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. MedsAcross supplies Ceritinib for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
ZYKADIA ® is 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. ZYKADIA is a kinase inhibitor indicated for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
Source: US FDA prescribing information
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. Ceritinib inhibited the in vitro proliferation of cell lines expressing EML4-ALK and NPM-ALK fusion proteins and demonstrated dose-dependent inhibition of EML4-ALK-positive NSCLC xenograft growth in mice and rats.
Source: US FDA prescribing information
Recommended Dosage: 450 mg orally once daily with food. Patient Selection Select patients for treatment of metastatic NSCLC with ZYKADIA based on the presence of ALK positivity in tumor specimens. Information on FDA-approved tests for the detection of ALK rearrangements in NSCLC is available at: http://www.fda.gov/CompanionDiagnostics. 2. 2 Recommended Dosage The recommended dosage of ZYKADIA is 450 mg orally once daily with food until disease progression or unacceptable toxicity. If a dose of ZYKADIA is missed, make up that dose unless the next dose is due within 12 hours.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
Gastrointestinal Adverse Reactions: ZYKADIA can cause gastrointestinal adverse reactions. If severe or intolerable, withhold if not responsive to antiemetics or antidiarrheals, upon improvement, resume ZYKADIA at a reduced dose. Hepatotoxicity: ZYKADIA can cause hepatotoxicity. Monitor liver laboratory tests at least monthly. Withhold then dose reduce, or permanently discontinue ZYKADIA. Interstitial Lung Disease/Pneumonitis: Occurred in 2.4% of patients. Permanently discontinue ZYKADIA in patients diagnosed with treatment-related interstitial lung disease (ILD)/pneumonitis. QT Interval Prolongation: ZYKADIA can cause QTc interval prolongation. Monitor electrocardiograms and electrolytes in patients with congestive heart failure, bradyarrhythmias, electrolyte abnormalities, or those who are taking medications that are known to prolong the QTc interval.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling: Gastrointestinal Adverse Reactions Hepatotoxicity Interstitial Lung Disease/Pneumonitis QT Interval Prolongation Hyperglycemia Bradycardia Pancreatitis The most common adverse reactions (incidence of ≥ 25%) in patients treated with ZYKADIA 450 mg with food are diarrhea, nausea, abdominal pain, vomiting, and fatigue, and with ZYKADIA 750 mg under fasted conditions are diarrhea, nausea, vomiting, fatigue, abdominal pain, decreased appetite, and weight loss.
Source: US FDA prescribing information
CYP3A Inhibitors and Inducers: Avoid concurrent use of ZYKADIA with strong CYP3A inhibitors or inducers. If concurrent use of a strong CYP3A inhibitor is unavoidable, dose reduce ZYKADIA. CYP3A Substrates: Avoid coadministration of ZYKADIA with sensitive CYP3A substrates. CYP2C9 Substrates: Avoid coadministration of ZYKADIA with CYP2C9 substrates for which minimal concentration changes may lead to serious toxicities.
Source: US FDA prescribing information
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F). Available in: Bottles of 84 tablets…………………………………………………………………………………NDC 0078-0694-84 Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Ceritinib, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Zykadia 150 mg tabletOral | Novartis Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Ceritinib in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 1 presentations of Ceritinib and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Ceritinib, including Zykadia.
Yes. The US FDA first approved Ceritinib on 29 April 2014, according to Drugs@FDA.
Yes. Ceritinib has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Ceritinib is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Ceritinib is classified under ATC code L01XE28 (Ceritinib).
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