HIGHLIGHTS OF PRESCRIBING INFORMATION 

These highlights do not include all the information needed to use LuciAle safely and effectively. See full prescribing information for LuciAle.

INDICATIONS AND USAGE

LuciAle is a kinase inhibitor indicated for:

• adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm or node positive) as detected by an FDAapproved test. 

• treatment of adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test.

DOSAGE AND ADMINISTRATION 

600 mg orally twice daily. Administer LuciAle with food. 

DOSAGE FORMS AND STRENGTHS 

Tablets: 75 mg×30 tablets

CONTRAINDICATIONS 

None.

WARNINGS AND PRECAUTIONS 

• Hepatotoxicity: Monitor liver laboratory tests every 2 weeks during the first 3 months of treatment, then once a month and as clinically indicated, with more frequent testing in patients who develop transaminase and bilirubin elevations. In case of severe ALT, AST, or bilirubin elevations, withhold, then reduce dose, or permanently discontinue LuciAle. 

• Interstitial Lung Disease (ILD)/Pneumonitis: Immediately withhold LuciAle in patients diagnosed with ILD/pneumonitis and permanently discontinue if no other potential causes of ILD/pneumonitis have been identified.

• Renal Impairment: Withhold LuciAle for severe renal impairment, then resume LuciAle at reduced dose upon recovery or permanently discontinue.

• Bradycardia: Monitor heart rate and blood pressure regularly. If symptomatic, withhold LuciAle then reduce dose, or permanently discontinue.

• Severe Myalgia and Creatine Phosphokinase (CPK) Elevation: Assess CPK every 2 weeks during the first month of treatment and in patients reporting unexplained muscle pain, tenderness, or weakness. In case of severe CPK elevations, withhold, then resume or reduce dose.

• Hemolytic Anemia: If hemolytic anemia is suspected, withhold LuciAle. If hemolytic anemia is confirmed, consider resuming at a reduced dose upon resolution or permanently discontinue. 

• Embryo-Fetal Toxicity: LuciAle can cause fetal harm. Advise femalesof reproductive potential of the potential risk to a fetus and to use effective contraception. 

ADVERSE REACTIONS 

The most common adverse reactions (incidence ≥20%) were hepatotoxicity, constipation, fatigue, myalgia, edema, rash and cough. 

USE IN SPECIFIC POPULATIONS 

Lactation: Do not breastfeed.

Storage 

Store at 20C to 25C (68F to 77F), excursions permitted between 15C and 30C (59F and 86F) [see USP Controlled Room Temperature]. Protect from moisture.