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At a glance

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.

Indications
  • ALK-positive metastatic non-small cell lung cancer (NSCLC)
Pharmacology

Ceritinib is a kinase inhibitor. Targets of Ceritinib inhibition identified in either biochemical or cellular assays at clinically relevant concentrations include ALK, insulin-like growth factor 1 receptor (IGF-1R), insulin receptor (InsR), and ROS1. Among these, Ceritinib is most active against ALK. Ceritinib inhibited autophosphorylation of ALK, ALK-mediated phosphorylation of the downstream signaling protein STAT3, and proliferation of ALK dependent cancer cells in in vitro and in vivo assays.

Dosage

Recommended Dose: 450 mg orally once daily with food until disease progression or unacceptable toxicity.

Hepatic Dose: Severe hepatic impairment (Child-Pugh C): Reduce dose by approximately one-third, rounded to the nearest multiple of the 150 mg dosage strength. No dose adjustment is recommended in patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment.

Side effects

Common Side Effects (≥10%):

  • Diarrhea
  • Nausea
  • Vomiting
  • Abdominal pain
  • Elevated liver enzymes (ALT/AST)
  • Hyperglycemia
  • Bradycardia
  • Pancreatitis

Serious Side Effects: Interstitial Lung Disease/Pneumonitis, QT Prolongation, Hepatotoxicity.

Use in pregnancy

Ceritinib can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Females of reproductive potential should use effective contraception during treatment and for 6 months following completion of therapy.

Pregnancy Category: D — always consult a doctor before taking during pregnancy.

Precautions & warnings
  • Gastrointestinal Reactions: Monitor and manage diarrhea, nausea, vomiting, or abdominal pain with standard care.
  • Hepatotoxicity: Monitor liver function tests (ALT, AST, total bilirubin) once a month and as clinically indicated.
  • Interstitial Lung Disease/Pneumonitis: Monitor for pulmonary symptoms.
  • QT Prolongation: Avoid in congenital long QT syndrome; monitor with ECGs and electrolytes.
  • Hyperglycemia: Monitor fasting serum glucose.
  • Bradycardia: Regularly monitor heart rate and blood pressure.
  • Pancreatitis: Monitor lipase and amylase.
  • Embryo-Fetal Toxicity: Can cause fetal harm; advise effective contraception.
Overdose effects

Information on Ceritinib overdosage is not available. In case of overdose, general supportive measures should be instituted.

Storage conditions

Store below 30°C in a cool and dry place, away from sunlight. Keep out of reach of children.

Ceritinib — see the full informationPharmacology, precautions, pregnancy, overdose and the rest on the generic page
⚠️ This information is for educational purposes only — not a substitute for medical advice. Consult a registered physician before taking any medicine.