Tasigna (Novartis Pharmaceuticals Canada, 50 mg): Uses, Side Effects and Dosage

What is Tasigna 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 imatinib.

Serious Warnings and Precautions

How does Tasigna work?

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 of making these abnormal cells.

What are the ingredients in Tasigna?

Medicinal ingredients: Nilotinib.

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

The 50 mg and 150 mg capsules also contain black iron oxide.

Tasigna comes in the following dosage forms:

Tasigna is supplied as a hard capsule, containing 50 mg, 150 mg or 200 mg nilotinib (as nilotinib hydrochloride monohydrate).

• The 50 mg capsules are red/yellow. A black imprint is stamped on each capsule (“NVR/ABL”).
• 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 50 mg capsules contains 120 capsules divided into 3 blister-cartons of 40 capsules/ carton.
• 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 confitions, or
• you are taking medicines that affect your heart beat (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 heart beat), 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, used to treat/or:

• Anti-HIV medicine from the class “antiproteases”:

  Ritonavir;

• Asthma:

  Formoterol, salmeterol;

• Blood coagulation disorders (such as blood clots or thromboses):

  Warfarin;

• Cancers:

  Imatinib, lapatinib, sunitinib, vorinostat;

• Dementia:

  Dihydroergotamine and ergotamine;

• Epilepsy:

  Carbamazepine, phenobarbital, phenytoin;

• Gastrointestinal motility disorder:

  Domperidone;

• Herbal product (also known as Hypericum Perforatum):

  St. John’s Wort;

• High blood pressure and some types of irregular heart beat:

  Verapamil;

• High level of fats in blood (class of drugs):

  Statins (such as simvastatin and lovastatin);

• Infections:

  Cefazolin, ciprofloxacin, clarithromycin, erythromycin, fluconazole, itraconazole, ketoconazole, levofloxacin, rifampin, tacrolimus, telithromycin, voriconazole;

• Irregular Heartbeat:

  Antiarrhythmics such as amiodarone, digoxin, disopyramide, flecainide, ibutilide, procainamide, propafenone, quinidine, sotalol;

• Malaria:

  Chloroquine;

• Medicines that can disturb electrolyte levels:

  Amphotericin B, enemas, high dose corticosteroids, laxatives, water pills;

• Medicines that may have an unwanted effect on the function of the heart (QT prolongation):

  Bepridil, chloroquine, clarithromycin, halofantrine, haloperidol, methadone, moxifloxacin, pimozide;

• Mood disorder:

  Citalopram, fluoxetine, tricyclic/tetracyclic antidepressants (e.g.: amitriptyline, imipramine, maprotiline), venlafaxine;

• Nausea:

  Dolasetron, metoclopramide, ondansetron, prochlorperazine;

• Opioids dependence (substitute treatment):

  Buprenorphine-;

• Pain (moderate to severe):

  Methadone, morphine;

• Pain and used as a sedative before or during surgery or medical procedure:

  Alfentanil and fentanyl;

• Pneumocystis carinii pneumonia:

  Pentamidine;

• Prevent organ transplantations rejections, and to treat autoimmune conditions:

  Cyclosporine A;

• Prevent the rejection of transplanted organs such as liver, heart and kidney:

  Cyclosporine, sirolimus and tacrolimus - medicines that suppress the “self-defense” ability of the body and fight infections;

• Relieve anxiety before surgery:

  Midazolam;

• Stabilize thinking and behaviour:

  Chlorpromazine, droperidol, ziprasidone;

• Thyroid deficiency:

  Levothyroxine;

• Tuberculosis:

  Rifampicin;

Taking Tasigna with Antacids:

While taking Tasigna, speak with your healthcare professional before taking antacids (medicines against 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 or your child have taken more Tasigna than directed, or if someone else accidentally takes the capsules, contact your doctor or the nearest hospital emergency room or a local poison control centre immediately. You may be asked to show them the pack of capsules.

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.

What are possible effects from using Tasigna?

As with all medicines, Tasigna can cause side effects. These are not all the possible side effects that may be experienced when taking Tasigna. If any side effects not listed here are experienced, or these affect you or your child severely, tell your doctor or pharmacist.

• 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

Serious side effects and what to do about them

Serious side effects and what to do about them

Serious side effects and what to do about them

Serious side effects and what to do about them

This is not a complete list of side effects.

For any unexpected effects while taking Tasigna, contact your doctor or pharmacist.

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 (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health 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 this

  Patient Medication Information by visiting the Health Canada website (https://www.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.

Last Revised: JUL 20, 2023

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