• Ischemic heart disease (heart disorder), ischemic cerebrovascular events (stroke or other problems due to decreased blood flow to the brain) and peripheral arterial occlusive disease (PAOD) (problems with decreased blood flow to your leg), rare fatal cases have been reported,
• Liver failure or liver toxicity (increase of liver enzymes), fatal cases have been reported,
• Pancreatitis (inflammation of the pancreas),
• Myelosuppression (decrease of the production of blood cells).

Tasigna is not to be used in patients who have uncorrectable low levels of potassium or magnesium.

Tasigna should only be stopped under the supervision of a doctor experienced in the treatment of patients with chronic myeloid leukemia (CML).

• imatinib.

How Tasigna works:

CML is caused by a change in your DNA (genetic material) that triggers a signal in your body to produce abnormal white blood cells. Tasigna blocks this signal to stop making these abnormal cells.

The ingredients in Tasigna are:

Medicinal ingredient: Nilotinib hydrochloride monohydrate

Non-medicinal ingredients: Capsules: Colloidal silicon anhydrous, crospovidone, gelatin, iron oxide yellow, iron oxide red, lactose monohydrate, magnesium stearate, poloxamer, and titanium dioxide.

The 150 mg capsules also contain black iron oxide.

Tasigna comes in the following dosage forms:

Capsules: 150 mg or 200 mg nilotinib (as nilotinib hydrochloride monohydrate).

• The 150 mg capsules are red. A black imprint is stamped on each capsule (“NVR/BCR”).
• The 200 mg capsules are light yellow. A red imprint is stamped on each capsule (“NVR/TKI”).

Tasigna is available in monthly packs:

• The monthly pack for 150 mg and 200 mg capsules contains 112 capsules divided into 4 individual weekly blister-packs.

Do not use Tasigna if:

• You have a condition that causes an abnormal electrical signal in your heart (prolongation of QT interval).
• You have uncorrectable low levels of potassium or magnesium.
• You are allergic (hypersensitive) to nilotinib or any of the other ingredients of Tasigna.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Tasigna. Talk about any health conditions or problems you may have, including if you:

• have electrolyte problems (e.g., low blood potassium levels) or conditions that could lead to electrolyte disturbances (e.g., vomiting, diarrhea, dehydration),
• have an eating disorder or are following a strict diet,
• have diabetes, especially with associated nerve disorders,
• had a stroke or other problems due to decreased blood flow to the brain,
• have problems with decreased blood flow to your legs,
• have liver/kidney disease,
• have had pancreatitis (inflammation of the pancreas),
• have had a surgical procedure involving the removal of the entire stomach (total gastrectomy),

• have ever had or might now have a hepatitis B virus infection (a viral infection of the liver). This is because during treatment with Tasigna, hepatitis B may become active again, which can be fatal in some cases. This is called hepatitis B reactivation. Your doctor will check for signs of this infection

  • before and during treatment with Tasigna.

Other warnings you should know about:

Lactose Intolerance: Tasigna contains lactose. Tell your doctor if you have lactose intolerance or one of the following rare hereditary diseases:

• Galactose intolerance
• Lapp lactase deficiency
• Glucose-galactose malabsorption.

Heart Conditions:

Tasigna can cause sudden cardiac death or other serious heart conditions such as QTc prolongation. QTc prolongation causes an irregular heart-beat, which can be life threatening. These heart rhythm disturbances are more likely if:

• you have a heart condition,
• you have a family history of heart conditions, or
• you are taking medicines that affect your heartbeat (antiarrhythmics) or medicines that may have an unwanted effect on the function of the heart (QT prolongation) (see also other drugs that may interact with Tasigna under “INTERACTIONS WITH THIS MEDICATION”).

If you experience any symptoms of a possible heart rhythm disturbance, such as dizziness, palpitations (sensation of rapid, pounding, or irregular heartbeat), fainting, or seizures, you should seek immediate medical attention.

Growth and Development:

Children and adolescents may grow more slowly when taking Tasigna. Your child’s doctor will measure their growth at regular visits.

Medical Tests:

Before and during the treatment with Tasigna, certain blood tests will be done. These will monitor how Tasigna is affecting your body. Electrocardiograms (ECG) may also be done regularly. An ECG is a test that measures how well your heart is working.

Driving and Heavy Machinery:

Tasigna may cause dizziness. DO NOT drive or use machines if you feel dizziness or are unable to see well while taking Tasigna.

Reproductive Health:

Men who take Tasigna must use highly effective birth control during treatment with Tasigna, and for at least 4 weeks after ending treatment. Tell your doctor right away if your female partner becomes pregnant.

Pregnancy and Breastfeeding:

Tasigna is not recommended during pregnancy as it may harm the fetus. Women who can get pregnant must use highly effective birth control during treatment with Tasigna and for at least 4 weeks after ending treatment.

You should not breast feed while taking Tasigna and for two weeks after the last dose.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following medicines may interact with Tasigna:

• An HIV medicine called ritonavir;
• Medicines used to treat asthma such as formoterol, salmeterol;
• Medicines used to prevent blood clots called warfarin;
• Medicines used to treat cancer such as imatinib, lapatinib, sunitinib, vorinostat;
• Medicine used to treat dementia such as dihydroergotamine, ergotamine;
• Medicines used to treat epilepsy such as carbamazepine, phenobarbital, phenytoin;
• A medicine used to treat slow stomach emptying called domperidone;
• An herbal medicine used to treat depression called St. John’s Wort;
• A medicine used to treat high blood pressure or irregular heartbeat called verapamil;
• Medicines used to lower cholesterol called statins (such as simvastatin, lovastatin);
• Medicines used to treat bacterial or fungal infections such as cefazolin, ciprofloxacin, clarithromycin, erythromycin, fluconazole, itraconazole, ketoconazole, levofloxacin, moxifloxacin, rifampicin, telithromycin, voriconazole, amphotericin B, pentamidine;
• Medicines used to treat irregular heartbeat such as amiodarone, digoxin, disopyramide, flecainide, ibutilide, procainamide, propafenone, quinidine, sotalol;
• Medicines used to treat malaria such as chloroquine, halofantrine;
• Medicines that can disturb electrolyte levels such as enemas, high dose corticosteroid, laxatives, water pills;
• A medicine used to treat angina called bepridil;
• Medicines used to treat depression and anxiety such as citalopram, fluoxetine, amitriptyline, imipramine, maprotiline, venlafaxine, midazolam;
• Medicines used to treat nausea such as dolasetron, metoclopramide, ondansetron, prochlorperazine;
• A medicine used to treat addiction called buprenorphine;
• Medicines used to treat pain such as methadone, morphine, alfentanil, fentanyl;
• Medicines used to prevent organ transplant rejection such as cyclosporine A, cyclosporine, sirolimus, tacrolimus;
• Medicines to stabilize thinking and behaviour such as chlorpromazine, haloperidol, droperidol, pimozide, ziprasidone;
• A medicine to treat low thyroid hormone called levothyroxine.

Taking Tasigna with Antacids:

While taking Tasigna, speak with your healthcare professional before taking antacids (medicines to treat heartburn). These medications need to be taken separately from Tasigna:

• antacids called H2 blockers which suppress the production of acid in the stomach – should be taken approximately 10 hours before or 2 hours after you take Tasigna;
• antacids such as those containing aluminum hydroxide, magnesium hydroxide and simethicone which neutralize the high acidity of the stomach – should be taken approximately 2 hours before or 2 hours after you take Tasigna.

Taking Tasigna with Food and Drink:

Do not take Tasigna with food. Taking Tasigna with food may increase the amount of Tasigna in the blood, possibly to a harmful level.

Do not take any products or juices containing grapefruit, star fruit, pomegranate, Seville oranges or similar fruits while taking Tasigna. This may increase the amount of Tasigna in blood, possibly to a harmful level.

How to take Tasigna:

• Always take Tasigna exactly as your healthcare professional has told you.
• Your healthcare professional may lower your dose or stop treatment. This may be based on a specific blood test result or if you feel unwell.
• If treatment with Tasigna is stopped, your healthcare professional will continue to carefully monitor your CML. Your doctor may tell you to re-start Tasigna if you require it.
• Swallow capsules whole with water on an empty stomach. Do not consume any food for at least 2 hours before the dose is taken and for at least 1 hour after the dose is taken.

If capsules cannot be swallowed:

• Open the capsules

• Mix the content of each capsule in one teaspoon of applesauce (pureed apple)

  Use only one single teaspoon of applesauce (not more).

  Use only applesauce (no other food).

Swallow the mixture immediately.

Usual dose

Adults:

Newly diagnosed Ph+ CML in chronic phase:

• Usual daily dose 600 mg: take two 150 mg capsules two times a day, approximately every 12 hours.
• Reduced daily dose 400 mg: take two 200 mg capsules once a day.

Chronic phase and accelerated phase Ph+ CML in patients who are no longer benefitting from previous treatment for CML:

• Usual daily dose 800 mg: take two 200 mg capsules two times a day, approximately every 12 hours.
• Reduced daily dose 400 mg: take two 200 mg capsules once a day.

Children and adolescents:

• Your child’s dose will depend on their body weight and height. The doctor will calculate the correct dose to use and tell you how many capsules of Tasigna to give to your child.
• Your child’s dose of Tasigna may change as your child grows.

Pediatric dosing of Tasigna

Overdose:

If you think you, or a person you are caring for, have taken too much Tasigna, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed Dose:

If a dose is missed, take the next dose as scheduled. Do not take a double dose to make up for the forgotten capsules.

Possible side effects from using Tasigna:

These are not all the possible side effects that you may have when taking Tasigna. If you experience any side effects not listed here are experienced, tell your healthcare professional.

• fatigue;
• weakness;
• muscle pain;
• itching;
• hair loss;
• upper respiratory tract infections;
• dyspepsia (digestion problems), eating disorder (anorexia), disturbed sense of taste;
• skin reddening;
• insomnia, depression, anxiety.

Call your doctor as soon as possible if you faint (loss of consciousness) or have an irregular heartbeat while taking Tasigna as these may be due to a serious heart condition.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

• Keep out of the reach and sight of children.
• Store at room temperature (15-30^oC).
• Store in the original package.

If you want more information about Tasigna:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the

Patient Medication Information by visiting the Health Canada Drug Product Database website (canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (http://www.novartis.ca), or by calling 1-800-363-8883.

Date of Authorization: 2026-06-26

TASIGNA is a registered trademark