TAFINLAR Rx

See full labeling for trametinib prior to starting combination therapy. Increased incidence of new cutaneous malignancies; perform skin evaluation prior to initiation, every 2 months during therapy, and up to 6 months after discontinuation. Monitor for non-cutaneous malignancies; permanently discontinue if RAS mutation-positive malignancy occurs. Permanently discontinue for all Grade 4 or any persistent Grade 3 hemorrhagic events. Risk of cardiomyopathy with trametinib; assess LVEF prior to initiation, after one month, and then at every 2–3 month intervals during treatment; withhold for symptomatic cardiomyopathy or asymptomatic LV dysfunction of >20% from baseline that is below institutional LLN. Withhold if fever ≥100.4°F, evaluate infection and assess renal function; prophylaxis with antipyretics when resuming or give steroids for subsequent pyrexia. Pre-existing diabetes or hyperglycemia; monitor serum glucose levels. Monitor for uveitis; if occurs, withhold and treat as clinically indicated; permanently discontinue for persistent Grade ≥2 lasting >6wks. G6PD deficiency: monitor for hemolytic anemia. 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 ≥2wks after last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2wks after last dose).

See full labeling for trametinib prior to starting combination therapy. Increased incidence of new cutaneous malignancies; perform skin evaluation prior to initiation, every 2 months during therapy, and up to 6 months after discontinuation. Monitor for non-cutaneous malignancies; permanently discontinue if RAS mutation-positive malignancy occurs. Permanently discontinue for all Grade 4 or any persistent Grade 3 hemorrhagic events. Risk of cardiomyopathy with trametinib; assess LVEF prior to initiation, after one month, and then at every 2–3 month intervals during treatment; withhold for symptomatic cardiomyopathy or asymptomatic LV dysfunction of >20% from baseline that is below institutional LLN. Withhold if fever ≥100.4°F, evaluate infection and assess renal function; prophylaxis with antipyretics when resuming or give steroids for subsequent pyrexia. Pre-existing diabetes or hyperglycemia; monitor serum glucose levels. Monitor for uveitis; if occurs, withhold and treat as clinically indicated; permanently discontinue for persistent Grade ≥2 lasting >6wks. G6PD deficiency: monitor for hemolytic anemia. 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 ≥2wks after last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2wks after last dose).

See full labeling for trametinib prior to starting combination therapy. Increased incidence of new cutaneous malignancies; perform skin evaluation prior to initiation, every 2 months during therapy, and up to 6 months after discontinuation. Monitor for non-cutaneous malignancies; permanently discontinue if RAS mutation-positive malignancy occurs. Permanently discontinue for all Grade 4 or any persistent Grade 3 hemorrhagic events. Risk of cardiomyopathy with trametinib; assess LVEF prior to initiation, after one month, and then at every 2–3 month intervals during treatment; withhold for symptomatic cardiomyopathy or asymptomatic LV dysfunction of >20% from baseline that is below institutional LLN. Withhold if fever ≥100.4°F, evaluate infection and assess renal function; prophylaxis with antipyretics when resuming or give steroids for subsequent pyrexia. Pre-existing diabetes or hyperglycemia; monitor serum glucose levels. Monitor for uveitis; if occurs, withhold and treat as clinically indicated; permanently discontinue for persistent Grade ≥2 lasting >6wks. G6PD deficiency: monitor for hemolytic anemia. 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 ≥2wks after last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2wks after last dose).

See full labeling for trametinib prior to starting combination therapy. Increased incidence of new cutaneous malignancies; perform skin evaluation prior to initiation, every 2 months during therapy, and up to 6 months after discontinuation. Monitor for non-cutaneous malignancies; permanently discontinue if RAS mutation-positive malignancy occurs. Permanently discontinue for all Grade 4 or any persistent Grade 3 hemorrhagic events. Risk of cardiomyopathy with trametinib; assess LVEF prior to initiation, after one month, and then at every 2–3 month intervals during treatment; withhold for symptomatic cardiomyopathy or asymptomatic LV dysfunction of >20% from baseline that is below institutional LLN. Withhold if fever ≥100.4°F, evaluate infection and assess renal function; prophylaxis with antipyretics when resuming or give steroids for subsequent pyrexia. Pre-existing diabetes or hyperglycemia; monitor serum glucose levels. Monitor for uveitis; if occurs, withhold and treat as clinically indicated; permanently discontinue for persistent Grade ≥2 lasting >6wks. G6PD deficiency: monitor for hemolytic anemia. 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 ≥2wks after last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2wks after last dose).

See full labeling for trametinib prior to starting combination therapy. Increased incidence of new cutaneous malignancies; perform skin evaluation prior to initiation, every 2 months during therapy, and up to 6 months after discontinuation. Monitor for non-cutaneous malignancies; permanently discontinue if RAS mutation-positive malignancy occurs. Permanently discontinue for all Grade 4 or any persistent Grade 3 hemorrhagic events. Risk of cardiomyopathy with trametinib; assess LVEF prior to initiation, after one month, and then at every 2–3 month intervals during treatment; withhold for symptomatic cardiomyopathy or asymptomatic LV dysfunction of >20% from baseline that is below institutional LLN. Withhold if fever ≥100.4°F, evaluate infection and assess renal function; prophylaxis with antipyretics when resuming or give steroids for subsequent pyrexia. Pre-existing diabetes or hyperglycemia; monitor serum glucose levels. Monitor for uveitis; if occurs, withhold and treat as clinically indicated; permanently discontinue for persistent Grade ≥2 lasting >6wks. G6PD deficiency: monitor for hemolytic anemia. 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 ≥2wks after last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2wks after last dose).