Truxima Use In Pregnancy & Lactation

Females and Males of Reproductive Potential: Fertility: No preclinical fertility studies have been conducted.
Animal data: Developmental toxicity studies performed in cynomolgus monkeys revealed no evidence of embryotoxicity in utero. Newborn offspring of maternal animals exposed to rituximab were noted to have depleted B cell populations during the post natal phase.
Contraception: Women of childbearing age should employ effective contraceptive methods during and for up to 12 months after 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. For these reasons rituximab should not be administered to pregnant women unless the possible benefit outweighs the potential risk.
Nursing Mothers: It is not known whether rituximab is excreted in human breast milk. Given, however, that maternal IgG enters breast milk, rituximab should not be administered to nursing mothers.