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Tasigna

Last reviewed on RxList: 1/10/2018
Tasigna Side Effects Center
RxList

Last reviewed on RxList 01/10/2018

Tasigna (nilotinib) is a kinase inhibitor that interferes with a protein that signals cancer cells to multiply 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. Tasigna is available in generic form. Common side effects of Tasigna include:

  • skin rash,
  • itching,
  • headache,
  • nausea,
  • fatigue,
  • tiredness,
  • joint or muscle aches or pain,
  • back pain,
  • diarrhea,
  • constipation,
  • temporary hair loss, or
  • cold symptoms (stuffy nose, sneezing, cough, or sore throat).

Tell your doctor if you have serious side effects of Tasigna including:

  • severe stomach or abdominal pain,
  • toe or joint pain,
  • painful urination,
  • a change in the amount of urine,
  • swelling hands/ankles/feet,
  • unusual or rapid weight gain,
  • symptoms of high blood sugar (such as increased thirst or urination), or
  • signs of liver disease (such as persistent vomiting, stomach or abdominal pain, yellowing eyes or skin, or dark urine).

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. Tasigna may interact with esomeprazole (Nexium) and other stomach acid reducers, ergotamine, dihydroergotamine, St. John's wort, theophylline, blood thinners or medication to prevent blood clots, antibiotics, tuberculosis medicine, antifungals, anti-malaria medication, cancer medication, immunosuppressants, medicine to prevent organ transplant rejection, heart or blood pressure medications, heart rhythm medications, medications to treat HIV/AIDS or hepatitis C, medicine to treat depression or mental illness, medicine to treat or prevent nausea, narcotics, sedatives, narcolepsy medication, seizure medication, or steroids. Tell your doctor all medications and supplements you use. 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.

Tasigna Consumer Information
RxList

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)

Tasigna Professional Information
RxList

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 and 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 the single open-label multicenter clinical trial, a total of 438 patients were treated (CML-CP=318; CML-AP=120).

The median duration of exposure in days for CML-CP and CML-AP patients is 245 (range 1-502) and 138 (range 2-503), respectively. The median dose intensity of 797 mg/day (range 145 - 1149) was similar for both the chronic and accelerated phase patients 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 18 (range 1- 185), and the median duration in days of dose interruptions for the CML-AP patients was 22 (range 1 - 163).

In CML-CP patients, the most commonly reported drug-related adverse reactions (>10%) were rash, pruritis, nausea, fatigue, headache, constipation, diarrhea and vomiting. The common serious drug-related adverse reactions were thrombocytopenia and neutropenia.

In CML-AP patients, the most commonly reported drug-related adverse reactions (>10%) were rash, pruritus and constipation. The common serious drug-related adverse reactions were thrombocytopenia, neutropenia, pneumonia, febrile neutropenia, leukopenia, intracranial hemorrhage, elevated lipase and pyrexia.

Sudden deaths and QT prolongation were reported. [See BOXED WARNING and WARNINGS AND PRECAUTIONS]

Discontinuation for drug related adverse reactions was observed in 11% of CML-CP and 8% of CMLAP patients.

Table 4 shows the percentage of patients experiencing treatment-emergent adverse reactions (excluding laboratory abnormalities) regardless of relationship to study drug. Adverse reactions reported in at least 10% of patients who received at least one dose of Tasigna are listed.

Table 4 : Treatment-emergent Adverse Reactions Reported in ≥10% of Patients in the Clinical Studya

Body System and preferred term CML-CP
n=318
CML-AP
n=120
  All Grades (%) CTC Gradesb 3 / 4 (%) All Grades (%) CTC Gradesb 3 / 4 (%)
Skin and subcutaneous tissue disorders: Rash 33 2 28 0
Pruritus 29 1 20 0
Gastrointestinal disorders: Nausea 31 1 18 <1
Diarrhea 22 3 19 2
Constipation 21 <1 18 0
Vomiting 21 <1 10 0
Abdominal pain 11 1 13 3
Nervous system disorders Headache 31 3 21 2
General disorders and administration site conditions Fatigue 28 1 16 <1
Pyrexia 14 1 24 2
Asthenia 14 0 12 2
Edema, peripheral 11 0 11 0
Musculoskeletal and connective tissue disorders Arthralgia 18 2 16 0
Myalgia 14 2 14 <1
Pain in extremity 13 1 16 2
Bone pain 11 <1 13 <1
Muscle spasms 11 <1 14 0
Back pain 10 <1 12 <1
Respiratory, thoracic and mediastinal disorders Cough 17 <1 13 0
Dyspnea 11 1 8 3
Infections and infestations Nasopharyngitis 16 <1 11 0
a Excluding laboratory abnormalities
b NCI Common Terminology Criteria for Adverse Events, Version 3.0

Table 5 shows the percentage of patients experiencing treatment-emergent Grade 3/4 laboratory abnormalities in patients who received at least one dose of Tasigna.

Table 5 : Incidence of Clinically Relevant Grade 3/4 Laboratory Abnormalities

  CML-CP
N=318
CML-AP
N=120
Grades 3/4 * Grades 3/4 *
Hematologic Parameters
-Thrombocytopenia 28%1 37%2
-Neutropenia2 28% 37%3
-Anemia 8% 23%
Biochemistry Parameters
-Elevated lipase 15% 17%
-Hyperglycemia 11% 4%
-Hypophosphatemia 10% 10%
-Elevated Bilirubin (total) 9% 10%
-Elevated SGPT (ALT) 4% 2%
-Hyperkalemia 4% 3%
-Hyponatremia 3% 3%
-Hypokalemia 1% 5%
-Elevated SGOT (AST) 1% 1%
-Decreased albumin 1% 1%
-Hypocalcemia 1% 4%
-Elevated alkaline phosphatase 1% 3%
-Elevated creatinine <1% 0%
*NCI Common Terminology Criteria for Adverse Events, version 3.0
1CML-CP: Thrombocytopenia: 11% were grade 3, 17% were grade 4
2CML-AP: Thrombocytopenia: 7% were grade 3, 30% were grade 4
3CML-AP: Neutropenia: 12% were grade 3, 25% were grade 4

Additional Data From Clinical Trials

The following drug related adverse reactions are ranked under a heading of frequency, the most frequent first using the following convention: common (1% -10%), and uncommon (0.1%-1%) adverse reactions single events are captured as unknown frequency. For laboratory abnormalities, very common events (≥1/10) not included in Table 4 are also reported. These adverse reactions are included based on clinical relevance, and ranked in order of decreasing seriousness within each category.

Infections and Infestations: Uncommon: pneumonia, urinary tract infection, gastroenteritis, pharyngitis. Unknown frequency: sepsis, bronchitis, herpes simplex, candidiasis.

Blood and Lymphatic System Disorders: Common: febrile neutropenia, pancytopenia. Unknown frequency: thrombocytosis, leukocytosis.

Endocrine Disorders: Uncommon: hyperthyroidism.

Unknown frequency: hypothyroidism, thyroiditis.

Metabolism and Nutrition Disorders: Common: hypomagnesemia, hyperkalemia, hyperglycemia, anorexia. Uncommon: hypokalemia, hyponatremia, hypocalcemia, hypophosphatemia, dehydration, decreased appetite, increased appetite.

Unknown frequency: diabetes mellitus, hypercalcemia, hyperphosphatemia.

Psychiatric Disorders: Common: Insomnia.

Uncommon: depression, anxiety.

Unknown frequency: disorientation, confusional state.

Nervous System Disorders: Common: dizziness, paresthesia

Uncommon: intracranial hemorrhage, migraine, tremor, hypoesthesia, hyperesthesia.

Unknown frequency: brain edema, loss of consciousness, optic neuritis, peripheral neuropathy.

Eye Disorders: Uncommon: eye hemorrhage, visual acuity reduced, periorbital edema, conjunctivitis, eye irritation, dry-eye.

Unknown frequency: papilloedema, diplopia, vision blurred, photophobia, eye swelling, blepharitis, eye pain.

Ear and Labyrinth Disorders: Common: vertigo.

Unknown frequency: hearing impaired, ear pain.

Cardiac Disorders: Common: palpitations, electrocardiogram QT prolonged.

Uncommon: cardiac failure, angina pectoris, atrial fibrillation, pericardial effusion, coronary artery disease, cardiomegaly, cardiac murmur, bradycardia.

Unknown frequency: myocardial infarction, ventricular dysfunction, pericarditis, cardiac flutter, extrasysoles,

Vascular Disorders: Common: hypertension, flushing.

Uncommon: hypertensive crisis, hematoma.

Unknown frequency: shock hemorrhagic, hypotension, thrombosis.

Respiratory, Thoracic and Mediastinal Disorders: Common: dyspnea, dyspnea exertional, cough, dysphonia.

Uncommon: pulmonary edema, pleural effusion, interstitial lung disease, pleuritic pain, pleurisy, epistaxis, pharyngolaryngeal pain, throat irritation.

Unknown frequency: pulmonary hypertension.

Gastrointestinal Disorders: Common: abdominal discomfort, dyspepsia, flatulence.

Uncommon: pancreatitis, gastrointestinal hemorrhage, melena, abdominal distension, mouth ulceration, gastroesophageal reflux, stomatitis, dry mouth

Unknown frequency: gastrointestinal ulcer perforation, retroperitoneal hemorrhage, hematemesis, gastric ulcer, esophagitis ulcerative, subileus.

Hepatobiliary Disorders: Uncommon: hepatitis

Unknown frequency: hepatotoxicity, hepatomegaly, jaundice.

Skin and Subcutaneous Tissue Disorders: Common: night sweats, eczema, urticaria, alopecia, erythema, hyperhidrosis, dry skin.

Uncommon: exfoliative rash, ecchymosis, swelling face,

Unknown frequency: erythema nodosum, skin ulcer, petechiae, photosensitivity.

Musculoskeletal and Connective Tissue Disorders: Common: musculoskeletal chest pain, musculoskeletal pain.

Uncommon: muscular weakness.

Unknown frequency: Arthritis, joint swelling.

Renal and Urinary Disorders: Uncommon: dysuria, micturition urgency, nocturia, pollakiuria.

Unknown frequency: renal failure, hematuria, urinary incontinence.

Reproductive System and Breast Disorders: Uncommon: breast pain, gynecomastia, erectile dysfunction.

General Disorders and Administration Site Conditions: Common: pyrexia.

Uncommon: chest pain, face edema, gravitational edema, influenza-like illness, chills, malaise.

Investigations: Very common: lipase increased.

Common: blood amylase increased, alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, blood alkaline phosphatase increased, gamma-glutamyltransferase increased, blood creatinine phosphokinase increased, blood glucose increased, weight decreased, weight increased.

Uncommon: blood lactate dehydrogenase increased, blood glucose decreased, blood creatinine increased, blood urea increased.

Unknown frequency: troponin increased, blood potassium decreased, blood bilirubin unconjugated increased.

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

Related Resources for Tasigna
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Read the Tasigna User Reviews »

© Tasigna Patient Information is supplied by Cerner Multum, Inc. and Tasigna Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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