Based on its mechanism of action, vemurafenib may promote growth and development of malignancies refer to the full prescribing information for vemurafenib. Vemurafenib is a low molecular weight, orally available inhibitor of some mutated forms of braf serinethreonine kinase, including braf v600e. Add a pdf to your office file office support microsoft office support. Etest strips must be kept dry with active desiccant. Do not use the etest gradient strips if the package has been damaged.
Leave vemurafenib in the provided packaging until it is ready to be taken. Vemurafenib is a cyp3a4 substrate and cyp1a2 inhibitor avoid coadministration of vemurafenib with strong cyp3a4 inhibitors eg, ketoconazole, itraconazole, clarithromycin, saquinavir, ritonavir, indinavir, nelfinavir, voriconazole and replace and use alternative drugs when possible. Vemurafenib is used to treat a type of skin cancer melanoma. Interrupt and then reduce or discontinue stivarga for hepatotoxicity as manifested by elevated liver. A onepage pdf is relatively simple to insert while the process for inserting. Monitor hepatic function prior to and during treatment see warnings and precautions 5. Vemurafenib is an orally bioavailable, atpcompetitive, smallmolecule inhibitor of brafv600e kinase with potential antineoplastic activity. Push the blue plastic cannula of the mix2vial firmly through the rubber stopper of the diluent vial fig. Feb 28, 2020 there are many drugs that interact with vemurafenib, like certain drugs that are used for hiv, infections, or seizures. Zelboraf vemurafenib dosing, indications, interactions. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. The log of the distribution coefficient octanolwater at ph 7 is 5. Jul 01, 2015 melanoma is a lifethreatening form of skin cancer that occurs due to genetic and environmental factors. The incidence of syncopal episodes is approximately 1% in patients.
Vemurafenib in chinese patients with brafv600 mutation. Exposure to ultraviolet radiation and sun sensitivity are additional risk factors for the disease. Use di water to dilute 5% to 7% sodium hypochlorite solution. Zelboraf vemurafenib is a kinase inhibitor available as 240 mg tablets for oral use. Preservcyt solution liquid pap specimens processed using the. It belongs to a class of drugs known as kinase inhibitors. If you only have the free reader, you can subscribe to the pdf pack service to combine files or download a 30day trial of acrobat xi pro. Melanoma is a rare, deadly disease without effective treatment options in china. Highlights of prescribing information tafinlar with. General information about the safe and effective use of trikafta. Other dermatological adverse effects include alopecia, eruptive nevi, and photosensitivity. Keep trikafta and all medicines out of the reach of children.
In patients with the mutation, vemurafenib is remarkably active compared with dacarbazine. How to insert a pdf file into another pdf file using. A second cohort of up to 50 similar patients already responding or stable with vemurafenib therapy will also be accrued. Effect of strong cyp3a4 inhibitors or inducers on vemurafenib 7. Vemurafenib zelboraf is a targeted therapy for advanced melanoma with certain genetic mutations to slow the growth and spread of cancer cells. Vemurafenib ro5185426, plx4032, zelboraf agent description. Vemurafenib is a selective inhibitor of oncogenic brafv600 kinase approved in more than 90 countries, based on results obtained primarily in caucasian patients. Yervoy ipilimumab can result in severe and fatal immunemediated adverse reactions. You might have it as a treatment for melanoma skin cancer that. 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. The fda has subsequently approved two additional agents that target braf mutated disease. If a family member, friend, or caregiver needs to give vemurafenib to you, they also need to follow these steps. A multicenter study of high dose aldesleukin proleukin.
Integra meshed bilayer wound matrix package insert. Start with nexavar sorafenib as a foundation for a systemic treatment plan 15. Facebook allows its members to attach and upload pdf files. This package insert is intended for the eye care professional, but should be made available to patients upon request. Latest approval of opdivo marks the fourth indication for the immunooncology treatment offering hope for improved survival to more patients. Vemurafenib provides a muchneeded treatment option for patients with metastatic melanoma with a braf v600e mutation.
Handling before using the etest gradient strips from an unopened package, visually inspect to ensure the package is intact. Examples of affected drugs include caffeine, warfarin, among others. Zelboraf is a prescription medicine used to treat a type of blood cell cancer called erdheimchester disease ecd, that can affect body tissues and organs, and that has a certain type of abnormal braf gene. Vemurafenib is a highly efficient braf inhibitor for metastatic melanoma patients carrying the v600 mutation. Cobimetinib cotellic cobimetinib is a tablet available in a 20 mg strength only. Vemurafenib in chinese patients with braf v600 mutation. Emcyt capsules are white and opaque, each containing estramustine phosphate sodium as the disodium salt monohydrate equivalent to 140 mg estramustine phosphate, for oral administration. It is not known if zelboraf is safe and effective in children under 18 years of age. Vemurafenib works by slowing the growth of certain cancer cells. As for all medicines, data on the use of zelboraf are continuously monitored. In the current study, patients could have been treatmentnaive or have previously received systemic therapy.
Highlights of prescribing information these highlights do. Based on mechanism of action, therapy can cause fetal harm when administered to pregnant women. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for decadron dexamethasone. If youre looking to insert the contents of your pdf file into an office.
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. Click on the vemurafenib zelboraf package insert below for reported side effects and possible drug interactions. When inserting pages, you can choose whether to insert an entire document or just. It has the molecular formula c 23 h 18 clf 2 n 3 o 3 s and a molecular weight of 489. Do not use trikafta after the expiration date on the package.
It is also used to treat a rare type of blood cell cancer called erdheimchester disease. For current full prescribing information, please visit revised. Melanoma that cannot be removed by surgery or has metastasized spread to other parts of the body. Vemurafenib is approved to treat patients whose disease has a certain mutation in the braf gene, including. Prevent moisture from penetrating into or forming within the package or storage container. Severe and sometimes fatal hepatotoxicity has occurred in clinical trials. Whenever possible, give vemurafenib to yourself and follow the steps below. These immunemediated reactions may involve any organ system. 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. Gloves are not necessary if you give the drug to yourself. Recommended dosage of harvoni in pediatric patients 3 years of is based on weight. Side effect videos nausea and vomiting diarrhea hair loss fatigue pain see dailymed package insert. Combining multiple documents into a single pdf file. Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet.
Visit to see full safety and prescribing information, including boxed warning. Vemurafenib has the chemical name propane1sulfonic acid 354chlorophenyl1hpyrrolo2,3bpyridine3carbonyl 2,4difluorophenylamide. Integra meshed bilayer wound matrix package insert instructions for use integra meshed bilayer wound matrix without negative pressure therapy application 1. The eye care professional should provide the patient with the appropriate instructions that pertain to the patients prescribed lenses. One tablet 90 mg of ledipasvir and 400 mg of sofosbuvir taken orally once daily with or without food. Vemurafenib is a medicine that targets proteins in cancer cells and stops the cancer cells from growing. See full prescribing information for complete boxed. The related drug information index provides comprehensive access to all drug information related to a specific drug types of content include full prescribing information, drug summaries, full prescribing information continuing medication education full pi cme, medication guides, risk evaluation and mitigation strategies rems summaries, rems continuing medication education rems cme, and. There are no available data on the use of vemurafenib in pregnant women to determine the drugassociated risk.
Vemurafenib zelboraf cancer information cancer research uk. Nitro pro enables you to combine pages from multiple pdfs into a single file. By continuing to browse this site you are agreeing to our use of cookies. Package insert materials not p rovided positive and n egative oral fluid controls timer precautions do not use the device after the expiration date printed on the pouch. Highlights of prescribing information perforation can. The preservcyt solution has been validated as an alternative medium for testing with the aptima ct assay. Keep vemurafenib out of reach of children and pets. Jan 10, 2018 if a family member, friend, or caregiver needs to give vemurafenib to you, they also need to follow these steps. The risk factors most associated with malignant melanoma include a family history of melanoma, atypical moles, and previous melanoma. Hepatotoxicity severe and sometimes fatal hepatotoxicity has occurred in clinical trials see warnings and precautions 5. Vemurafenib is administered during the outpatient intervals between cycles of hd il2 and following completion. Vemurafenib is a kinase inhibitor available as 240 mg tablets for oral use. These cancer cells have a certain type of abnormal braf gene.
It is used to treat melanoma, a type of skin cancer, and erdheimchester disease. See full prescribing information for complete boxed warning. Patient information is perforated for dispensing to the. The solubility of sunitinib malate in aqueous media over the range ph 1. Combine or merge files into a single pdf, adobe acrobat dc. While holding onto the diluent vial, carefully remove the outer package from the mix2vial, being careful to leave the mix2vial attached firmly to the diluent vial fig. Product information for auspar zelboraf vemurafenib roche products pty ltd pm20110079534 final 17 december 2012. Using aseptic technique, peel open the outer pouch and gently drop the inner foil pouch onto a sterile field or surface. Vemurafenib zelboraf vemurafenib is a type of targeted cancer drug called a cancer growth blocker. 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. 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. Cobimetinib and vemurafenib target two different kinases in the rasrafmekerk pathway. This is not a list of all drugs or health problems that interact with vemurafenib.
The name vemurafenib comes from v 600 e mu tated b raf in h ib ition. Vemurafenib is also being studied in the treatment of other types of cancer. Side effects reported with zelboraf are carefully evaluated and any necessary action taken to protect patients. Mar 24, 2020 nexavar is a kinase inhibitor indicated for the treatment of. This product information was approved at the time this auspar was published. I wish to import a pdf file to accompany my post in facebook. May 14, 2019 sunitinib malate is a yellow to orange powder with a pka of 8. Add files directly to your pdf or link to files on the web. Please read all of this leaflet carefully before you start using this medicine because it contains important information for you. Zelboraf fda prescribing information, side effects and uses.
Youll need to have adobe acrobat or abode reader installed to see or read pdf files. Tablets are supplied in packages containing three bottles, with each bottle containing 28 tablets, for a total of 84 tablets per package ndc 5041917103. Oraltox should remain in the sealed pouch until ready for use. Zelboraf is not used to treat melanoma with a normal braf gene. Braftovi encorafenib capsules, for oral use initial u.
Information below provided by the pharmaceutical company. Data sources include ibm watson micromedex updated 10 apr 2020, cerner multum updated 6 apr 2020. Limited data are available regarding the efficacy and safety of vemurafenib in asian patients. Vemurafenib also inhibits other kinases in vitro such as craf, araf, wildtype braf, srms, ack1, map4k5, and fgr at similar concentrations. Dec 01, 2018 zelboraf is a prescription medicine used to treat. Emcyt estramustine phosphate sodium capsules description. Csl behring immune globulin intravenous human, 10%. Gently transfer the vemurafenib from its package to a small medicine or other. Six weeks of vemurafenib therapy per package insert precedes up to 2 courses of hd il2. The efficacy of vemurafenib in chinese patients with braf v600mutated unresectable or metastatic melanoma was similar to that observed in predominantly caucasian populations additional file 5. Health canada approves opdivo nivolumab for the treatment. A novel therapeutic combination approach for treating.
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