XALKORI is a kinase inhibitor indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. (1) This indication is based on response rate. There are no data available demonstrating improvement in patient reported outcomes or survival with XALKORI.

• 250 mg taken orally twice daily with or without food. (2.1)
• Dosing interruption and/or dose reduction to 200 mg taken orally twice daily may be required based on individual safety and tolerability, then to 250 mg taken orally once daily if further reduction is necessary. (2.2)
• Renal Impairment: Adjust the XALKORI dose to 250 mg taken orally once daily in patients with severe renal impairment not requiring peritoneal dialysis or hemodialysis. (2.3)

• Capsules: 250 mg and 200 mg (3)

• None (4)

• Hepatotoxicity: Drug-induced hepatotoxicity with fatal outcome has occurred. Monitor monthly and as clinically indicated with more frequent testing in patients with Grade 2–4 elevations. Temporarily suspend, dose reduce, or permanently discontinue XALKORI as indicated. (5.1)
• Pneumonitis: Severe, including fatal, treatment-related pneumonitis has been observed. Monitor patients for pulmonary symptoms indicative of pneumonitis. Permanently discontinue in patients diagnosed with treatment-related pneumonitis. (5.2)
• QT Interval Prolongation: In patients who have a history of or predisposition for QTc prolongation, or who are taking medications that are known to prolong the QT interval, consider periodic monitoring with electrocardiograms and electrolytes. (5.3)
• Bradycardia: Avoid using XALKORI in combination with bradycardic agents. Monthly monitoring of pulse rate and blood pressure is recommended. In cases of symptomatic bradycardia, hold XALKORI and re-eva luate the use of concomitant medications. (2.2, 5.4, 6)
• ALK Testing: Detection of ALK-positive NSCLC using an FDA-approved test, indicated for this use, is necessary for selection of patients for treatment with XALKORI. (5.5)
• Pregnancy: XALKORI can cause fetal harm when administered to a pregnant woman. (5.6, 8.1)
• Renal Impairment: In patients with severe renal impairment not requiring peritoneal dialysis or hemodialysis, adjust the XALKORI dose. (2.3, 5.7, 8.7)

The most common adverse reactions (≥25%) are vision disorder, nausea, diarrhea, vomiting, edema, and constipation. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.