Tafinlar is indicated, in combination with trametinib, for the adjuvant treatment of patients with. Stivarga regorafenib is a prescription medicine used to treat people with. Highlights of prescribing information these highlights do not include all the information needed to use feraheme safely and effectively. Authorization of 12 months may be granted for treatment of brain metastases from melanoma with a braf v600 activating mutation in combination with dabrafenib tafinlar. The recommended dosage of tafinlar is 150 mg orally taken twice daily in combination with trametinib until disease recurrence or unacceptable toxicity for up to 1 year. Hepatic function should be monitored closely in patients who discontinue vemlidy. For the full list of side effects and restrictions with tafinlar, see. Keep tafinlar and all medicine out of the reach of children. The recommended dose of tafinlar is 150 mg orally twice daily as a single agent or in combination with trametinib 2 mg orally once daily.
Call your doctor for medical advice about side effects. Discontinuation of antihepatitis b therapy may result in severe acute exacerbations of hepatitis b. Refer to the trametinib prescribing information for recommended trametinib dosing information. These are not all the possible side effects of braftovi and mektovi. Tafinlar, in combination with trametinib, indicated for.
Tafinlar prescribing information mekinist prescribing information copay info. Tafinlar 50 mg capsule 000780682xx tafinlar 75 mg capsule 000780681xx vii. Is caused by a defect in a gene called anaplastic lymphoma kinase alk and has spread to other parts of the body. When tafinlar is taken in combination with trametinib, the most common side effects which may affect more than 1 in 5 people are fever, tiredness, nausea, chills, headache, diarrhoea, vomiting, joint pain and rash. Hepatotoxicity may be severe, and in some cases fatal. Adjuvant use in melanoma may be renewed for up to 1 year of therapy. Pegasys monotherapy is only indicated for the treatment of patients with chc and compensated liver disease if there are contraindications or significant intolerance to other hcv antiviral drugs. What will be different about this product monograph. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended see warnings and precautions 5. When possible, interrupt therapy with brilinta for fivedays prior to surgery that has a major risk of bleeding.
Etopophos solutions may be administered at infusion rates up to 3. Tafinlar is used on its own or in combination with another cancer medicine, trametinib. Baseline left ventricular ejection fraction lvef within normal limits. Talk with your health care provider about your risk for. It is very slightly soluble at ph 1 and practically insoluble above ph 4 in aqueous media. Highlights of prescribing information these highlights do not include all the information needed to use jevtana safely and effectively. Tafinlar will be approved based on the following criterion. Tafinlar is indicated, in combination with trametinib, for the treatment of patients with unresectable or metastatic melanoma with braf v600e or v600k mutations as detected by an fda approved test. Jakafi is indicated for treatment of intermediate or highrisk myelofibrosis mf, including primary mf, postpolycythemia vera mf and postessential thrombocythemia mf in adults. In clinical trials, one class iii patients death was judged attributable to the interruption of flolan. If your doctor decides that you will receive treatment with the combination of tafinlar and trametinib, read the trametinib leaflet carefully as well as this leaflet.
These highlights do not include all the information needed to use. Prior authorization is required to ensure the safe, clinically appropriate and costeffective use of tafinlar while maintaining optimal therapeutic outcomes. It may occur as early as the first week after start of therapy. Tafinlar is indicated, in combination with trametinib, for the treatment of patients with metastatic nonsmall cell lung cancer nsclc with braf v600e mutation as detected by an fdaapproved test. Take tafinlar at least 1 hour before or at least 2 hours after a meal. Tafinlar is not indicated for treatment of patients with wildtype braf melanoma. General information about the safe and effective use of tafinlar medicines are sometimes prescribed for purposes other than those listed in a medication guide. Follow applicable special handling and disposal procedures. Cometriq is indicated for the treatment of patients with progressive, metastatic medullary. Initial approval criteria coverage is provided in the following conditions. Combined braf and mek inhibition in melanoma with braf v600 mutations.
Care and management of unique toxicities associated with mapk pathwaytargeted therapies in patients with advanced melanoma. Extravasation of etopophos may result in swelling, pain, cellulitis, and necrosis including skin necrosis. The printed package leaflet of the medicinal product must state the name and address of the. See full prescribing information for complete boxed warning. Tafinlar will be approved based on all the following criteria. Aortitis has been reported in patients receiving filgrastim products.
Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers e. 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. Highlights of prescribing information these highlights do not include all the information needed to use tagrisso. When administered in combination with trametinib, take the oncedaily dose of trametinib at the same time each day with either the morning dose or the evening dose of tafinlar. This leaflet is part iii of a threepart product monograph published when. If you have difficulty viewing the document below, please click here to view the full prescribing information, including the boxed warning. Tagrisso osimertinib tablets, for oral use initial u. Authorization of 12 months may be granted for adjuvant treatment of cutaneous melanoma with a braf v600 activating mutation in combination with dabrafenib. Highlights of prescribing information these highlights do.
Flolan is a potent pulmonary and systemic vasodilator and can cause hypotension and other. The active substance in tafinlar, dabrafenib, works by blocking braf, a protein involved in stimulating cell division. Embryofetal toxicity and venous and arterial thromboembolism embryofetal toxicity pomalyst is contraindicated in pregnancy. This medicinal product is subject to additional monitoring. Zykadia is a prescription medicine that is used to treat people with nonsmall cell lung cancer nsclc that. Dabrafenibtrametinib combination therapy for melanoma. Tafinlar within 6 hours of the next dose of tafinlar. Tafinlar have not been established in pediatric patients.
Tafinlar dabrafenib capsules for oral use are supplied as. In melanoma and non small cell lung cancer with the braf v600 mutation, the abnormal. It is not known if zykadia is safe and effective in children. Length of authorization coverage is provided for six months and may be renewed. Recommended dosage modifications for tafinlar for adverse reactions. Hepatotoxicity has been observed in clinical trials and postmarketing experience. For more information about using tafinlar, see the package leaflet or contact your doctor or pharmacist. Highlights of prescribing information tafinlar with. Thalidomide is a known human teratogen that causes severe birth defects or embryofetal death. Pegasys in combination with ribavirinis indicated for the treatment of pediatric patients 5. Vincristine sulfate vincristine sulfate this product information is intended only for residents of the united states. Tafinlar 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. N352amino4pyrimidinyl21,1dimethylethyl4thiazolyl2fluorophenyl2,6difluorobenzenesulfonamide methanesulfonate 1.
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