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Use in Pregnancy: IgG immunoglobulins are known to cross the placental barrier.
B-cell levels in human neonates following maternal exposure to MabThera 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 MabThera should not be administered to pregnant women unless the possible benefit outweighs the potential risk.
MabThera SC: The SC formulation contains recombinant human hyaluronidase (rHuPH20) (see Description).
Use in Lactation: It is not known whether rituximab is excreted in human breast milk. Given, however, that maternal IgG enters breast milk, MabThera should not be administered to nursing mothers.
