Ingilterra - Ingliż - MHRA (Medicines & Healthcare Products Regulatory Agency)

imported (united states - trametinib - tablet - 2mg

Ġappun - Ingliż - すりの適正使用協議会 RAD-AR Council, Japan

novartis pharma k.k. - trametinib dimethyl sulfoxide - yellow oval tablet, major axis: 9.0 mm, minor axis: 5.0 mm, thickness: 3.8 mm

Ġappun - Ingliż - すりの適正使用協議会 RAD-AR Council, Japan

novartis pharma k.k. - trametinib dimethyl sulfoxide - pale red circular tablet, diameter: 7.6 mm, thickness: 3.8 mm

Singapor - Ingliż - HSA (Health Sciences Authority)

novartis (singapore) pte ltd - trametinib dimethylsulfoxide 5.30 mg eqv trametinib - powder, for solution - trametinib dimethylsulfoxide 5.30 mg eqv trametinib 4.7 mg

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - dabrafenib mesilate, quantity: 88.88 mg (equivalent: dabrafenib, qty 75 mg) - capsule - excipient ingredients: colloidal anhydrous silica; microcrystalline cellulose; titanium dioxide; magnesium stearate; hypromellose; iron oxide red; purified water; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - unresectable or metastatic melanoma,tafinlar in combination with trametinib is indicated for the treatment of patients with brafv600 mutation positive unresectable stage iii or metastatic (stage iv) melanoma.,tafinlar as monotherapy is indicated for the treatment of patients with braf v600 mutation positive unresectable stage iii or metastatic (stage iv) melanoma.,adjuvant treatment of melanoma,tafinlar in combination with trametinib, is indicated for the adjuvant treatment of patients with a braf v600 mutation and involvement of the lymph node(s), following complete resection.,anaplastic thyroid cancer (atc),tafinlar in combination with trametinib is indicated for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (atc) with a braf v600 mutation and with no satisfactory locoregional treatment options.,non-small cell lung cancer (nsclc),tafinlar in combination with trametinib is indicated for the treatment of patients with advanced non-small cell lung cancer (nsclc) with a braf v600 mutation.,low-grade glioma,tafinlar in combination with trametinib is indicated for the treatment of paediatric patients 1 year of age and older with low-grade glioma (lgg) with a braf v600e mutation who require systemic therapy (see section 5.1 clinical studies).,high-grade glioma,tafinlar in combination with trametinib is indicated for the treatment of paediatric patients 1 year of age and older with high-grade glioma (hgg) with a braf v600e mutation who have progressed following prior treatment and have no satisfactory alternative treatment options (see section 5.1 clinical studies).

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - dabrafenib mesilate, quantity: 59.25 mg (equivalent: dabrafenib, qty 50 mg) - capsule - excipient ingredients: colloidal anhydrous silica; microcrystalline cellulose; titanium dioxide; magnesium stearate; hypromellose; iron oxide red; purified water; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - unresectable or metastatic melanoma,tafinlar in combination with trametinib is indicated for the treatment of patients with brafv600 mutation positive unresectable stage iii or metastatic (stage iv) melanoma.,tafinlar as monotherapy is indicated for the treatment of patients with braf v600 mutation positive unresectable stage iii or metastatic (stage iv) melanoma.,adjuvant treatment of melanoma,tafinlar in combination with trametinib, is indicated for the adjuvant treatment of patients with a braf v600 mutation and involvement of the lymph node(s), following complete resection.,anaplastic thyroid cancer (atc),tafinlar in combination with trametinib is indicated for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (atc) with a braf v600 mutation and with no satisfactory locoregional treatment options.,non-small cell lung cancer (nsclc),tafinlar in combination with trametinib is indicated for the treatment of patients with advanced non-small cell lung cancer (nsclc) with a braf v600 mutation.,low-grade glioma,tafinlar in combination with trametinib is indicated for the treatment of paediatric patients 1 year of age and older with low-grade glioma (lgg) with a braf v600e mutation who require systemic therapy (see section 5.1 clinical studies).,high-grade glioma,tafinlar in combination with trametinib is indicated for the treatment of paediatric patients 1 year of age and older with high-grade glioma (hgg) with a braf v600e mutation who have progressed following prior treatment and have no satisfactory alternative treatment options (see section 5.1 clinical studies).

Stati Uniti - Ingliż - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - dabrafenib mesylate (unii: b6dc89i63e) (dabrafenib - unii:qgp4ha4g1b) - dabrafenib 50 mg - tafinlar®  is indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with braf v600e mutation as detected by an fda-approved test. 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 dosage and administration (2.1)] . tafinlar is indicated, in combination with trametinib, for the adjuvant treatment of patients with melanoma with braf v600e or v600k mutations, as detected by an fda-approved test, and involvement of lymph node(s), following complete resection [see dosage and administration (2.1)] . tafinlar is indicated, in combination with trametinib, for the treatment of patients with metastatic non-small cell lung cancer (nsclc) with braf v600e mutation as detected by an fda-approved test [see dosage and administration (2.1)] . tafinlar is indicated, in combination with trametinib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (atc) with braf v600e mutation and with no satisfactory locoregional treatment options [see dosage and administration (2.1)] . tafinlar is indicated, in combination with trametinib, for the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with braf v600e mutation who have progressed following prior treatment and have no satisfactory alternative treatment options [see dosage and administration (2.1)] . this indication is approved under accelerated approval based on overall response rate (orr) and duration of response (dor) [see clinical studies (14.6)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). tafinlar is indicated, in combination with trametinib, for the treatment of pediatric patients 1 year of age and older with low-grade glioma (lgg) with a braf v600e mutation who require systemic therapy [see dosage and administration (2.1)] . - tafinlar is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to braf inhibition [see indications and usage (1.6), clinical pharmacology (12.1)] . - tafinlar is not indicated for treatment of patients with wild-type braf solid tumors [see warnings and precautions (5.2)] . none. risk summary based on findings from animal reproduction studies and its mechanism of action [see clinical pharmacology (12.1)] , tafinlar can cause fetal harm when administered to a pregnant woman. there is insufficient data in pregnant women exposed to tafinlar to assess the risks. dabrafenib was teratogenic and embryotoxic in rats at doses three times greater than the human exposure at the recommended adult clinical dose of 150 mg twice daily (see data) . advise pregnant women of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data in a combined female fertility and embryo-fetal development study in rats conducted during the period of organogenesis, developmental toxicity consisted of embryo-lethality, ventricular septal defects, and variation in thymic shape at a dabrafenib dose of 300 mg/kg/day [approximately three times the human exposure at the recommended adult dose based on area under the curve (auc)]. at doses of 20 mg/kg/day or greater (equivalent to the human exposure at the recommended adult dose based on auc), rats demonstrated delays in skeletal development and reduced fetal body weight. risk summary there are no data on the presence of dabrafenib in human milk, or the effects of dabrafenib on the breastfed child or on milk production. because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with tafinlar and for 2 weeks following the last dose. pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating tafinlar. contraception based on data from animal studies and its mechanism of action, tafinlar can cause fetal harm when administered to pregnant women [see use in specific populations (8.1 )]. females advise female patients of reproductive potential to use effective contraception during treatment with tafinlar and for 2 weeks after the last dose. counsel patients to use a non-hormonal method of contraception since tafinlar can render hormonal contraceptives ineffective [see drug interactions (7.2)] . males to avoid potential drug exposure to pregnant partners and female partners of reproductive potential, advise male patients (including those who have had vasectomies) with female partners of reproductive potential to use condoms during treatment with tafinlar and for 2 weeks after the last dose. infertility females advise female patients of reproductive potential that tafinlar may impair fertility. a reduction in fertility was observed in female rats at dose exposures equivalent to the human exposure at the recommended adult dose. a reduction in the number of corpora lutea was noted in pregnant rats at dose exposures approximately three times the human exposure at the recommended adult dose [see nonclinical toxicology (13.1)]. males advise male patients of the potential risk for impaired spermatogenesis which may be irreversible. effects on spermatogenesis have been observed in animals treated with dabrafenib at dose exposures up to three times the human exposure at the recommended adult dose [see nonclinical toxicology (13.1)]. braf v600e mutation-positive unresectable or metastatic solid tumors and lgg the safety and effectiveness of tafinlar in combination with trametinib have been established in pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with braf v600e mutation who have progressed following prior treatment and have no satisfactory alternative treatment options; or with lgg with braf v600e mutation who require systemic therapy. use of tafinlar in combination with trametinib for these indications is supported by evidence from studies x2101 and g2201 that enrolled 171 patients (1 to < 18 years) with braf v600 mutation-positive advanced solid tumors, of which 4 (2.3%) patients were 1 to < 2 years of age, 39 (23%) patients were 2 to < 6 years of age, 54 (32%) patients were 6 to < 12 years of age, and 74 (43%) patients were 12 to < 18 years of age [see adverse reactions (6.1), clinical pharmacology (12.3), clinical studies (14.6, 14.7)] . the safety and effectiveness of tafinlar in combination with trametinib have not been established for these indications in pediatric patients less than 1 year old. the safety and effectiveness of tafinlar as a single agent in pediatric patients have not been established. juvenile animal toxicity data in a repeat-dose toxicity study in juvenile rats, an increased incidence of kidney cysts and tubular deposits were noted at doses as low as 0.2 times the human exposure at the recommended adult dose based on auc. additionally, forestomach hyperplasia, decreased bone length, and early vaginal opening were noted at doses as low as 0.8 times the human exposure at the recommended adult dose based on auc. of the 586 patients with various solid tumors who received single agent tafinlar, 22% were aged 65 years and older. of the 187 patients with melanoma who received single-agent tafinlar in the break-3 study, 21% were aged 65 years or older [see clinical studies (14.1)] . no overall differences in the effectiveness or safety of tafinlar were observed between geriatric patients as compared to younger adults in the break-3 study. of the 994 patients with melanoma who received tafinlar plus trametinib in the combi-d, combi-v, and combi-ad studies [see clinical studies (14.2, 14.3)] , 21% were aged 65 years and older and 5% were aged 75 years and older. no overall differences in the effectiveness of tafinlar plus trametinib were observed in geriatric patients as compared to younger adults across these melanoma studies. the incidences of peripheral edema (26% vs. 12%) and anorexia (21% vs. 9%) were increased in geriatric patients as compared to younger adults in these studies. of the 171 patients with nsclc who received tafinlar in study brf113928, there were insufficient numbers of geriatric patients to determine whether they respond differently from younger adults [see clinical studies (14.4)] . of the 26 patients with atc who received tafinlar in study brf117019, 77% were aged 65 years and older, and 31% were aged 75 years and older [see clinical studies (14.5)] . this study in atc did not include sufficient numbers of younger adults to determine whether they respond differently compared to geriatric patients. dose adjustment is not recommended for patients with mild (bilirubin ≤ upper limit of normal (uln) and aspartate aminotransferase (ast) > uln or bilirubin > 1x to 1.5x uln and any ast) hepatic impairment. as hepatic metabolism and biliary secretion are the primary routes of elimination of dabrafenib and its metabolites, patients with moderate (bilirubin > 1.5x to 3x uln and any ast) to severe (bilirubin > 3x to 10x uln and any ast) hepatic impairment may have increased exposure. an appropriate dosage has not been established for patients with moderate to severe hepatic impairment [see clinical pharmacology (12.3)] . - read this “instructions for use” carefully before you prepare and take or give tafinlar oral suspension for the first time and each time you get a refill. there may be new information. - this “instructions for use” does not take the place of talking with your healthcare provider about your or your child’s medical condition and treatment. - your healthcare provider or pharmacist should show you how to prepare and take or give a dose of tafinlar oral suspension correctly. always take or give tafinlar exactly as your healthcare provider tells you to. - if you have any questions about how to prepare and take or give a dose of tafinlar oral suspension, talk to your healthcare provider or pharmacist. - always use the dosing cup that comes with your tafinlar pack. if your pack does not contain a dosing cup, contact your healthcare provider or pharmacist. - use only clean water to rinse. do not use soap or dishwashing liquid to clean the dosing cup. - if at any time tafinlar oral suspension gets on your or your child’s skin, wash the area well with soap and water. - if at any time tafinlar oral suspension gets in your or your child’s eyes, rinse the eyes well with cool water. - if you spill any tafinlar oral suspension, follow the instructions at the end of this “instructions for use” in section e. “how to clean up any spilled tafinlar oral suspension”. - you will receive the tafinlar tablets in a sealed bottle. the tafinlar tablets must be mixed in water before taking or giving a dose of tafinlar oral suspension. the tablets break apart (disperse) in the water and may not fully dissolve. follow the instructions below to mix the tablets in water. - the prescribed number of tablets - 1 dosing cup - 1 teaspoon - drinking water - add cool drinking water up to the markings on the dosing cup, as follows: - if the prescribed dose is 1 to 4 tablets, you will need about 5 ml of water. - if the prescribed dose is 5 to 15 tablets, you will need about 10 ml of water. - do not throw away (dispose of) the cap. - if you are opening the bottle for the first time, remove the seal from the bottle. - add the prescribed number of tablets into the water in your dosing cup. - the bottle contains 2 plastic canisters to keep the tablets dry. if either canister falls out when you are taking out the tablets, re-insert it back into the bottle. - with your other hand, gently stir the water and tablets with the handle of a teaspoon until the tablets break apart (disperse). - it may take 3 minutes or more for the tablets to disperse. after the tablets disperse, the tafinlar oral suspension should be cloudy white, but may contain small pieces. - take or give the tafinlar oral suspension no later than 30 minutes after the tablets have been dispersed in water. - if more than 30 minutes have passed, throw away the tafinlar oral suspension following the instructions in section d and restart from the beginning of section a. if you are not sure how to throw away the tafinlar oral suspension, ask your healthcare provider or pharmacist. - if the prescribed dose is 1 to 4 tablets: do steps 7 through 9 one time. - if the prescribed dose is 5 to 15 tablets: do steps 7 through 9 two times. - if the prescribed dose is 1 to 3 tablets, the feeding tube size that may be used is 10 french gauge or larger. - if the prescribed dose is 4 to 15 tablets, the feeding tube size that may be used is 12 french gauge or larger. - if any of the tafinlar oral suspension comes into contact with your skin or eyes when you are following the steps below, follow the instructions in the section “important information you need to know before taking or giving tafinlar tablets for oral suspension”. - if any of the tafinlar oral suspension spills, follow the instruction in section e. “how to clean up any spilled tafinlar oral suspension”. - wash and dry your hands before giving a dose of tafinlar oral suspension. - it is important to give all of the medicine residue that is left in the oral syringe and feeding tube. repeat steps 4 through 7 three times to make sure that you give a full dose of tafinlar. - shake off excess water then wipe dry using clean paper towels. - you can also wash the teaspoon in a dishwasher. - throw away unused tafinlar tablets or oral suspension, or old dosing cups into the trash. do not pour tafinlar oral suspension down the drain. - ask your healthcare provider or pharmacist about how to safely throw away tafinlar tablets or oral suspension if you are not sure. - store the bottle of tafinlar tablets for oral suspension at room temperature between 68°f to 77°f (20°c to 25°c). - store the bottle of tafinlar tablets for oral suspension, along with the two plastic canisters inside the original packaging, with the cap tightly closed. the canisters contain a drying agent (desiccant) to help keep your medicine dry. - tafinlar tablets for oral suspension come in a bottle with a child-resistant cap. - throw away any tafinlar oral suspension if it is not taken or given within 30 minutes after it is prepared. t2024-24

Ingilterra - Ingliż - MHRA (Medicines & Healthcare Products Regulatory Agency)

novartis pharmaceuticals uk ltd - dabrafenib mesilate - capsule - 50mg

Ingilterra - Ingliż - MHRA (Medicines & Healthcare Products Regulatory Agency)

novartis pharmaceuticals uk ltd - dabrafenib mesilate - capsule - 75mg

New Zealand - Ingliż - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - dabrafenib mesilate 59.25mg equivalent to dabrafenib 50 mg;  ;   - capsule - 50 mg - active: dabrafenib mesilate 59.25mg equivalent to dabrafenib 50 mg     excipient: colloidal silicon dioxide hypromellose iron oxide red magnesium stearate microcrystalline cellulose purified water titanium dioxide - tafinlar is indicated for the treatment of patients with braf v600 mutation positive unresectable stage iii or metastatic (stage iv) melanoma. tafinlar in combination with trametinib is indicated for the treatment of patients with unresectable or metastatic melanoma with a braf v600 mutation. tafinlar in combination with mekinist, is indicated for the adjuvant treatment of patients with stage iii melanoma with a braf v600 mutation, following complete resection.