Rixathon Use In Pregnancy & Lactation

Females and Males of Reproductive Potential: Fertility: No preclinical fertility studies have been conducted.
Contraception: Due to the long retention time of rituximab in B cell depleted patients, women of childbearing age must employ effective contraceptive methods during and for 12 months after treatment with RIXATHON.
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.
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 RIXATHON should not be administered to pregnant women unless the possible benefit outweighs the potential risk.
Breast-feeding: Maternal IgG enters breast milk, and rituximab has been reported to be excreted at low concentrations in human breast milk. Given that the clinical significance of this finding for infants is not known, rituximab should not be administered to nursing mothers.