Drug Interaction Report

MONITOR: Coadministration of pegvaliase with other PEGylated products may increase the risk of hypersensitivity reactions, including anaphylaxis. In a single-dose study of pegvaliase in adults with phenylketonuria, two patients experienced hypersensitivity reactions during concomitant injections of medroxyprogesterone acetate suspension, a formulation containing PEG 3350. The first patient experienced a hypersensitivity reaction on day 15 after a single 0.67 mg dose of pegvaliase within 15 minutes following medroxyprogesterone acetate injection, and subsequently experienced anaphylaxis on day 89 within 30 minutes after the next dose of medroxyprogesterone acetate injection. The second patient experienced a hypersensitivity reaction on day 40 after a single 0.08 mg dose of pegvaliase within 10 minutes following medroxyprogesterone acetate injection. Both patients had high anti-PEG IgG antibody titers at or around the time of the hypersensitivity reactions. In clinical trials, the majority of patients developed anti-PEG IgM and IgG antibodies after treatment with pegvaliase. The clinical effects of concomitant treatment with different PEGylated products is unknown.

MANAGEMENT: Close monitoring for anaphylaxis and other hypersensitivity reactions is recommended during concomitant use of pegvaliase with other PEGylated products or products that contain polyethylene glycol (e.g., certolizumab pegol; doxorubicin liposomal; eflapegrastim; epoetin beta-methoxy polyethylene glycol; irinotecan liposomal; medroxyprogesterone acetate suspension; naloxegol; pegademase bovine; pegaptanib; pegaspargase; pegfilgrastim; peginesatide; peginterferons; pegloticase; pegvisomant; certain formulations of recombinant antihemophilic factor and coagulation factor IX).