Rixathon Use In Pregnancy & Lactation

Contraception in males and 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: Limited data on rituximab excretion into breast milk suggest very low milk levels (relative infant dose less than 0.4%). Few cases of follow-up of breastfed infants describe normal growth and development up to 1.5 years. However, as these data are limited, and the long-term outcomes of breastfed infants remain unknown. Breastfeeding is not recommended while being treated with rituximab and optimally for 12 months following rituximab treatment.
Fertility: Animal studies did not reveal deleterious effects of rituximab on reproductive organs.