Akeega

Discontinue if myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) is confirmed. Monitor CBCs weekly for the first month, every 2 weeks for the next 2 months, monthly for the remaining first year, then every other month as clinically indicated. Do not start therapy until recovery from hematological toxicity due to previous chemotherapy; discontinue if toxicities unresolved within 28 days after interruption (see full labeling). Risk for mineralocorticoid excess; monitor BP, serum potassium, fluid retention at least weekly for the first 2 months, the once monthly. Control hypertension and correct hypokalemia before and during treatment. Underlying conditions (eg, heart failure, recent MI, cardiovascular disease, ventricular arrhythmia); monitor closely. Monitor for adrenocortical insufficiency. Stress (may need higher corticosteroid dose). Monitor LFTs prior to starting treatment, every 2 weeks for the first 3 months, and monthly thereafter. Permanently discontinue if concurrent ALT elevation >3×ULN and total bilirubin >2×ULN develops without biliary obstruction or other causes of elevation, or if ALT/AST ≥20×ULN at any time. Preexisting diabetes (esp. those taking thiazolidinediones-containing products). Monitor blood glucose; may need to adjust antidiabetic dose. Discontinue promptly if posterior reversible encephalopathy syndrome (PRES) is suspected. Moderate or severe hepatic impairment: not recommended. Severe renal impairment: monitor. Embryo-fetal toxicity. Advise males with female partners of reproductive potential to use effective contraception during and for 4 months after the last dose. Pregnancy (should handle tabs with protection [eg, gloves]), nursing mothers: not established in women.