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Belimumab Pregnancy and Breastfeeding Warnings

Belimumab is also known as: Benlysta

Medically reviewed on December 6, 2017

Belimumab Pregnancy Warnings

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: C
US FDA pregnancy category: C

Comments: Women of child-bearing potential must use effective contraception during treatment and for at least 4 months after the last treatment.

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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Belimumab Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. BENLYSTA (belimumab)." GlaxoSmithKline, Research Triangle Park, NC.
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. "Product Information. BENLYSTA (belimumab)." GlaxoSmithKline, Research Triangle Park, NC.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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