Tasigna

The recommended adult dose of Tasigna (Nilotinib) varies based on the phase of CML and whether previous treatments have been given.

Doses for children and adolescents are based on body size. Your doctor will calculate the correct dose. Doses should be taken twice daily, approximately 12 hours apart and swallowed whole with a glass of water.

Do not take Tasigna (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 Tasigna (Nilotinib) is absorbed and used by the body. Anything other than one teaspoonful of applesauce may change how Tasigna (Nilotinib) works for you.

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.

It is important to take Tasigna (Nilotinib) 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 Tasigna (Nilotinib) 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.

50 mg
Each hard, gelatin, size 4 capsule with red opaque cap and light yellow opaque body, and black radial imprint "NVR/ABL" on cap, filled with white-to-yellowish powder, contains 50 mg of nilotinb. Nonmedicinal ingredients: colloidal silicon, anhydrous, crospovidone, lactose monohydrate, poloxamer and magnesium stearate; capsule shell: gelatin, titanium dioxide (E171), iron oxide, red (E172), and iron oxide, yellow (E172); printing ink: shellac, iron oxide, black (E172), propylene glycol, and ammonium hydroxide.

150 mg
Each red, opaque, size 1, hard gelatin capsule with black axial imprint "NVR/BCR" contains 150 mg of Tasigna (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 of Tasigna (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. printing ink: includes red iron oxide.

Do not take Tasigna (Nilotinib) if you:

• are allergic to Tasigna (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

There may be an interaction between Tasigna (Nilotinib) and any of the following:

• alpha blockers (e.g., Alfuzosin, Doxazosin, Silodosin, Tamsulosin)
• Amiodarone
• antacids (e.g., aluminum hydroxide, calcium carbonate, magnesium hydroxide)
• anti-emetic medications (e.g., Granisetron, Ondansetron)
• antipsychotic medications (e.g., Aripiprazole, Chlorpromazine, Clozapine, Haloperidol, Quetiapine, Risperidone)
• Apalutamide
• Apixaban
• Aprepitant
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• BCG
• benzodiazepines (e.g., Clonazepam, Diazepam, Lorazepam)
• Bosentan
• Bromocriptine
• budesonide
• Calcitriol
• calcium carbonate
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, Verapamil)
• cancer medications (e.g., brentuximab, Carboplatin, Cyclophosphamide, Doxorubicin, Ifosfamide, Vincristine)
• cannabis
• chloroquine
• Cobicistat
• Colchicine
• conivaptan
• Cyclosporine
• Darifenacin
• Deferasirox
• diabetes medications (e.g., Canagliflozin, Glyburide, insulin, Linagliptin, Liraglutide, Metformin, Rosiglitazone)
• Digoxin
• Disopyramide
• diuretics (water pills; e.g., Hydrochlorothiazide, Indapamide, Amiloride, Furosemide)
• Domperidone
• Dronedarone
• echinacea
• efavirenz
• Eletriptan
• Eliglustat
• Enzalutamide
• Eplerenone
• ergot alkaloids (e.g., ergotamine, Dihydroergotamine)
• estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)
• etravirine
• Everolimus
• Fentanyl
• Flecainide
• fluticasone
• formoterol
• grapefruit and grapefruit juice
• grazoprevir
• Guanfacine
• H2-blockers (e.g., Cimetidine, Famotidine, Ranitidine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• Indacaterol
• Ivabradine
• laxatives
• Levothyroxine
• Lomitapide
• lumacaftor and Ivacaftor
• Macitentan
• macrolide antibiotics (e.g., azithromycin, clarithromycin, erythromycin)
• maraviroc
• Mefloquine
• Methadone
• Mexiletine
• mifepristone
• Modafinil
• Naloxegol
• nitrates (e.g., isosorbide dinitrate, isosorbide mononitrate, nitroglycerine)
• olodaterol
• Oxycodone
• pentamidine
• phosphodiesterase 5 inhibitors (e.g., Sildenafil, Tadalafil, Vardenafil)
• Pimecrolimus
• procainamide
• Propafenone
• other protein kinase inhibitors (e.g., Bosutinib, Dasatinib, imatinib, Pazopanib)
• proton pump inhibitors (e.g., Lansoprazole, Omeprazole)
• quinidine
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, levofloxacin, Norfloxacin)
• rifabutin
• rifampin
• rifapentine
• St. John's wort
• salmeterol
• Saxagliptin
• seizure medications (e.g., Carbamazepine, Gabapentin, Levetiracetam, Phenobarbital, Phenytoin, primidone, Topiramate)
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., Desvenlafaxine, Duloxetine, Venlafaxine)
• siltuximab
• Sirolimus
• sofosbuvir
• Solifenacin
• Sotalol
• "statin" anti-cholesterol medications (e.g., Atorvastatin, Lovastatin, Simvastatin)
• Tacrolimus
• Ticagrelor
• Tocilizumab
• Tofacitinib
• Tolvaptan
• Tolterodine
• Trazodone
• tricyclic antidepressants (e.g., Amitriptyline, Desipramine, Nortriptyline)
• Ulipristal
• vaccines
• vilanterol
• 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 Tasigna (Nilotinib). 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.

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 Tasigna (Nilotinib).

Anemia: Tasigna (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: Tasigna (Nilotinib) 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, Tasigna (Nilotinib) 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: Tasigna (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 your blood sugar more frequently while using Tasigna (Nilotinib).

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

Fluid and electrolyte balance: Tasigna (Nilotinib) may cause the levels of electrolytes such as potassium, sodium, magnesium, chloride, and calcium in the blood to change while taking Tasigna (Nilotinib). 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 Tasigna (Nilotinib).

Excess fluid may also build up in the body as a result of taking Tasigna (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 Tasigna (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 Tasigna (Nilotinib) for treatment.

Heart disease: Recent studies have shown that Tasigna (Nilotinib) may 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.

If you have heart disease such as recent heart attack, Congestive Heart Failure, slow heart rate, or Angina, discuss with your doctor how Tasigna (Nilotinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Tasigna (Nilotinib), and whether any special monitoring is needed.

Heart rhythm: Tasigna (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 Tasigna (Nilotinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Tasigna (Nilotinib), and whether any special monitoring is needed.

Infection: As well as killing cancer cells, Tasigna (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.

Lactose intolerance: Tasigna (Nilotinib) contains lactose. If you have galactose intolerance (galactosemia, glucose-galactose malabsorption, or Lapp lactase deficiency) you should not take Tasigna (Nilotinib). Talk to your doctor about other alternatives.

Kidney function: Tasigna (Nilotinib) can cause decreased kidney function. If you have reduced kidney function or Kidney Disease, discuss with your doctor how Tasigna (Nilotinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Tasigna (Nilotinib), and whether any special monitoring is needed.

Liver function: Decreased liver function or liver disease may cause Tasigna (Nilotinib) to build up in the body, causing side effects.

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

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.

Lung inflammation: Lung inflammation (interstitial lung disease) causing difficulty breathing has occurred in rare instances for some people taking Tasigna (Nilotinib). This complication can be serious and sometimes fatal. If you experience new or worsening shortness of breath or cough (with or without fever) at any time while you are taking Tasigna (Nilotinib), contact your doctor immediately.

Muscle effects: Muscle damage has been associated with the use of Tasigna (Nilotinib). Report any unexplained muscle pain, tenderness, weakness or cramps, or any brown or discoloured urine to your doctor immediately, particularly if you are also experiencing malaise (a general feeling of being unwell) or fever.

Pancreatitis: Tasigna (Nilotinib) can cause the pancreas to become inflamed. If you have a history of pancreatitis, discuss with your doctor how Tasigna (Nilotinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Tasigna (Nilotinib), 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.

Sudden cardiac death: In rare instances, Tasigna (Nilotinib) has been associated with sudden death. This may be more likely to happen if you already have a heart condition, but it has also been reported to happen to people without previous heart problems. This possibility should be discussed with your doctor before starting Tasigna (Nilotinib).

Tumour lysis syndrome: Tasigna (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 or shortness of breath, or 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 Tasigna (Nilotinib) should not receive certain vaccines. Talk to your doctor about whether any vaccines you are scheduled to take may be used with Tasigna (Nilotinib).

Pregnancy: Tasigna (Nilotinib) may cause harm to an unborn fetus and should not be used during pregnancy. If you or your partner become pregnant while taking Tasigna (Nilotinib), contact your doctor immediately. Both men and women of childbearing age who are taking Tasigna (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 Tasigna (Nilotinib) passes into breast milk. If you are a breast-feeding mother and are taking Tasigna (Nilotinib), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of Tasigna (Nilotinib) have not been established for children younger than 2 years of age. It should only be prescribed or given by health care professionals familiar with the use of cancer chemotherapy for children. If you have concerns about Tasigna (Nilotinib) being used to treat children, discuss this with your doctor.