Respiratory and thoracic cancers:

Indications for XALKORI:

Treatment of metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test.

Adult:

Confirm ALK or ROS1-positive NSCLC with an FDA-approved test before treating. Swallow whole. 250mg twice daily until disease progression or intolerance. Concomitant strong CYP3A inhibitors: if unavoidable, reduce to 250mg once daily. Moderate hepatic impairment (AST and total bilirubin >1.5–≤3xULN): 200mg twice daily; severe (AST and total bilirubin >3xULN): 250mg once daily. Severe renal impairment (CrCl <30mL/min) not requiring dialysis: 250mg once daily. Dose modifications for hematologic and non-hematologic toxicities: see full labeling.

Children:

Not established.

Warnings/Precautions:

Monitor ALT, AST and total bilirubin every 2 weeks during first 2 months, then monthly, and more frequently for elevated transaminases; temporarily suspend, reduce dose, or permanently discontinue as clinically indicated. Monitor CBCs with differential monthly and more frequently if Grade 3 or 4 abnormalities, fever or infection occurs. 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, or those who are taking drugs known to prolong the QT interval): consider monitoring ECG, electrolytes periodically. Torsade de pointes, ventricular tachycardia, serious arrhythmia: permanently discontinue if QTc >500ms or ≥60ms change from baseline. Monitor HR and BP regularly; discontinue if life-threatening bradycardia occurs. Discontinue if onset of severe visual loss; perform eye evaluation. Hepatic impairment. Severe renal impairment. Embryo-fetal toxicity. Pregnancy; exclude status prior to initiation. Use effective contraception during and for at least 45 days (females) or 90 days (males w. female partners) after final dose. Nursing mothers: not recommended (during and for 45 days after final dose).

Pharmacologic Class:

Tyrosine kinase inhibitor.

Interactions:

Avoid concomitant strong CYP3A inhibitors (eg, itraconazole, ketoconazole, grapefruit, or grapefruit juice); see Adults. Avoid concomitant strong CYP3A inducers (eg, rifampin). Avoid concomitant CYP3A substrates with narrow therapeutic indices (eg, oral midazolam); if needed, reduce doses. Avoid concomitant agents known to cause bradycardia (eg, beta-blockers, non-dihydropyridine calcium channel blockers, clonidine, digoxin); adjust dose or discontinue. Avoid drugs known to prolong QT interval. Caution with moderate CYP3A inhibitors.

Adverse Reactions:

Vision disorders, nausea, diarrhea, vomiting, edema, constipation, elevated transaminases, fatigue, decreased appetite, upper RTI, dizziness, neuropathy; hepatotoxicity (may be fatal), pneumonitis (may be fatal), QT prolongation, bradycardia.

Generic Availability:

NO

How Supplied:

Caps—60

Pricing for XALKORI

250mg capsule (Qty: 60)
Appx. price $17518
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