Zykadia® 150 mg hard capsules
Each hard capsule contains 150 mg ceritinib.
For the full list of excipients, see section 6.1.
Hard capsule.
Capsule with white opaque body and blue opaque cap, with “LDK 150MG” imprinted on the cap and “NVR” on the body, containing white to almost white powder.
Zykadia is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.
Treatment with Zykadia should be initiated and supervised by a physician experienced in the use of anti-cancer medicinal products.
ALK testing
An accurate and validated ALK assay is necessary for the selection of ALK-positive NSCLC patients (see section 5.1).
ALK-positive NSCLC status should be established prior to initiation of Zykadia therapy. Assessment for ALK-positive NSCLC should be performed by laboratories with demonstrated proficiency in the specific technology being utilised.
Posology
The recommended dose of Zykadia is 750 mg taken orally once daily at the same time each day.
The maximum recommended dose is 750 mg daily. Treatment should continue as long as clinical benefit is observed.
If a dose is missed, the patient should make up that dose, unless the next dose is due within 12 hours.
Zykadia should be discontinued in patients unable to tolerate 300 mg daily.
Dose adjustment due to adverse reactions
Temporary dose interruption and/or dose reduction of Zykadia m
