experience new or increased vitreous floaters. Severe or worsening vitreous floaters and/or photopsia could also be signs of a retinal hole or pending retinal detachment. Advise patients to exercise caution when driving or operating machinery due to the risk of developing a vision disorder.
Neuropathy attributed to study drug was reported in 34 (13%) patients. Grade 2 motor neuropathy and grade 3 peripheral neuropathy were reported in 1 patient each.
Bradycardia was reported in 12 (5%) patients treated with XALKORI. All of these cases were grade 1 or 2 in severity.
Complex renal cysts were reported in 2 (1%) patients treated with XALKORI. There were no reports of abnormal urinalyses or renal impairment in these cases.
Grade 3 or 4 laboratory abnormalities of neutropenia, thrombocytopenia, and lymphopenia were observed in 5.2%, 0.4%, and 11.4% of patients, respectively.
Drug Interactions: Exercise caution with concomitant use of moderate CYP3A inhibitors. Avoid grapefruit or grapefruit juice which may increase plasma concentrations of crizotinib. Avoid concomitant use of strong CYP3A inducers and inhibitors. Dose reduction may be needed for coadministered drugs that are predominantly metabolized by CYP3A.
Nursing Mothers: Given the potential for serious adverse reactions in nursing infants, consider whether to discontinue nursing or discontinue XALKORI.
Hepatic Impairment: XALKORI has not been studied in patients with hepatic impairment. As crizotinib is extensively metabolized in the liver, hepatic impairment is likely to increase plasma crizotinib concentrations. Use caution in patients with hepatic impairment.
Renal Impairment: No starting dose adjustment is needed for patients with mild and moderate renal impairment. No data are available for patients with end-stage renal disease. Use caution in patients with severe renal impairment or patients with end-stage renal disease.
Generic Name for XALKORI
Crizotinib 200mg, 250mg; caps.
Legal Classification:
Rx
Pharmacological Class for XALKORI
Tyrosine kinase inhibitor.
Manufacturer of XALKORI
Pfizer Inc.
Indications for XALKORI
Treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
Adult dose for XALKORI
Swallow whole. 250mg twice daily. Dose interruption and/or dose reduction to 200mg twice daily may be required based on individual safety/tolerability, then to 250mg once daily if necessary. Dose reduction for hematologic and non-hematologic toxicities: see literature.
Children's dosing for XALKORI
Not established.
Warnings/Precautions for XALKORI
Risk of hepatotoxicity. Monitor CBCs with differential, ALT, total bilirubin monthly, and more frequently in Grade 2–4 elevations, or if fever/infection occurs; temporarily suspend, reduce dose, or permanently discontinue as indicated. Risk of severe pneumonitis: monitor for pulmonary symptoms; permanently discontinue if occurs. Congenital long QT syndrome; avoid. History of or predisposition for QTc prolongation (eg, CHF, bradyarrhythmias, electrolyte abnormalities, concomitant drugs that prolong QT interval): consider monitoring ECG, electrolytes periodically; permanently discontinue if Grade 4 QTc prolongation occurs. Test for ALK-positive NSCLC with FDA-approved test before treating. Hepatic impairment. Severe renal impairment or ESRD. Pregnancy (Ca |
