HIGHLIGHTS OF PRESCRIBING INFORMATION 

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

INDICATIONS AND USAGE

LUCICRIZ is a kinase inhibitor indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test.

DOSAGE AND ADMINISTRATION

 Recommended Dose: 250 mg orally, twice daily.  

 Renal Impairment: 250 mg orally, once daily in patients with severe renal impairment (creatinine clearance <30 mL/min) not requiring dialysis. 

DOSAGE FORMS AND STRENGTHS 

Capsules: 250mg×60 capsules

CONTRAINDICATIONS 

None.

WARNINGS AND PRECAUTIONS 

 Hepatotoxicity: Fatal hepatotoxicity occurred in 0.1% of patients. Monitor with periodic liver testing. Temporarily suspend, dose reduce, or permanently discontinue LUCICRIZ.

 Interstitial Lung Disease (ILD)/Pneumonitis: Occurred in 2.9% of patients. Permanently discontinue in patients with ILD/pneumonitis.

 QT Interval Prolongation: Occurred in 2.1% of patients. Monitor electrocardiograms and electrolytes in patients who have a history of or predisposition for QTc prolongation, or who are taking medications that prolong QT. Temporarily suspend, dose reduce, or permanently discontinue LUCICRIZ. 

 Bradycardia: LUCICRIZ can cause bradycardia. Monitor heart rate and blood pressure regularly. Temporarily suspend, dose reduce, or permanently discontinue LUCICRIZ.

 Severe Visual Loss: Reported in 0.2% of patients. Discontinue LUCICRIZ in patients with severe visual loss. Perform an ophthalmological evaluation. 

 Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception.

ADVERSE REACTIONS 

The most common adverse reactions (≥25%) are vision disorders, nausea, diarrhea, vomiting, edema, constipation, elevated transaminases, fatigue, decreased appetite, upper respiratory infection, dizziness, and neuropathy.

DRUG INTERACTIONS 

 CYP3A Inhibitors: Avoid concurrent use of LUCICRIZ with strong CYP3A inhibitors. 

 CYP3A Inducers: Avoid concurrent use of LUCICRIZ with strong CYP3A inducers. 

 CYP3A Substrates: Avoid concurrent use of LUCICRIZ with CYP3A substrates with narrow therapeutic indices. 

USE IN SPECIFIC POPULATIONS 

Lactation: Do not breastfeed while taking LUCICRIZ.

Storage 

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