Lucius Version of Ceritinib: Dosage and Administration, Indications, Precautions

Lucius Version of Ceritinib: Dosage and Administration, Indications, Precautions

Indications

Ceritinib 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 dose: 450 mg orally once daily, taken with meals.

Use in Specific Populations

Lactation: Breastfeeding is not recommended.

Severe Hepatic Impairment: For patients with severe hepatic impairment (Child-Pugh Class C), reduce the dose of LuciCer.

Drug Interactions

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

CYP3A and CYP2C9 Substrates: Avoid concomitant use of ZYKADIA with CYP3A or CYP2C9 substrates that have a narrow therapeutic index.

Warnings and Precautions

Gastrointestinal Adverse ReactionsCeritinib can cause gastrointestinal adverse events. If severe or intolerable and unresponsive to antiemetics or antidiarrheals, hold treatment; upon improvement, resume ceritinib at a reduced dose.

HepatotoxicityCeritinib can cause hepatotoxicity. Monitor liver laboratory parameters at least once monthly. In case of severe hepatotoxicity, hold, reduce the dose of, or permanently discontinue ceritinib.

Interstitial Lung Disease (ILD)/PneumonitisILD/pneumonitis occurs in 2.4% of patients. Permanently discontinue ceritinib in patients diagnosed with treatment-related ILD/pneumonitis.

QT Interval ProlongationCeritinib can prolong the QTc interval. Monitor electrocardiograms and electrolytes in patients with congestive heart failure, bradyarrhythmias, electrolyte abnormalities, or those taking drugs known to prolong the QTc interval. Hold, reduce the dose of, or permanently discontinue LuciCer as appropriate.

HyperglycemiaCeritinib can cause hyperglycemia. Monitor fasting blood glucose before and periodically during treatment. Initiate or optimize antihyperglycemic medications as indicated. Hold, reduce the dose of, or permanently discontinue ceritinib based on clinical conditions.

BradycardiaCeritinib can cause bradycardia. Monitor heart rate and blood pressure regularly. Hold, reduce the dose of, or permanently discontinue ceritinib as needed.

PancreatitisElevations in lipase and/or amylase and pancreatitis may occur. Monitor lipase and amylase before treatment and periodically during treatment as clinically indicated. Hold or reduce the dose of ceritinib accordingly.

Embryo-Fetal ToxicityCeritinib 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 ceritinib with food are diarrhea, nausea, abdominal pain, vomiting, and fatigue; in patients taking 750 mg ceritinib under fasting conditions, the adverse reactions include diarrhea, nausea, vomiting, fatigue, abdominal pain, decreased appetite, and weight loss.

Contraindications

Not established.

Dosage Form

Tablets.

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) for short-distance transport.