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