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 immunoglobulin G subclass 4 (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 elimination half-life (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 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.3

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.3

Eligible women may self-enroll or be enrolled by their healthcare provider into the Lilly Migraine Pregnancy Registry by contacting 1-833-464-4724.3 This registry is only available in the United States.

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).

1Kielbasa 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

2Emgality [package insert]. Indianapolis, IN: Eli Lilly and Company; 2019.

3Ephross 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: July 19, 2021


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