Ceritinib (Zykadia) is a targeted therapy developed by Novartis, specifically indicated for the treatment of non-small cell lung cancer (NSCLC) with specific genetic mutations. As a crucial anticancer medication, a comprehensive understanding of its indications, specifications, characteristics, and proper storage methods is essential to ensure therapeutic efficacy and medication safety.

What are the Indications for Ceritinib (Zykadia)?

Primary Treatment Population

Ceritinib is a kinase inhibitor primarily indicated for the treatment of metastatic non-small cell lung cancer (NSCLC) in adults.

Its indication is restricted to patients whose tumors are anaplastic lymphoma kinase (ALK)-positive.

This indication is based on rigorous clinical trial results, which confirmed its efficacy in the treatment of ALK-positive NSCLC.

Patient Selection Criteria

Prior to initiating ceritinib treatment for metastatic NSCLC, eligible patients must be selected based on the detection of ALK positivity in tumor specimens.

Testing must be performed using a U.S. FDA-approved detection method to ensure the precision of the treated population.

Specifications and Characteristics of Ceritinib (Zykadia)

Capsule Formulation

Ceritinib capsules are 150 mg hard gelatin capsules with opaque blue caps and opaque white bodies, containing a white to off-white powder.

The opaque blue cap is marked "LDK150MG" in black ink, and the opaque white body is marked "NVR" in black ink.

Tablet Formulation

Ceritinib tablets are 150 mg film-coated tablets, light blue, round, biconvex with beveled edges, and no score lines. One side is embossed with "NVR" and the other side with "ZY1".

The choice of formulation may be determined based on the patient's swallowing ability and personal preference.

Dosage Strength Explanation

Both the capsule and tablet formulations contain 150 mg of the active ingredient.

This standardized dosage design facilitates precise dose adjustments by physicians based on individual patient conditions.

Storage Methods for Ceritinib (Zykadia)

Temperature Requirements

Ceritinib should be stored at 20°C to 25°C (68°F to 77°F), with allowable fluctuations between 15°C and 30°C (59°F and 86°F).

Packaging Specifications

Ceritinib 150 mg capsules are supplied in bottles of 70 capsules, while 150 mg tablets are supplied in bottles of 84 tablets.

Proper storage not only ensures the medication's efficacy but also reduces the risk of drug deterioration caused by improper storage conditions.