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Dosage and Administration of Ceritinib

Updated: Feb 28, 2022



Ceritinib, a kinase inhibitor is approved and used to treat patients with a certain sort of late-stage (metastatic) NSCLC (non-small cell lung cancer), which is caused by a defect in a gene known as anaplastic lymphoma kinase (ALK). Ceritinib is a tyrosine kinase inhibitor (TKI) that inhibits proteins that promote the maturing of cancerous cells. Ceritinib is intended for patients with metastatic ALK-positive non-small cell lung cancer.


Dosage & Administration: The recommended dose of Ceritinib is 450 mg taken by mouth (orally) once a day with food at a persistent time every day. Food for patients while taking this medicine can range from a snack to a full meal. Carry on with ceritinib treatment as long as the patient is deriving most clinical benefit from therapy. The maximum recommended ceritinib dose is 450 mg taken by mouth once daily with food. The ceritinib dosage in the form of capsules of ceritinib should be swallowed whole with water. Dosage should not be chewed/crushed. In case any dose of ceritinib is missed, the patient should avoid taking the missed dose, but take the upcoming or next prescribed dose.


Dosage Adjustment: The temporary Ceritinib dose interruption and/or dose reduction may be needed based on individual safety as well as tolerability. If the reduction of doses is needed because of a disadvantageous drug reaction, then the daily dose of Ceritinib needs to be lower by lessening of 150 mg. Prior recognition and management of disadvantageous drug reactions with worthwhile supportive care measures need to be pondered. Therapy with Ceritinib should be suspended in patients unable to tolerate 150 mg administered daily with food.


During treatment with Ceritinib, the concurrent use of strong CYP3A inhibitors should be avoided. If concomitant administration of a strong CYP3A inhibitor is inevitable, lessen the Ceritinib dose by almost one-third, rounded to the nearest multiple of the Ceritinib 150 mg dosage strength. Patients should be deliberately observed for safety. In case long‐term concomitant treatment with a strong CYP3A inhibitor is inevitable and the patient tolerates the lessened dose efficiently, the dose may be increased anew with precise monitoring for safety, for avoiding potential under‐treatment. Following the suspension of a strong CYP3A inhibitor, recommence the Ceritinib dose that was administered before commencing the strong CYP3A inhibitor.


Presentation & Storage Conditions: The ceritinib 150 mg tablet hard capsules supplied under the brand name Zykadia, and Spexib in a few countries by Novartis, are opaque white and opaque blue capsules. The opaque blue cap is mainly marked with black ink “LDK 150MG” and the opaque white body is marked with black ink “NVR”. The capsule of ceritinib contains a white to whitish powder. The blister packaging of ceritinib is made from PCTFE/PVC backed with a heat-sealable lacquered aluminum foil. The single blister strip of Ceritinib contains ten hard capsules. And the multipacks contain 150 (3 packs of 50) hard capsules. Ceritinib 150 mg capsules should be stored below 30 °C. Store in the original container.

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