Ceritinib is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) that is positive for anaplastic lymphoma kinase (ALK) as detected by an FDA-approved test.

Ceritinib Capsules (LuciCer) Simple Instructions

Please use under the guidance of a physician

Product Name: LuciCer

Manufacturer: Lucius Pharmaceuticals (Laos) Co., Ltd.

Chinese name: Ceritinib capsules

English name: Ceritinib capsules

Drug approval number: 06 L 1126/24

【Indications】

LuciCer is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive as approved by the FDA.

【Usage and Dosage】

Recommended dose: 450 mg orally once daily with meals.

【Specification】

150mg/pill, 50 pills/box.

【Contraindications】

none

【Warnings and precautions】

 Gastrointestinal adverse reactions: LuciCer can cause gastrointestinal adverse events. If severe or intolerable and unresponsive to antiemetics or antidiarrheals, discontinue use; after improvement, resume LuciCer at a reduced dose.

 Hepatotoxicity: LuciCer can cause hepatotoxicity. Monitor liver laboratory parameters at least monthly. If severe hepatotoxicity occurs, suspend use, reduce the dose, or permanently discontinue LuciCer.

 Interstitial Lung Disease/Pneumonitis: Occurred in 2.4% of patients. Permanently discontinue LuciCer in patients diagnosed with relevant interstitial lung disease (ILD)/pneumonitis.

 QT Interval Prolongation: LuciCer may cause QTc interval prolongation. Monitor ECG and electrolytes in patients with congestive heart failure, bradyarrhythmias, electrolyte abnormalities, or those taking medications known to prolong the QTc interval. Interrupt, reduce dose, or permanently discontinue LuciCer. 

Hyperglycemia: LuciCer can cause hyperglycemia. Monitor fasting blood glucose regularly before and after treatment. Initiate or optimize antihyperglycemic medications as directed. Suspend, reduce dose, or permanently discontinue LuciCer as appropriate.

 Bradycardia: LuciCer can cause bradycardia. Monitor heart rate and blood pressure regularly. Suspend use, reduce dosage, or permanently discontinue LuciCer as appropriate.

 Pancreatitis: Elevated lipase and/or amylase and pancreatitis may occur. Monitor lipase and amylase before treatment and periodically after treatment as clinically necessary. Decision to suspend or reduce LuciCer dose may be made.

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

【Adverse Reactions】

The most common adverse reactions (incidence ≥ 25%) in patients taking 450 mg LuciCer with food were diarrhea, nausea, abdominal pain, vomiting, and fatigue; taking 750 mg LuciCer under fasting conditions caused diarrhea, nausea, vomiting, fatigue, abdominal pain, decreased appetite, and weight loss.

【Drug Interactions】

CYP3A Inhibitors and Inducers: Avoid concomitant use of LuciCer with strong CYP3A inhibitors or inducers. If concomitant use of a strong CYP3A inhibitor is unavoidable, reduce the dose of LuciCer

CYP3A Substrates: Avoid co-administration of LuciCer with sensitive CYP3A substrates.

CYP2C9 Substrates: Avoid co-administration of LuciCer with CYP2C9 substrates as small changes in concentration may result in significant toxicity.

【Use by specific groups】

Lactation: Breastfeeding is not recommended.

Severe Hepatic Impairment: Reduce the dose of LuciCer in patients with severe hepatic impairment (Child-Pugh C).

【Storage】

Storage temperature is 20℃ to 25℃ (68℉ to 77℉), short-distance transportation is allowed between 15℃ to 30℃ (59℉ to 86℉). Protect from moisture.