Pregnancy: There are no adequate data from the use of Actemra in pregnant women. A study in monkeys did not indicate any dysmorphogenic potential but has yielded higher number of spontaneous abortion /embryo-fetal death at a high dose (see Pharmacology: Toxicology: Other under Actions). The relevance of these data for humans is unknown. Women of childbearing potential must use effective contraception during and up to 6 months after treatment. Actemra should not be used during pregnancy unless clearly indicated by medical need.
Nursing Mothers: It is unknown whether Actemra is excreted in human breast milk. Although endogenous immunoglobulins of the IgG isotope are secreted into human milk, a systemic absorption of Actemra via breast feeding is unlikely due to the rapid proteolytic degradation of such proteins in the digestive system. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Actemra should be made taking into account the benefit of breast-feeding to the child and the benefit of Actemra therapy to the woman.