Drug Action
Ceritinib is a tyrosine kinase inhibitor, with particular activity against anaplastic lymphoma kinase (ALK).
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Drug reference
Ceritinib is a tyrosine kinase inhibitor, with particular activity against anaplastic lymphoma kinase (ALK).
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First-line treatment of anaplastic lymphoma kinase (ALK)- positive advanced non-small cell lung cancer (specialist use only) | Anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer previously treated with crizotinib (specialist use only) ▶BY MOUTH ▶Adult: 450 mg once daily, dose interruption, dose reduction or discontinuation may be required based on individual safety and tolerability—consult product literature; discontinue treatment if patient unable to tolerate at least 150 mg daily
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DUE TO INTERACTIONS ▶Manufacturer advises if concurrent use of potent inhibitors of CYP3A4 is unavoidable, reduce the dose by one-third (rounded to the nearest multiple of the 150 mg dosage form).
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Congenital long QT syndrome
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Diabetes mellitus. history or susceptibility to QT-interval prolongation CAUTIONS, FURTHER INFORMATION ▶QT-interval prolongation QT-interval prolongation has been observed in clinical studies, which may lead to an increased risk for ventricular tachyarrhythmias (e.g. torsade de pointes) or sudden death. Risk factors include pre-existing bradycardia, other relevant pre-existing cardiac disease or electrolyte disturbances; manufacturer advises to monitor ECG and electrolytes periodically.
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NICE decisions ▶Ceritinib for previously treated anaplastic lymphoma kinase- positive non-small cell lung cancer (June 2016) NICE TA395 Ceritinib (Zykadia ®) is recommended, within its marketing authorisation, as an option for treating advanced anaplastic lymphoma kinase-positive non-small cell lung cancer in adults previously treated with crizotinib; only if the manufacturer provides the discount agreed in the patient access scheme. www.nice.org.uk/guidance/ta395 ▶Ceritinib for untreated ALK-positive non-small cell lung cancer (January 2018) NICE TA500 Ceritinib (Zykadia ®) is recommended, within its marketing authorisation, as an option for untreated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer in adults, only if the manufacturer provides it with the discount agreed in the patient access scheme. www.nice.org.uk/guidance/ta500 Scottish Medicines Consortium (SMC) decisions SMC No. 1097/15 The Scottish Medicines Consortium has advised (December 2015) that ceritinib (Zykadia ®) is accepted for use within NHS Scotland for the treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer previously treated with crizotinib. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that Immune system and malignant disease is equivalent or lower.
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RISKS OF INCORRECT DOSING OF ORAL ANTI-CANCER MEDICINES See Cytotoxic drugs p. 938.
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→Appendix 1: ceritinib
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▶Common or very common Anaemia. appetite decreased. arrhythmias. asthenia. azotaemia. constipation. diarrhoea. dysphagia. gastrointestinal discomfort. gastrooesophageal reflux disease. hepatic disorders. hyperbilirubinaemia. hyperglycaemia. hypophosphataemia. nausea. oesophageal disorder. pericardial effusion. pericarditis. QT interval prolongation . renal impairment. respiratory disorders. skin reactions. vision disorders. vitreous floater. vomiting. weight decreased ▶Uncommon Pancreatitis SIDE-EFFECTS, FURTHER INFORMATION Gastro-intestinal effects Manufacturer advises monitor for signs of gastro- intestinal toxicity and consider dose reduction or discontinuation of treatment. Interstitial lung disease Manufacturer advises monitor patients who exhibit pulmonary symptoms and consider dose reduction or discontinuation of treatment.
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Manufacturer recommends effective contraception in women of childbearing potential during treatment and for up to 3 months after discontinuation of treatment.
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Manufacturer advises avoid unless essential—no information available. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Manufacturer advises avoid—no information available.
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Manufacturer advises caution in severe impairment (limited information available). Dose adjustments Manufacturer advises reduce dose by approx. 33% in severe impairment (round to the nearest multiple of the 150 mg dosage strength).
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Manufacturer advises caution in severe impairment—no information available.
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▶Manufacturer advises monitor fasting plasma-glucose concentration, amylase and lipase levels before treatment initiation and periodically thereafter as clinically indicated. ▶Manufacturer advises measure baseline liver function, then monitor every 2 weeks for the first three months of treatment and monthly thereafter; if transaminases are elevated, more frequent monitoring should be performed as clinically indicated. ▶Manufacturer advises monitor for pulmonary symptoms indicative of interstitial lung disease and pneumonitis— discontinue treatment if diagnosis confirmed; also monitor heart rate and blood pressure regularly.
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Manufacturer advises Zykadia ® capsules should be taken with food at the same time each day—consult product literature for dosing information if patients are unable to take capsules with food.
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There can be variation in the licensing of different medicines containing the same drug. Capsule CAUTIONARY AND ADVISORY LABELS 21, 25 EXCIPIENTS: May contain Gelatin, propylene glycol ▶Zykadia (Novartis Pharmaceuticals UK Ltd) A Ceritinib 150 mg Zykadia 150mg capsules | 150 capsule P £4,923.45
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Patients and carers should be counselled on the administration of capsules. Missed doses If a dose is more than 12 hours late, the missed dose should not be taken and the next dose should be taken at the normal time. Driving and skilled tasks Manufacturer advises patients and their carers should be counselled on the effects on driving and skilled tasks—increased risk of fatigue and vision disorders.
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450 mg once daily, dose interruption, dose
First-line fragment. Read the complete Indications and Dose section above.
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