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.

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Planning to Become Pregnant: Washout Period

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.1,2

The t1/2 of galcanezumab is 27 days.1,2

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. 

Pregnancy or related events can be reported to

  • the Food and Drug Administration at 1-800-FDA-1088 or www.fda.gov/medwatch, or
  • Eli Lilly and Company at 1-800-LILLYRX (1-800-545-5979).

References

The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).

1Emgality [package insert]. Indianapolis, IN: Eli Lilly and Company; 2019.

2Kielbasa 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

Glossary

IgG = immunoglobulin G

IgG4 = immunoglobulin G (subclass) 4

t1/2 = elimination half-life

Date of Last Review: January 11, 2021


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