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What postmarketing data is available for patients who are pregnant or nursing and taking galcanezumab?
Eli Lilly and Company continues to monitor the postmarketing safety of galcanezumab. Reporting rates of pregnancy events from the Eli Lilly and Company spontaneous AE database are provided in this response.
Postmarketing Spontaneous Reports
This medical response may not completely match the information in the current local labeling for GALCANEZUMAB. Please see local labeling for approved label information.
Through March 27, 2021, Medical Dictionary for Regulatory Activities (MedDRA) terms related to pregnancy and lactation that have been reported in the Eli Lilly and Company spontaneous adverse event database are provided in .
Rarely Reported (≥0.01% and <0.1%)
Very Rarely Reported (<0.01%)
Maternal exposure during pregnancy
Exposure during pregnancy, exposure via breast milk, fetal exposure during pregnancy, maternal exposure before pregnancy, maternal exposure during breastfeeding, maternal exposure timing unspecified, paternal exposure during pregnancy, pregnancy with advanced maternal age, premature baby, premature delivery
Postmarketing data do not necessarily represent the rate of occurrence of an adverse event (AE) in a treated population, but they represent a reporting rate of a particular AE to the company. Spontaneous reporting of AEs can be highly variable and is not appropriately controlled clinical information on which to base an assessment of whether a particular drug product is the causal agent of an event.2
Spontaneous reporting has limited use due to
- lack of control population
- under-reporting or reporting bias, and
- missing or incomplete information regarding medical history or concomitant medications.2
Postmarketing Spontaneous Reports From the WHO Pharmacovigilance Database
The World Health Organization (WHO) published a report of postmarketing pregnancy events reported by patients receiving either erenumab, galcanezumab, or fremanezumab through December 31, 2019.3 Reports classified in the "Pregnancy and neonatal topics" standard MedDRA query (SMQ; MedDRA version 22.1) were retrieved from the WHO pharmacovigilance database of safety reports of suspected adverse drug reactions (VigiBase). This analysis included 94 safety reports from the specified SMQ, of which 31 were associated with galcanezumab, and of those 28 were safety reports reporting only drug exposure. The remaining 3 reports comprised 1 report of spontaneous abortion, and 2 reports of a maternal adverse drug reaction. Based on the VigiBase data, the WHO review of the use of calcitonin gene-related peptide monoclonal antibodies in pregnancy and lactation did not identify
- specific maternal toxicities
- patterns of major birth defects, or
- increased reporting of spontaneous abortion.3
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.4
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.4
Eligible women may self-enroll or be enrolled by their healthcare provider into the Lilly Migraine Pregnancy Registry by contacting 1-833-464-4724.4 This registry is only available in the United States.
1Data on file, Eli Lilly and Company and/or one of its subsidiaries.
2Goldman SA. Limitations and strengths of spontaneous reports data. Clin Ther. 1998;20(suppl 3):C40-C44. http://dx.doi.org/10.1016/S0149-2918(98)80007-6
3Noseda R, Bedussi F, Gobbi C, et al. Safety profile of erenumab, galcanezumab and fremanezumab in pregnancy and lactation: analysis of the WHO pharmacovigilance database. Cephalalgia. 2021;41(7):789-798. http://dx.doi.org/10.1177/0333102420983292
4Ephross 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