Mekinist package insert pdf keyword after analyzing the system lists the list of keywords related and the list of websites with related content, in addition you can see which keywords most interested. Mekinist package insert pdf keyword after analyzing the system lists the list of keywords related and the list of websites with related content, in addition you can see which keywords most interested customers on the this website. To reduce the risk of graft rejection when used in conjunction with highdose busulfan and cyclophosphamide as a preparative regimen for. Vemurafenib inn, marketed as zelboraf is an inhibitor of the braf enzyme developed by plexxikon now part of daiichisankyo and genentech for the treatment of latestage melanoma. Vemurafenib is also being studied in the treatment of other types of cancer. Highlights of prescribing information perforation can occur. Refer to the trametinib prescribing information for.
Zelboraf is not indicated for treatment of patients with wildtype braf melanoma. The adverse event profile associated with vemurafenib therapy can present clinical challenges. Management strategies for recurrent pyrexia are also discussed in the csp. Effects of vemurafenib on drug metabolizing enzymes. The name vemurafenib comes from v 600 e mu tated b raf in h ib ition. Vemurafenib is a substrate and inhibitor of pglycoprotein pgp and breast cancer resistance protein bcrp. Zelboraf vemurafenib is indicated for the treatment of patients with erdheimchester disease ecd with braf v600 mutation.
Highlights of prescribing information tafinlar with. Zelboraf vemurafenib dosing, indications, interactions. Vemurafenib is a highly efficient braf inhibitor for metastatic melanoma patients carrying the v600 mutation. Before taking vemurafenib, patients must have braf v600 mutationpositive tumour status confirmed by a. Zelboraf is an orallyadministered drug to treat patients with latestage metastatic or unresectable. Zelboraf is indicated for the treatment of patients with unresectable or metastatic melanoma with braf v600e mutation as detected by an fdaapproved test. Vemurafenib is a moderate inhibitor of cyp1a2, and a weak inhibitor of 2d6 in vivo. Refer to the trametinib prescribing information for recommended trametinib dosing information. Based on mechanism of action, therapy can cause fetal harm when administered. Nov 05, 2019 cobimetinib is a fumarate salt appearing as white to offwhite solid and exhibits a ph dependent solubility. Highlights of prescribing information perforation can. Please refer to the full prescribing information of fulvestrant. Hepatotoxicity severe and sometimes fatal hepatotoxicity has occurred in clinical trials see warnings and precautions 5.
Highlights of prescribing information these highlights do not. Based on mechanism of action, therapy can cause fetal harm when administered to pregnant women. Zelboraf, innvemurafenib european medicines agency. Gemzar vials contain no antimicrobial preservatives and are intended for single use only. This product information was approved at the time this auspar was published. Vemurafenib is approved to treat patients whose disease has a certain mutation in the braf gene, including. Interrupt and then reduce or discontinue stivarga for hepatotoxicity as manifested by elevated liver. Vemurafenib zelboraf is a kinase inhibitor indicated for the treatment of patients with unresectable stage iiic or metastatic melanoma with braf v600e mutation as detected. Substances that are inducers of cyp3a4 activity may increase metabolism and decrease. In the event of toxicity, doses may be delayed, but all treatment must be administered within 16 weeks of the first dose see clinical studies 14. This product information was approved at the time this auspar.
Based on its mechanism of action, vemurafenib may promote growth and development of malignancies refer to the full prescribing information for vemurafenib. See full prescribing information for complete boxed. This leaflet is part iii of a threepart product monograph. Vemurafenib is the first fdaapproved braf inhibitor for the treatment of braf v600e mutationpositive advanced melanoma. Prior authorizationnotification zelboraf vemurafenib. The nccn compendium is a derivative work of the nccn guidelines. Managing side effects of vemurafenib therapy for advanced. Zelboraf prescribing information for important safety information. Zelboraf vemurafenib is a kinase inhibitor available as 240 mg tablets for oral use. Zelboraf is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with braf v600e mutation as detected by an fdaapproved test. Vemurafenib zelboraf is a kinase inhibitor indicated for the treatment of patients with unresectable stage iiic or metastatic melanoma with braf v600e mutation as detected by an fdaapproved test. Zelboraf fda prescribing information, side effects and uses.
Follow applicable special handling and disposal procedures. Read the medication guide provided by your pharmacist before you start taking vemurafenib and each time you get a refill. Click on the vemurafenib zelboraf package insert below for reported side effects and possible drug interactions. Highlights of prescribing information advanced renal cell. Effects of vemurafenib on drug metabolising enzymes. Monitor hepatic function prior to and during treatment see warnings and precautions 5. It has the molecular formula c 23 h 18 clf 2 n 3 o 3 s and a molecular weight of 489. Substances that are inducers of cyp3a4 activity may increase metabolism. Indications and usage tepadina is an alkylating drug indicated. In study 1, grade 3 peripheral neuropathy occurred in 8% 40503 of patients, and grade 4 in 0. Dacarbazine for injection is reconstituted and administered intravenously ph 34. Each vial contains 200 mg of dacarbazine the active ingredient, citric acid monohydrate and mannitol.
Mekinist package insert pdf keyword found websites listing. Side effect videos nausea and vomiting diarrhea hair loss fatigue pain see dailymed package insert. Vemurafenib has the chemical name propane1sulfonic acid 354chlorophenyl1hpyrrolo2,3bpyridine3carbonyl 2,4difluorophenylamide. Nov 01, 2014 vemurafenib is the first fdaapproved braf inhibitor for the treatment of braf v600e mutationpositive advanced melanoma. Due to browser popup and site security settings, the prescribing information pdf did not automatically load. Vemurafenib, approved for use in patients with braf v600epositive advanced melanoma, is poised to be the first genotypedriven medicine to reach the melanoma oncology clinics. Cobimetinib is a fumarate salt appearing as white to offwhite solid and exhibits a ph dependent solubility.
Vemurafenib selectively binds to the atpbinding site of brafv600e kinase and inhibits its activity, which may result in an inhibition of an overactivated mapk signaling pathway downstream in brafv600e kinaseexpressing tumor cells and a reduction. Vemurafenib selectively binds to the atpbinding site of. When given with ibrance, the recommended dose of fulvestrant is 500 mg administered on days 1, 15, 29, and once monthly thereafter. Currently available data are described in sections 4.
The recommended dose of yervoy ipilimumab is 3 mgkg administered intravenously iv over 90 minutes every 3 weeks for a maximum of 4 doses. Zelboraf is specifically indicated for the treatment of patients with melanoma whose tumors express a. Cotellic cobimetinib tablets are supplied as white, round, filmcoated 20 mg. Before taking zelboraf, patients must have braf v600 mutationpositive tumour status confirmed by a. Highlights of prescribing information these highlights do not include all the information needed to use tagrisso. Vemurafenib, the first agent to target mutated braf, is an option for the treatment of advanced or metastatic melanoma based on favorable results from the brim3 trial. Vemurafenib is an orally bioavailable, atpcompetitive, smallmolecule inhibitor of brafv600e kinase with potential antineoplastic activity.
Please refer to the full prescribing information for the aromatase inhibitor being used. Cotellic is not indicated for treatment of patients with wildtype braf melanoma. The adverse event profile associated with vemurafenib. Tepadina thiotepa for injection prescribing information. Review the full prescribing information for vemurafenib for recommended dose modifications. Zelboraf vemurafenib is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with braf v600e mutation as detected by an fdaapproved test. Product information for auspar zelboraf vemurafenib roche products pty ltd pm20110079534 final 17 december 2012. In the event of toxicity, doses may be delayed, but. Compared to either drug alone, coadministration of cobimetinib and vemurafenib resulted in increased apoptosis. Please click here to view the full prescribing information. Standard commercial pa guidelines kaiser permanente. These highlights do not include all the information needed to use. Before starting vemurafenib, a dermatologic evaluation, baseline monitoring of ecg, electrolytes, liver enzymes, and bilirubin should.
When given with ibrance, the recommended dose of fulvestrant is 500 mg administered on days 1, 15, 29, and once. The safety and efficacy of vemurafenib in children less than 18 years old have not been established. Effect of strong cyp3a4 inhibitors or inducers on vemurafenib 7. There are no available data on the use of vemurafenib in pregnant women to determine the drugassociated risk. The fda has subsequently approved two additional agents that target braf mutated disease. Zelboraf is not indicated for use in patients with wildtype braf melanoma. Compared to either drug alone, coadministration of cobimetinib and vemurafenib resulted in increased apoptosis in 12 vitro and reduced tumor growth in mouse implantation models of tumor cell lines harboring braf v600e mutations. Cotellic is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with a braf v600e or v600k mutation, in combination with vemurafenib.
Side effect videos nausea and vomiting diarrhea hair loss fatigue pain see dailymed. Library commercial nsa yes yes no part d effective. Dacarbazine is an anticancer agent designated chemically. Cotellic cobimetinib tablets are supplied as white, round, filmcoated 20 mg tablets for oral administration, debossed on one side with cob.
Melanoma that cannot be removed by surgery or has metastasized spread to other parts of the body. Dacarbazine for injection is a colorless to an ivory colored solid which is light sensitive. Please refer to the package insert of the cobas 4800. Call your doctor for medical advice about side effects. The safety and efficacy of vemurafenib has not been established in noncaucasian patients. Jul 01, 2015 vemurafenib, the first agent to target mutated braf, is an option for the treatment of advanced or metastatic melanoma based on favorable results from the brim3 trial. In trial 1, the incidence of grade 34 hemorrhages was 1. Hemorrhage, including major hemorrhages defined as symptomatic bleeding in a critical area or organ, can occur with cotellic.
Cobimetinib and vemurafenib target two different kinases in the rasrafmekerk pathway. Cobimetinib cotellic cobimetinib is a tablet available in a 20 mg strength only. These are not all the possible side effects of braftovi and mektovi. Please see both accompanying full cotellic prescribing information and full. Tagrisso osimertinib tablets, for oral use initial u. If your healthcare provider prescribes zelboraf vemurafenib, also read the medication guide that comes with zelboraf.
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