Ctrl

K

Nilotinib

Class
Targeted therapy
Subclass
Tyrosine kinase inhibitors
Substance name
Nilotinib
Brand names
Tasigna®
Common formulations
Capsule
Dosage and administration
Adults patients
No dosages available
Other off-label uses
•
Treatment of gastrointestinal stromal tumors (adjuvant setting)
Indications for use
Labeled indications
Adults
•
Treatment of chronic myeloid leukemia (Philadelphia chromosome-positive, chronic phase, resistant or intolerant to prior therapy)
Off-label indications
Adults
•
Treatment of gastrointestinal stromal tumors (adjuvant setting)
Safety risks
Contraindications
Hypersensitivity to the drug or any other excipient in the formulation
Pre-existing long QT syndrome, or concomitant use of nilotinib with other medication known to prolong the QT interval
Warnings and precautions
Cardiovascular risk
•
Use caution with cardiac disease.
Dyslipidemia
•
Use caution with chronic myelogenous leukemia and a history of high lipid profile.
Edema
•
Use caution with newly diagnosed chronic myelogenous leukemia.
Exacerbation of acute pancreatitis
•
Use caution with a history of pancreatitis or other Pancreatic disorders known to cause elevation in lipase levels.
Hematologic disorder
•
Use caution with risk factors for anemia, neutropenia, and thrombocytopenia.
Hyperbilirubinemia
•
Use caution with hepatic impairment.
Hyperglycemia
•
Use caution with diabetes mellitus.
Torsades de pointes
•
Use caution with a history of cardiac arrhythmias, unstable angina and significant bradycardia.
Tumor lysis syndrome
•
Use caution who received nilotinib therapy for resistant or intolerant chronic myelogenous leukemia.
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required.
Renal replacement therapy
Any modality
•
Use acceptable. No dose adjustment required.
Hepatic impairment
Any severity
•
Reduce dose. Monitor for toxicity. - If possible, consider alternative therapy.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: D
•
Avoid use. Evidence of fetal harm in humans. Based on findings from animal studies and the mechanism of action, this drug can cause fetal harm when administered to a pregnant woman.
•
Females of reproductive potential should have a pregnancy test prior to starting treatment.
•
Advise female patients of reproductive potential to use effective contraception during treatment and for at least 14 days after the last dose.
•
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 harm to the fetus.
Breastfeeding
Consider alternative agents that may be safer.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
No overt adverse effects reported in breastfed infants.
Adverse reactions
Very common > 10%
•
Alopecia, anemia, cough, ↓ WBC count, ↓ blood lymphocyte count, ↓ platelet count, ↓ serum phosphate, dry skin patches, hypertension, ↑ blood glucose, ↑ serum cholesterol, ↑ serum lipase, ↑ serum triglycerides, influenza virus infection, peripheral edema, pharyngitis, abdominal pain, arthralgia, asthenia, back pain, constipation, diarrhea, dyspnea, fatigue, fever, generalized pruritus, headache, insomnia, limb pain, loss of appetite, muscle spasms, musculoskeletal pain, nausea, night sweats, skin rash, throat pain, vomiting, upper respiratory tract infections
Common 1-10%
•
↓ serum calcium, ↓ serum potassium, ↓ serum sodium, dermatitis, febrile neutropenia, gastrointestinal bleeding, growth restriction, hypoalbuminemia, ICH, ↑ serum ALP, ↑ serum TBIL, ↑ serum potassium, ↑ serum transaminases, peripheral artery disease, pneumonia, ↑QT interval, indigestion, muscle weakness, stable ischemic heart disease, thrombosis
Uncommon < 1%
•
Acute ischemic stroke, cerebrovascular accident, facial nerve palsy, myocardial infarction, pleural effusion, pleural effusion, sudden death syndrome
Unknown frequency
•
Acute pancreatitis, carcinoma, ↑ pulmonary artery pressure, raynaud's phenomenon, respiratory failure, thrombotic microangiopathy, tumor lysis syndrome
Interactions
Drug(s)
Check Interactions
Reset

What did you think about this content?

Create free account

Sign up for free to access the full drug resource