If you wish to report an adverse event or product complaint, please call 1-800-LILLYRX (1-800-545-5979)
Emgality ® (galcanezumab-gnlm) injection
100 mg/mL, 120 mg/mL
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
Is it necessary to stop Emgality® (galcanezumab-gnlm) before becoming pregnant?
There is no information on which to base a recommendation for a washout period for those who are receiving Emgality (galcanezumab) and are planning to become pregnant.
Planning to Become Pregnant
No Adverse Effect Observed on Fertility Parameters With Galcanezumab Exposure (Preclinical Data Only)
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).2 No adverse effect was observed on fertility parameters such as
No Adverse Effect Observed on Fetal Development or Postnatal Parameters with Galcanezumab Exposure (Preclinical Data Only)
Embryofetal development studies conducted in rats and rabbits at exposures greater than expected clinically revealed no evidence of harm to the developing fetus.2
In offspring exposed to galcanezumab in utero and through lactation at exposures greater than expected clinically in the prenatal and postnatal development study in rats, there were no effects on
No Information for Recommendation of Galcanezumab Washout Period Prior to Pregnancy
There is no information on which to base a recommendation for a washout period for those who are receiving galcanezumab and are planning to become pregnant.
Galcanezumab is an IgG4 monoclonal antibody and is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.2,3
The elimination half-life (t1/2) of galcanezumab is 27 days.2,3
HCP Considerations When Prescribing Galcanezumab to a Patient Who is Planning to Become Pregnant
In determining the most appropriate approach in a patient treated with galcanezumab who is planning to become pregnant, clinicians should
- take into consideration the t1/2 of the molecule, and
- use their clinical judgment.
Pregnancy Registry and Observational Study Will Compare Maternal, Fetal, and Infant Outcomes
A pregnancy exposure registry and subsequent registry-based prospective observational study in the United States will compare maternal, fetal, and infant outcomes.
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
Lilly Migraine Pregnancy Registry Enrollment Information
Eligible women may self-enroll, or be enrolled by their healthcare provider into the Lilly Migraine Pregnancy Registry by
- accessing the registry website at www.migrainepregnancyregistry.com, or
- calling 1-833-464-4724.2,4
This registry is only available in the United States.
Enclosed Prescribing Information
References
The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).
1Data on file, Eli Lilly and Company and/or one of its subsidiaries.
2Emgality [package insert]. Indianapolis, IN: Eli Lilly and Company; 2021.
3Kielbasa W, Helton DL. A new era for migraine: pharmacokinetic and pharmacodynamic insights into monoclonal antibodies with a focus on galcanezumab, an anti-CGRP antibody. Cephalalgia. 2019;39(10):1284-1297. http://dx.doi.org/10.1177/0333102419840780
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.
Date of Last Review: June 25, 2022