Ceritinib capsules LuciCer 150mg

Product Name: LuciCer

Chinese Name: Ceritinib Capsules

English Name: Ceritinib Capsules

Specification: 150 mg/capsule; 50 capsules/box.

[Indications]

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

[Dosage and Administration]

Recommended Dosage: 450 mg orally once daily, taken with food.

[Contraindications] None.

[Warnings and Precautions]

Gastrointestinal Adverse Reactions: LuciCer can cause gastrointestinal adverse events. If severe or intolerable, and unresponsive to antiemetics or antidiarrheals, withhold treatment; upon improvement, resume LuciCer at a reduced dose.

Hepatotoxicity: LuciCer can cause hepatotoxicity. Monitor liver laboratory parameters at least monthly. Withhold, reduce dose, or permanently discontinue LuciCer for severe hepatotoxicity.

Interstitial Lung Disease (ILD)/Pneumonitis: Occurred in 2.4% of patients. Permanently discontinue LuciCer in patients diagnosed with treatment-related ILD/pneumonitis.

QT Interval Prolongation: LuciCer can cause QTc interval prolongation. Monitor ECGs and electrolytes in patients with congestive heart failure, bradyarrhythmias, electrolyte abnormalities, or those taking drugs known to prolong the QTc interval. Withhold, reduce dose, or permanently discontinue LuciCer.

Hyperglycemia: LuciCer can cause hyperglycemia. Monitor fasting glucose prior to and periodically during treatment. Initiate or optimize anti-hyperglycemic medications as indicated. Withhold, reduce dose, or permanently discontinue LuciCer as appropriate.

Bradycardia: LuciCer can cause bradycardia. Monitor heart rate and blood pressure periodically. Withhold, reduce dose, or permanently discontinue LuciCer as appropriate.

Pancreatitis: Elevations in lipase and/or amylase and pancreatitis may occur. Monitor lipase and amylase levels prior to treatment; monitor periodically after treatment as clinically indicated. Consider suspending use or reducing the dosage of LuciCer.

Embryo-Fetal Toxicity: LuciCer can cause fetal harm. Females of reproductive potential are advised of the potential risk to the fetus and should use effective contraception.

[Adverse Reactions]

The most common adverse reactions (incidence ≥25%) in patients taking 450 mg of LuciCer with food were diarrhea, nausea, abdominal pain, vomiting, and fatigue; taking 750 mg of LuciCer under fasting conditions resulted in 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 with a strong CYP3A inhibitor is unavoidable, reduce the dosage of LuciCer.

CYP3A Substrates: Avoid concomitant use of LuciCer with sensitive CYP3A substrates.

CYP2C9 Substrates: Avoid concomitant use of LuciCer with CYP2C9 substrates, as small changes in concentration may lead to serious toxicity.

[Use in Specific Populations]

Lactation: Breastfeeding is not recommended.

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

[Storage]

Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Protect from moisture.