Xenpozyme

Have medical resuscitation equipment readily available. Discontinue immediately and treat if a severe hypersensitivity reaction (eg, anaphylaxis) or severe infusion-associated reaction occurs; consider benefits/risks of retreating after a severe reaction. Consider temporarily holding or slowing the infusion rate, and/or reducing Xenpozyme dose if a mild to moderate hypersensitivity reaction or a mild to moderate infusion-associated reaction occurs. Consider testing for IgE ADA and other lab testing (eg, serum tryptase and complement activation) in those with severe hypersensitivity reactions. Obtain baseline ALT/AST levels within 1 month prior to initiation, within 72 hours prior to any infusion during dose escalation, or prior to the next scheduled infusion upon resuming after a missed dose. Withhold treatment temporarily or adjust dose if transaminase levels are elevated above baseline and >2xULN prior to the next scheduled dose until liver transaminases return to baseline value. Pregnancy: not recommended (risk of fetal malformations during dosage initiation or escalation, or at any time during pregnancy); if needed, exclude status prior to initiation. Advise females of reproductive potential to use effective contraception during and for 14 days after the last dose if treatment is discontinued. Nursing mothers.