Generic name: CERITINIB 150mg
Dosage form: capsule
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2.1 Patient Selection
Select patients for treatment of metastatic NSCLC with ZYKADIA based on the presence of ALK positivity in tumor specimens [see Indications and Usage (1) and Clinical Studies (14.1)].
Information on FDA-approved tests for the detection of ALK rearrangements in NSCLC is available at: http://www.fda.gov/CompanionDiagnostics.
2.2 Dosing and Administration
The recommended dose of ZYKADIA is 750 mg orally once daily until disease progression or unacceptable toxicity. Take ZYKADIA at least 1 hour before or at least 2 hours after a meal [see Clinical Pharmacology (12.3)].
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.
2.3 Dose Modifications for Adverse Reactions
Recommendations for dose modifications of ZYKADIA for adverse reactions are provided in Table 2.
Discontinue ZYKADIA for patients unable to tolerate 300 mg daily.
|Dose Reduction Schedule||Dose Level|
|Starting dose||750 mg taken orally once daily|
|First dose reduction||600 mg taken orally once daily|
|Second dose reduction||450 mg taken orally once daily|
|Third dose reduction||300 mg taken orally once daily|
|Adverse Reaction||ZYKADIA Dose Modification|
|Gastrointestinal Adverse Reactions|
|Lipase or amylase elevation greater than 2 times ULN||Withhold and monitor serum lipase and amylase.
Resume ZYKADIA with a 150 mg dose reduction after recovery to less than 1.5 times ULN.
|Severe or intolerable nausea, vomiting or diarrhea despite optimal antiemetic or antidiarrheal therapy||Withhold until improved, then resume ZYKADIA with a 150 mg dose reduction.|
|Persistent hyperglycemia greater than 250 mg/dL despite optimal antihyperglycemic therapy||Withhold until hyperglycemia is adequately controlled, then resume ZYKADIA with a 150 mg dose reduction.
If adequate hyperglycemic control cannot be achieved with optimal medical management, discontinue ZYKADIA.
|Any Grade treatment-related ILD/pneumonitis||Permanently discontinue ZYKADIA.|
|QTc interval greater than 500 msec on at least 2 separate ECGs||Withhold until QTc interval is less than 481 msec or recovery to baseline if baseline QTc is greater than or equal to 481 msec, then resume ZYKADIA with a 150 mg dose reduction.|
|QTc interval prolongation in combination with torsades de pointes or polymorphic ventricular tachycardia or signs/symptoms of serious arrhythmia||Permanently discontinue ZYKADIA.|
|Symptomatic bradycardia that is not life-threatening||Withhold until recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above, evaluate concomitant medications known to cause bradycardia, and adjust the dose of ZYKADIA.|
|Clinically significant bradycardia requiring intervention or life-threatening bradycardia in patients taking a concomitant medication also known to cause bradycardia or a medication known to cause hypotension||Withhold until recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above.
If the concomitant medication can be adjusted or discontinued, resume ZYKADIA with a 150 mg dose reduction, with frequent monitoring.
|Life-threatening bradycardia in patients who are not taking a concomitant medication also known to cause bradycardia or known to cause hypotension||Permanently discontinue ZYKADIA.|
|ALT or AST elevation greater than 5 times ULN with total bilirubin elevation less than or equal to 2 times ULN||Withhold until recovery to baseline or less than or equal to 3 times ULN, then resume ZYKADIA with a 150 mg dose reduction.|
|ALT or AST elevation greater than 3 times ULN with total bilirubin elevation greater than 2 times ULN in the absence of cholestasis or hemolysis||Permanently discontinue ZYKADIA.|
|AST: aspartate aminotransferase; ALT: alanine aminotransferase; ULN: upper limit of normal; ILD: interstitial lung disease; ECG: electrocardiogram; bpm: beats per minute|
2.4 Dose Modification for Strong CYP3A4 Inhibitors
Avoid concurrent use of strong CYP3A inhibitors during treatment with ZYKADIA [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].
If concomitant 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 CYP3A4 inhibitor.
2.5 Dose Modification for Patients with Severe Hepatic Impairment
For patients with severe hepatic impairment (Child-Pugh C), reduce the dose of ZYKADIA by approximately one-third, rounded to the nearest multiple of the 150 mg dosage strength [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
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- Drug class: multikinase inhibitors