Zykadia

Zykadia

ceritinib

Manufacturer:

Novartis

Distributor:

DKSH
Concise Prescribing Info
Contents
Ceritinib
Indications/Uses
Monotherapy for 1st-line treatment of adults w/ anaplastic lymphoma kinase (ALK) +ve advanced NSCLC. Monotherapy for adults w/ ALK +ve advanced NSCLC previously treated w/ crizotinib.
Dosage/Direction for Use
Administration
Should be taken with food.
Special Precautions
Discontinue use if diagnosed w/ treatment-related ILD/pneumonitis. Avoid use in patients w/ congenital long QT syndrome. Monitor & manage patients using standard of care for severe GI reactions. Monitor liver lab tests including ALT, AST & total bilirubin once mthly & as clinically indicated. Periodically monitor ECGs & electrolytes in patients w/ CHF, bradyarrhythmias, electrolyte abnormalities or taking medications prolonging QTc interval. Monitor fasting serum glucose, lipase & amylase prior to & periodically thereafter. Regularly monitor heart rate & BP. Avoid use in combination w/ other products causing bradycardia eg, β-blockers, non-dihydropyridine Ca-channel blockers, clonidine, digoxin. Hepatotoxicity; severe hepatic & renal impairment. Women of childbearing potential should use effective contraception during & for 6 mth after therapy. Males should use effective contraception during & for 3 mth after therapy. Pregnancy. Not to be used during lactation & for 2 wk after therapy. Ped patients.
Adverse Reactions
Diarrhea, nausea, vomiting, abdominal pain, constipation, esophageal disorder; fatigue, non-cardiac chest, back & musculoskeletal pain, pyrexia, pain in extremity, pruritus; decreased appetite, wt loss; cough, ILD/pneumonitis; headache, dizziness; prolonged QT interval, pericarditis; rash; increased ALT, AST, GGT, alkaline phosphatase, creatinine, amylase & lipase; hyperglycemia, hyperbilirubinemia, hypophosphatemia; anemia, neutropenia, thrombocytopenia.
Drug Interactions
Increased systemic exposure w/ strong CYP3A4/P-gp inhibitor eg, ketoconazole; grapefruit, grapefruit juice. Decreased systemic exposure w/ strong CYP3A4/P-gp inducer eg, rifampicin. Increased systemic exposure of sensitive CYP3A (eg, midazolam) & CYP2C9 (eg, warfarin) substrates. Avoid co-administration w/ drugs causing bradycardia & QT interval prolongation.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01ED02 - ceritinib ; Belongs to the class of anaplastic lymphoma kinase (ALK) inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Zykadia cap 150 mg
Packing/Price
150's;50's
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