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Recommended Dose: 250 mg orally, twice daily

• Renal Impairment: 250 mg orally, once daily in patients with severe renal impairment (creatinine clearance <30 mL/min) not requiring dialysis.

 

Geriatric Use

No differences in safety or efficacy were observed between older and younger patients. Clinical studies of Crizotinib in patients with ROS1-positive metastatic NSCLC did not include sufficient numbers of patients age 65 years and older to determine whether they respond differently from younger patients

 

Hepatic Impairment

Caution should be used in patients with hepatic impairment

 

Renal Impairment

No starting dose adjustment is needed for patients with mild (CLcr 609 mL/min) or moderate (CLcr 309 mL/min) renal impairment based on a population pharmacokinetic analysis.

Increased exposure to crizotinib occurred in patients with severe renal impairment (CLcr <30 mL/min) not requiring dialysis. Crizotinib should be administered at a dose of 250 mg taken orally once daily in patients with severe renal impairment not requiring dialysis.

Pediatric Dose

The safety and effectiveness of Crizotinib in pediatric patients have not been established.

 

 

CYP3A Inhibitors: Concurrent use of Crizotinib should be avoided with strong CYP3A inhibitors including but not limited to atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, and voriconazole

CYP3A Inducers: Concurrent use of Crizotinib should be avoided with strong CYP3A inducers including but not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, and St. John’s Wort

CYP3A Substrates: Concurrent use of Crizotinib should be avoided with CYP3A substrates with narrow therapeutic indices including but not limited to alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus

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