Spexib

Ceritinib (Zangada) Instructions

Common name: Ceritinib

Trade name: spexib

All names: Ceritinib, Zangada, Ceritinib, Ceritinib, Ceritinib, LDK378, Zykadia, spexib

Indications and uses of ceritinib

ZYKADIA is a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed or are intolerant to crizotinib.

Ceritinib Dosage and Administration

750 mg orally once daily. Give ZYKADIA on an empty stomach (i.e. do not give it within 2 hours after a meal).

Ceritinib dosage forms and specifications

Capsules: 150 mg

Ceritinib Contraindications

None

Ceritinib Warnings and Precautions

1. Severe and persistent gastrointestinal toxicity: The dose was adjusted in 38% of patients due to the occurrence of diarrhea, nausea, vomiting or abdominal pain. If there is no response to antiemetics or antidiarrheals, withhold administration, then reduce ZYKADIA dose.

2. Hepatotoxicity: ZYKADIA may cause hepatotoxicity. Monitor liver laboratory tests at least monthly. Withhold and then reduce dose, or permanently discontinue ZYKADIA.

3. Interstitial lung disease (ILD)/pneumonia: occurs in 4% of patients. Permanently discontinue ZYKADIA in patients diagnosed with treatment-related ILD/pneumonitis.

4. QT interval prolongation: ZYKADIA may cause QTc interval prolongation. Monitor ECG and electrolytes in patients with congestive heart failure, bradyarrhythmias, electrolyte abnormalities, or in patients taking medications known to prolong the QTc interval. Withhold and then reduce dose, or permanently discontinue ZYKADIA.

5. Hyperglycemia: ZYKADIA may cause hyperglycemia. Monitor glucose and initiate or optimize antihyperglycemic medications as indicated. Withhold and then reduce dose, or permanently discontinue ZYKADIA.

6. Bradycardia: ZYKADIA may cause bradycardia. Monitor heart rate and blood pressure regularly. Withhold and then reduce dose, or permanently discontinue ZYKADIA.

7. Embryo-fetal toxicity: ZYKADIA may cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus.

Adverse reactions of ceritinib

The most common adverse reactions (incidence of at least 25%) are diarrhea, nausea, elevated transaminases, vomiting, abdominal pain, fatigue, loss of appetite and constipation.

Celitinib drug interactions

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

2. CYP3A and CYP2C9 substrates: Avoid concurrent use of ZYKADIA with CYP3A or CYP2C9 substrates that have narrow therapeutic indexes.