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.

Does galcanezumab affect 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

This medical response may not completely match the information in the current local labeling for GALCANEZUMAB. Please see local labeling for approved label information.

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 pregnancy exposure registry in the United States will compare maternal, fetal, and infant outcomes among pregnant women with migraine exposed to galcanezumab to those exposed or not exposed to other migraine medications.2

This study will enroll mothers with live births into each of the following groups:

  • women with migraine exposed to galcanezumab up to 5 months before or during pregnancy
  • pregnant women with migraine exposed to other migraine preventative medications, and
  • pregnant women with migraine not exposed to migraine preventative medications.2

Eligible women may self-enroll or be enrolled by their healthcare provider into the Lilly Migraine Pregnancy Registry by contacting 1-833-464-4724.2 This registry is only available in the United States.

References

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

2Ephross SA, Schroeder KM, Kellier-Steele NA, et al. Registry-based, prospective, observational study to assess maternal, fetal, and infant outcomes following exposure to migraine treatments, including galcanezumab. Poster presented at: Diamond Headache Clinic Research & Educational Foundation; July 15-18, 2021; Lake Buena Vista, FL.

Fecha de la última revisión: 2021 M07 19


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