Xospata

Risk of differentiation syndrome (may be fatal); initiate corticosteroids if suspected and monitor until resolved. Discontinue if posterior reversible encephalopathy syndrome (PRES) develops. Monitor ECG prior to initiation, on Days 8 and 15 of Cycle 1, and prior to the start of next 2 cycles; interrupt and reduce dose if QTcF >500msec. Correct hypokalemia or hypomagnesemia prior to and during therapy. Evaluate if pancreatitis develops. Assess blood counts/chemistries including creatine phosphokinase prior to initiation, at least once weekly for the 1^st month, once every other week for the 2^nd month, and once monthly thereafter. Embryo-fetal toxicity. Advise use of effective contraception during and for ≥6 months (females of reproductive potential) or ≥4 months (males w. female partners) after final dose. Pregnancy: exclude status within 7 days prior to initiation. Nursing mothers: not recommended (during and for 2 months after final dose).