Mekinist

See full labeling for dabrafenib prior to starting combination therapy. With dabrafenib: risk of new primary malignancies, cutaneous, and non-cutaneous; monitor and perform skin evaluation prior to initiation, every 2 months during therapy, and up to 6 months after discontinuation. Monitor for pulmonary embolism (permanently discontinue if life-threatening), colitis, GI perforations, skin toxicities and secondary infections. Withhold if uncomplicated deep vein thrombosis or pulmonary embolism occurs for up to 3wks. Permanently discontinue for all Grade 4 hemorrhagic events or any persistent Grade 3 events. Risk of cardiomyopathy; assess LVEF prior to initiation, after one month, and then at every 2–3 month intervals during treatment; withhold for up to 4wks if absolute LVEF decreases by ≥10% from baseline and is less than the lower limit of normal (LLN); permanently discontinue if symptomatic cardiomyopathy or absolute LVEF decrease of >20% from baseline that is below LLN. Perform eye exam periodically and at any time for visual disturbances; withhold for up to 3wks, if retinal pigment epithelial detachment is diagnosed. Permanently discontinue if documented retinal vein occlusion, interstitial lung disease or pneumonitis occurs. Withhold if fever ≥100.4°F, evaluate infection and assess renal function; prophylaxis with antipyretics when resuming or give steroids for subsequent pyrexia. Withhold if intolerable or severe skin toxicity occurs; permanently discontinue if unresolved after 3wks. Interrupt treatment if hemophagocytic lymphohistiocytosis (HLH) suspected; discontinue and manage appropriately if confirmed. Pre-existing diabetes or hyperglycemia; monitor serum glucose levels. Severe renal or moderate to severe hepatic impairment. Embryo-fetal toxicity. Advise to use effective non-hormonal contraception (females of reproductive potential) or use of condoms (males w. female partners) during and for 4 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 4 months after last dose).

See full labeling for dabrafenib prior to starting combination therapy. With dabrafenib: risk of new primary malignancies, cutaneous, and non-cutaneous; monitor and perform skin evaluation prior to initiation, every 2 months during therapy, and up to 6 months after discontinuation. Monitor for pulmonary embolism (permanently discontinue if life-threatening), colitis, GI perforations, skin toxicities and secondary infections. Withhold if uncomplicated deep vein thrombosis or pulmonary embolism occurs for up to 3wks. Permanently discontinue for all Grade 4 hemorrhagic events or any persistent Grade 3 events. Risk of cardiomyopathy; assess LVEF prior to initiation, after one month, and then at every 2–3 month intervals during treatment; withhold for up to 4wks if absolute LVEF decreases by ≥10% from baseline and is less than the lower limit of normal (LLN); permanently discontinue if symptomatic cardiomyopathy or absolute LVEF decrease of >20% from baseline that is below LLN. Perform eye exam periodically and at any time for visual disturbances; withhold for up to 3wks, if retinal pigment epithelial detachment is diagnosed. Permanently discontinue if documented retinal vein occlusion, interstitial lung disease or pneumonitis occurs. Withhold if fever ≥100.4°F, evaluate infection and assess renal function; prophylaxis with antipyretics when resuming or give steroids for subsequent pyrexia. Withhold if intolerable or severe skin toxicity occurs; permanently discontinue if unresolved after 3wks. Interrupt treatment if hemophagocytic lymphohistiocytosis (HLH) suspected; discontinue and manage appropriately if confirmed. Pre-existing diabetes or hyperglycemia; monitor serum glucose levels. Severe renal or moderate to severe hepatic impairment. Embryo-fetal toxicity. Advise to use effective non-hormonal contraception (females of reproductive potential) or use of condoms (males w. female partners) during and for 4 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 4 months after last dose).

See full labeling for dabrafenib prior to starting combination therapy. With dabrafenib: risk of new primary malignancies, cutaneous, and non-cutaneous; monitor and perform skin evaluation prior to initiation, every 2 months during therapy, and up to 6 months after discontinuation. Monitor for pulmonary embolism (permanently discontinue if life-threatening), colitis, GI perforations, skin toxicities and secondary infections. Withhold if uncomplicated deep vein thrombosis or pulmonary embolism occurs for up to 3wks. Permanently discontinue for all Grade 4 hemorrhagic events or any persistent Grade 3 events. Risk of cardiomyopathy; assess LVEF prior to initiation, after one month, and then at every 2–3 month intervals during treatment; withhold for up to 4wks if absolute LVEF decreases by ≥10% from baseline and is less than the lower limit of normal (LLN); permanently discontinue if symptomatic cardiomyopathy or absolute LVEF decrease of >20% from baseline that is below LLN. Perform eye exam periodically and at any time for visual disturbances; withhold for up to 3wks, if retinal pigment epithelial detachment is diagnosed. Permanently discontinue if documented retinal vein occlusion, interstitial lung disease or pneumonitis occurs. Withhold if fever ≥100.4°F, evaluate infection and assess renal function; prophylaxis with antipyretics when resuming or give steroids for subsequent pyrexia. Withhold if intolerable or severe skin toxicity occurs; permanently discontinue if unresolved after 3wks. Interrupt treatment if hemophagocytic lymphohistiocytosis (HLH) suspected; discontinue and manage appropriately if confirmed. Pre-existing diabetes or hyperglycemia; monitor serum glucose levels. Severe renal or moderate to severe hepatic impairment. Embryo-fetal toxicity. Advise to use effective non-hormonal contraception (females of reproductive potential) or use of condoms (males w. female partners) during and for 4 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 4 months after last dose).

See full labeling for dabrafenib prior to starting combination therapy. With dabrafenib: risk of new primary malignancies, cutaneous, and non-cutaneous; monitor and perform skin evaluation prior to initiation, every 2 months during therapy, and up to 6 months after discontinuation. Monitor for pulmonary embolism (permanently discontinue if life-threatening), colitis, GI perforations, skin toxicities and secondary infections. Withhold if uncomplicated deep vein thrombosis or pulmonary embolism occurs for up to 3wks. Permanently discontinue for all Grade 4 hemorrhagic events or any persistent Grade 3 events. Risk of cardiomyopathy; assess LVEF prior to initiation, after one month, and then at every 2–3 month intervals during treatment; withhold for up to 4wks if absolute LVEF decreases by ≥10% from baseline and is less than the lower limit of normal (LLN); permanently discontinue if symptomatic cardiomyopathy or absolute LVEF decrease of >20% from baseline that is below LLN. Perform eye exam periodically and at any time for visual disturbances; withhold for up to 3wks, if retinal pigment epithelial detachment is diagnosed. Permanently discontinue if documented retinal vein occlusion, interstitial lung disease or pneumonitis occurs. Withhold if fever ≥100.4°F, evaluate infection and assess renal function; prophylaxis with antipyretics when resuming or give steroids for subsequent pyrexia. Withhold if intolerable or severe skin toxicity occurs; permanently discontinue if unresolved after 3wks. Interrupt treatment if hemophagocytic lymphohistiocytosis (HLH) suspected; discontinue and manage appropriately if confirmed. Pre-existing diabetes or hyperglycemia; monitor serum glucose levels. Severe renal or moderate to severe hepatic impairment. Embryo-fetal toxicity. Advise to use effective non-hormonal contraception (females of reproductive potential) or use of condoms (males w. female partners) during and for 4 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 4 months after last dose).

See full labeling for dabrafenib prior to starting combination therapy. With dabrafenib: risk of new primary malignancies, cutaneous, and non-cutaneous; monitor and perform skin evaluation prior to initiation, every 2 months during therapy, and up to 6 months after discontinuation. Monitor for pulmonary embolism (permanently discontinue if life-threatening), colitis, GI perforations, skin toxicities and secondary infections. Withhold if uncomplicated deep vein thrombosis or pulmonary embolism occurs for up to 3wks. Permanently discontinue for all Grade 4 hemorrhagic events or any persistent Grade 3 events. Risk of cardiomyopathy; assess LVEF prior to initiation, after one month, and then at every 2–3 month intervals during treatment; withhold for up to 4wks if absolute LVEF decreases by ≥10% from baseline and is less than the lower limit of normal (LLN); permanently discontinue if symptomatic cardiomyopathy or absolute LVEF decrease of >20% from baseline that is below LLN. Perform eye exam periodically and at any time for visual disturbances; withhold for up to 3wks, if retinal pigment epithelial detachment is diagnosed. Permanently discontinue if documented retinal vein occlusion, interstitial lung disease or pneumonitis occurs. Withhold if fever ≥100.4°F, evaluate infection and assess renal function; prophylaxis with antipyretics when resuming or give steroids for subsequent pyrexia. Withhold if intolerable or severe skin toxicity occurs; permanently discontinue if unresolved after 3wks. Interrupt treatment if hemophagocytic lymphohistiocytosis (HLH) suspected; discontinue and manage appropriately if confirmed. Pre-existing diabetes or hyperglycemia; monitor serum glucose levels. Severe renal or moderate to severe hepatic impairment. Embryo-fetal toxicity. Advise to use effective non-hormonal contraception (females of reproductive potential) or use of condoms (males w. female partners) during and for 4 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 4 months after last dose).