Each red, round nexavar filmcoated tablet contains sorafenib tosylate 274 mg equivalent to 200 mg of sorafenib and the following inactive ingredients. Dosage is typically half of that applied for malignant cancers 400 mg vs 800 mg. The role of sorafenib in the treatment of advanced. Sorafenib is designed to block tumor cell growth in several ways. Nexavar sorafenib side effects, images, uses, dosage. Nexavar tablets are round, biconvex, red filmcoated tablets, debossed with the bayer cross on one side and 200 on the other side. See full prescribing information for complete boxed warning. Sorafenib is used to treat liver cancer, thyroid cancer, or a type of kidney cancer called. The recommended daily dose of sorafenib is 400 mg 2 x 200 mg tablets taken twice daily without food at least 1 hour before or 2 hours after a meal. Nexavar is increased, the patient should be monitored carefully for toxicity see drug interactions 7.
Tell your healthcare provider about all the medicines you take, including prescription and overthecounter medicines, vitamins, and herbal supplements. If youre looking to insert the contents of your pdf file into an office file, as opposed to simply inserting the pdf as an attachment, then your best bet is to open that pdf with word 20 or 2016. Get sorafenib tablets at best price with product specifications. How sorafenib works, side effects, interactions and. Hcc, multikinase inhibitor, advanced stage, sorafenib. Highlights of prescribing information these highlights. Find patient medical information for sorafenib oral on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Sorafenib, a multikinase inhibitor, is approved for the treatment of advanced renal cell carcinoma andor hepatocellular carcinoma in more than 80 countries. Antineoplastic pregnancy risk category d action decreases tumor cell proliferation in vitro and inhibits tumor growth of murine renal cell carcinoma. Sorafenib side effects, dosage, interactions drugs. Niosh list of antineoplastic and other hazardous drugs in healthcare settings, 2016. Sorafenib tosylate inhibits both wildtype and v599e mutant braf activity with ic50 of 22 nm and 38 nm, respectively. The following conditions are contraindicated with this drug. It interferes with the growth of cancer cells, which are eventually destroyed by the body.
Check with your physician if you have any of the following. In addition to the drug costs of folfox4 and sorafenib therapy. Niosh list of antineoplastic and other hazardous drugs in. Word will convert the pdf to editable text and you can then copy and paste that text into your office document. Several of these targets are thought to be involved in angiogenesis making of blood vessels. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. 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. See full prescribing information for complete boxed. In other words, folfox4 was both cheaper and more effective than the alternative. Do not breastfeed during treatment with nexavar and for 2 weeks after receiving the last dose of nexavar.
Tablets containing sorafenib tosylate 274 mg equivalent to 200 mg of sorafenib. Sorafenib is a multitargeted potent antiangiogenic tyrosine kinase inhibitor. Nexavar is an anticancer medicine used to treat a certain type of liver, kidney, or thyroid cancer called. Extreme high moderate low section 1 chemical product and company identification product name sorafenib tosylate statement of hazardous nature considered a hazardous substance according to osha 29 cfr 1910. Nexavar is indicated for the treatment of patients with advanced renal cell carcinoma rcc. Dose increase or reduction is recommended based on individual safety and tolerability. Sorafenib is a kinase inhibitor drug approved for the treatment of primary kidney cancer. Sorafenib tosylate weakly inhibits fgfr1 with ic50 of 580 nm. Continue treatment until disease progression or unacceptable toxicity. Sorafenib targets several enzymes on the surface of cancer cells, as well as targets within the cell. Sorafenib definition of sorafenib by medical dictionary. The recommended dose of nexavar in adults is 400 mg sorafenib two tablets of 200 mg twice daily equivalent to a total daily dose of 800 mg. Sorafenib codeveloped and comarketed by bayer and onyx pharmaceuticals as nexavar, is a kinase inhibitor drug approved for the treatment of primary kidney cancer advanced renal cell carcinoma, advanced primary liver cancer hepatocellular carcinoma, flt3itd positive aml and radioactive iodine resistant advanced thyroid carcinoma. Sorafenib caused embryofetal toxicities in animals at maternal exposures that were significantly lower than the human exposures at the recommended dose of 400 mg twice daily.
Phase ii study of sorafenib in patients with advanced hepatocellular carcinoma article pdf available in journal of clinical oncology 2426. Sorafenibinduced hepatitis is characterized by a hepatocellular pattern of liver damage with significant increases of transaminases which may result in hepatic failure and death. 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. Omics international is a scientific organization that drives the progress of research through open access journals and organizes international conferences sorafenib. Data sources include ibm watson micromedex updated 10 apr 2020, cerner multum updated 6 apr 2020. Estimated api price per kg in usd for sorafenib obtained from the import, export data from major ports of india pharmacompass api reference price for sorafenib determined using sample data obtained from indian trade importexport. This document has been prepared in accordance with standards for workplace safety, which. Population pharmacokinetic analysis of sorafenib in. Learn about nexavar sorafenib, including how it is thought to work, treatment options, and financial support. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. 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. If you get pregnant while taking sorafenib or within 6 months after your last dose, call your doctor right away. Tace with or without sorafenib in intermediate stage hepatocellular carcinoma the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Sorafenib tosylate is a white to yellowish or brownish solid with a molecular formula of c 21 h 16 clf 3 n 4 o 3 x c 7 h 8 o 3 s and a molecular weight of 637.
The most common 10% nonhematologic adverse drug reactions were rash, pruritis, headache, nausea, fatigue, alopecia, myalgia, and upper abdominal pain. Sorafenib in dtc monograph addendum updated version may be found at. What are the possible side effects of sorafenib nexavar. Liver cancer is the fifth most common cancer in the world. The recommended daily dose of nexavar is 400 mg 2 x 200 mg tablets taken twice daily without food at least 1 hour before or 2 hours after a meal. Sorafenib tablets, sorafenib tablets manufacturers. Sorafenib is approved for the treatment of patients with advanced renal cancer and unresectable hepatocellular carcinoma hcc. Background and aim a large number of studies have tried to combine sorafenib with tace for patients with unresectable hepatocellular carcinoma hcc and the results were controversial. Nexavar definition of nexavar by medical dictionary.
Dpi drug package insert epa environmental protection agency. Combination therapy of sorafenib and tace for unresectable. The sorafenibassociated handfoot syndrome is characterized by symmetric. Full text sorafenib in advanced hepatocellular carcinoma. Sorafenib is taken without food, 1 hour before or 2 hours after a meal. Sorafenib is a potent inhibitor of wildtype braf, oncogenic brafv6600e, craf and proangiogenic receptor tyrosine kinases namely vegfr1, 2, 3, pdgfr. On the other hand, sorafenib administered at a standard dose of 400 mg twice daily was well tolerated for a patient undergoing hd, with drug plasma. In fact, his words were misquoted and the context was omitted. Costeffectiveness analysis of folfox4 and sorafenib for the treatment of.
Use birth control that you can trust to prevent pregnancy while taking sorafenib and for 6 months after stopping sorafenib. Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity occurs. For more information, go to edit pdf content in word. Sorafenibasssociated handfoot syndrome treated with topical. Sorafenib is a cancer medication that interferes with the growth and spread of cancer cells in the body. Blood glucose levels in diabetic patients should be checked regularly in order to assess if antidiabetic medicinal products dosage needs to be adjusted. Hypertensive crisis was reported in 2359 patients sorafenib. By connor th, mackenzie ba, debord dg, trout db, ocallaghan jp. Its approval was based on the results of the pivotal sharp and sorafenib asiapacific ap trials in childpugh cp class a patients with advanced hcc, which showed significantly longer median overall survival os and time to radiological progression ttp with. Listing a study does not mean it has been evaluated by the u. Interrupt nexavar if qtc interval is greater than 500 milliseconds or for an increase from baseline of 60 milliseconds or greater. Precautions and warnings with sorafenib prior to starting treatment with sorafenib, your healthcare provider needs to know if you have a history of problems with your liver, kidneys, or heart.
Sorafenib is also used to treat hepatocellular carcinoma a type of liver cancer that cannot be treated with surgery and a certain type of thyroid cancer that has spread to other parts of the body and cannot be treated with radioactive iodine. Sorafenib is used to treat latestage kidney cancer advanced renal cell carcinoma, liver cancer hepatocellular carcinoma that cannot be treated by surgery, and differentiated thyroid cancer that has come back or spread to other parts of your body. Tace with or without sorafenib in intermediate stage. Pdf pharmacokinetics of sorafenib in patients with renal. Other precautions for safely using sorafenib include warnings of. Costeffectiveness analysis of folfox4 and sorafenib for the. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment.
Sorafenib is used to treat advanced renal cell carcinoma rcc. Sorafenib tosylate is practically insoluble in aqueous media, slightly soluble in ethanol and soluble in peg 400 each red, round nexavar filmcoated tablet contains sorafenib tosylate 274 mg equivalent to 200 mg of. Hepatocellular carcinoma hcc, a type of liver cancer, when it cannot be treated with surgery renal cell carcinoma rcc, a type of kidney cancer. Grade 34 hypertension was observed in 56359 patients 16% receiving inlyta and 39355 patients 11% receiving sorafenib. Azacitidine is designed to slow the production of leukemia cells and help the bone marrow produce more healthy and normal functioning cells. Nexavar sorafenib dosing, indications, interactions. Sorafenib tosylate also potently inhibits mvegfr2 flk1, mvegfr3, mpdgfr. Get emergency medical help if you have signs of an allergic reaction hives, difficult breathing, swelling in your face or throat or a severe skin reaction fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling.