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COMPOSITION ERiNLAR (ceritinib) hard gelatin capsules contain Ceritinib INN 150 mg. PHARMACEUTICAL DOSAGE FORM AND STRENGTHS ERiNLAR (Ceritinib) is presented as 150 mg hard gelatin capsule for oral administration. THERAPEUTIC INDICATIONS ERiNLAR (ceritinib) 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 The recommended dose of ERiNLAR (ceritinib) is 450 mg orally once daily with food until disease progression or unacceptable toxicity If a dose of ERiNLAR (ceritinib) is missed, make up that dose unless the next dose is due within 12 hours. If vomiting occurs during the course of treatment, do not administer an additional dose and continue with the next scheduled dose of ERiNLAR (ceritinib). Dose Modifications for Adverse Reactions Recommendations for dose modifications of ERiNLAR (ceritinib) for adverse reactions are provided in table 2. Discontinue ERiNLAR (ceritinib) for patients unable to tolerate 150 mg daily with food. Dose Modification for Strong CYP3A Inhibitors Avoid concurrent use of strong CYP3A inhibitors during treatment with ERiNLAR (ceritinib) Dose Modification for Patients with Severe Hepatic Impairment For patients with severe hepatic impairment (Child-Pugh C), reduce the dose of ERiNLAR (ceritinib). ADVERSE REACTIONS
  • Gastrointestinal Adverse Reactions

  • Hepatotoxicity

  • Interstitial Lung Disease/Pneumonitis

  • QT Interval Prolongation

  • Hyperglycemia

  • Bradycardia

  • Pancreatitis

USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary: Based on animal studies and its mechanism of action, ERiNLAR (ceritinib) can cause fetal harm when administered to a pregnant woman. Lactation Risk Summary: 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, advise a woman not to breastfeed during treatment with ERiNLAR (ceritinib) and for 2 weeks following completion of therapy. Females and Males of Reproductive Potential Contraception Females ERiNLAR (ceritinib) can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with ceritinib and for 6 months following completion of therapy. Males Based on the potential for genotoxicity, advise males with female partners of reproductive potential to use condoms during treatment with ERiNLAR (ceritinib) and for 3 months following completion of therapy. Pediatric Use The safety and effectiveness of ERiNLAR (ceritinib) in pediatric patients have not been established. Geriatric Use No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Hepatic Impairment No dose adjustment is recommended in patients with mild (Child-Pugh A) or moderate (Child- Pugh B) hepatic impairment (see dosage and administration). PHARMACEUTICAL INFORMATIONS Storage condition Store below 30°C, store in a cool & dry place. Keep away from light. Keep out of the reach of children. HOW SUPPLIED ERiNLAR: Each commercial box contains 7×4’s capsules in alu-alu blister