Benlysta Use In Pregnancy & Lactation

Fertility: There are no data on the effects of BENLYSTA on human fertility. Effects on male and female fertility have not been evaluated in animal studies (see Pharmacology: Toxicology: Non-Clinical Information under Actions).
Pregnancy: There are limited data on the use of BENLYSTA in pregnant women. Post-marketing data from a prospective pregnancy registry have collected pregnancy information in women exposed to belimumab. Due to the small sample size achieved, no definitive conclusions from this registry can be made regarding a potential risk of birth defects following exposure to belimumab. Immunoglobulin G (IgG) antibodies, including belimumab, can cross the placenta. BENLYSTA should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
If prevention of pregnancy is warranted, women of childbearing potential should use adequate contraception while using BENLYSTA and for at least four months after the last BENLYSTA treatment.
Animal studies did not indicate direct or indirect harmful effects with respect to maternal toxicity, pregnancy or embryofoetal development. Treatment-related findings were limited to reversible reductions in B cells in infant monkeys (see Pharmacology: Toxicology: Non-Clinical Information under Actions). Monitor infants of treated mothers for B-cell reduction and depending upon the results, consider delaying infant vaccination with live viral vaccines. B-cell reduction in infants may also interfere with the response to immunisations (see Precautions).
Lactation: The safety of BENLYSTA for use during lactation has not been established. There are no data regarding the excretion of belimumab in human milk, or systemic absorption of belimumab after ingestion. Although belimumab was excreted into the milk of cynomolgus monkeys, published literature suggests that human neonatal and infant consumption of breast milk does not result in clinically significant absorption of maternal IgG antibodies into circulation.
It is recommended that a decision should be made about BENLYSTA therapy in breast-feeding mothers, taking into account the importance of breast-feeding to the infant and the importance of the drug to the mother, and any potential adverse effects on the breastfed child from belimumab or from the underlying maternal condition.