Trametinib dimethyl sulfoxide is a white to almost white powder. Vemurafenib zelboraf, dabrafenib tafinlar, and trametinib mekinist are. Cometriq is indicated for the treatment of patients with progressive, metastatic medullary. Central nervous system cns depression and abuse and misuse. Stivarga regorafenib is a prescription medicine used to treat people with. Care and management of unique toxicities associated with mapk pathwaytargeted therapies in patients with advanced melanoma. Mekinist as a single agent is indicated for the treatment of patients with unresectable or metastatic melanoma with braf v600e or v600k mutations, as detected by an fdaapproved. Product monograph for important warnings and precautions for dabrafenib in. Mekinist will be approved based on all of the following criteria. Specialty guideline management tafinlar dabrafenib policy. The thxidbraf kit is an in vitro diagnostic device intended for the qualitative detection of the braf v600e and v600k mutations in dna samples extracted from formalinfixed paraffinembedded ffpe human melanoma tissue. Mekinist is a medicine that contains the active substance trametinib. Tafinlar, in combination with mekinist, is indicated for the adjuvant treatment of patients with melanoma with braf v600e or v600k mutations, as detected by an fdaapproved test, and involvement of lymph node s, following complete resection. Tafinlar, when used in combination with mekinist, may cause a type of skin cancer called cutaneous squamous cell carcinoma, keratoacanthoma, basal cell carcinoma, or melanoma.
Mekinist is indicated, as a single agent or in combination with dabrafenib, for the treatment of patients with unresectable or metastatic melanoma with braf v600e or v600k mutations as detected by an fda approved test. Mekinist in combination with dabrafenib is not recommended in patients who have. Additionally, mekinist in combination with dabrafenib is used to treat patients with metastatic nonsmall cell. Many patients who received xyrem during clinical trials in narcolepsy were receiving central nervous system. Arterial occlusion has occurred in at least 35% of iclusig treated patients including fatal myocardial infarction, stroke, stenosis of large arterial. Withhold mekinist for uncomplicated dvt and pe for up to 3 weeks. Specialty guideline management mekinist trametinib policy i.
Dabrafenib tafinlar, novartis pharmaceuticals corp. Trametinib is an oral small molecule kinase inhibitor of mitogenactivated extracellular signal regulated kinase 1 and. Dabrafenibtrametinib combination therapy for melanoma. The recommended dosage of mekinist is 2 mg orally taken once daily in combination with dabrafenib until disease recurrence or unacceptable toxicity. Highlights of prescribing information these highlights do. Asymptomatic, absolute decrease in lvef of 10% or greater from baseline and is below lln that improves to normal lvef value within 4 weeks following interruption of mekinist. Monitor patients receiving cotellic, when administer ed with vemurafenib, for signs or symptoms of noncutaneous malignancies. Mekinist reference guide for safe and effective use from the american society of healthsystem pharmacists ahfs di.
It is used either on its own or in combination with another medicine containing dabrafenib to. Highlights of prescribing information these highlights do not include all the information needed to use feraheme safely and effectively. That has spread to other parts of the body metastatic or cannot be removed by surgery unresectable, and. Tafinlar is not indicated for the treatment of patients with wildtype braf melanoma. Mekinist trametinib rationale for inclusion in pa program. Idhifa for relapsed refractory acute myeloid leukemia. Highlights of prescribing information venous thromboembolism. Tafinlar is indicated, in combination with trametinib, for the treatment of patients with metastatic nonsmall cell lung cancer nsclc with braf v600e mutation. Highlights of prescribing information perforation can. Dabrafenib as monotherapy or in combination with trametinib is indicated for the. Highlights of prescribing information tafinlar with.
Cotellic can cause muscle problems that can be severe. Assess left ventricular ejection fraction before treatment with tafinlar and mekinist, after 1 month of treatment, then every 2 to 3 months thereafter. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for arimidex anastrozole. Prior authorization is required to ensure the safe, clinically appropriate and costeffective use of mekinist while maintaining optimal therapeutic outcomes.
Talk with your health care provider about your risk for these cancers. The recommended dosage regimen of mekinist is 2 mg orally once daily. Zelboraf fda prescribing information, side effects and uses. The first fdaapproved ivd for braf v600e and v600k mutation detection in metastic melanoma. Initiate treatment with letairis in females of reproductive potential only after a negative pregnancy test. Zelboraf is not used to treat melanoma with a normal braf gene. If improved within 4 weeks, resume mekinist at a lower dose reduced by 0. Highlights of prescribing information perforation can occur. The agency considered that tafinlar when used alone or in combination with trametinib had shown clinically relevant benefit in patients with advanced nonsmall cell. Dec 01, 2018 zelboraf is a prescription medicine used to treat. Mekinist is not indicated for the treatment of patients who have received prior braf inhibitor therapy.
The european medicines agency decided that tafinlars benefits in cancers that carry the braf v600 mutation are greater than its risks and it can be authorised for use in the eu. Mekinist is indicated, in combination with dabrafenib, for the adjuvant treatment of patients with melanoma with braf v600e or v600k mutations as detected by an fdaapproved test, and involvement of lymph nodes, following complete resection. Authorization of 12 months may be granted for treatment of brain metastases from melanoma with a braf v600 activating mutation in combination with trametinib mekinist. Mekinist is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with braf v600e or v600k mutations as detected by an fdaapproved test. Administer feraheme as an intravenous infusion in 50200 ml 0. In the combid study, adverse reactions leading to discontinuation of mekinist occurred in 11% of patients receiving mekinist plus dabrafenib. Treatment with cotellic may increase the level of an enzyme in your blood called creatine phosphokinase cpk and may be a sign of muscle damage. Tafinlar is used in combination with trametinib mekinist and either cetuximab or panitumumab 2. These highlights do not include all the information needed to use. Tafinlar dabrafenib capsules and mekinist trametinib tablets are prescription medicines that can be used in combination to treat people with a type of skin cancer called melanoma. Take mekinist at least 1 hour before or at least 2 hours after a meal. Tafinlar, when used in combination with mekinist, may cause a.
As the impact of nintedanib on the effectiveness of hormonal contraception is unknown, advise women using hormonal contraceptives to add a barrier method. Your healthcare provider will do blood tests to check your liver function. Mekinist will be approved based on the following criterion. Authorization of 12 months may be granted for adjuvant treatment of cutaneous melanoma with a braf v600 activating mutation in combination with trametinib. Braf testing for melanoma kinase inhibitor responses evicore. If you have difficulty viewing the document below, please click here to view the full prescribing information, including the boxed warning. The recommended dose of feraheme is an initial 510 mg dose followed by a second 510 mg dose 3 to 8 days later. In clinical trials at recommended doses, obtundation and clinically significant respiratory depression occurred in adult patients treated with xyrem see warnings and precautions 5. Refer to the dabrafenib prescribing information for. Use caution when treating patients at higher cardiovascular risk including known coronary. Mekinist trametinib, in combination with dabrafenib, is indicated for the adjuvant treatment of patients with melanoma with a braf v600.
Highlights of prescribing information these highlights do not include all the information needed to use gleevec safely and effectively. Mulpleta is a thrombopoietin receptor agonist for the treatment of thrombocytopenia in. Dabrafenib is a selective kinase inhibitor that is active against several mutated forms of braf kinase including braf v600e, braf v600k, and braf v600d. Refer to the dabrafenib prescribing information for recommended dabrafenib dosing information. Highlights of prescribing information urothelial carcinoma. See full prescribing information for complete boxed warning. Cardiomyopathy, including cardiac failure, can occur. This leaflet is part iii of a threepart product monograph. Highlights of prescribing information cardiomyopathy. Infusion reactions and cardiopulmonary arrest 1 indications and usage 1. Check your skin and tell your health care provider right away about any. Oct 06, 2019 among the 209 patients receiving mekinist plus dabrafenib, 26% were exposed to mekinist for 6 months to 12 months while 46% were exposed to mekinist for 1 year. Similar safety and efficacy of once and twicedaily.
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