Emgality® (Galcanezumab)

Para consultar la información para prescribir completa de Emgality® (Galcanezumab) de clic en el siguiente enlace: Información para prescribir

La información es proporcionada en respuesta a su solicitud, y puede contener datos relacionados a dosis, usos, formulaciones y poblaciones diferentes a la Información para Prescribir del producto. Consulte la Información para Prescribir en la liga que aparece arriba.

Can galcanezumab be used in pregnancy and lactation?

The safety of galcanezumab in pregnancy and lactation is unknown as these were exclusionary criteria in the clinical trials. Galcanezumab should be used in pregnancy only if the potential benefit justifies the potential risk to the mother or fetus.

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Summary of Galcanezumab Safety in Pregnancy and Lactation

There are insufficient human data to establish the safety of galcanezumab

  • during pregnancy, or
  • in women exposed via a male partner treated with galcanezumab.1

Effects of galcanezumab on human fetal development are unknown, as women who were pregnant or lactating were excluded from entering clinical studies.1

Women and men with reproductive potential were required to use a reliable method of birth control

  • during the clinical studies and
  • for 5 months following the final dose.1

Pregnancy was a criterion for permanent discontinuation from all galcanezumab studies.1

There are no data on

  • the presence of galcanezumab in human milk
  • the effects on the breastfed infant, or
  • the effects on milk production.1

Human IgG is known to be excreted in breast milk.1 As galcanezumab is an IgG4 mAb, it may be transmitted from the mother to the breastfed infant. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for galcanezumab and any potential adverse effects on the breastfed infant.1

Pregnancy Registry

A galcanezumab pregnancy registry is currently under review with the United States Food and Drug Administration. 

References

1Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Glossary

IgG = immunoglobulin G

mAb = monoclonal antibody

Fecha de la última revisión: 2021 M01 11


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