Concurrent use of QT interval prolonging medications may ↑ risk of QT interval prolongation and torsade de pointes.
Grapefruit/grapefruit juice ↑ levels and the risk of toxicity; concurrent ingestion should be avoided.
St. John's wort ↓ levels and effectiveness; concurrent use should be avoided.
PO (Adults): 450 mg once daily; continue until disease progression or unacceptable toxicity; Concurrent use of strong CYP3A inhibitors– ↓ dose by ࡩ, rounded to the nearest 150-mg strength.
Hepatic Impairment PO (Adults): Severe hepatic impairment– ↓ dose by ࡩ, rounded to the nearest 150-mg strength.
Tablets: 150 mg
Assess for signs and symptoms of interstitial lung disease or pneumonitis (trouble breathing, shortness of breath, fever, cough with or without mucus, chest pain). If these symptoms occur, discontinue therapy permanently.
Monitor ECG periodically during therapy. If QTc interval is >500 msec on at least 2 separate ECGs, hold ceritinib until QTc interval <481 msec or recovery to baseline if QTc ≥481 msec, then resume ceritinib with a 150 mg dose reduction. If QTc interval prolongation occurs in combination with torsades de pointes or polymorphic ventricular tachycardia or signs and symptoms of serious arrhythmia, discontinue ceritinib permanently.
If symptomatic bradycardia that is not life-threatening occurs, hold ceritinib until recovery to asymptomatic bradycardia or a heart rate ≥ 60 bpm, evaluate concurrent medications causing bradycardia, and adjust dose of ceritinib. If clinically significant bradycardia requiring intervention or life-threatening bradycardia in patients taking concurrent medication known to cause bradycardia or a medication known to cause hypotension occurs, hold ceritinib until recovery to asymptomatic bradycardia or a heart rate ≥60 bpm. If concurrent medication can be adjusted or discontinued, resume ceritinib with a 150 mg dose reduction and frequent monitoring. If life-threatening bradycardia occurs in patients not taking medications known to cause bradycardia or hypotension, discontinue ceritinib permanently.
Assess for nausea, vomiting, diarrhea. If severe or intolerable nausea, vomiting, or diarrhea continue despite optimal antiemetic or antidiarrheal therapy, hold ceritinib until improved; then resume with a 150 mg dose reduction.
Lab Test Considerations: Test patient for ALK positivity in tumor specimens through an FDA approved test prior to starting therapy.
Monitor liver function tests at least monthly. If ALT or AST >5 times the upper limit of normal (ULN) and total bilirubin is ≤2 x ULN, hold ceritinib until recovery to baseline or ≤3 x ULN, then resume ceritinib with a 150 mg dose reduction. If ALT or AST >3 x ULN and total bilirubin is >2 x ULN in the absence of cholestasis or hemolysis, permanently discontinue ceritinib.
Monitor fasting blood glucose prior to and periodically during therapy. If persistent hyperglycemia >250 m g/dL despite anti-hyperglycemic therapy, hold ceritinib until hyperglycemia is adequately controlled, then resume with a 150 mg dose reduction. If adequate hyperglycemic control cannot be achieved, discontinue therapy.
May cause ↓ hemoglobin and serum phosphate; ↑ creatinine.
Monitor serum lipase and amylase prior to and periodically during therapy. May cause ↑ serum lipase and amylase. If ↑ lipase or amylase >2 x upper ULN, hold ceritinib and monitor serum lipase and amylase. When recovery to <1.5 x ULN, resume with 150 mg dose reduction.
PO Administer on an empty stomach, at least 1 hr before or 2 hr after meals.
Instruct patient to take ceritinib as directed. Take missed doses as soon as remembered unless within 12 hrs of next dose. If vomiting occurs, do not administer additional dose, continue with next scheduled dose. Instruct patient to read Patient Information prior to starting therapy and with each Rx refill in case of changes.
Inform patient to avoid consuming grapefruit and grapefruit juice during therapy.
Advise patient to notify health care professional if nausea, vomiting, and diarrhea is severe or persistent; if signs and symptoms of hepatotoxicity (feeling tired, itchy skin, skin or whites of eyes turn yellow, nausea and vomiting, decreased appetite, pain on right side of stomach, dark or brown, tea-colored urine, bleed or bruise easily); pneumonitis; QTc interval prolongation or bradycardia (new chest pain, changes in heartbeat, palpitations, dizziness, fainting, or changes in or use of a new heart or BP medication); hyperglycemia (increased thirst, increased hunger, headaches, trouble thinking or concentration, urinating often, blurred vision, tiredness, breath smells like fruit), or pancreatitis (upper abdominal pain that may spread to the back and get worse with eating) occur.
Rep: Advise female patient of reproductive potential to use effective contraceptives during and for at least 6 mo following completion of therapy, to notify health care provider if pregnancy is planned or suspected, and to avoid breast feeding during and for at least 2 wk after end of therapy. Advise males with female partners of reproductive potential to use condoms during therapy and for 3 mo following completion of therapy.
Slowed progression of metastatic NSCLC.
ceritinib is a sample topic from the Davis's Drug Guide.
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