Emgality for Migraine in Breastmilk

Levels of galcanezumab (μg/mL) in the breastmilk of women at the selected timepoints before and after each treatment (24H pre, 24H post, 7D post, 28D post). For the third treatment, only 7D post will be collected. This outcome will be measured by breastmilk concentration (μg/mL).

Levels of galcanezumab (μg/mL) in the breastmilk of women at the selected timepoints before and after each treatment (24H pre, 24H post, 7D post, 28D post). For the third treatment, only 7D post will be collected. This outcome will be measured by average breastmilk concentration (CAVE, determined using pharmacokinetic methods).

Levels of galcanezumab (μg/mL) in the breastmilk of women at the selected timepoints before and after each treatment (24H pre, 24H post, 7D post, 28D post). For the third treatment, only 7D post will be collected. This outcome will be measured by maximum concentration of galcanezumab in breastmilk (CMAX).

Levels of galcanezumab (μg/mL) in the breastmilk of women at the selected timepoints before and after each treatment (24H pre, 24H post, 7D post, 28D post). For the third treatment, only 7D post will be collected. This outcome will be measured by absolute average galcanezumab dose to the infant in a 24-hour period.

Levels of galcanezumab (μg/mL) in the breastmilk of women at the selected timepoints before and after each treatment (24H pre, 24H post, 7D post, 28D post). For the third treatment, only 7D post will be collected. This outcome will be measured by maximum galcanezumab dose to the infant in a 24-hour period.

Levels of galcanezumab (μg/mL) in the breastmilk of women at the selected timepoints before and after each treatment (24H pre, 24H post, 7D post, 28D post). For the third treatment, only 7D post will be collected. This outcome will be measured by average relative infant dose (RIDAVE).

The investigators hypothesize that given that galcanezumab is an IgG mAb, it will similarly show very low concentrations, and acceptable relative infant dose (RID) (<1%).

Levels of galcanezumab (μg/mL) in the breastmilk of women at the selected timepoints before and after each treatment (24H pre, 24H post, 7D post, 28D post). For the third treatment, only 7D post will be collected. This outcome will be measured by maximum relative infant dose (RIDMAX).

The investigators hypothesize that given that galcanezumab is an IgG mAb, it will similarly show very low concentrations, and acceptable relative infant dose (RID) (<1%).

The Ages and Stages Questionnaire, third edition, (ASQ-3) will be completed by participating mothers at the following timepoints postpartum, to determine the developmental age of infants at 6 months. The questionnaire scores 5 areas of development: Communication, Gross Motor, Fine Motor, Problem Solving and Personal-Social. Cumulative scores range from 0 to 60. Higher scores indicate more positive outcomes. Each version of the ASQ-3 has different cutoff scores that indicate whether the child's development appears to be on schedule, requires monitoring or requires further assessment. (Above and Monitoring Ranges indicate on schedule infant development for age).

The Ages and Stages Questionnaire, third edition, (ASQ-3) will be completed by participating mothers at the following timepoints postpartum, to determine the developmental age of infants at 12 months. The questionnaire scores 5 areas of development: Communication, Gross Motor, Fine Motor, Problem Solving and Personal-Social. Cumulative scores range from 0 to 60. Higher scores indicate more positive outcomes. Each version of the ASQ-3 has different cutoff scores that indicate whether the child's development appears to be on schedule, requires monitoring or requires further assessment. (Above and Monitoring Ranges indicate on schedule infant development for age).

Newborn adjusted length (in cm) will be collected by manual review of infant medical records at all visits occurring in the first 12 months of life.

Newborn weight (in kg) will be collected by manual review of infant medical records at all visits occurring in the first 12 months of life.

Newborn head circumference (in cm) will be collected by manual review of infant medical records at all visits occurring in the first 12 months of life.

The number of and nature of each newborn infections will be collected by manual review of infant medical records at all visits occurring in the first 12 months of life.

The number of instances of newborn constipation along with any relevant evidence will be collected by manual review of infant medical records at all visits occurring in the first 12 months of life.

Levels of galcanezumab (μg/mL) in the breastmilk of women at the selected timepoints before and after each treatment (24H pre, 24H post, 7D post, 28D post). For the third treatment, only 7D post will be collected. The average peak level of galcanezumab concentration will be determined from this.

The maternal migraine diary will be completed by participating mothers in the months surrounding their galcanezumab treatments. It tracks headache severity by asking participants to self-report their percieved headache severity on a scale of 0-10 daily.

The maternal migraine diary will be completed by participating mothers in the months surrounding their galcanezumab treatments. It tracks headache dats by asking participants to self-report whether or not they experienced at least one migraine daily.

The maternal migraine diary will be completed by participating mothers in the months surrounding their galcanezumab treatments. It tracks acute medication use by asking participants to self-report what acute medications they use to manage their migraines and when.