LuciCriz

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.