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Tasigna

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Tasigna Capsules

Tasigna Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Tasigna (nilotinib) is a kinase inhibitor that interferes with a protein that signals cancer cells to multiply. Tasigna is available in generic form termed nilotinib. Tasigna is used to treat adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia in the chronic phase of the disease; it is also used to treat both chronic and accelerated Philadelphia chromosome positive myeloid leukemia in adults that are resistant or intolerant to prior therapy, including imatinib. The most common side effects of Tasigna are rash, pruritus, headache, nausea, fatigue, and muscle aches.

Tasigna comes in a gelatin capsule at strengths of 150 and 200 mg. It is usually taken without food twice a day, at least 1 hour before or 2 hours after eating any food. The dosage is usually 300 mg per day, or 400 mg per day in those patients that are resistant or intolerant to prior therapy. However, because of the extensive and dire side effects in persons with underlying problems such as sudden death, hepatotoxicity, QT prolongation, myelosupression and other electrolyte and enzyme abnormalities, physicians often need to adjust the dose depending on several health factors; patients and physicians need to check the multiple tables available to develop a safe dose according to the patient's concurrent health problems and medications they take. Women who are pregnant should not take this drug; women who are breastfeeding should be cautioned that benefits to the mother must be weighed against the relatively unstudied risks to the infant. Safety and effectiveness of Tasigna use in pediatrics has not been established.

Our Tasigna Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Tasigna in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using nilotinib and call your doctor at once if you have a serious side effect such as:

  • headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;
  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;
  • pale skin, weakness, easy bruising or bleeding;
  • blood in your urine or stools;
  • severe pain in your upper stomach spreading to your back;
  • nausea, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
  • lower back pain, numbness or tingly feeling around your mouth;
  • urinating less than usual or not at all;
  • muscle weakness, tightness, or contraction;
  • fast or slow heart rate, weak pulse, feeling short of breath; or
  • sudden severe headache, confusion, problems with vision, feeling like you might pass out.

Other common side effects may include:

  • diarrhea, constipation;
  • mild skin rash, temporary hair loss;
  • headache, back pain, joint or muscle pain;
  • tired feeling; or
  • cold symptoms such as stuffy nose, sneezing, cough, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Tasigna (Nilotinib Capsules) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Tasigna Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, headache, tiredness, constipation, and diarrhea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

This medication decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. Tell your doctor right away if you develop any of the following serious symptoms: severe tiredness, pale skin, signs of infection (such as fever, chills, persistent sore throat), easy bruising/bleeding (such as bloody/black stool, bloody/pink urine).

Tell your doctor right away if you have any serious side effects, including: severe stomach/abdominal pain, toe/joint pain, painful urination, change in the amount of urine, symptoms of high blood sugar (such as increased thirst/urination), signs of liver disease (such as persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin, dark urine).

Get medical help right away if you have any very serious side effects, including: fast/pounding/irregular heartbeat, severe dizziness, fainting, seizures, signs of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), signs of a stroke (such as weakness on one side of the body, slurred speech, sudden vision changes, confusion), signs of bleeding in the brain (such as sudden severe headache, sudden vision changes, confusion, loss of consciousness), signs of blood circulation disease (such as numbness/pain in the legs, leg pain with physical activity, decrease in walking distance).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Tasigna (Nilotinib Capsules)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Tasigna FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions can occur with Tasigna and are discussed in greater detail in other sections of the package insert [see BOXED WARNING, WARNINGS AND PRECAUTIONS].

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 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 nilotinib 300 mg twice daily group was 48 months (range 0.1 to 59 months). The median actual dose intensity was 594 mg/day in the nilotinib 300 mg twice daily group.

The most common ( > 10%) non-hematologic adverse drug reactions were rash, pruritus, headache, nausea, fatigue, alopecia and myalgia. Upper abdominal pain, constipation, diarrhea, dry skin, muscle spasms, arthralgia, abdominal pain, peripheral edema, vomiting, and asthenia were observed less commonly ( ≤ 10% and > 5%) and have been of mild to moderate severity, manageable and generally did not require dose reduction. Pleural and pericardial effusions, occurred in 1% and < 1% of patients, respectively. Gastrointestinal hemorrhage was reported in 3% of patients.

Increase in QTcF > 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 > 500 msec while on study drug.

The most common hematologic adverse drug reactions (all grades) were myelosuppression including: thrombocytopenia (18%), neutropenia (15%) and anemia (7%). See Table 7 for Grade 3/4 laboratory abnormalities.

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

In 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; CMLAP=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 ( ≥ 10%) were rash, pruritus, nausea, fatigue, headache, constipation, diarrhea, vomiting and myalgia. The common serious drug-related adverse reactions ( ≥ 1% and < 10%) were thrombocytopenia, neutropenia and anemia.

In patients with CML-AP, the most commonly reported non-hematologic adverse drug reactions ( ≥ 10%) were rash, pruritus and fatigue. The common serious adverse drug reactions ( ≥ 1% and < 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 > 60 msec from baseline was observed in 4.1% of the patients and QTcF of > 500 msec was observed in 4 patients ( < 1%) [see BOXED WARNING, WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY].

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 5 and 6 show the percentage of patients experiencing non-hematologic adverse reactions (excluding laboratory abnormalities) regardless of relationship to study drug. Adverse reactions reported in greater than 10% of patients who received at least 1 dose of Tasigna are listed.

Table 5: Most Frequently Reported Non-hematologic Adverse Reactions (Regardless of Relationship to Study Drug) in Patients with Newly Diagnosed Ph+ CML-CP ( ≥ 10% in Tasigna 300 mg Twice Daily or Imatinib 400 mg Once Daily Groups) 48-Month Analysisa

  Patients 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
Body System and Preferred Term All Grades (%) CTC Gradesb 3/4 (%)
Skin and subcutaneous tissue disorders Rash 38 18 < 1 2
Pruritus 21 7 < 1 0
Alopecia 13 7 0 0
Dry skin 12 6 0 0
Gastrointestinal disorders Nausea 22 41 2 1
Constipation 19 8 < 1 0
Diarrhea 18 45 < 1 3
Vomiting 15 26 < 1 < 1
Abdominal pain upper 17 13 1 < 1
Abdominal pain 15 12 2 0
Dyspepsia 9 12 0 0
Nervous system disorders Headache 32 23 3 < 1
Dizziness 11 10 < 1 < 1
General disorders and administration site conditions Fatigue 23 19 1 1
Pyrexia 13 13 < 1 0
Asthenia 14 12 < 1 0
Peripheral edema 10 21 < 1 0
Face edema < 1 14 0 < 1
Musculoskeletal and connective tissue disorders Myalgia 19 19 < 1 < 1
Arthralgia 20 16 < 1 < 1
Muscle spasms 12 34 0 1
Pain in extremity 13 15 < 1 < 1
Back pain 17 16 1 1
Respiratory, thoracic and mediastinal disorders Cough 17 13 0 0
Oropharyngeal pain 11 6 0 0
Dyspnea 10 6 2 < 1
Infections and infestations Nasopharyngitis 25 21 0 0
Upper respiratory tract infection 16 14 < 1 0
Influenza 12 9 0 0
Eye disorders Eyelid edema 1 18 0 < 1
Periorbital edema < 1 15 0 0
Psychiatric disorders Insomnia 11 9 0 0
aExcluding laboratory abnormalities
bNCI Common Terminology Criteria for Adverse Events, Version 3.0

Table 6: Most Frequently Reported Non-hematologic Adverse Reactions in Patients with Resistant or Intolerant Ph+ CML Receiving Tasigna 400 mg Twice Daily (Regardless of Relationship to Study Drug) ( ≥ 10% in any Group) 24-Month Analysisa

Body System and Preferred Term CML-CP
N=321
CML-AP
N=137
All Grades (%) CTC Gradesb 3/4 (%) All Grades (%) CTC Gradesb 3/4 (%)
Skin and subcutaneous tissue disorders Rash 36 2 29 0
Pruritus 32 < 1 20 0
Night sweat 12 < 1 27 0
Alopecia 11 0 12 0
Gastrointestinal disorders Nausea 37 1 22 < 1
Constipation 26 < 1 19 0
Diarrhea 28 3 24 2
Vomiting 29 <1 13 0
Abdominal pain 15 2 16 3
Abdominal pain upper 14 < 1 12 < 1
Dyspepsia 10 < 1 4 0
Nervous system disorders Headache 35 2 20 1
General disorders and administration site conditions Fatigue 32 3 23 < 1
Pyrexia 22 < 1 28 2
Asthenia 16 0 14 1
Peripheral edema 15 < 1 12 0
Musculoskeletal and connective tissue disorders Myalgia 19 2 16 < 1
Arthralgia 26 2 16 0
Muscle spasms 13 < 1 15 0
Bone pain 14 <1 15 2
Pain in extremity 20 2 18 1
Back pain 17 2 15 < 1
Musculoskeletal pain 11 < 1 12 1
Respiratory, thoracic and mediastinal disorders Cough 27 <1 18 0
Dyspnea 15 2 9 2
Oropharyngeal pain 11 0 7 0
Infections and infestations Nasopharyngitis 24 < 1 15 0
Upper respiratory tract infection 12 0 10 0
Metabolism and nutrition disorders Decreased appetitec 15 < 1 17 < 1
Psychiatric disorders Insomnia 12 1 7 0
Vascular disorders Hypertension 10 2 11 < 1
aExcluding laboratory abnormalities
bNCI Common Terminology Criteria for Adverse Events, Version 3.0 cAlso includes preferred term anorexia

Laboratory Abnormalities

Table 7 shows the percentage of patients experiencing treatment-emergent Grade 3/4 laboratory abnormalities in patients who received at least one dose of Tasigna.

Table 7: Percent Incidence of Clinically Relevant Grade 3/4* Laboratory Abnormalities

  Patient Population
Newly Diagnosed Ph+ CML-CP Resistant or Intolerant Ph+
TASIGNA 300 mg twice daily
N=279 (%)
Imatinib 400 mg once daily
N=280 (%)
CML-CP CML-AP
TASIGNA 400 mg twice daily
N=321 (%)
TASIGNA 400 mg twice daily
N=137 (%)
Hematologic Parameters
Thrombocytopenia 10 9 301 423
Neutropenia 12 21 312 424
Anemia 4 6 11 27
Biochemistry Parameters
Elevated lipase 9 4 18 18
Hyperglycemia 6 < 1 12 6
Hypophosphatemia 6 10 17 15
Elevated bilirubin (total) 4 < 1 7 9
Elevated SGPT (ALT) 4 3 4 4
Hyperkalemia 2 1 6 4
Hyponatremia 1 < 1 7 7
Hypokalemia < 1 2 2 9
Elevated SGOT (AST) 1 1 3 2
Decreased albumin 0 < 1 4 3
Hypocalcemia < 1 < 1 2 5
Elevated alkaline phosphatase 0 < 1 < 1 1
Elevated creatinine 0 < 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

Additional Data From Clinical Trials

The following adverse drug reactions were reported in 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 ( ≥ 1% and < 10%), uncommon ( ≥ 0.1% and < 1%), and unknown frequency (single events). For laboratory abnormalities, very common events ( ≥ 10%), which were not included in Tables 5 and 6, 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. Newly diagnosed Ph+CML-CP 48 month analysis and,
  2. Resistant or intolerant Ph+CML-CP and CMP-AP 24 months' analysis.

Infections and Infestations: Common: folliculitis, upper respiratory tract infection (including pharyngitis, nasopharyngitis, rhinitis). Uncommon: pneumonia, bronchitis, urinary tract infection, candidiasis (including oral candidiasis), gastroenteritis. Unknown frequency: 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: 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, insomnia, anxiety. Unknown frequency: disorientation, confusional state, amnesia, dysphoria.

Nervous System Disorders: Common: dizziness, peripheral neuropathy, hypoesthesia, paresthesia. Uncommon: intracranial hemorrhage, migraine, loss of consciousness (including syncope), tremor, disturbance in attention, hyperesthesia. Unknown frequency: transient ischemic attack, brain edema, optic neuritis, lethargy, dysesthesia, restless legs syndrome.

Eye Disorders: Common: eye hemorrhage, periorbital edema, 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: papilloedema, 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, pericardial effusion, coronary artery disease, cyanosis, cardiac murmur. Unknown frequency: myocardial infarction, ventricular dysfunction, pericarditis, ejection fraction decrease.

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

Respiratory, Thoracic and Mediastinal Disorders: Common: dyspnea, dyspnea exertional, epistaxis, cough, dysphonia. Uncommon: pulmonary edema, pleural effusion, interstitial lung disease, pleuritic pain, pleurisy, pharyngolaryngeal pain, throat irritation. Unknown frequency: pulmonary hypertension, wheezing, oropharyngeal pain.

Gastrointestinal Disorders: Common: pancreatitis, abdominal discomfort, abdominal distension, dyspepsia, 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: night sweats, eczema, urticaria, erythema, hyperhidrosis, contusion, acne, dermatitis (including allergic, exfoliative and acneiform), dry skin. Uncommon: exfoliative rash, drug eruption, pain of skin, ecchymosis, swelling of face. 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. Uncommon: musculoskeletal stiffness, muscular weakness, 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: face edema, 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. Common: hemoglobin decreased, blood amylase increased, gamma-glutamyltransferase increased, blood creatinine phosphokinase increased, blood alkaline phosphatase increased, weight decreased, weight increased, lipoprotein increased (including very low density and high density). Uncommon: blood lactate dehydrogenase increased, blood urea increased, globulins decreased. Unknown frequency: troponin increased, blood bilirubin unconjugated increased, insulin C-peptide decreased, blood parathyroid hormone increased.

Read the entire FDA prescribing information for Tasigna (Nilotinib Capsules) »

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Tasigna Capsules - User Reviews

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