Zykadia

Zykadia Dosage/Direction for Use

ceritinib

Manufacturer:

Novartis

Distributor:

DKSH
Full Prescribing Info
Dosage/Direction for Use
Patient Selection: Select patients for treatment of metastatic NSCLC with ZYKADIA based on the presence of ALK positivity in tumor specimens [see Pharmacology: Pharmacodynamics: Clinical Studies: Previously Untreated ALK-Positive Metastatic NSCLC under Actions].
Recommended Dosage: The recommended dosage of ZYKADIA is 450 mg orally once daily with food until disease progression or unacceptable toxicity [see Pharmacology: Pharmacokinetics under Actions].
If a dose of ZYKADIA is missed, make up that dose unless the next dose is due within 12 hours.
If vomiting occurs during the course of treatment, do not administer an additional dose and continue with the next scheduled dose of ZYKADIA.
Dosage Modifications for Adverse Reactions: (see Table 4.)

Click on icon to see table/diagram/image

Discontinue ZYKADIA for patients unable to tolerate 150 mg taken orally once daily with food.
Dosage modifications for selected adverse reactions of ZYKADIA are provided in Table 5. If dose reduction is required due to an adverse reaction not listed in Table 5, then reduce the daily dose of ZYKADIA by 150 mg. (See Table 5.)

Click on icon to see table/diagram/image

Dosage Modification for Strong CYP3A Inhibitors: Avoid concurrent use of strong CYP3A inhibitors during treatment with ZYKADIA [see Effect of Other Drugs on ZYKADIA under Interactions, Pharmacology: Pharmacokinetics under Actions].
If concurrent use of a strong CYP3A inhibitor is unavoidable, reduce the ZYKADIA dose by approximately one-third, rounded to the nearest multiple of the 150 mg dosage strength. After discontinuation of a strong CYP3A inhibitor, resume the ZYKADIA dose that was taken prior to initiating the strong CYP3A inhibitor.
Dosage Modification for Patients With Severe Hepatic Impairment: For patients with severe hepatic impairment (Child-Pugh C), reduce the ZYKADIA dose by approximately one-third, rounded to the nearest multiple of the 150 mg dosage strength [see Hepatic Impairment under Precautions, Pharmacology: Pharmacokinetics under Actions].
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