Jakafi is indicated for treatment of intermediate or highrisk myelofibrosis mf, including primary mf, postpolycythemia vera mf and postessential thrombocythemia mf in adults. Highlights of prescribing information patients at risk of. Mar 24, 2020 each red, round nexavar filmcoated tablet contains sorafenib tosylate 274 mg equivalent to 200 mg of sorafenib and the following inactive ingredients. Highlights of prescribing information these highlights do not include all the information needed to use tarceva safely and effectively. Learn about nexavar sorafenib, including how it is thought to work, treatment options, and financial support. Dose increase or reduction is recommended based on individual safety and tolerability. Sorafenib in combination with gemcitabine and cisplatin not recommended in patients with squamous cell lung cancer 1. Afinitor is a prescription medicine used to treat adults with a type of cancer known as neuroendocrine tumor net of the stomach and intestine gastrointestinal or lung that has progressed and cannot be treated with surgery. The following package inserts, as listed above, are approved by the relevant health authorities.
Highlights of prescribing information tafinlar with. Sorafenib for the treatment of advanced renal cell carcinoma. Management of suspected adverse drug reactions may require temporary. Major avoid coadministration of sorafenib with rifabutin due to decreased plasma concentrations of sorafenib.
Highlights of prescribing information these highlights do not include all the information needed to use tasignasafely and effectively. 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. Pdf molecular mechanisms of sorafenib action in liver cancer cells. Download leaflet view the patient leaflet in pdf format. Cytarabine injection, an antineoplastic, is a sterile solution of cytarabine for intravenous and subcutaneous use which contains no preservative and is available in 20 mgml mg50 ml pharmacy bulk package. Highlights of prescribing information these highlights do not include all the information needed to use sutent safely and effectively. Sorafenib remains a viable therapeutic option for patients with advanced hepatocellular carcinoma but may present some risks for a veteran population. Sorafenib is a multikinase inhibitor that decreases tumour cell proliferation in vitro. Refer to the prescribing information for paclitaxel for dosage information. Mar 06, 2019 sorafenib is available only with your doctors prescription. Read all of this leaflet carefully before you start taking this medicine. Sorafenib does not appear to affect gemcitabine pharmacokinetics 24 28. Full prescribing information about the drug is available at high interpatient.
Sorafenib and sunitinib are potent inhibitors of multiple protein kinase targets involved in tumor cell proliferation and angiogenesis. Use sorafenib with caution in patients who have, or may develop prolongation of qtc, such as patients with a congenital long qt syndrome, patients tr eated. The in vitro screening assay included the mutated oncogenic form of braf. Get emergency help right away if you get symptoms such as chest pain, shortness of breath, racing heartbeat, swelling in lower legs, feet and abdomen, feel lightheaded or faint. Get emergency help right away if you get symptoms such as chest pain, shortness of breath, racing heartbeat, swelling in lower legs, feet and abdomen, feel lightheaded or faint, tiredness, nausea, vomiting, or sweat a lot. Interrupt nexavar if qtc interval is greater than 500 milliseconds or for an increase from baseline of 60 milliseconds or greater. Evaluating sorafenib in veterans with advanced hepatocellular carcinoma avaho. Do not take nexavar if you have a specifi c type of lung cancer squamous cell and receive carboplatin and paclitaxel or if you are allergic to sorafenib or any of the other ingredients in nexavar. Official site for healthcare professionals nexavar sorafenib. Highlights of prescribing information recurrent or.
Nexavar sorafenib dosing, indications, interactions. Sorafenib was initially identified as an inhibitor of raf serinethreonine kinase isoforms, which are in the ras signaling pathway. See full prescribing information for complete boxed warning. Severe and sometimes fatal hepatotoxicity has occurred in clinical trials. Continue treatment until disease progression or unacceptable toxicity. Evaluating sorafenib in veterans with advanced hepatocellular. Owing to recent failures of clinical trials undertaken. The printed package leaflet of the medicinal product must state the name and. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Tablets containing sorafenib tosylate 274 mg equivalent to 200 mg of sorafenib. Sorafenib has also been associated with qt prolongation. Nexavar tablets are round, biconvex, red filmcoated tablets, debossed with the bayer cross on.
Bayer response nexavar stn 21923012 14 oct 11 3 nexavar tablets are round, biconvex, red filmcoated tablets, debossed with the bayer cross on one side and. Nexavar sorafenib dose, indications, adverse effects. Use for treatment in members who have symptomatic anemia with serum erythropoietin sorafenib in 2008 for the treatment of unresectable hcc. Nexavar is a kinase inhibitor indicated for the treatment of. Pdf sorafenib in the treatment of advanced hepatocellular. Highlights of prescribing information these highlights do not include all the information needed to use ofev safely and effectively. Refer to everolimus prescribing information for recommended everolimus dosing information. Sorafenib in dtc monograph addendum updated version may be found at. Sorafenib is a kinase inhibitor drug approved for the treatment of primary kidney cancer. Before starting nexavar, tell your doctor if you have. Concomitant use may increase the risk for qt prolongation. Hepatotoxicity see full prescribing information for complete boxed warning. Table 2 lists the recommended dosage reductions of.
Sorafenib induced hepatitis is characterized by a hepatocellular pattern of liver damage with significant increases of transaminases which may result in hepatic failure and death. Sorafenib has been shown to prolong the qtqtc interval see section 5. Pdf sorafenib, a multikinase inhibitor, recently received fda approval for the treatment of. In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. Prnexavar sorafenib tablets tablet, 200 mg sorafenib as. The dose modification rule for sorafenib as listed in the package insert requests treatment interruption upon grade. The study found that median survival and timetodiseaseprogression were nearly 3 months longer for patients treated with sorafenib nexavar than for patients who took placebo. Presently, sorafenib is the sole drug that has been approved for firstline treatment of hcc 114 115 116. Highlights of prescribing information these highlights. The recommended dose of nexavar in adults is 400 mg sorafenib two tablets of 200.
Sorafenib is a cyp3a4 substrate and rifabutin is a cyp3a4 inducer. Every effort is made to ensure that these are regularly updated. Tasigna nilotinib capsules, for oral use initial u. See full prescribing information for complete boxed. Refer to the pembrolizumab prescribing information for recommended pembrolizumab dosing information. Nexavar is indicated for the treatment of patients with.