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Tasigna

(nilotinib)

How does this medication work? What will it do for me?

Nilotinib belongs to group of the cancer-fighting medications known as antineoplastics, and specifically to the family of medications called protein tyrosine kinase inhibitors. Nilotinib is used to treat adults who have chronic phase (long-lasting) or accelerated phase (fast-growing) forms of chronic myeloid leukemia (CML) that is Philadelphia chromosome positive. It is used when other therapies have been tried, including imatinib, and not produced a response, or other therapies have produced unacceptable levels of side effects.

Nilotinib has also been granted a notice of compliance with conditions (NOC/c) by Health Canada for the treatment of newly diagnosed Philadelphia chromosome positive CML in chronic phase. This means that Health Canada has approved this medication to be marketed based on promising evidence of effectiveness, but additional results of studies are needed to verify its effectiveness. An NOC/c is used to allow access to products that are used to treat or prevent serious, life-threatening, or severely debilitating illness.

In CML, the body produces abnormal white blood cells. Nilotinib works by blocking the signal that triggers the production of these abnormal white blood cells.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

The usual recommended adult dose of nilotinib for the treatment of CML that has been previously treated, is 400 mg taken by mouth twice daily.

The recommended adult dose of nilotinib for the treatment of newly diagnosed CML is 300 mg taken by mouth, twice daily.

Doses should be taken approximately 12 hours apart and swallowed whole with a glass of water.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Do not take nilotinib with food; take the dose at least 1 hour before or 2 hours after eating. If you are not able to swallow capsules, the capsules may be carefully opened and the contents sprinkled on one single teaspoonful of applesauce. This must be swallowed immediately. Only applesauce may be used and only one single teaspoonful of applesauce may be used. Food affects how nilotinib is absorbed and used by the body. Anything other than one teaspoonful of applesauce may change how nilotinib works for you.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature in the original package, which will help to protect it from light and moisture. Keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

150 mg
Each red, opaque, size 1, hard gelatin capsule with black axial imprint "NVR/BCR", contains 150 mg nilotinib. Nonmedicinal ingredients: colloidal silicon anhydrous, crospovidone, lactose monohydrate, Poloxamer 188, magnesium stearate; capsule shell: gelatin, titanium dioxide (E 171), red iron oxide red (E 172), yellow iron oxide (E172); printing ink: includes black (E 172) iron oxide.

200 mg
Each light yellow, opaque, size 0, hard gelatin capsule, with red axial imprint "NVR/TKI", contains 200 mg nilotinib. Nonmedicinal ingredients: colloidal silicon anhydrous, crospovidone, lactose monohydrate, poloxamer 188, magnesium stearate; capsule shell: contains gelatin, titanium dioxide, yellow iron oxide, and red iron oxide.

Who should NOT take this medication?

Do not take nilotinib if you:

  • are allergic to nilotinib or any ingredients of the medication
  • have long QT syndrome (a type of irregular heartbeat)
  • have low levels of potassium or magnesium in the blood, that cannot be corrected

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal pain
  • anxiety
  • bone pain
  • changed sense of taste
  • constipation
  • diarrhea
  • difficulty sleeping
  • dizziness
  • dry mouth
  • dry skin
  • fatigue
  • flushing
  • gas (flatulence)
  • hair loss or thinning
  • headache
  • itching
  • joint pain
  • loss of appetite
  • mouth sores
  • muscle pain
  • muscle spasms and cramps
  • nausea
  • night sweats
  • pain involving the chest muscles
  • sensation of spinning (vertigo)
  • sense of taste changed
  • skin reddening
  • upper respiratory tract infection
  • vomiting
  • weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • cough
  • fever
  • hives
  • increased blood cholesterol
  • increased blood pressure
  • infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
  • numbness or tingling of the hands of feet
  • rapid weight gain
  • signs of anemia (low red blood cells; e.g., pale skin, unusual tiredness or weakness)
  • signs of bleeding (e.g., bloody nose, blood in urine, coughing blood, cuts that don't stop bleeding, black stools)
  • signs of bleeding in the stomach (e.g., bloody, black, or tarry stools, spitting up of blood, vomiting blood or material that looks like coffee grounds)
  • signs of a blood clot in the arm or leg (tenderness, pain, swelling, warmth, or redness in the arm or leg) or lungs (difficulty breathing, sharp chest pain that is worse when breathing in, coughing, coughing up blood, sweating, or passing out)
  • signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
  • signs of heart failure (e.g., difficulty breathing, rapid or irregular heartbeat, shortness of breath)
  • signs of heart rhythm changes (e.g., dizziness, fainting, rapid heartbeat, pounding heartbeat)
  • signs of kidney problems (e.g., decreased urination, nausea, vomiting, swelling of the feet and ankles)
  • signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
  • signs of migraine (e.g., severe headache with/without nausea, vomiting, sensitivity to light)
  • signs of thyroid problems (e.g., fast heart beat, bulging eyes, weight loss, swelling at front of neck)
  • skin rash
  • symptoms of high blood sugar or worsening diabetes (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
  • swelling of ankles or feet
  • urinary tract problems (e.g., difficulty or pain when passing urine, increased frequency of urination, blood in urine)
  • vision or eye problems

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of a heart attack (e.g., chest pain, shoulder pain, difficulty breathing, dizziness)
  • signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, swelling of the face and throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

HEALTH CANADA ADVISORY

May 4, 2016

Health Canada has issued new information concerning the use of Tasigna (nilotinib). To read the full report, visit Health Canada's website at www.hc-sc.gc.ca.

Previous advisories on Tasigna (nilotinib) were issued on April 12, 2013.

To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Anemia: Nilotinib may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired, or pale skin, contact your doctor as soon as possible.

Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood.

Blood clotting: This medication can reduce the number of platelet cells in the blood. Platelets help the blood to clot, and a shortage could make you bleed more easily. Tell your doctor of any signs that your blood is not clotting as quickly as usual. Such symptoms may include black and tarry stools, blood in the urine, easy bruising, or cuts that won't stop bleeding.

Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including platelets, in your blood.

Cancer: Although not common, noltinib has been associated with several different types of cancer including gastric, pancreatic, colon, malignant melanoma, ovarian, and skin cancer. Discuss any concerns that you may have, with your doctor.

Diabetes: Nilotinib may cause an increase in blood sugar levels and glucose tolerance may change. If you have diabetes, you may find it necessary to monitor their blood sugar more frequently while using this medication.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Fluid and electrolyte balance: Nilotinib may cause the levels of electrolytes such as potassium, sodium, magnesium, chloride, and calcium in the blood to change while taking this medication. If you experience symptoms of fluid and electrolyte imbalance such as muscle pains or cramps; dry mouth; numb hands, feet, or lips; or racing heartbeat, contact your doctor as soon as possible. Your doctor will do blood tests regularly to monitor the levels of these electrolytes in your blood while you are taking this medication.

Excess fluid may also build up in the body as a result of taking nilotinib. Swelling in the feet, legs or ankles or difficulty breathing, may be signs of this happening. Contact your doctor if you experience this.

Grapefruit, grapefruit juice, star fruit, pomegranate, seville oranges: These fruits affect how nilotinib is removed from the body and may cause too much of the medication to build up in the body and cause possibly harmful side effects. They should not be eaten at any time while taking this medication for treatment.

Heart disease: Recent studies have shown that nilotinib can contribute to atherosclerosis, a condition where plaque builds up in the walls of blood vessels, making them narrower. If a piece of the plaque breaks off or a blood clot forms on the plaque, a blood vessel may be totally blocked, preventing blood flow. This can result in heart attack or stroke.

People with heart disease such as recent heart attack, congestive heart failure, slow heart rate, or angina should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Heart rhythm: Nilotinib can cause changes to the normal rhythm of the heart, including an irregular heartbeat called QT prolongation. QT prolongation is a serious life-threatening condition that can cause fainting, seizures, and sudden death. If you are at risk for heart rhythm problems (e.g., people with heart failure, angina, low potassium or magnesium levels), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Infection: As well as killing cancer cells, nilotinib can reduce the number of cells that fight infection in the body (white blood cells). If possible, avoid contact with people with contagious infections.

Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.

Kidney function: If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: Nilotinib may reduce liver function and can cause liver failure. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Pancreatitis: Nilotinib can cause the pancreas to become inflamed. If you have a history of pancreatitis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Report signs of pancreatitis such as abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, or swollen abdomen to your doctor immediately.

Red blood cells: Nilotinib may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired, or pale skin, contact your doctor as soon as possible.

Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood.

Sudden cardiac death: Rarely, nilotinib has been associated with sudden death. This possibility should be discussed with your doctor before starting this medication.

Tumour lysis syndrome: Nilotinib, like many other cancer medications, causes many cancer cells to be suddenly killed when treatment is first started. This can overwhelm the body with waste products from the cells. As a result, the body may not be able to keep up with getting rid of all the waste. When this happens, you may experience nausea, shortness of breath, notice cloudy urine or joint pain. This is called tumour lysis syndrome. Your doctor may prescribe some medications to help your body get rid of the waste products. Make sure you understand how to use these medications and report any of these signs or symptoms to your doctor immediately.

Vaccinations: People taking this medication should not receive certain vaccines. Talk to your doctor about whether any vaccines you are scheduled to take may be used with this medication.

Pregnancy: This medication may cause harm to an unborn fetus and should not be used during pregnancy. If you or your partner become pregnant while taking this medication, contact your doctor immediately. Both men and women  of childbearing age who are taking nilotinib should use an effective method of birth control (e.g., birth control pill, condoms) during treatment and for at least 4 weeks after finishing treatment. 

Breast-feeding: It is not known if nilotinib passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of this medication have not been clearly established for children. It should only be prescribed or given by health care professionals familiar with the use of cancer chemotherapy in children. If you have concerns about this medication being used to treat children, discuss this with your doctor.

What other drugs could interact with this medication?

There may be an interaction between nilotinib and any of the following:

  • abiraterone
  • alfuzosin
  • amantadine
  • amiodarone
  • amphoteracin B
  • antacids
  • anticancer medications (e.g., doxorubicin, methotrexate, vincristine)
  • anti-emetic medications (e.g., granisetron, ondansetron)
  • antipsychotic medications (e.g., chlorpromazine, clozapine, haloperidol, quietiapine, risperidone)
  • apixaban
  • aprepitant
  • aripiprazole
  • atomoxetine
  • "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
  • bicalutamide
  • boceprevir
  • bosentan
  • bosutinib
  • calcium carbonate
  • calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
  • captopril
  • carbamazepine
  • carvedilol
  • celecoxib
  • chloral hydrate
  • chloroquine
  • chlorpheniramine
  • cisapride
  • codeine
  • colchicine
  • conivaptan
  • crizotinib
  • cyclosporine
  • dabigatran
  • dabrafenib
  • dapsone
  • dasatinib
  • deferasirox
  • dexamethasone
  • dextromethorphan
  • diabetes medications (e.g., chlorpropamide, glipizide, glyburide, nateglinide, rosiglitazone)
  • digoxin
  • diphenhydramine
  • disopyramide
  • domperidone
  • dronedarone
  • echinacea
  • enzalutamide
  • everolimus
  • flecainide
  • formoterol
  • fosphenytoin
  • galantamine
  • grapefruit and grapefruit juice
  • H2-blockers (e.g., cimetidine, famotidine, ranitidine)
  • HIV non-nucleoside reverse transcriptase inhibitors (e.g., delaviridine, efavirenz, etravirine, nevirapine)
  • HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
  • imatinib
  • indacaterol
  • indapamide
  • ivabradine
  • ivacaftor
  • lapatinib
  • leflunomide
  • lithium
  • lomitapide
  • losartan
  • macrolide antibiotics (e.g., azithromycin, clarithromycin, erythromycin, telithromycin)
  • mefloquine
  • mestranol
  • methadone
  • metronidazole
  • metoprolol
  • mexiletine
  • mifepristone
  • mirabegron
  • mirtazapine
  • montelukast
  • natalizumab
  • nefazodone
  • nelfinavir
  • octreotide
  • olodaterol
  • oxcarbazepine
  • paliperidone
  • pazopanib
  • pentamidine
  • phenobarbital
  • phenytoin
  • pimecrolimus
  • pimozide
  • pravastatin
  • primidone
  • procainamide
  • propafenone
  • propranolol
  • proton pump inhibitors (e.g., lansoprazole, omeprazole)
  • prucalopride
  • quinidine
  • quinine
  • quinolone antibiotics (e.g., ciprofloxacin, levofloxacin, norfloxacin)
  • rifabutin
  • rifampin
  • rifapentine
  • rivaroxaban
  • roflumilast
  • romidepsin
  • saquinavir
  • selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, duloxetine, fluoxetine, paroxetine, sertraline)
  • silodosin
  • simeprevir
  • sipuleucel-T
  • solifenacin
  • sotalol
  • St. John's wort
  • stiripentol
  • sulfamethoxazole
  • sunitinib
  • tacrolimus
  • tamoxifen
  • tetrabenazine
  • tetracycline
  • thiazolidinediones (e.g., pioglitazone, rosiglitazone)
  • timolol
  • tocilizumab
  • tolterodine
  • tofactitinib
  • topotecan
  • tramadol
  • trastuzumab
  • trazodone
  • tretinoin
  • tricyclic antidepressants (e.g., amitriptyline, desipramine, nortriptyline)
  • trimethoprim
  • vaccines (live)
  • vandetanib
  • vardenafil
  • venlafaxine
  • vorinostat
  • warfarin
  • zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2017. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Tasigna

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