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Women of childbearing potential: Women of childbearing potential should use contraception while receiving ocrelizumab and for 12 months after the last infusion of ocrelizumab.
Pregnancy: There is a limited amount of data from the use of ocrelizumab in pregnant women. Ocrelizumab is an immunoglobulin G (IgG). IgG is known to cross the placental barrier. Postponing vaccination with live or live-attenuated vaccines should be considered for neonates and infants born to mothers who have been exposed to ocrelizumab in utero. No B cell count data have been collected in neonates and infants exposed to ocrelizumab and the potential duration of B-cell depletion in neonates and infants is unknown (see Precautions).
Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 antibodies during pregnancy.
Animal studies (embryo-foetal toxicity) do not indicate teratogenic effects. However, B-cell depletion in utero was detected. Reproductive toxicity was observed in pre- and post-natal development studies (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Ocrelizumab should be avoided during pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus.
Breast-feeding: It is unknown whether ocrelizumab/metabolites are excreted in human milk. Available pharmacodynamic/toxicological data in animals have shown excretion of ocrelizumab in milk (see Pharmacology: Toxicology: Preclinical safety data under Actions). A risk to neonates and infants cannot be excluded. Women should be advised to discontinue breast-feeding during therapy.
Fertility: Preclinical data reveal no special hazards for humans based on studies of male and female fertility in cynomolgus monkeys.
