Zykadia

Anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).

Adult 450 mg once daily at the same time each day. Max: 450 mg daily.

Should be taken with food: Take at the same time every day. Swallow whole, do not chew/crush.

Hypersensitivity.

Hepatotoxicity; interstitial lung disease (ILD)/pneumonitis; QT interval prolongation; asymptomatic cases of bradycardia; GI adverse reactions; hyperglycaemia; elevations of lipase &/or amylase. Monitor liver function prior to start of treatment, every 2 wk during the 1st 3 mth of treatment & mthly thereafter. Monitor for pulmonary symptoms indicative of ILD/pneumonitis. Severe renal impairment. Moderate to severe hepatic impairment. Minor influence on the ability to drive or use machines. Women of childbearing potential. Pregnancy & lactation. Childn ≤18 yr.

Anaemia; decreased appetite; diarrhoea, nausea, vomiting, abdominal pain; rash; fatigue; liver laboratory test abnormalities, wt decreased, blood creatinine increased.

Increased plasma conc w/ strong CYP3A inhibitors (eg, ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole & nefazodone) or P-gp inhibitors. Decreased plasma conc w/ strong CYP3A inducers (eg, carbamazepine, phenobarb, phenytoin, rifabutin, rifampicin & St. John's wort) or P-gp inducers. Altered solubility & reduced bioavailability w/ acid reducing agents (eg, proton pump inhibitors, H₂-receptor antagonists, antacids). Inhibited metabolism of midazolam (CYP3A4 substrate) & diclofenac (CYP2C9 substrate). Avoid co-administration w/ CYP3A substrates known to have narrow therapeutic indices (eg, astemizole, cisapride, ciclosporin, ergotamine, fentanyl, pimozide, quinidine, tacrolimus, alfentanil & sirolimus) & CYP2C9 substrates known to have narrow therapeutic indices (eg, phenytoin & warfarin). Increased plasma conc of CYP2A6 & CYP2E1 substrates; BCRP substrates (eg, rosuvastatin, topotecan, sulfasalazine); P-gp substrates (eg, digoxin, dabigatran, colchicine, pravastatin). Reduced effectiveness of OCs. Increased risk of QT prolongation w/ anti-arrhythmics eg, class I or III anti-arrhythmics, or other medicinal products that may lead to QT prolongation eg, astemizole, domperidone, droperidol, choloroquine, halofantrine, clarithromycin, haloperidol, methadone, cisapride, moxifloxacin. Increased bioavailability w/ food; grapefruit & grapefruit juice. Avoid co-administration w/ agents known to cause bradycardia eg, β-blockers, non-dihydropyridine Ca channel blockers, clonidine & digoxin.

Targeted Cancer Therapy

L01ED02 - ceritinib ; Belongs to the class of anaplastic lymphoma kinase (ALK) inhibitors. Used in the treatment of cancer.

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