Although there are no data on pozelimab use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, monoclonal antibodies can be actively transported across the placenta.^L47850

In an animal reproduction study in monkeys, pozelimab did not adversely affect embryofetal or postnatal development when administered from pregnancy confirmation through parturition at doses that produced exposure up to 3.3 to 3.8 times the predicted clinical exposures.^L47850

Carcinogenicity studies have not been conducted with pozelimab. The mutagenic potential of pozelimab has not been evaluated; however, monoclonal antibodies are not expected to alter DNA or chromosomes.^L47850

Fertility studies have not been conducted with pozelimab. In a 6-month toxicity study in sexually-mature male and female monkeys, pozelimab had no adverse effects on histological or functional markers of reproductive function (e.g., estrous cyclicity, testicular volume, ejaculate amount, total sperm count per ejaculate, sperm motility and morphology, and histology of reproductive organs) at doses up to 100 mg/kg/week (11.9 to 13.9-fold the predicted exposures at the recommended clinical doses, on an AUC basis).^L47850

The most significant side effect of pozelimab is serious bacterial infections, particularly meningococcal infections due to the inhibition of the complement system. Meningococcal infections can deteriorate quickly if not detected and treated early; therefore, complete and updated or prophylaxis meningococcal vaccinations are recommended for patients according to the Advisory Committee on Immunization Practices (ACIP).^L47850