Nilotinib

Name: Nilotinib

How should this medicine be used?

Nilotinib comes as a capsule to take by mouth. It is usually taken without food twice a day. Nilotinib should be taken on an empty stomach, at least 1 hour before or 2 hours after eating any food. Take nilotinib at around the same times every day. Try to space your doses about 12 hours apart. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take nilotinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole with a glass of water; do not split, chew, or crush them. If you are not able to swallow the capsules whole, mix the contents of a capsule in one teaspoon of applesauce. Swallow the mixture immediately (within 15 minutes.) Do not store the mixture for future use.

Your doctor may decrease your dose of nilotinib during your treatment. This will depend on how well the medication works for you and any side effects you may experience. Continue to take nilotinib even if you feel well. Do not stop taking nilotinib without talking to your doctor.

Is nilotinib available as a generic drug?

GENERIC AVAILABLE: No

Nilotinib Side Effects

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

Stop using nilotinib and call your doctor at once if you have:

  • swelling, rapid weight gain, feeling short of breath;
  • bone marrow suppression--fever, chills, painful mouth sores, pale skin, easy bruising or bleeding, red or pink urine, bloody or tarry stools, cough, trouble breathing, feeling light-headed, rapid heart rate;
  • kidney problems--lower back pain, little or no urinating;
  • pancreas problems--severe pain in your upper stomach spreading to your back, nausea and vomiting;
  • high or low potassium---confusion, slow or uneven heart rate, weak pulse, extreme thirst, increased urination, leg discomfort, tingly feeling, muscle weakness or limp feeling;
  • low calcium--numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes;
  • low sodium--headache, confusion, slurred speech, hallucinations, vomiting, severe weakness, muscle cramps, loss of coordination, feeling unsteady, seizure (convulsions), shallow breathing;
  • liver problems--nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • bleeding in the brain--sudden headache, confusion, vision problems, and feeling like you might pass out.

Common side effects may include:

  • diarrhea, constipation, stomach discomfort;
  • mild itching or rash, temporary hair loss;
  • runny or stuffy nose, sneezing, sore throat;
  • mild headache, back pain, joint or muscle pain; or
  • tired feeling.

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.

Side Effects of Nilotinib

Nilotinib may cause serious side effects including: See the “Nilotinib Drug Precautions” section.

The most common side effects of nilotinib include:

  • low blood count 
  • rash
  • nausea 
  • fever
  • headache
  • itching
  • tiredness
  • stomach (abdominal) pain
  • diarrhea
  • constipation
  • muscle and joint pain
  • back pain
  • muscle spasms
  • weakness
  • hair loss
  • runny or stuffy nose, sneezing, sore throat
  • cough

Tell your doctor if you have any side effect that bothers you or does not go away.

These are not all of the possible side effects of nilotinib. For more information, ask your doctor or pharmacist.

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

Nilotinib Food Interactions

Grapefruit and grapefruit juice may interact with nilotinib and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

What is nilotinib?

Nilotinib is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Nilotinib is used to treat a type of blood cancer called Philadelphia chromosome positive chronic myeloid leukemia (CML).

Nilotinib is usually given after other medications have been tried without success.

Nilotinib may also be used for purposes not listed in this medication guide.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Nilotinib side effects

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

Stop using nilotinib and call your doctor at once if you have:

  • swelling, rapid weight gain, feeling short of breath;

  • bone marrow suppression--fever, chills, painful mouth sores, pale skin, easy bruising or bleeding, red or pink urine, bloody or tarry stools, cough, trouble breathing, feeling light-headed, rapid heart rate;

  • kidney problems--lower back pain, little or no urinating;

  • pancreas problems--severe pain in your upper stomach spreading to your back, nausea and vomiting;

  • high or low potassium---confusion, slow or uneven heart rate, weak pulse, extreme thirst, increased urination, leg discomfort, tingly feeling, muscle weakness or limp feeling;

  • low calcium--numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes;

  • low sodium--headache, confusion, slurred speech, hallucinations, vomiting, severe weakness, muscle cramps, loss of coordination, feeling unsteady, seizure (convulsions), shallow breathing;

  • liver problems--nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

  • bleeding in the brain--sudden headache, confusion, vision problems, and feeling like you might pass out.

Common side effects may include:

  • diarrhea, constipation, stomach discomfort;

  • mild itching or rash, temporary hair loss;

  • runny or stuffy nose, sneezing, sore throat;

  • mild headache, back pain, joint or muscle pain; or

  • tired feeling.

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.

Cautions for Nilotinib

Contraindications

  • Hypokalemia, hypomagnesemia, or long QT syndrome.1 11

Warnings/Precautions

Warnings

Prolongation of QT Interval

Plasma concentration-dependent QT interval prolongation has occurred; may be associated with torsades de pointes, leading to syncope, seizure, and/or sudden death.1 (See Sudden Death under Cautions.)

ECG monitoring is recommended at baseline, 7 days after initiation of drug, approximately 7 days after any dosage adjustments, and periodically during therapy to monitor for QT interval effects.1 (See Prolongation of QT Interval under Dosage and Administration.)

Contraindicated in patients with hypokalemia, hypomagnesemia, or long QT syndrome.1

Concomitant use of potent CYP3A4 inhibitors (e.g., atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole, grapefruit) or antiarrhythmics or other drugs that prolong QT interval (e.g., amiodarone, chloroquine, clarithromycin, disopyramide, haloperidol, methadone, moxifloxacin, pimozide, procainamide, quinidine, sotalol) may result in substantial prolongation of QT interval; avoid concomitant use of these agents.1 (See Interactions.)

Administration with food may result in substantial prolongation of QT interval; do not administer with food.1 (See Oral Administration under Dosage and Administration.)

Sudden Death

Sudden deaths reported in patients receiving nilotinib.1 Possibility that ventricular repolarization abnormalities may have contributed to their occurrence.1 (See Prolongation of QT Interval under Cautions.)

Other Warnings and Precautions

Hematologic Effects

Grade 3 or 4 myelosuppression (neutropenia, anemia, and thrombocytopenia) reported; usually reversible by withholding or reducing the dosage.1 (See Adverse Hematologic Effects under Dosage and Administration.)

Perform CBCs every 2 weeks during the first 2 months of therapy and monthly (or as clinically indicated) thereafter.1

Elevated Serum Lipase

Grade 3 or 4 elevations in serum lipase reported.1 Caution in patients with a previous history of pancreatitis.1 Monitor serum lipase monthly or as clinically indicated; interruption of therapy and/or dosage reduction may be required.1 (See Other Nonhematologic Adverse Effects under Dosage and Administration.)

If lipase elevations are accompanied by abdominal symptoms, interrupt therapy and consider diagnostic testing to exclude pancreatitis.1

Hepatic Effects

Grade 3 or 4 elevations of serum bilirubin, AST, ALT, and/or alkaline phosphatase reported.1 Monitor hepatic function tests monthly or as clinically indicated; interruption of therapy and/or dosage reduction may be required.1 (See Other Nonhematologic Adverse Effects under Dosage and Administration.)

Pharmacogenetic analysis evaluating potential association between genetic polymorphisms of uridine diphosphate-glucuronosyltransferase (UGT) 1A1 and nilotinib-associated hyperbilirubinemia found increased risk of hyperbilirubinemia with the (TA)7/(TA)7 genotype relative to the (TA)6/(TA)6 and (TA)6/(TA)7 genotypes; largest increases in bilirubin observed in patients with the (TA)7/(TA)7 genotype (UGT1A1*28).1

Electrolyte Abnormalities

Grade 3 or 4 electrolyte abnormalities (hypophosphatemia, hypokalemia, hyperkalemia, hypocalcemia, and hyponatremia) reported.1

Correct electrolyte abnormalities prior to administration of nilotinib; monitor electrolytes periodically during therapy.1

Total Gastrectomy

Nilotinib exposure is reduced in patients who have undergone total gastrectomy.1 Consider more frequent follow-up of these patients.1 If necessary, consider increasing nilotinib dosage or instituting alternative therapy.1

Lactose Intolerance

Contains lactose monohydrate; not recommended in patients with rare hereditary problems of galactose intolerance, severe lactase deficiency with severe intolerance to lactose-containing products, or glucose-galactose malabsorption.1

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm; maternal and embryofetal toxicity demonstrated in animals.1 Avoid pregnancy during therapy.1 (See Advice to Patients.) If used during pregnancy or if patient becomes pregnant, apprise of potential fetal hazard.1

Cardiac Disorders

Clinical trials excluded patients with a history of uncontrolled or clinically important cardiovascular disease, including recent MI, CHF, unstable angina, and clinically important bradycardia.1 Caution advised in such patients.1 (See Prolongation of QT Interval under Cautions.)

Specific Populations

Pregnancy

Category D.1 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Lactation

Distributed into milk in rats; not known whether nilotinib is distributed into human milk.1 Discontinue nursing or drug.1

Pediatric Use

Safety and efficacy not established.1

Geriatric Use

In newly diagnosed chronic-phase CML patients, no difference in major molecular response rates between patients ≥65 years of age and younger adults.1

In chronic-phase CML patients receiving nilotinib after failure of prior therapy that included imatinib, no difference in major cytogenetic response rates between patients ≥65 years of age and younger adults.1

In accelerated-phase CML patients receiving nilotinib after failure of prior therapy that included imatinib, hematologic response rate was 29% in patients ≥65 years of age compared with 44% in patients <65 years of age.1

No major differences in safety relative to younger adults.1

Hepatic Impairment

Increased nilotinib exposure in patients with hepatic impairment.1 (See Absorption: Special Populations, under Pharmacokinetics.) If possible, consider alternative therapy.1 If nilotinib therapy is required, reduce initial dosage and closely monitor QT interval.1 (See Hepatic Impairment under Dosage and Administration.)

Renal Impairment

Not studied in patients with renal impairment; however, renal impairment not expected to decrease nilotinib clearance.1

Common Adverse Effects

Adverse nonhematologic effects: Rash, pruritus, headache, nausea, fatigue, myalgia, nasopharyngitis, constipation, diarrhea, abdominal pain, vomiting, arthralgia, pyrexia, upper respiratory infection, back pain, cough, asthenia.1

Grade 3/4 adverse hematologic effects: Thrombocytopenia, neutropenia, anemia.1 16

Advice to Patients

  • A copy of the manufacturer’s patient information (medication guide) for nilotinib should be provided to all patients with each prescription of the drug.1 19 Importance of patients reading the medication guide prior to initiation of therapy and each time the prescription is refilled.1

  • Risk of QT interval prolongation.1 Importance of informing clinician immediately if feelings of lightheadedness or faintness or an irregular heartbeat occurs.1

  • Importance of advising patients that nilotinib is a long-term therapy.1 Importance of taking only as prescribed; do not alter the dosage or discontinue therapy without first consulting clinician.1

  • Importance of advising patients to swallow nilotinib capsules whole with water.1 Alternatively, instruct patients who cannot swallow capsules to open nilotinib capsules, sprinkle the contents of each capsule on one teaspoonful of applesauce, and swallow the mixture immediately (within 15 minutes).1 Advise patients that foods other than applesauce should not be used and that no more than one teaspoonful of applesauce should be mixed with the contents of each capsule.1

  • Importance of advising patients that if a dose is missed, the next dose should be taken at the regularly scheduled time; the dose should not be doubled.1

  • Importance of advising patients to take nilotinib on an empty stomach (at least 1 hour before and at least 2 hours after eating any food); advise patients receiving nilotinib twice daily to take doses approximately 12 hours apart.1

  • Importance of advising patients to separate doses of nilotinib and doses of antacids or H2-receptor antagonists by at least several hours.1

  • Importance of informing clinicians if patient is lactose intolerant.1

  • Importance of advising patients to avoid any grapefruit products or any other foods that inhibit CYP3A4 while taking nilotinib.1

  • Importance of women informing a clinician immediately if they are or plan to become pregnant or plan to breast-feed; necessity for clinicians to advise women to avoid pregnancy during therapy, and advise pregnant women of risk to the fetus.1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal products (e.g., St. John’s wort), as well as any concomitant illnesses (e.g., long QT syndrome).1

  • Importance of informing patients of other important precautionary information.1 (See Cautions.)

What are some things I need to know or do while I take Nilotinib?

  • Tell all of your health care providers that you take nilotinib. 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 nilotinib 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 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 nilotinib, call your doctor right away.

What are some other side effects of Nilotinib?

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.

Pronunciation

(nye LOE ti nib)

Index Terms

  • AMN107
  • Nilotinib HCl
  • Nilotinib Hydrochloride Monohydrate

Pharmacology

Selective tyrosine kinase inhibitor that targets BCR-ABL kinase, c-KIT and platelet derived growth factor receptor (PDGFR); does not have activity against the SRC family. Inhibits BCR-ABL mediated proliferation of leukemic cell lines by binding to the ATP-binding site of BCR-ABL and inhibiting tyrosine kinase activity. Nilotinib has activity in imatinib-resistant BCR-ABL kinase mutations.

Metabolism

Hepatic; oxidation and hydroxylation, via CYP3A4 to primarily inactive metabolites

Excretion

Feces (93%; 69% as parent drug)

Time to Peak

3 hours

Half-Life Elimination

~15 to 17 hours

Protein Binding

~98%

Special Populations Note

Total gastrectomy: Median steady-state trough concentrations are decreased by 53%.

Adverse Reactions

>10%:

Cardiovascular: Peripheral edema (≤15%; grade 3/4: <1%), hypertension (10% to 11%)

Central nervous system: Headache (20% to 35%), fatigue (21% to 32%), insomnia (7% to 12%), dizziness (≤12%)

Dermatologic: Skin rash (≤38%; grades 3/4: ≤2%), pruritus (20% to 32%), night sweats (12% to 27%), alopecia (11% to 13%), xeroderma (>5% to 12%)

Endocrine & metabolic: Increased serum glucose (50%), hyperglycemia (≤50%; grades 3/4: 7% to 12%), increased serum cholesterol (28%), hypophosphatemia (≥10%; grades 3/4: 5% to 17%)

Gastrointestinal: Nausea (20% to 37%), vomiting (11% to 29%), diarrhea (14% to 28%), increased serum lipase (28%; grades 3/4: 9% to 18%), constipation (17% to 26%), upper abdominal pain (12% to 18%; grades 3/4: <1%), abdominal pain (15% to 16%), decreased appetite (including anorexia; 15%)

Hematologic & oncologic: Neutropenia (grades 3/4: 12% to 42%; median duration: 15 days), thrombocytopenia (grades 3/4: 10% to 42%; median duration: 22 days), anemia (grades 3/4: 4% to 27%)

Hepatic: Hepatic: Increased serum ALT (10% to 72%; grades 3/4: 4%), increased serum AST (10% to 47%; grades 3/4: 1% to 3%), hyperbilirubinemia (≥10%; grades 3/4: 4% to 9%), increased serum ALT (≥10%; grades 3/4: 4%), increased serum AST (≥10%; grades 3/4: 1% to 3%)

Infection: Influenza (≤13%)

Neuromuscular & skeletal: Arthralgia (16% to 26%), limb pain (11% to 20%), back pain (15% to 19%), myalgia (14% to 19%), weakness (11% to 16%), ostealgia (14% to 15%), muscle spasm (11% to 15%), musculoskeletal pain (11% to 12%)

Respiratory: Cough (14% to 27%), nasopharyngitis (≤27%), upper respiratory tract infection (≤17%), dyspnea (9% to 15%; exertional), oropharyngeal pain (≤12%), flu-like symptoms (11%)

Miscellaneous: Fever (11% to 28%)

1% to 10%:

Cardiovascular: Ischemic heart disease (5% to 9%), peripheral arterial disease (3% to 4%), cerebral ischemia (1% to 3%), pericardial effusion (≤2%; grades 3/4: ≤1%), angina pectoris, cardiac arrhythmia (including AV block, atrial fibrillation, bradycardia, cardiac flutter, extrasystoles, and tachycardia), chest discomfort, chest pain (including noncardiac), flushing, palpitations, prolonged Q-T interval on ECG

Central nervous system: Anxiety, depression, flank pain, hypoesthesia, malaise, myasthenia, pain, paresthesia, peripheral neuropathy, vertigo, voice disorder

Dermatologic: Acne vulgaris, dermatitis (including allergic and acneiform), eczema, erythema, folliculitis, hyperhidrosis, urticaria

Endocrine & metabolic: Hypokalemia (grades 3/4: ≤9%), hyponatremia (grades 3/4: ≤7%), hyperkalemia (grades 3/4: 2% to 6%), hypocalcemia (grades 3/4: ≤5%), decreased serum albumin (grades 3/4: ≤4%), fluid retention (grades 3/4: 3% to 4%), diabetes mellitus, hypercalcemia, hypercholesterolemia, hyperlipidemia, hyperphosphatemia, hypertriglyceridemia, hypomagnesemia, increased gamma-glutamyl transferase, increased HDL cholesterol, increased VLDL, weight gain, weight loss

Gastrointestinal: Dyspepsia (4% to 10%)exertional, gastrointestinal hemorrhage (≤5%), abdominal distension, abdominal distress, dysgeusia, flatulence, increased serum amylase, pancreatitis

Genitourinary: Pollakiuria

Hematologic & oncologic: Hemorrhage (grades 3/4: 1% to 2%), bruise, cutaneous papilloma, decreased hemoglobin, eosinophilia, febrile neutropenia, hemophthalmos, leukopenia, lymphocytopenia, pancytopenia

Hepatic: Ascites (≤2%; grades 3/4: ≤1%), increased serum alkaline phosphatase (grades 3/4: ≤1%), hepatic insufficiency

Immunologic: Change in serum protein (decreased globulins)

Neuromuscular & skeletal: Increased creatine phosphokinase, neck pain

Ophthalmic: Eyelid edema (1%), conjunctivitis, eye pruritus, periorbital edema, xerophthalmia

Respiratory: Pleural effusion (≤2%; grades 3/4: ≤1%), pulmonary edema (≤2%; grades 3/4: ≤1%), epistaxis

Frequency not defined:

Cardiovascular: Hypotension, occlusive arterial disease (basilar, peripheral), pericarditis, reduced ejection fraction, shock (hemorrhagic), thrombosis, ventricular dysfunction

Central nervous system: Amnesia, breast induration, cerebral edema, confusion, disorientation, dysesthesia, dysphoria, lethargy, restless leg syndrome

Dermatologic: Dermal ulcer, erythema multiforme, erythema nodosum, exfoliative dermatitis, furuncle, hyperkeratosis, palmar-plantar erythrodysesthesia, psoriasis, skin atrophy, skin blister, skin discoloration, skin hyperpigmentation, skin hypertrophy, skin photosensitivity, tinea pedis

Endocrine & metabolic: Altered hormone level (insulin C-peptide decreased), hypermenorrhea, hyperparathyroidism (secondary), hyperuricemia, hypoglycemia, thyroiditis

Gastrointestinal: Cholestasis, enterocolitis, gastric ulcer (perforation possible), gingivitis, hematemesis, hemorrhoids, hiatal hernia, intestinal obstruction, oral lesion (papilloma), rectal hemorrhage, ulcerative esophagitis

Genitourinary: Hematuria, urinary incontinence, urine discoloration

Hematologic & oncologic: Increased parathyroid hormone, leukocytosis, paraproteinemia, petechiae, retroperitoneal hemorrhage, thrombocythemia

Hepatic: Hepatomegaly

Hypersensitivity: Hypersensitivity

Infection: Abscess, reactivation of HBV, sepsis

Local: Local swelling (nipple), localized edema

Neuromuscular & Skeletal: Arthritis

Ophthalmic: Blepharitis, diplopia, eye pain, optic neuritis, papilledema, photophobia, retinopathy (central serous chorioretinopathy), swelling of eye

Otic: Auditory impairment, otalgia, tinnitus

Renal: Renal failure

Respiratory: Pulmonary hypertension, wheezing

Miscellaneous: Benign nodule (sebaceous hyperplasia), cyst (dermal), troponin increased

<1%, postmarketing, and/or case reports: Allergic skin reaction, arteriosclerosis, ascorbic acid deficiency (Oak 2016), blurred vision, bronchitis, candidiasis, cardiac failure, cardiomegaly, cerebral infarction, chills, conjunctival hemorrhage, coronary artery disease, cyanosis, decreased visual acuity, dehydration, dysuria, ecchymoses, erectile dysfunction, esophageal pain, eye irritation, facial edema, gastritis, gastroenteritis, gastroesophageal reflux disease, gout, gynecomastia, heart murmur, hematoma, hepatitis, hepatotoxicity, herpes simplex infection, hyperemia (scleral, conjunctival, ocular), hyperesthesia, hypertensive crisis, hyperthyroidism, hypothyroidism, increased appetite, increased blood urea nitrogen, increased lactate dehydrogenase, increased serum creatinine, interstitial pulmonary disease, intracranial hemorrhage, jaundice, joint swelling, lack of concentration, local alterations in temperature sensations, local discomfort (sensitive teeth), loss of consciousness, mastalgia, melena, mesenteric artery occlusion, migraine, myocardial infarction, nocturia, nonhemorrhagic stroke, occlusive arterial disease (coronary), oral mucosa ulcer, pharyngolaryngeal pain, photopsia, pleurisy, pleuritic chest pain, pneumonia, sinusitis, skin pain, stiffness, stomatitis, syncope, throat irritation, transient ischemic attacks, tremor, tumor lysis syndrome, urinary tract infection, urinary urgency, xerostomia

Nilotinib Breastfeeding Warnings

Use is not recommended. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: The effects in the nursing infant are unknown.

(web3)