Ceritinib INN

Ceritinib INN 150 mg Capsule

Composition: Each capsule contains Ceritinib INN 150 mg.

Indications: Cerinib is indicated for the treatment of 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: Patient Selection: Patients should be selected for treatment of metastatic NSCLC with Cerinib based on the presence of ALK positivity in tumor specimens. The recommended dose of Cerinib is 450 mg orally once daily with food until disease progression or unacceptable toxicity. If a dose of Cerinib is missed, that dose should be made up unless the next dose is due within 12 hours. If vomiting occurs during the course of treatment, an additional dose should not be administered and the next scheduled dose of Cerinib should be continued. Or, as directed by the registered physician.

Use in Pregnancy and Lactation: Cerinib can cause fetal harm when administered to a pregnant woman. If it is used during pregnancy or if the patient becomes pregnant while taking it, the patient should be apprised of the potential hazard to the fetus. Lactation: There are no data regarding the presence of Ceritinib or its metabolites in human milk, the effects of Ceritinib on the breastfed infant, or its effects on milk production. Because of the potential for serious adverse reactions including gastrointestinal adverse reactions,
hepatotoxicity, pneumonitis, bradycardia and pancreatitis, a woman should be advised not to breastfeed during treatment with Cerinib and for 2 weeks following completion of therapy.

Packing: Each box contains 30 capsules in blister pack.

Prescribing Description

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