Rixathon Use In Pregnancy & Lactation

Women of childbearing potential/Contraception in females: Due to the long retention time of rituximab in B cell depleted patients, women of childbearing potential should use effective contraceptive methods during and for 12 months following treatment with rituximab.
Pregnancy: IgG immunoglobulins are known to cross the placental barrier.
B cell levels in human neonates following maternal exposure to rituximab have not been studied in clinical trials. There are no adequate and well-controlled data from studies in pregnant women, however transient B-cell depletion and lymphocytopenia have been reported in some infants born to mothers exposed to rituximab during pregnancy. Similar effects have been observed in animal studies (see Pharmacology: Toxicology: Preclinical safety data under Actions). For these reasons rituximab should not be administered to pregnant women unless the possible benefit outweighs the potential risk.
Breast-feeding: Whether rituximab is excreted in human milk is not known. However, because maternal IgG is excreted in human milk, and rituximab was detectable in milk from lactating monkeys, women should not breastfeed while treated with rituximab and for 12 months following rituximab treatment.
Fertility: Animal studies did not reveal deleterious effects of rituximab on reproductive organs.