Risk of severe anemia & severe hypoxia. Monitor for anemia & hypoxia before initiation of & periodically throughout treatment. Use of erythropoiesis-stimulating agents for treatment of anemia is not recommended in patients treated w/ Welireg. Permanently discontinue treatment in case of life-threatening hypoxia or recurrent symptomatic hypoxia. Closely monitor for adverse reactions in patients who are dual UGT2B17 & CYP2C19 poor metabolizers. Has not been studied in patients w/ severe renal impairment (eGFR 15-29 mL/min/1.73 m
2); moderate or severe hepatic impairment (total bilirubin >1.5 x ULN & any AST). Exposure during pregnancy can cause embryo-fetal harm. Do not breastfeed during treatment & for 1 wk after the last dose. Females of reproductive potential should use effective non-hormonal contraception during treatment & for 1 wk after the last dose. Male patients w/ female partners of reproductive potential should use effective contraception during treatment & for 1 wk after the last dose. May impair fertility in males & females of reproductive potential. Safety & effectiveness have not been established in ped patients.
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