Israel - English - Ministry of Health

novartis israel ltd - trametinib as dimethyl sulfoxide - film coated tablets - trametinib as dimethyl sulfoxide 0.5 mg - trametinib - trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutation. trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior braf inhibitor therapy. non-small cell lung cancer (nsclc) :trametinib in combination with dabrafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a braf v600 mutation.adjuvant treatment of melanoma :trametinib in combination with dabrafenib is indicated for the adjuvant treatment of adult patients with stage iii melanoma with a braf v600 mutation, following complete resection.braf v600e mutation-positive locally advanced or metastatic anaplastic thyroid cancertafinlar 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 optionsbraf v600e mutation-positive unresectable or metastatic solid tumorsmekinist is indicated, in combination with dabrafenib, for the treatment of adult and pediatric patients 6 years 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. limitations of use: trametinib is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to braf inhibitiontrametinib is indicated, in combination with dabrafenib, for the treatment of pediatric patients 6 year of age and older with low-grade glioma (lgg) with a braf v600e mutation who require systemic therapy

Israel - English - Ministry of Health

novartis israel ltd - trametinib as dimethyl sulfoxide - film coated tablets - trametinib as dimethyl sulfoxide 2 mg - trametinib - trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutation. trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior braf inhibitor therapy. non-small cell lung cancer (nsclc) :trametinib in combination with dabrafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a braf v600 mutation.adjuvant treatment of melanoma :trametinib in combination with dabrafenib is indicated for the adjuvant treatment of adult patients with stage iii melanoma with a braf v600 mutation, following complete resection.braf v600e mutation-positive locally advanced or metastatic anaplastic thyroid cancertafinlar 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 optionsbraf v600e mutation-positive unresectable or metastatic solid tumorsmekinist is indicated, in combination with dabrafenib, for the treatment of adult and pediatric patients 6 years 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. limitations of use: trametinib is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to braf inhibitiontrametinib is indicated, in combination with dabrafenib, for the treatment of pediatric patients 6 year of age and older with low-grade glioma (lgg) with a braf v600e mutation who require systemic therapy

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - trametinib dimethyl sulfoxide, quantity: 2.254 mg (equivalent: trametinib, qty 2 mg) - tablet, film coated - excipient ingredients: mannitol; colloidal anhydrous silica; microcrystalline cellulose; magnesium stearate; croscarmellose sodium; sodium lauryl sulfate; hypromellose; titanium dioxide; polysorbate 80; iron oxide red; macrogol 400 - unresectable or metastatic melanoma,mekinist in combination with dabrafenib is indicated for the treatment of patients with braf v600 mutation positive unresectable stage iii or metastatic (stage iv) melanoma.,mekinist as a monotherapy is indicated for the treatment of patients with braf v600 mutation positive unresectable stage iii or metastatic (stage iv) melanoma and in whom either there is intolerance to braf inhibitors or braf inhibitors cannot be used.,mekinist as monotherapy has not demonstrated clinical activity in patients who have progressed on braf inhibitor therapy (see section 5.1 clinical trials).,adjuvant treatment of melanoma,mekinist in combination with dabrafenib is indicated for the adjuvant treatment of patients with melanoma with a braf v600 mutation and involvement of the lymph node(s), following complete resection.,anaplastic thyroid cancer (atc),mekinist in combination with dabrafenib is indicated for the treatment of patients with locally advanced or metastatic anaplastic thyroid canc

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - trametinib dimethyl sulfoxide, quantity: 0.5635 mg (equivalent: trametinib, qty 0.5 mg) - tablet, film coated - excipient ingredients: sodium lauryl sulfate; hypromellose; mannitol; microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; croscarmellose sodium; titanium dioxide; iron oxide yellow; macrogol 400 - unresectable or metastatic melanoma,mekinist in combination with dabrafenib is indicated for the treatment of patients with braf v600 mutation positive unresectable stage iii or metastatic (stage iv) melanoma.,mekinist as a monotherapy is indicated for the treatment of patients with braf v600 mutation positive unresectable stage iii or metastatic (stage iv) melanoma and in whom either there is intolerance to braf inhibitors or braf inhibitors cannot be used.,mekinist as monotherapy has not demonstrated clinical activity in patients who have progressed on braf inhibitor therapy (see section 5.1 clinical trials).,adjuvant treatment of melanoma,mekinist in combination with dabrafenib is indicated for the adjuvant treatment of patients with melanoma with a braf v600 mutation and involvement of the lymph node(s), following complete resection.,anaplastic thyroid cancer (atc),mekinist in combination with dabrafenib is indicated for the treatment of patients with locally advanced or metastatic anaplastic thyroid canc

Singapore - English - HSA (Health Sciences Authority)

novartis (singapore) pte ltd - trametinib dimethyl sulfoxide 0.5635mg eqv trametinib - tablet, film coated - trametinib dimethyl sulfoxide 0.5635mg eqv trametinib 0.5mg

Singapore - English - HSA (Health Sciences Authority)

novartis (singapore) pte ltd - trametinib dimethyl sulfoxide 2.254mg eqv trametinib - tablet, film coated - trametinib dimethyl sulfoxide 2.254mg eqv trametinib 2mg

United States - English - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - trametinib dimethyl sulfoxide (unii: bsb9vj5tut) (trametinib - unii:33e86k87qn) - trametinib .5 mg - mekinist® is indicated, as a single agent in braf-inhibitor treatment-naïve patients 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 [see dosage and administration (2.1)] . 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 fda-approved test, and involvement of lymph node(s), following complete resection [see dosage and administration (2.1)]. mekinist is indicated, in combination with dabrafenib, 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)] . mekinist is indicated, in combination with dabrafenib, 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)] . mekinist is indicated, in combination with dabrafenib, 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 and duration of response [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). mekinist is indicated, in combination with dabrafenib, 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)] . mekinist is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to braf inhibition [see indications and usage (1.5), clinical pharmacology (12.1)] . none. risk summary based on its mechanism of action [see clinical pharmacology (12.1)] and findings from animal reproduction studies, mekinist can cause fetal harm when administered to a pregnant woman. there is insufficient data in pregnant women exposed to mekinist to assess the risks. trametinib was embryotoxic and abortifacient in rabbits at doses greater than or equal to those resulting in exposures approximately 0.3 times the human exposure at the recommended adult clinical dose (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 reproductive toxicity studies, administration of trametinib to rats during the period of organogenesis resulted in decreased fetal weights at doses greater than or equal to 0.031 mg/kg/day [approximately 0.3 times the human exposure at the recommended adult dose based on area under the curve (auc)]. in rats, at a dose resulting in exposures 1.8-fold higher than the human exposure at the recommended adult dose, there was maternal toxicity and an increase in post-implantation loss. in pregnant rabbits, administration of trametinib during the period of organogenesis resulted in decreased fetal body weight and increased incidence of variations in ossification at doses greater than or equal to 0.039 mg/kg/day (approximately 0.08 times the human exposure at the recommended adult dose based on auc). in rabbits administered trametinib at 0.15 mg/kg/day (approximately 0.3 times the human exposure at the recommended adult dose based on auc) there was an increase in post-implantation loss, including total loss of pregnancy, compared with control animals. risk summary there are no data on the presence of trametinib in human milk, or the effects of trametinib 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 mekinist and for 4 months following the last dose. pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating mekinist. contraception based on data from animal studies and its mechanism of action, mekinist 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 mekinist and for 4 months after the last dose. 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 mekinist and for 4 months after the last dose. infertility females advise female patients of reproductive potential that mekinist may impair fertility. increased follicular cysts and decreased corpora lutea were observed in female rats at dose exposures equivalent to 0.3 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 mekinist in combination with dabrafenib 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 mekinist in combination with dabrafenib 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 mekinist in combination with dabrafenib have not been established for these indications in pediatric patients less than 1 year old. the safety and effectiveness of mekinist as a single agent in pediatric patients have not been established. juvenile animal toxicity data in a repeat-dose toxicity study in juvenile rats, decreased bone length and corneal dystrophy were observed at doses resulting in exposures as low as 0.3 times the human exposure at the recommended adult dose based on auc. additionally, a delay in sexual maturation was noted at doses resulting in exposures as low as 1.6 times the human exposure at the recommended adult dose based on auc. of the 214 patients with melanoma who received single agent mekinist in the metric study, 27% were aged 65 years and older and 4% were over 75 years old [see clinical studies (14.1)] . this study of single agent mekinist in melanoma did not include sufficient numbers of geriatric patients to determine whether they respond differently from younger adults. of the 994 patients with melanoma who received mekinist plus dabrafenib in the combi-d, combi-v, and combi-ad studies [see clinical studies (14.1, 14.2)] , 21% were aged 65 years and older and 5% were aged 75 years and older. no overall differences in the effectiveness of mekinist plus dabrafenib 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%) increased in geriatric patients as compared to younger adults in these studies. of the 93 patients with nsclc who received mekinist in study brf113928, there were insufficient numbers of geriatric patients aged 65 and older to determine whether they respond differently from younger adults [see clinical studies (14.4)] . of the 26 patients with atc who received mekinist in study brf117019, 77% were aged 65 years and older and 31% were aged 75 years and older [see clinical studies (14.4)] . this study in atc did not include sufficient numbers of younger adults to determine whether they respond differently compared to geriatric patients. no dose adjustment is recommended in 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. a recommended dosage of mekinist has not been established for patients with moderate (bilirubin > 1.5x to 3x uln and any ast) or severe (bilirubin > 3x to 10x uln and any ast) hepatic impairment. consider the risk-benefit profile of mekinist related to dosing prior to determining whether to administer mekinist to patients with moderate or severe hepatic impairment. in patients with moderate hepatic impairment, 3 patients who received a starting dose of 1.5 mg orally once daily and two patients who received a starting dose of 2 mg orally once daily did not experience dose limiting toxicities (dlts) during the first cycle of therapy. in patients with severe hepatic impairment, 3 patients who received a starting dose of 1 mg orally once daily did not experience dlts during the first cycle; one patient who received a starting dose of 1.5 mg orally once daily experienced a dlt (grade 3 acneiform rash). compared to patients with normal hepatic function, there was no increase in exposure of trametinib in patients with moderate or severe hepatic impairment [see clinical pharmacology (12.3)] . - mekinist for oral solution should only be given by a caregiver. - read this “instructions for use” carefully before you start giving mekinist 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. - instructions for reconstitution are on the folding box. reconstitution of powder into solution must be performed by pharmacists only. - your healthcare provider or pharmacist should show the caregiver how to measure and give a dose of mekinist correctly. always give mekinist exactly as the healthcare provider tells you to. - if you have any questions about how to give a dose of mekinist, talk to the healthcare provider or pharmacist. - you will receive the mekinist prescription in an amber-colored bottle that contains the oral solution that the pharmacist has already mixed. if you receive mekinist as a powder, contact the healthcare provider or pharmacist. - if at any time mekinist oral solution gets on your or your child’s skin, wash the area well with soap and water. - if at any time mekinist oral solution gets in your or your child’s eyes, rinse the eyes well with cool water. - ask the healthcare provider or pharmacist about how to safely dispose of mekinist oral solution. - when mekinist is prepared as an oral solution, it can be used for 35 days. throw away (dispose of) any remaining oral solution after 35 days. - if you spill any mekinist oral solution, follow the instructions at the end of this "instructions for use" in the section called “how to clean up any spilled mekinist oral solution.” - store the bottle of oral solution at room temperature below 25°c (77°f). - do not freeze mekinist oral solution. - store the bottle of oral solution upright with the cap tightly closed. - keep mekinist oral solution in the box it comes in and away from direct light. - when mekinist is prepared as an oral solution, it can be used for 35 days . throw away (dispose of) any remaining oral solution after 35 days. - do not use the oral solution after the expiration date written or printed by the pharmacist on the label has passed. - keep mekinist oral solution and all medicines out of the reach of children. - store the oral syringe with the mekinist oral solution. - keep oral syringes out of the reach of children. - gather your supplies: - 1 bottle adapter (already inserted into the bottle neck) - 1 amber bottle containing oral solution - 1 reusable oral syringe - if any of the mekinist oral solution 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 giving mekinist oral solution ” above. - if any mekinist oral solution spills, follow the instructions in the section “how to clean up any spilled mekinist oral solution ” at the end of this "instructions for use". - if you have powder , do not give mekinist and contact your pharmacist or healthcare provider. - if you have solution , continue to step 4 below. - your pharmacist prepared the solution to an exact concentration. do not add any more water to the solution you received from the pharmacy. - do not give mekinist oral solution if the expiration date has passed or there is no date on the bottle label. - note: if you are unsure of the expiration date, contact your healthcare provider or pharmacist. - if foam appears, put the amber bottle on a flat surface and let it sit there until the foam disappears. - mekinist oral solution may be given through a feeding tube, as directed by the healthcare provider. - only use a nasogastric (ng) or gastric (g-tube) feeding tube with a minimum size of 4 french gauge. - always use the 20 ml oral syringe provided in this pack to give a dose of mekinist oral solution. - you may need an enfit adapter (not included in pack) to connect the 20 ml oral syringe to the feeding tube. - store the oral syringe with the mekinist oral solution. - keep oral syringes out of the reach of children. - throw away (dispose of) unused solution into the trash. do not pour solution down the drain. - ask the healthcare provider or pharmacist about how to safely throw away (dispose of) mekinist if you are not sure. - use a new oral syringe for each new bottle of mekinist. throw away (dispose of) the used oral syringe into the trash. - ask the healthcare provider or pharmacist how to safely throw away (dispose of) the oral syringe if you are not sure. t2024-17

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - trametinib dimethyl sulfoxide 0.5635mg equivalent to trametinib 0.5 mg;   - film coated tablet - 0.5 mg - active: trametinib dimethyl sulfoxide 0.5635mg equivalent to trametinib 0.5 mg   excipient: colloidal silicon dioxide croscarmellose sodium hypromellose magnesium stearate mannitol microcrystalline cellulose opadry yellow 03b120006 purified water sodium laurilsulfate - mekinist in combination with dabrafenib is indicated for the treatment of patients with brafv600 mutation positive unresectable stage iii or metastatic (stage iv) melanoma. mekinist as a monotherapy is indicated for the treatment of patients with brafv600 mutation positive unresectable stage iii or metastatic (stage iv) melanoma and in whom either there is an intolerance to braf inhibitors or braf inhibitors cannot be used. mekinist as monotherapy has not demonstrated clinical activity in patients who have progressed on braf inhibitor therapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - trametinib dimethyl sulfoxide 2.254mg equivalent to trametinib 2 mg;   - film coated tablet - 2 mg - active: trametinib dimethyl sulfoxide 2.254mg equivalent to trametinib 2 mg   excipient: colloidal silicon dioxide croscarmellose sodium hypromellose magnesium stearate mannitol microcrystalline cellulose opadry pink ys-1-14762-a purified water sodium laurilsulfate - mekinist in combination with dabrafenib is indicated for the treatment of patients with brafv600 mutation positive unresectable stage iii or metastatic (stage iv) melanoma. mekinist as a monotherapy is indicated for the treatment of patients with brafv600 mutation positive unresectable stage iii or metastatic (stage iv) melanoma and in whom either there is an intolerance to braf inhibitors or braf inhibitors cannot be used. mekinist as monotherapy has not demonstrated clinical activity in patients who have progressed on braf inhibitor therapy.

Philippines - English - FDA (Food And Drug Administration)

novartis healthcare philippines, inc. - trametinib - film-coated tablet - 500 mcg