Critical precautions for WELIREG therapy involve vigilant monitoring for anemia and hypoxia, managing potential embryo-fetal toxicity through contraception, and considering interactions with other medications, particularly CYP3A4 substrates and hormonal contraceptives.

Key Warnings, Precautions, and Interaction Considerations for WELIREG

WELIREG carries a boxed warning for Embryo-Fetal Toxicity; exposure during pregnancy can cause fetal harm. Pregnancy status must be verified before initiating treatment, and effective non-hormonal contraception is mandatory for females of reproductive potential during and for one week after the last dose, as WELIREG can reduce the efficacy of hormonal contraceptives. Male patients with female partners of reproductive potential must also use effective contraception. Anemia is a common and potentially severe adverse effect requiring baseline and periodic hemoglobin monitoring; dose adjustments or discontinuation may be necessary. Similarly, Hypoxia can occur, necessitating baseline and periodic oxygen saturation monitoring, with potential for dose modification or discontinuation. Caution is advised with concomitant use of UGT2B17 or CYP2C19 inhibitors, which may increase WELIREG exposure, and sensitive CYP3A4 substrates, whose concentrations may be reduced by WELIREG. Lactation should be avoided during and for one week post-treatment. Potential for infertility in males and females exists.