Piqray

Severe hyperglycemia. Test fasting plasma glucose (FPG), HbA1c, and optimize blood glucose prior to initiation. Consider premedication with metformin prior to initiation based on risk factors (eg, hyperglycemia, GI tolerability, clinical situation). After initiating, monitor FPG or blood glucose at least once weekly for the first 2 weeks, then at least once every 4 weeks, and as indicated. Monitor HbA1c every 3 months and as indicated. Monitor FPG more frequently during first few weeks of treatment in those with risk factors for hyperglycemia (eg, obesity, elevated FPG, HbA1c >ULN, or age ≥75). Interrupt, reduce dose, or discontinue therapy based on severity of the hyperglycemia. Diabetes. Permanently discontinue if severe hypersensitivity occurs. Prior history of severe cutaneous reactions (eg, SJS, EM, TEN, DRESS): do not reintroduce. Interrupt therapy if signs/symptoms of severe cutaneous reactions occur; permanently discontinue if confirmed. Interrupt and evaluate if new or worsening respiratory symptoms occur; permanently discontinue if pneumonitis is confirmed. Monitor for diarrhea or colitis; interrupt, reduce dose, or discontinue therapy based on severity. Severe renal impairment (CrCl <30mL/min). Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for 1 week after last dose. Nursing mothers: not recommended (during and for 1 week after last dose).