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Pharmacologic classification: kinase inhibitor
Therapeutic classification: antineoplastic
Pregnancy risk category: D
AVAILABLE FORMS
Capsules: 200 mg
INDICATIONS AND DOSAGES
Treatment of chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia in adults who are resistant to or intolerant of prior therapy that included imatinib--
Adults: 400 mg P.O. b.i.d, about 12 hours apart without food. Dosage may be adjusted based on myelosuppression during therapy.
CONTRAINDICATIONS AND CAUTIONS
Contraindicated with known hypersensitivity to any component of the drug, prolonged QT interval, hypokalemia, hypomagnesemia, pregnancy, lactation.
Use cautiously in patients with a history of pancreatitis, liver impairment, or when taking with a strong CYP3A4 inhibitors.
INTERACTIONS
Drug-drug.
Drugs that prolong the QT interval: May increase risk of sudden death if used together. Monitor patient closely and adjust dosages as needed.
Strong CYP3A4 inhibitors such as ketoconazole and ritonavir: May increase serum nilotinib levels. Avoid use together.
Strong CYP3A4 inducers such as phenytoin and rifampin: May decrease serum nilotinib levels. Avoid use together.
Drug-herb.
St. John’s wort: May cause unpredictable changes in serum concentration. Avoid using together.
Drug-food.
Grapefruit juice: May increase serum level of drug. Avoid using together.
All food: Increases serum drug level. Take drug on empty stomach at least 1 hour before or 2 hours after food.
ADVERSE REACTIONS
CNS: anxiety, dizziness, fatigue, headache, insomnia, pyrexia, asthenia, paresthesia, vertigo.
CV: prolonged QT interval, sudden cardiac death, peripheral edema, palpitations, hypertension, flushing.
GI: anorexia, diarrhea, nausea, vomiting, constipation, abdominal pain, dyspepsia, flatulence.
Hematologic: neutropenia, leukopenia, anemia, pancytopenia, thrombocytopenia.
Hepatic: elevated liver enzymes.
Metabolic: electrolyte abnormalities.
Musculoskeletal: arthralgia, myalgia, pain in limbs, bone pain, muscle spasms, back pain.
Respiratory: cough, dyspnea, nasopharyngitis.
Skin: rash, pruritus, night sweats, eczema, urticaria, alopecia, erythema, hyperhidrosis, dry skin.
Reactions may be common, uncommon, life-threatening,
or COMMON AND LIFE-THREATENING.
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nilotinib