Guidelines for Use
Our guideline for ALECTINIB (Alecensa) requires a diagnosis of metastatic non-small cell lung cancer (NSCLC) AND the patient is positive for anaplastic lymphoma kinase (ALK) oncogene as detected by an FDA approved test.
Rationale
Promote appropriate utilization of ALECTINIB (Alecensa) based on its FDA approved indication.
Indications for Use
Alecensa is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) as detected by an FDA approved test.
Dosage and Administration
The recommended dose of Alecensa is 600 mg orally twice daily with food. Alecensa therapy is continued until disease progression or unacceptable toxicity.
The dose of Alecensa can be modified if certain adverse reactions or laboratory abnormalities occur (e.g., elevated hepatic transaminases, bradycardia, elevated CPK). The dose should be reduced first to 450 mg twice daily, then to 300 mg twice daily, and discontinued if intolerability persists thereafter. If treatment-related ILD/pneumonitis, elevated ALT or AST greater than 3 times ULN with total bilirubin greater than 2 times ULN in the absence of cholestasis or hemolysis, grade 4 renal impairment, or life-threatening bradycardia occurs, Alecensa should be permanently discontinued.
The contents of the capsule should not be opened or dissolved. If a dose is missed or vomiting occurs after taking a dose, the next dose should be taken at the scheduled time.
References
Alecensa [Prescribing Information]. South San Francisco, CA: Genentech, Inc. November 2017.