Emgality® (Galcanezumab)

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

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What effect does galcanezumab have on fertility?

There are no adequate data on the effect on fertility with the use of galcanezumab in humans. Galcanezumab should be used in pregnancy only if the potential benefit justifies the potential risk to the mother or fetus.

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Becoming Pregnant: Effect on Fertility

There are no adequate data on the effect on fertility with the use of galcanezumab in humans, as patients of reproductive potential were required to use birth control during the studies.1

Galcanezumab was administered to rats at subcutaneous doses of up to 250 mg/kg  (representing exposures 4-18 times the highest proposed clinical dose of 300 mg). No adverse effect was observed on fertility parameters such as

  • reproductive organs
  • estrous cycle
  • sperm analysis, or
  • mating and fertility.1

Clinicians should use their clinical judgment in determining the most appropriate approach in a patient treated with galcanezumab who is planning to become pregnant.

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.

Fecha de la última revisión: 2021 M01 11


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