Highlights of prescribing information these highlights do not include all the information needed to use jevtana safely and effectively. 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. 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. Take tafinlar at least 1 hour before or at least 2 hours after a meal. Dabrafenibtrametinib combination therapy for melanoma. When possible, interrupt therapy with brilinta for fivedays prior to surgery that has a major risk of bleeding. These are not all the possible side effects of braftovi and mektovi. 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. Length of authorization coverage is provided for six months and may be renewed. The active substance in tafinlar, dabrafenib, works by blocking braf, a protein involved in stimulating cell division. 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. Etopophos solutions may be administered at infusion rates up to 3. Tafinlar is indicated, in combination with trametinib, for the adjuvant treatment of patients with.
Keep tafinlar and all medicine out of the reach of children. 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. Jakafi is indicated for treatment of intermediate or highrisk myelofibrosis mf, including primary mf, postpolycythemia vera mf and postessential thrombocythemia mf in adults. Hepatotoxicity may be severe, and in some cases fatal. If you have difficulty viewing the document below, please click here to view the full prescribing information, including the boxed warning. Recommended dosage modifications for tafinlar for adverse reactions. 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. Tafinlar will be approved based on the following criterion. Tafinlar 50 mg capsule 000780682xx tafinlar 75 mg capsule 000780681xx vii. Stivarga regorafenib is a prescription medicine used to treat people with. Vincristine sulfate vincristine sulfate this product information is intended only for residents of the united states. These highlights do not include all the information needed to use.
Hepatotoxicity has been observed in clinical trials and postmarketing experience. This medicinal product is subject to additional monitoring. Highlights of prescribing information these highlights do. Combined braf and mek inhibition in melanoma with braf v600 mutations. Tafinlar have not been established in pediatric patients. Initial approval criteria coverage is provided in the following conditions. Talk with your health care provider about your risk for. Tafinlar dabrafenib capsules for oral use are supplied as. Prior authorization is required to ensure the safe, clinically appropriate and costeffective use of tafinlar while maintaining optimal therapeutic outcomes. Extravasation of etopophos may result in swelling, pain, cellulitis, and necrosis including skin necrosis. Discontinuation of antihepatitis b therapy may result in severe acute exacerbations of hepatitis b. Care and management of unique toxicities associated with mapk pathwaytargeted therapies in patients with advanced melanoma. Call your doctor for medical advice about side effects.
What will be different about this product monograph. Tafinlar will be approved based on all the following criteria. Dabrafenib mesylate is a white to slightly colored solid with three pk a s. This leaflet is part iii of a threepart product monograph published when. Highlights of prescribing information tafinlar with.
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. See full prescribing information for complete boxed warning. It is not known if zykadia is safe and effective in children. 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. N352amino4pyrimidinyl21,1dimethylethyl4thiazolyl2fluorophenyl2,6difluorobenzenesulfonamide methanesulfonate 1. Zykadia is a prescription medicine that is used to treat people with nonsmall cell lung cancer nsclc that. Tafinlar is used on its own or in combination with another cancer medicine, trametinib. For more information about using tafinlar, see the package leaflet or contact your doctor or pharmacist. Geriatrics 65 years of age in clinical studies, elderly patients 65 years experienced more serious adverse events when taking tafinlar see warnings and precautions, special populations.
Tafinlar is not indicated for treatment of patients with wildtype braf melanoma. 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. The printed package leaflet of the medicinal product must state the name and address of the. It is very slightly soluble at ph 1 and practically insoluble above ph 4 in aqueous media. Tafinlar prescribing information mekinist prescribing information copay info. Hepatic function should be monitored closely in patients who discontinue vemlidy. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended see warnings and precautions 5. Tagrisso osimertinib tablets, for oral use initial u. In melanoma and non small cell lung cancer with the braf v600 mutation, the abnormal.
Follow applicable special handling and disposal procedures. Cometriq is indicated for the treatment of patients with progressive, metastatic medullary. Is caused by a defect in a gene called anaplastic lymphoma kinase alk and has spread to other parts of the body. In clinical trials, one class iii patients death was judged attributable to the interruption of flolan.
Authorization of 12 months may be granted for adjuvant treatment of cutaneous melanoma with a braf v600 activating mutation in combination with dabrafenib. 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. Refer to the trametinib prescribing information for recommended trametinib dosing information. Pegasys in combination with ribavirinis indicated for the treatment of pediatric patients 5. For the full list of side effects and restrictions with tafinlar, see. Adjuvant use in melanoma may be renewed for up to 1 year of therapy. Thalidomide is a known human teratogen that causes severe birth defects or embryofetal death. Tafinlar within 6 hours of the next dose of tafinlar. It may occur as early as the first week after start of therapy.
Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers e. Highlights of prescribing information these highlights do not include all the information needed to use tagrisso. Baseline left ventricular ejection fraction lvef within normal limits. Aortitis has been reported in patients receiving filgrastim products. General information about the safe and effective use of tafinlar medicines are sometimes prescribed for purposes other than those listed in a medication guide.
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