Tasigna

Nilotinib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• rash
• itching
• nausea
• vomiting
• diarrhea
• constipation
• heartburn
• gas
• loss of appetite
• headache
• dizziness
• tiredness
• difficulty falling asleep or staying asleep
• night sweats
• muscle cramps
• back, bone, joint, limb, or muscle pain
• hair loss
• dry or reddened skin
• numbness, burning, or tingling in the hands or feet

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• unusual bleeding or bruising
• blood in urine
• bloody or black, tarry stools
• unusual tiredness or weakness
• fever, chills, sore throat, ongoing cough and congestion, or other signs of infection
• shortness of breath
• swelling of hands, ankles, feet, or face
• sudden stomach area pain
• yellowing of the skin and eyes

Nilotinib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

Common side effects include:

• headache,
• stomach pain,
• constipation,
• diarrhea,
• weight changes,
• weakness,
• nausea and vomiting,
• swelling of arms and legs,
• rash,
• itching,
• fever,
• dizziness,
• hair loss,
• coughing,
• runny or stuffy nose, and
• muscle pain.

Increased blood glucose and high blood pressure may also occur.

Serious side effects include

• fainting,
• seizures,
• fever associated with reduced white blood cells,
• reduced platelets and red blood cell counts,
• infection,
• bleeding in the brain,
• reduced liver function,
• pancreatitis,
• and increased or reduced thyroid function.

Other important side effects caused by Nilotinib include:

• low phosphate (hypophosphatemia),
• low potassium (hypokalemia),
• high potassium (hyperkalemia),
• low calcium (hypocalcemia),
• and low sodium (hyponatremia) concentrations in the blood.

Nilotinib may cause a type of abnormal heart rhythm called prolongation of QT interval. Prolongation of the QT interval may lead to sudden death. ECGs should be obtained prior to starting nilotinib, 7 days after start of treatment, after dose adjustments, and as needed thereafter. Low potassium or low magnesium may increase the risk of QT prolongation. Therefore, low potassium and low magnesium should be corrected prior to starting treatment. Food and/or drugs that reduce break down of nilotinib in the liver and/or medicinal products that prolong QT interval may increase the risk of QT prolongation and should not be combined with nilotinib.

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Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Tasigna passes into your breast milk. You and your doctor should decide if you will take Tasigna or breastfeed. You should not do both.

Take Tasigna exactly as your doctor tells you to take it. Do not change your dose or stop taking Tasigna unless your doctor tells you. Tasigna is a long-term treatment.

Tasigna comes in capsule form and is taken twice a day, without food.

Take Tasigna on an empty stomach. Take Tasigna at least 2 hours after you eat and at least 1 hour before you eat.

Swallow Tasigna capsules whole with water. If you cannot swallow Tasigna capsules whole, tell your doctor.

• If you cannot swallow Tasigna capsules whole:
  • Open the Tasigna capsules and sprinkle the contents in 1 teaspoon of applesauce (puréed apple).
    • Do not use more than 1 teaspoon of applesauce.
    • Only use applesauce. Do not sprinkle Tasigna onto other foods.
  • Swallow the mixture right away (within 15 minutes).

If you miss a dose, just take your next dose as scheduled. Do not make up for a missed dose.

During treatment with Tasigna your doctor will do tests to check for side effects and to see how well Tasigna is working for you. The tests will check your:
      ○  heart
      ○  blood cells (white blood cells, red blood cells, and platelets). Your blood cells should be checked every two weeks for the first two months and then monthly.
      ○  electrolytes (potassium, magnesium)
      ○  pancreas and liver function
      ○  bone marrow samples

Your doctor may change your dose. Your doctor may have you stop Tasigna for some time or lower your dose if you have side effects with it.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include drowsiness and vomiting.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Do not change the dose or stop using this medicine without checking first with your doctor.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the medication guide if you do not have one.

It is best to take this medicine on an empty stomach (at least 1 hour before or 2 hours after a meal).

Swallow the capsule whole with water. If you have trouble swallowing the capsule, the capsules can be opened and the contents can be sprinkled in one teaspoon of applesauce. Do not sprinkle Tasigna® on other foods. This mixture must be taken immediately within 15 minutes and should not be stored for later use.

If you are taking a stomach medicine (eg, famotidine), take it at least 10 hours before or 2 hours after taking nilotinib.

If you are taking an antacid that contains aluminum, magnesium, or simethicone, take it at least 2 hours before or 2 hours after taking nilotinib.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For the treatment of Ph+ CML-CP and CML-AP after other treatments have failed:
    • Adults—400 milligrams (mg) two times a day, with about 12 hours between the two doses. Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.
  • For the treatment of newly diagnosed Ph+ CML-CP:
    • Adults—300 milligrams (mg) two times a day, with about 12 hours between the two doses. Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• Tell all of your health care providers that you take Tasigna. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• If you have upset stomach, throwing up, loose stools (diarrhea), or are not hungry, talk with your doctor. There may be ways to lower these side effects.
• Blood clots have happened with this medicine. Sometimes, blood clots like heart attack and stroke have happened. Talk with the doctor.
• Patients with cancer who take Tasigna may be at a greater risk of getting a bad health problem called tumor lysis syndrome (TLS). Sometimes, this has been deadly. Call your doctor right away if you have a fast heartbeat or a heartbeat that does not feel normal; any passing out; trouble passing urine; muscle weakness or cramps; upset stomach, throwing up, loose stools, or not able to eat; or feel sluggish.
• Liver problems have happened. Call your doctor right away if you get signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• If you have high blood sugar (diabetes), talk with your doctor. This medicine may raise blood sugar.
• Check your blood sugar as you have been told by your doctor.
• Tell your doctor if you have signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Talk with your doctor before getting any vaccines. Use with this medicine may either raise the chance of an infection or make the vaccine not work as well.
• If you need to take an antacid or a drug like famotidine or ranitidine, talk with your doctor about how to take it while taking Tasigna (nilotinib).
• Avoid grapefruit and grapefruit juice.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant.
• Use birth control that you can trust to prevent pregnancy while taking this medicine.
• If you are pregnant or you get pregnant while taking Tasigna, call your doctor right away.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
• Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
• Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Chest pain or pressure, a fast heartbeat, or passing out.
• A heartbeat that does not feel normal.
• Dizziness.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Change in eyesight.
• Very bad headache.
• Feeling very tired or weak.
• Leg pain, leg feels cold, or change in skin color of the leg.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Upset stomach or throwing up.
• Belly pain.
• Not hungry.
• Hard stools (constipation).
• Loose stools (diarrhea).
• Muscle or joint pain.
• Back pain.
• Hair loss.
• Not able to sleep.
• Runny nose.
• Stuffy nose.
• Sneezing.
• Nose and throat irritation.
• Feeling tired or weak.
• Itching.
• Night sweats.
• Dry skin.
• Muscle spasm.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

      Pregnancy

Pregnancy Category D [see Warnings and Precautions (5.16)].

Risk Summary

Based on its mechanism of action and findings in animals, Tasigna may cause fetal harm when administered to a pregnant woman. Women should be advised to avoid becoming pregnant while on Tasigna. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Animal Data

Nilotinib was studied for effects on embryo-fetal development in pregnant rats and rabbits given oral doses of 10, 30, 100 mg/kg/day, and 30, 100, 300 mg/kg/day, respectively, during organogenesis. In rats, nilotinib at doses of 100 mg/kg/day (approximately 5.7 times the AUC in patients at the dose of 400 mg twice daily) was associated with maternal toxicity (decreased gestation weight, gravid uterine weight, net weight gain, and food consumption). Nilotinib at doses greater than or equal 30 mg/kg/day (approximately 2 times the AUC in patients at the dose of 400 mg twice daily) resulted in embryo-fetal toxicity as shown by increased resorption and post-implantation loss, and at 100 mg/kg/day, a decrease in viable fetuses. In rabbits, maternal toxicity at 300 mg/kg/day (approximately one-half the human exposure based on AUC) was associated with mortality, abortion, decreased gestation weights and decreased food consumption. Embryonic toxicity (increased resorption) and minor skeletal anomalies were observed at a dose of 300 mg/kg/day. Nilotinib is not considered teratogenic.

When pregnant rats were dosed with nilotinib during organogenesis and through lactation, the adverse effects included a longer gestational period, lower pup body weights until weaning and decreased fertility indices in the pups when they reached maturity, all at a maternal dose of 360 mg/m2 (approximately 0.7 times the clinical dose of 400 mg twice daily based on body surface area). At doses up to 120 mg per m2 (approximately 0.25 times the clinical dose of 400 mg twice daily based on body surface area) no adverse effects were seen in the maternal animals or the pups.

      Nursing Mothers

It is not known whether nilotinib is excreted in human milk. One study in lactating rats demonstrates that nilotinib is excreted into milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Tasigna, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

      Pediatric Use

The safety and effectiveness of Tasigna in pediatric patients have not been established.

      Geriatric Use

In the clinical trials of Tasigna (patients with newly diagnosed Ph+ CML-CP and resistant or intolerant Ph+ CML-CP and CML-AP), approximately 12% and 30% of patients were 65 years or over respectively.

• Patients with newly diagnosed Ph+ CML-CP: There was no difference in major molecular response between patients aged less than 65 years and those greater than or equal to 65 years.
  
• Patients with resistant or intolerant CML-CP: There was no difference in major cytogenetic response rate between patients aged less than 65 years and those greater than or equal to 65 years.
  
• Patients with resistant or intolerant CML-AP: The hematologic response rate was 44% in patients less than 65 years of age and 29% in patients greater than or equal to 65 years.

No major differences for safety were observed in patients greater than or equal to 65 years of age as compared to patients less than 65 years.

      Cardiac Disorders

In the clinical trials, patients with a history of uncontrolled or significant cardiovascular disease, including recent myocardial infarction, congestive heart failure, unstable angina or clinically significant bradycardia, were excluded. Caution should be exercised in patients with relevant cardiac disorders [see Boxed Warning, Warnings and Precautions (5.2)].

      Hepatic Impairment

Nilotinib exposure is increased in patients with impaired hepatic function. In a study of subjects with mild to severe hepatic impairment following a single dose administration of 200 mg of Tasigna, the mean AUC values were increased on average of 35%, 35%, and 56% in subjects with mild (Child-Pugh class A, score 5 to 6), moderate (Child-Pugh class B, score 7 to 9) and severe hepatic impairment (Child-Pugh class C, score 10 to 15), respectively, compared to a control group of subjects with normal hepatic function. Table 8 summarizes the Child-Pugh Liver Function Classification applied in this study. A lower starting dose is recommended in patients with hepatic impairment and the QT interval should be monitored closely in these patients [see Dosage and Administration (2.2), Warnings and Precautions (5.10)].

Usual Adult Dose of Tasigna for Chronic Myelogenous Leukemia:

For use in patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase:
Initial dose: 300 mg orally twice daily, approximately 12 hours apart

For use in patients with chronic phase or accelerated phase Ph+ CML resistant to or intolerant to prior therapy that included imatinib:
Initial dose: 400 mg orally twice daily, approximately 12 hours apart

Treatment should continue as long as the patient does not show evidence of progression or unacceptable toxicity.

Applies to nilotinib: oral capsule

General

The most frequently reported side effects included nausea, rash, headache, fatigue, pruritus, vomiting, diarrhea, cough, constipation, arthralgia, nasopharyngitis, pyrexia, night sweats, and myelosuppression (e.g., thrombocytopenia, neutropenia, and anemia).[Ref]

Cardiovascular

Very common (10% or more): Hypertension (up to 11%)
Common (1% to 10%): Flushing, arrhythmia, angina pectoris, atrioventricular block, cardiac flutter, extrasystoles, atrial fibrillation, tachycardia, bradycardia, palpitations, QT prolongation, peripheral artery stenosis, ischemic heart disease, ischemic cerebrovascular events
Uncommon (0.1% to 1%): Hypertensive crisis, peripheral arterial occlusive disease, intermittent claudication, limb arterial stenosis, hematoma, arteriosclerosis, cardiac failure, myocardial infarction, pericardial effusion, coronary artery stenosis, cardiac murmur, coronary artery disease, cyanosis, cardiomegaly, myocardial ischemia
Frequency not reported: Ventricular dysfunction, pericarditis, decreased ejection fraction, hemorrhagic shock, hypotension, thrombosis, arterial vascular occlusive events, increased troponin[Ref]

Hematologic

Very common (10% or more): Thrombocytopenia (up to 31%), neutropenia (up to 17%), anemia (up to 14%)
Common (1% to 10%): Leukopenia, eosinophilia, febrile neutropenia, pancytopenia, lymphopenia, decreased hemoglobin
Frequency not reported: Thrombocythemia, leukocytosis[Ref]

Dermatologic

Very common (10% or more): Rash (up to 39%), pruritus (up to 32%), night sweats (up to 27%), alopecia (up to 14%), dry skin (up to 12%)
Common (1% to 10%): Folliculitis, eczema, urticaria, erythema, hyperhidrosis, contusion, acne, dermatitis (e.g., allergic, exfoliative, and acneiform)
Uncommon (0.1% to 1%): Exfoliative rash, drug eruption, skin pain, ecchymosis, face swelling
Frequency not reported: Psoriasis, erythema multiforme, erythema nodosum, skin ulcer, palmar-plantar erythrodysesthesia syndrome, petechiae, photosensitivity, blister, dermal cyst, sebaceous hyperplasia, skin atrophy, skin discoloration, skin exfoliation, skin hyperpigmentation, skin hypertrophy, hyperkeratosis, subcutaneous abscess, furuncle, tinea pedis[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 37%), vomiting (up to 29%), diarrhea (up to 28%), elevated lipase (up to 28%), constipation (up to 26%), upper abdominal pain (up to 18%), abdominal pain (up to 16%), dyspepsia (up to 10%)
Common (1% to 10%): Gastrointestinal (GI) hemorrhage, pancreatitis, abdominal distention, abdominal discomfort, flatulence, gastroenteritis, increased blood amylase
Uncommon (0.1% to 1%): Melena, mouth ulceration, gastroesophageal reflux, stomatitis, esophageal pain, dry mouth, gastritis, sensitivity of teeth
Frequency not reported: GI ulcer perforation, anal abscess, retroperitoneal hemorrhage, hematemesis, rectal hemorrhage, gastric ulcer, esophagitis ulcerative, subileus, enterocolitis, hemorrhoids, hiatus hernia, gingivitis, ascites[Ref]

Nervous system

Very common (10% or more): Headache (up to 35%), dizziness (up to 12%)
Common (1% to 10%): Peripheral neuropathy, hypoesthesia, paresthesia, dysgeusia
Uncommon (0.1% to 1%): Intracranial hemorrhage, ischemic stroke, transient ischemic attack, cerebral infarction, migraine, loss of consciousness/syncope, tremor, disturbance in attention, hyperesthesia
Frequency not reported: Basilar artery stenosis, brain edema, optic neuritis, lethargy, dysesthesia, restless leg syndrome, cerebrovascular accident[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (up to 26%), pain in extremity (up to 20%), myalgia (up to 19%), back pain (up to 19%), bone pain (up to 15%), muscle spasms (up to 15%), musculoskeletal pain (up to 12%)
Common (1% to 10%): Musculoskeletal chest pain, neck pain, flank pain, muscular weakness
Uncommon (0.1% to 1%): Musculoskeletal stiffness, joint swelling
Frequency not reported: Arthritis[Ref]

Respiratory

Very common (10% or more): Nasopharyngitis (up to 27%), cough (up to 27%), upper respiratory tract infection (up to 17%), dyspnea (up to 15%), influenza (up to 13%), oropharyngeal pain (up to 12%)
Common (1% to 10%): Epistaxis, exertional dyspnea, dysphonia, pharyngitis, rhinitis, pleural effusion
Uncommon (0.1% to 1%): Pneumonia, bronchitis, pulmonary edema, interstitial lung disease, pleuritic pain, pleurisy, pharyngolaryngeal pain, throat irritation
Frequency not reported: Pulmonary hypertension, wheezing[Ref]

Metabolic

Very common (10% or more): Hyperglycemia/increased blood glucose (up to 50%), elevated total cholesterol (up to 28%), decreased appetite/anorexia (up to 17%), elevated triglycerides (up to 12%), increased lipoprotein cholesterol, hypophosphatemia/decreased blood phosphorus
Common (1% to 10%): Electrolyte imbalance, hypomagnesemia, hypocalcemia, decreased albumin, hypokalemia, hyponatremia, hyperkalemia, hypercalcemia, hyperphosphatemia, diabetes mellitus, hypercholesterolemia, increased blood creatinine phosphokinase, increased weight, decreased weight, decreased globulins, hyperlipidemia, hypertriglyceridemia, elevated alkaline phosphatase
Uncommon (0.1% to 1%): Elevated creatinine, gout, dehydration, increased appetite, increased blood lactate dehydrogenase, fluid retention, decreased blood glucose, dyslipidemia
Frequency not reported: Hypoglycemia, hyperuricemia
Postmarketing reports: Tumor lysis syndrome[Ref]

Genitourinary

Common (1% to 10%): Pollakiuria
Uncommon (0.1% to 1%): Urinary tract infection, dysuria, micturition urgency, nocturia
Frequency not reported: Hematuria, urinary incontinence, chromaturia[Ref]

Other

Very common (10% or more): Fatigue (up to 32%), pyrexia (up to 28%), asthenia (up to 16%), peripheral edema (up to 15%)
Common (1% to 10%): Vertigo, malaise, chest pain (e.g., non-cardiac), pain, chest discomfort
Uncommon (0.1% to 1%): Candidiasis, herpes virus infection, feeling body temperature change, chills, face edema, gravitational edema, sudden deaths, influenza-like illness
Frequency not reported: Sepsis, hearing impairment, ear pain, tinnitus, localized edema[Ref]

Endocrine

Common (1% to 10%): Increased blood insulin
Uncommon (0.1% to 1%): Hyperthyroidism, hypothyroidism, gynecomastia, erectile dysfunction, breast pain
Frequency not reported: Hyperparathyroidism secondary, thyroiditis, breast induration, nipple swelling, increased blood parathyroid hormone, decreased insulin C-peptide, decreased blood insulin, menorrhagia[Ref]

Psychiatric

Very common (10% or more): Insomnia (up to 12%)
Common (1% to 10%): Depression, anxiety
Frequency not reported: Disorientation, confusion, amnesia, dysphoria[Ref]

Hepatic

Very common (10% or more): Increased ALT (up to 72%), hyperbilirubinemia/increased blood bilirubin (up to 59%), increased AST (up to 47%)
Common (1% to 10%): Abnormal hepatic function, increased gamma-glutamyltransferase
Uncommon (0.1% to 1%): Hepatotoxicity, toxic hepatitis, jaundice
Frequency not reported: Cholestasis, hepatomegaly, increased unconjugated blood bilirubin[Ref]

Ocular

Common (1% to 10%): Eye hemorrhage, eye pruritus, conjunctivitis, dry eye/xerophthalmia, eyelid edema, periorbital edema
Uncommon (0.1% to 1%): Vision impairment, blurred vision, reduced visual acuity, photopsia, eye irritation, conjunctival hemorrhage, hyperemia (e.g., scleral, conjunctival, ocular)
Frequency not reported: Papilloedema, diplopia, photophobia, eye swelling, blepharitis, eye pain, chorioretinopathy, allergic conjunctivitis, ocular surface disease[Ref]

Renal

Uncommon (0.1% to 1%): Increased blood urea
Frequency not reported: Renal failure[Ref]

Oncologic

Common (1% to 10%): Skin papilloma
Frequency not reported: Oral papilloma, paraproteinemia[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity[Ref]

Some side effects of Tasigna may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.