It is used to treat adults with advanced stages of a form of lung cancer called nonsmall. Zykadia should be discontinued in patients unable to tolerate 150 mg daily. If your healthcare provider prescribes zelboraf vemurafenib, also read the medication guide that comes with zelboraf. The printed package leaflet of the medicinal product must state the name and address of the. For treatment as monotherapy in patients with anaplastic lymphoma kinase alkpositive locally advanced not amenable to curative therapy or metastatic nonsmall cell lung cancer nsclc who have progressed on or who were intolerant to crizotinib. In the pnet study, 183 patients 1% receiving sutent had grade 3 epistaxis, and no patients had other grade 3 or 4 bleeding events. The indications below including fdaapproved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
Zykadia ceritinib capsules prescribing information. Highlights of prescribing information these highlights do not include all the information needed to use zykadia safely and effectively. Treatment should continue until disease progression or unacceptable toxicity occurs. Over the course of treatment, patients who tolerate inlyta for at least two consecutive weeks with no adverse reactions grade 2 according to the common toxicity criteria for adverse events ctcae, are normotensive, and are not receiving antihypertension medication, may. Ceritinib causes concentrationdependent prolongation of the qt interval. Zykadia is a prescription medicine that is used to treat people with nonsmall cell lung cancer nsclc that. Highlights of prescribing information these highlights do not include all the information needed to use sutent safely and effectively. Characteristics smpc for the other product must be consulted for the. In patients who develop an acute onset of new or progressive pulmonary symptoms, such as dyspnea, cough or fever, treatment wit h tarceva should be. Highlights of prescribing information interstitial lung.
Risks from concomitant use with opioids concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma. Page 6 of 37 haemorrhage throughout the iressa lung cancer clinical trials, the incidence of haemoptysispulmonary. Refer to the obinutuzumab prescribing information for recommended obinutuzumab dosing information. Our accredited programs assist in meeting the requirements of licensure. Zykadia ceritinib capsules, for oral use initial u. It is used to treat adults with advanced stages of a form of lung cancer called non small.
If concomitant use cannot be avoided, reduce daily dosage of ceritinib by approximately 33% and round to the nearest 150mg strength e. Hepatotoxicity see full prescribing information for complete boxed warning. Ceritinib gained us food and drug administration approval in 2014 following accelerated. What is the role of ceritinib zykadia in the treatment. Program prior authorization zykadia ceritinib change control date change 92014 new policy 92015 updated diagnosis verbiage and formatting from diagnosis of metastatic non. Refer to everolimus prescribing information for recommended everolimus dosing information.
Patients treated with ceritinib were allowed a maximum of three dose reductions 150 mg per reduction, to a lowest dose of 300 mgday. Highlights of prescribing information these highlights do not include all the information needed to use tagrisso. Dabrafenibtrametinib ntrk gene fusion positive tumors. Dose increase or reduction is recommended based on individual safety and tolerability. If dose reduction is required due to an adverse drug reaction adr not listed in table 1, then this should be achieved by decrements of 150 mg daily. Highlights of prescribing information hyperlipidemia. Xalkori is indicated for the treatment of patients with metastatic nonsmall cell lung cancer nsclc whose tumors are anaplastic lymphoma kinase alk or ros1positive as detected by an fdaapproved test. Zykadia ceritinib is a kinase inhibitor indicated for the treatment of patients with.
Zykadia ceritinib capsules, for oral use pancreatitis. Zykadia for nonsmall cell lung cancer resubmission. The time to response is similar among the agents and range between 1. For patients treated with chemotherapy, dose reductions followed package insert or local guidelines. Recommended dosage the recommended dosage of lorbrena is 100 mg orally once daily, with or without food, until disease progression or unacceptable toxicity see clinical pharmacology 12. Although incidence rates have been declining, largely due to smoking cessation efforts, lung cancer remains the leading cause of cancerrelated deaths. If vomiting occurs during the course of treatment, do not administer an additional dose and continue with the next scheduled dose of zykadia 1. Zykadia is a cancer medicine that contains the active substance ceritinib. Tagrisso is indicated for the treatment of patients with metastatic egfr t790m mutationpositive nsclc, as detected by an fdaapproved test, whose disease has progressed on or after egfr tyrosine kinase inhibitor tki therapy.
Refer to an fdaapproved test s package insert for instructions on the identification of patients eligible for treatment with xalkori. When ceritinib is coadministered with other medicinal products, the summary of product characteristics smpc for the other product must be consulted for the recommendations regarding coadministration with cyp3a4 inhibitors. Ventana alk d5f3 cdx assay is intended for the qualitative detection of the anaplastic lymphoma kinase alk protein in formalinfixed, paraffinembedded ffpe nonsmall cell lung carcinoma nsclc tissue stained with a benchmark xt. Zykadia ceritinib approved for patients with crizotinibresistant. However, ceritinib was shown to provide clinical benefit in those whose disease progressed on crizotinib, leading to the fda approval of ceritinib for. If nefazodone is discontinued, resume ceritinib at the dosage used prior to initiation of nefazodone 1. Indications the indications below including fdaapproved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy. Ceritinib and alectinib are exclusively excreted in the feces. Cotellic is a prescription medicine that is used with the medicine zelboraf, to treat a. Do not ingest if tablets are broken, cracked, or otherwise not intact. In animal studies, administration of ceritinib to rats and rabbits during organogenesis at maternal plasma exposures below the recommended human dose caused increases in skeletal anomalies in rats and rabbits. Major when possible, avoid concurrent use of foscarnet with other drugs known to prolong the qt interval, such as escitalopram.
Zykadia ceritinib is a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase alkpositive metastatic nonsmall cell lung cancer. Alectinib for advanced alkpositive nonsmallcell lung. Introducing new recommended dose for zykadia ceritinib. Postgraduate healthcare education, llc phe is the source of powerpak c. Ceritinib is twenty times more potent at inhibiting alk than crizotinib. On cycle 1 day 22, start venclexta according to the 5week rampup schedule see table 1. Highlights of prescribing information these highlights do not include all the information needed to use alecensa safely and effectively.
Cancers of the lungs and bronchus constitute the second most common type of cancer in the united states, with 222,500 cases predicted in 2017. A second alk tyrosine kinase inhibitor, ceritinib zykadia, gained accelerated approval from the fda in 2014 for patients with alkpositive metastatic nsclc whose disease had progressed or. So far, the month of march has yielded two new approvals by the fda. Highlights of prescribing information these highlights. Based on its mechanism of action and findings in animal studies, zykadia can cause fetal harm when administered to a pregnant woman. Ventana alk d5f3 cdx assay is intended for the qualitative detection of the anaplastic lymphoma kinase alk protein in formalinfixed, paraffinembedded ffpe non. Alecensa alectinib package insert, san francisco, ca. Zykadia ceritinib dosing, indications, interactions. Jakafi is indicated for treatment of intermediate or highrisk myelofibrosis mf, including primary mf, postpolycythemia vera mf and postessential thrombocythemia mf in adults.
Oncology pharmacy consults targeted therapies in nonsmall. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for tikosyn dofetilide. Please see complete prescribing information including patient information. Highlights of prescribing information patients at risk. Gilotrif is indicated for the firstline treatment of patients with metastatic nonsmall cell lung cancer. Xalkori can cause fetal harm when administered to a pregnant woman based on its mechanism of action. Development history and fda approval process for zykadia. Anafranil clomipramine hydrochloride capsules, usp. It is not known if lorbrena is safe and effective in children. History and development of zykadia ceritinib 1994 researchers identify anaplastic lymphoma kinase alk. Diazepam injection, usp concomitant use of barbiturates.
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