Does Tasigna (nilotinib) cause side effects?

Tasigna (nilotinib) is a kinase inhibitor used to treat chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL).

Kinase inhibitors prevent the growth of tumors by reducing the action of proteins that control cell division, growth and survival. These proteins are usually present in larger quantities or are more active in cancer cells. By reducing the activity of these proteins, growth and survival of cancer cells are reduced. 

Common side effects of Tasigna include

Serious side effects of Tasigna include

Drug interactions of Tasigna include several drugs that reduce its break down by the liver such as amiodarone, disopyramide, procainamide, quinidine, and sotalol, because the blood concentration of Tasigna may be increased which may increase the occurrence of adverse effects.

  • Certain drugs such as dexamethasone, carbamazepine, phenobarbital, rifampin, rifabutin, rifapentin, phenytoin, and St John's wort decrease the concentration of Tasigna resulting in decreased blood levels and possibly reduced effect.
  • Food increases the blood concentration of Tasigna. Therefore, Tasigna should be taken on an empty stomach, at least 2 hours after eating any food. Individuals should wait one hour after taking Tasigna before eating any food.

Tasigna is harmful to a fetus and should not be used during pregnancy. It is unknown if Tasigna is excreted in human milk. Some related drugs are excreted in breast milk. To avoid any risk to the infant, nursing mothers should consider discontinuing breastfeeding or Tasigna.

What are the important side effects of Tasigna (nilotinib)?

Common side effects include:

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:

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.

Tasigna (nilotinib) side effects list for healthcare professionals

The following serious adverse reactions can occur with Tasigna and are discussed in greater detail in other sections of labeling:

  • Myelosuppression
  • QT Prolongation
  • Sudden Deaths
  • Cardiac and Arterial Vascular Occlusive Events
  • Pancreatitis and Elevated Serum Lipase
  • Hepatotoxicity
  • Electrolyte Abnormalities
  • Hemorrhage
  • Fluid Retention

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In Adult Patients With Newly Diagnosed Ph+ CML-CP

The data below reflect exposure to Tasigna from a randomized trial in patients with newly diagnosed Ph+ CML in chronic phase treated at the recommended dose of 300 mg twice daily (n=279).

  • The median time on treatment in the Tasigna 300 mg twice daily group was 61 months (range 0.1 to 71 months).
  • The median actual dose intensity was 593 mg/day in the Tasigna 300 mg twice daily group.

The most common (greater than 10%) non-hematologic adverse drug reactions were

  • rash,
  • pruritus,
  • headache,
  • nausea,
  • fatigue,
  • alopecia,
  • myalgia, and
  • upper abdominal pain.

Constipation, diarrhea, dry skin, muscle spasms, arthralgia, abdominal pain, peripheral edema, vomiting, and asthenia were observed less commonly (less than or equal to 10% and greater than 5%) and have been of mild-to-moderate severity, manageable and generally did not require dose reduction.

Increase in QTcF greater than 60 msec from baseline was observed in 1 patient (0.4%) in the 300 mg twice daily treatment group. No patient had an absolute QTcF of greater than 500 msec while on study drug.

The most common hematologic adverse drug reactions (all grades) were myelosuppression including:

  • thrombocytopenia (18%),
  • neutropenia (15%) and
  • anemia (8%).

See Table 9 for Grade 3/4 laboratory abnormalities.

Discontinuation due to adverse reactions, regardless of relationship to study drug, was observed in 10% of patients.

In Adult Patients With Resistant Or Intolerant Ph+ CML-CP And CML-AP

  • In the single open-label multicenter clinical trial, a total of 458 patients with Ph+ CML-CP and CML-AP resistant to or intolerant to at least one prior therapy including imatinib were treated (CML-CP=321; CML-AP=137) at the recommended dose of 400 mg twice daily.
  • The median duration of exposure in days for CML-CP and CML-AP patients is 561 (range 1 to 1096) and 264 (range 2 to 1160), respectively. The median dose intensity for patients with CML-CP and CML-AP is 789 mg/day (range 151 to 1110) and 780 mg/day (range 150 to 1149), respectively and corresponded to the planned 400 mg twice daily dosing.
  • The median cumulative duration in days of dose interruptions for the CML-CP patients was 20 (range 1 to 345), and the median duration in days of dose interruptions for the CML-AP patients was 23 (range 1 to 234).
  • In patients with CML-CP, the most commonly reported non-hematologic adverse drug reactions (greater than or equal to 10%) were rash, pruritus, nausea, fatigue, headache, constipation, diarrhea, vomiting and myalgia. The common serious drug-related adverse reactions (greater than or equal to 1% and less than 10%) were thrombocytopenia, neutropenia and anemia.
  • In patients with CML-AP, the most commonly reported non-hematologic adverse drug reactions (greater than or equal to 10%) were rash, pruritus and fatigue. The common serious adverse drug reactions (greater than or equal to 1% and less than 10%) were thrombocytopenia, neutropenia, febrile neutropenia, pneumonia, leukopenia, intracranial hemorrhage, elevated lipase and pyrexia.
  • Sudden deaths and QT prolongation were reported. The maximum mean QTcF change from baseline at steady-state was 10 msec. Increase in QTcF greater than 60 msec from baseline was observed in 4.1% of the patients and QTcF of greater than 500 msec was observed in 4 patients (less than 1%).
  • Discontinuation due to adverse drug reactions was observed in 16% of CML-CP and 10% of CML-AP patients.

Most Frequently Reported Adverse Reactions

Tables 7 and 8 show the percentage of adult patients experiencing non-hematologic adverse reactions (excluding laboratory abnormalities) regardless of relationship to study drug. Adverse reactions reported in greater than 10% of adult patients who received at least 1 dose of Tasigna are listed.

Table 7: Most Frequently Reported Non-Hematologic Adverse Reactions (Regardless of Relationship to Study Drug) in Adult Patients with Newly Diagnosed Ph+ CML-CP (Greater than or equal to 10% in Tasigna 300 mg Twice Daily or Imatinib 400 mg Once Daily Groups) 60-Month Analysisa

Body System and Adverse ReactionPatients with Newly Diagnosed Ph+ CML-CP
TASIGNA 300 mg twice daily
N=279
Imatinib 400 mg once daily
N=280
TASIGNA 300 mg twice daily
N=279
Imatinib 400 mg once daily
N=280
All Grades (%)CTC Gradesb 3/4 (%)
Skin and subcutaneous tissue disordersRash3819<12
Pruritus217<10
Alopecia13700
Dry skin12600
Gastrointestinal disordersNausea224122
Constipation208<10
Diarrhea194614
Vomiting1527<1<1
Abdominal pain upper18141<1
Abdominal pain151220
Dyspepsia101200
Nervous system disordersHeadache32233<1
Dizziness1211<1<1
General disorders and administration site conditionsFatigue232011
Pyrexia1413<10
Asthenia1412<10
Peripheral edema920<10
Face edema<1140<1
Musculoskeletal and connective tissue disordersMyalgia1919<1<1
Arthralgia2217<1<1
Muscle spasms123401
Pain in extremity1516<1<1
Back pain191711
Respiratory, thoracic and mediastinal disordersCough171300
Oropharyngeal pain12600
Dyspnea1162<1
Infections and infestationsNasopharyngitis272100
Upper respiratory tract infection1714<10
Influenza13900
Gastroenteritis7100<1
Eye disordersEyelid edema1190<1
Periorbital edema<11500
Psychiatric disordersInsomnia11900
Vascular disorderHypertension1041<1
aExcluding laboratory abnormalities
bNCI Common Terminology Criteria for Adverse Events, Version 3.0

Table 8: Most Frequently Reported Non-Hematologic Adverse Reactions in Adult Patients with Resistant or Intolerant Ph+ CML Receiving TASIGNA 400 mg Twice Daily (Regardless of Relationship to Study Drug) (Greater than or equal to 10% in any Group) 24-Month Analysisa

Body System and Adverse ReactionCML-CP
N=321
CML-AP
N=137
All Grades (%)CTC Gradesb 3/4 (%)All Grades (%)CTC Gradesb 3/4 (%)
Skin and subcutaneous tissue disordersRash362290
Pruritus32<1200
Night sweat12<1270
Alopecia110120
Gastrointestinal disordersNausea37122<1
Constipation26<1190
Diarrhea283242
Vomiting29<1130
Abdominal pain152163
Abdominal pain upper14<112<1
Dyspepsia10<140
Nervous system disordersHeadache352201
General disorders and administration site conditionsFatigue32323<1
Pyrexia22<1282
Asthenia160141
Peripheral edema15<1120
Musculoskeletal and connective tissue disordersMyalgia19216<1
Arthralgia262160
Muscle spasms13<1150
Bone pain14<1152
Pain in extremity202181
Back pain17215<1
Musculoskeletal pain11<1121
Respiratory, thoracic and mediastinal disordersCough27<1180
Dyspnea15292
Oropharyngeal pain11070
Infections and infestationsNasopharyngitis24<1150
Upper respiratory tract infection120100
Metabolism and nutrition disordersDecreased appetitec15<117<1
Psychiatric disordersInsomnia12170
Vascular disordersHypertension10211<1
aExcluding laboratory abnormalities
bNCI Common Terminology Criteria for Adverse Events, Version 3.0
cAlso includes preferred term anorexia

Laboratory Abnormalities

Table 9 shows the percentage of adult patients experiencing treatment-emergent Grade 3/4 laboratory abnormalities in patients who received at least one dose of Tasigna.

Table 9: Percent Incidence of Clinically Relevant Grade 3/4* Laboratory Abnormalities

Patient Population
Newly Diagnosed Adult Ph+ CML-CPResistant or Intolerant Adult Ph+
CML-CPCML-AP
TASIGNA 300 mg twice daily
N=279 (%)
Imatinib 400 mg once daily
N=280 (%)
TASIGNA 400 mg twice daily
N=321 (%)
TASIGNA 400 mg twice daily
N=137 (%)
Hematologic Parameters
Thrombocytopenia109301423
Neutropenia1222312424
Anemia461127
Biochemistry Parameters
Elevated lipase941818
Hyperglycemia7<1126
Hypophosphatemia8101715
Elevated bilirubin (total)4<179
Elevated SGPT (ALT)4344
Hyperkalemia2164
Hyponatremia1<177
Hypokalemia<1229
Elevated SGOT (AST)1132
Decreased albumin0<143
Hypocalcemia<1<125
Elevated alkaline phosphatase0<1<11
Elevated creatinine0<1<1<1
*NCI Common Terminology Criteria for Adverse Events, version 3.0
1CML-CP: Thrombocytopenia: 12% were Grade 3, 18% were Grade 4
2CML-CP: Neutropenia: 16% were Grade 3, 15% were Grade 4
3CML-AP: Thrombocytopenia: 11% were Grade 3, 32% were Grade 4
4CML-AP: Neutropenia: 16% were Grade 3, 26% were Grade 4

Elevated total cholesterol (all grades) occurred in 28% (Tasigna 300 mg twice daily) and 4% (imatinib). Elevated triglycerides (all grades) occurred in 12% and 8% of patients in the Tasigna and imatinib arms, respectively. Hyperglycemia (all Grades) occurred in 50% and 31% of patients in the Tasigna and imatinib arms, respectively.

Most common biochemistry laboratory abnormalities (all grades) were

  • alanine aminotransferase increased (72%),
  • blood bilirubin increased (59%),
  • aspartate aminotransferase increased (47%),
  • lipase increased (28%),
  • blood glucose increased (50%),
  • blood cholesterol increased (28%), and
  • blood triglyceride increased (12%).

Treatment Discontinuation In Ph+ CML-CP Patients Who Have Achieved A Sustained Molecular Response (MR4.5)

In eligible patients who discontinued Tasigna therapy after attaining a sustained molecular response (MR4.5), musculoskeletal symptoms (e.g. myalgia, pain in extremity, arthralgia, bone pain, spinal pain, or musculoskeletal pain), were reported more frequently than before treatment discontinuation in the first year, as noted in Table 10. The rate of new musculoskeletal symptoms generally decreased in the second year after treatment discontinuation.

In the newly diagnosed population in whom musculoskeletal symptoms occurred at any time during the TFR phase, 23/53 (43.4%) had not resolved by the TFR end date or data cut-off date. In the population previously treated with imatinib in whom musculoskeletal events occurred at any time during the TFR phase, 32/57 (56.1%) had not resolved by the data cut-off date.

The rate of musculoskeletal symptoms decreased in patients who entered the Tasigna treatment reinitiation (NTRI) phase, at 11/88 (12.5%) in the newly diagnosed population and 14/56 (25%) in the population previously treated with imatinib. Other adverse reactions observed in the Tasigna re-treatment phase were similar to those observed Tasigna use in patients with newly diagnosed Ph+ CML-CP and resistant or intolerant Ph+ CML-CP and CML-AP.

Table 10: Musculoskeletal symptoms occurring upon treatment discontinuation in the context of treatment-free remission (TFR)

Ph+ CML-CP patientsEntire TFR period in all TFR patientsBy time interval, in subset of patients in TFR greater than 48 weeks
NMedian follow-up in TFRPatients with musculoskeletal symptomsNYear prior to TASIGNA discontinuation1st year after TASIGNA discontinuation2nd year after TASIGNA discontinuation
All GradesGrade 3/4All GradesGrade 3/4All GradesGrade 3/4All GradesGrade 3/4
Newly Diagnosed19076 weeks28%1%10017%0%34%2%9%0%
Previously treated with imatinib12699 weeks45%2%7314%0%48%3%15%1%

Additional Data From Clinical Trials

The following adverse drug reactions were reported in adult patients in the Tasigna clinical studies at the recommended doses. These adverse drug reactions are ranked under a heading of frequency, the most frequent first using the following convention: common (greater than or equal to 1% and less than 10%), uncommon (greater than or equal to 0.1% and less than 1%), and unknown frequency (single events).

For laboratory abnormalities, very common events (greater than or equal to 10%), which were not included in Tables 7 and 8, are also reported. These adverse reactions are included based on clinical relevance and ranked in order of decreasing seriousness within each category, obtained from 2 clinical studies:

  1. Adult patients with newly diagnosed Ph+ CML-CP 60 month analysis and,
  2. Adult patients with resistant or intolerant Ph+ CML-CP and CMP-AP 24 months' analysis.
Infections And Infestations

Common: folliculitis. Uncommon: pneumonia, bronchitis, urinary tract infection, candidiasis (including oral candidiasis). Unknown frequency: hepatitis B reactivation, sepsis, subcutaneous abscess, anal abscess, furuncle, tinea pedis.

Neoplasms Benign, Malignant, And Unspecified

Common: skin papilloma. Unknown frequency: oral papilloma, paraproteinemia.

Blood And Lymphatic System Disorders

Common: leukopenia, eosinophilia, febrile neutropenia, pancytopenia, lymphopenia. Unknown frequency: thrombocythemia, leukocytosis.

Immune System Disorders

Unknown frequency: hypersensitivity.

Endocrine Disorders

Uncommon: hyperthyroidism, hypothyroidism. Unknown frequency: hyperparathyroidism secondary, thyroiditis.

Metabolism And Nutrition Disorders

Very Common: hypophosphatemia. Common: electrolyte imbalance (including hypomagnesemia, hyperkalemia, hypokalemia, hyponatremia, hypocalcemia, hypercalcemia, hyperphosphatemia), diabetes mellitus, hyperglycemia, hypercholesterolemia, hyperlipidemia, hypertriglyceridemia. Uncommon: gout, dehydration, increased appetite. Unknown frequency: hyperuricemia, hypoglycemia.

Psychiatric Disorders

Common: depression, anxiety. Unknown frequency: disorientation, confusional state, amnesia, dysphoria.

Nervous System Disorders

Common: peripheral neuropathy, hypoesthesia, paresthesia. Uncommon: intracranial hemorrhage, ischemic stroke, transient ischemic attack, cerebral infarction, migraine, loss of consciousness (including syncope), tremor, disturbance in attention, hyperesthesia. Unknown frequency: basilar artery stenosis, brain edema, optic neuritis, lethargy, dysesthesia, restless legs syndrome.

Eye Disorders

Common: eye hemorrhage, eye pruritus, conjunctivitis, dry eye (including xerophthalmia). Uncommon: vision impairment, vision blurred, visual acuity reduced, photopsia, hyperemia (scleral, conjunctival, ocular), eye irritation, conjunctival hemorrhage. Unknown frequency: papilledema, diplopia, photophobia, eye swelling, blepharitis, eye pain, chorioretinopathy, conjunctivitis allergic, ocular surface disease.

Ear And Labyrinth Disorders

Common: vertigo. Unknown frequency: hearing impaired, ear pain, tinnitus.

Cardiac Disorders

Common: angina pectoris, arrhythmia (including atrioventricular block, cardiac flutter, extrasystoles, atrial fibrillation, tachycardia, bradycardia), palpitations, electrocardiogram QT prolonged. Uncommon: cardiac failure, myocardial infarction, coronary artery disease, cardiac murmur, coronary artery stenosis, myocardial ischemia, pericardial effusion, cyanosis. Unknown frequency: ventricular dysfunction, pericarditis, ejection fraction decrease.

Vascular Disorders

Common: flushing. Uncommon: hypertensive crisis, peripheral arterial occlusive disease, intermittent claudication, arterial stenosis limb, hematoma, arteriosclerosis. Unknown frequency: shock hemorrhagic, hypotension, thrombosis, peripheral artery stenosis.

Respiratory, Thoracic And Mediastinal Disorders

Common: dyspnea exertional, epistaxis, dysphonia. Uncommon: pulmonary edema, pleural effusion, interstitial lung disease, pleuritic pain, pleurisy, pharyngolaryngeal pain, throat irritation. Unknown frequency: pulmonary hypertension, wheezing.

Gastrointestinal Disorders

Common: pancreatitis, abdominal discomfort, abdominal distension, dysgeusia, flatulence. Uncommon: gastrointestinal hemorrhage, melena, mouth ulceration, gastroesophageal reflux, stomatitis, esophageal pain, dry mouth, gastritis, sensitivity of teeth. Unknown frequency: gastrointestinal ulcer perforation, retroperitoneal hemorrhage, hematemesis, gastric ulcer, esophagitis ulcerative, subileus, enterocolitis, hemorrhoids, hiatus hernia, rectal hemorrhage, gingivitis.

Hepatobiliary Disorders

Very Common: hyperbilirubinemia. Common: hepatic function abnormal. Uncommon: hepatotoxicity, toxic hepatitis, jaundice. Unknown frequency: cholestasis, hepatomegaly.

Skin And Subcutaneous Tissue Disorders

Common: eczema, urticaria, erythema, hyperhidrosis, contusion, acne, dermatitis (including allergic, exfoliative and acneiform). Uncommon: exfoliative rash, drug eruption, pain of skin, ecchymosis. Unknown frequency: 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.

Musculoskeletal And Connective Tissue Disorders

Common: bone pain, musculoskeletal chest pain, musculoskeletal pain, back pain, neck pain, flank pain, muscular weakness. Uncommon: musculoskeletal stiffness, joint swelling. Unknown frequency: arthritis.

Renal And Urinary Disorders

Common: pollakiuria. Uncommon: dysuria, micturition urgency, nocturia. Unknown frequency: renal failure, hematuria, urinary incontinence, chromaturia.

Reproductive System And Breast Disorders

Uncommon: breast pain, gynecomastia, erectile dysfunction. Unknown frequency: breast induration, menorrhagia, nipple swelling.

General Disorders And Administration Site Conditions

Common: pyrexia, chest pain (including non-cardiac chest pain), pain, chest discomfort, malaise. Uncommon: gravitational edema, influenza-like illness, chills, feeling body temperature change (including feeling hot, feeling cold). Unknown frequency: localized edema.

Investigations

Very Common: alanine aminotransferase increased, aspartate aminotransferase increased, lipase increased, lipoprotein cholesterol (including very low density and high density) increased, total cholesterol increased, blood triglycerides increased. Common: hemoglobin decreased, blood amylase increased, gamma-glutamyltransferase increased, blood creatinine phosphokinase increased, blood alkaline phosphatase increased, weight decreased, weight increased, globulins decreased. Uncommon: blood lactate dehydrogenase increased, blood urea increased. Unknown frequency: troponin increased, blood bilirubin unconjugated increased, insulin C-peptide decreased, blood parathyroid hormone increased.

In Pediatric Patients With Newly Diagnosed Ph+ CML-CP Or Resistant Or Intolerant Ph+ CML-CP

The data below reflect exposure to Tasigna from two studies in pediatric patients from 2 to less than 18 years of age with either newly diagnosed Ph+ CML-CP or imatinib/dasatinib resistant or intolerant Ph+ CML-CP treated at the recommended dose of 230 mg/m² twice daily (n=69).

The median time on treatment with Tasigna was 13.8 months (range: 0.7 to 30.9 months). The median actual dose intensity was 435.5 mg/m²/day (range: 149 to 517 mg/m²/day), and the median relative dose intensity was 94.7% (range: 32 to 112%). Forty patients (58.0%) had relative dose intensity superior to 90%.

In pediatric patients with Ph+ CML-CP, the most common (greater than 20%) non-hematologic adverse drug reactions were

  • headache,
  • rash,
  • hyperbilirubinemia,
  • alanine aminotransferase increased,
  • pyrexia,
  • nausea,
  • upper respiratory tract infection,
  • aspartate aminotransferase increased, and
  • vomiting.

The most common (greater than 5%) Grade 3/4 non-hematologic adverse drug reactions were alanine aminotransferase increased and hyperbilirubinemia.

Laboratory abnormalities of hyperbilirubinemia (Grade 3/4: 13%) and transaminase elevation (AST Grade 3/4: 1%, ALT Grade 3/4: 9%), were reported at a higher frequency than in adult patients.

The most common hematological adverse drug reactions (greater than or equal to 30% of patients, of all grades) were

  • decreases in total white blood cells (54%),
  • platelet count (44%),
  • absolute neutrophils (41%),
  • absolute lymphocytes (32%), and
  • hemoglobin (30%).

Discontinuation due to adverse reactions occurred in 9 patients (13%). The adverse reactions leading to discontinuation were hyperbilirubinemia (6%) and rash (4%).

Increase in QTcF greater than 30 msec from baseline was observed in 17 patients (25%). No patient had an absolute QTcF of greater than 500 msec or QTcF increase of greater than 60 msec from baseline.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Tasigna. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood And Lymphatic System Disorders: thrombotic microangiopathy

What drugs interact with Tasigna (nilotinib)?

Effect Of Other Drugs On Tasigna

Strong CYP3A Inhibitors

Concomitant use with a strong CYP3A inhibitor increased nilotinib concentrations compared to Tasigna alone, which may increase the risk of Tasigna toxicities. Avoid concomitant use of strong CYP3A inhibitors with Tasigna. If patients must be coadministered a strong CYP3A4 inhibitor, reduce Tasigna dose.

Strong CYP3A Inducers

Concomitant use with a strong CYP3A inducer decreased nilotinib concentrations compared to Tasigna alone, which may reduce Tasigna efficacy. Avoid concomitant use of strong CYP3A inducers with Tasigna.

Proton Pump Inhibitors (PPIs)

Concomitant use with a PPI decreased nilotinib concentrations compared to Tasigna alone, which may reduce Tasigna efficacy. Avoid concomitant use of PPI with Tasigna. As an alternative to PPIs, use H2 blockers approximately 10 hours before or approximately 2 hours after the dose of Tasigna, or use antacids approximately 2 hours before or approximately 2 hours after the dose of Tasigna.

Drugs That Prolong The QT Interval

Avoid coadministration of Tasigna with agents that may prolong the QT interval such as anti-arrhythmic drugs.

Summary

Tasigna (nilotinib) is a kinase inhibitor used to treat chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL). Common side effects of Tasigna 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, muscle pain, increased blood glucose, and high blood pressure (hypertension). Tasigna is harmful to a fetus and should not be used during pregnancy. It is unknown if Tasigna is excreted in human milk.

Treatment & Diagnosis

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Medically Reviewed on 8/17/2020
References
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Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.