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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.
Summary of Galcanezumab Safety in Pregnancy and Lactation
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 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 immunoglobulin G (IgG) is known to be excreted in breast milk; therefore, galcanezumab 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
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.
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