Benlysta Pregnancy Warnings
This drug should be used during pregnancy only if the benefit outweighs the risk.
AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned.
Risk Summary: Available data on use of this drug in pregnant women are insufficient to determine whether there is a drug-associated risk for major birth defects or miscarriage. There are risks to the mother and fetus associated with SLE. Monoclonal antibodies, such as this drug, are actively transported across the placenta during the third trimester of pregnancy and may affect immune response in the in utero-exposed infant.
Comments:
-A pregnancy exposure registry is available.
-Women of child-bearing potential should use effective contraception during therapy and for at least 4 months after.
Animal studies did not show maternal toxicity, developmental toxicity, or teratogenicity. This drug crosses the placenta. Reversible reductions in B cells and IgM were seen; B cells recovered by 3 months and IgM by 6 months of life in the offspring. Fetal and infant deaths were seen in animal studies. The cause of the deaths is not known; the relevance of these findings to humans is not known. There are no adequate or well-controlled studies in pregnant women.
To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves. For additional information see: http://pregnancyregistry.gsk.com/belimumab.html .
AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.
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