Galcanezumab

The Basics

What is Galcanezumab?

Used to help prevent migraine headaches as well as to treat the symptoms of a cluster headache.

Brand names for Galcanezumab

Emgality

How Galcanezumab is classified

Antibodies – Monoclonal

Galcanezumab During Pregnancy

Galcanezumab pregnancy category

Category N/ANote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Galcanezumab while pregnant

There are no adequate data on the developmental risk associated with the use of EMGALITY in pregnant women. Administration of galcanezumab-gnlm to rats and rabbits during the period of organogenesis or to rats throughout pregnancy and lactation at plasma exposures greater than that expected clinically did not result in adverse effects on development (see Animal Data). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% – 4% and 15% – 20%, respectively. The estimated rate of major birth defects (2.2% – 2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal And/Or Embryo/Fetal Risk Published data have suggested that women with migraine may be at increased risk of preeclampsia during pregnancy.

Taking Galcanezumab While Breastfeeding

What are recommendations for lactation if you're taking Galcanezumab?

No information is available on the clinical use of galcanezumab during breastfeeding. Because galcanezumab is a large protein molecule with a molecular weight of about 147,000, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant’s gastrointestinal tract. Until more data become available, galcanezumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. Galcanezumab is a human immunoglobulin G4 (IgG4) antibody. Holder pasteurization (62.5 degrees C for 30 minutes) decreases the concentration of endogenous immunoglobulin G in mature milk by 60 to 79%.[1][2] A study of 67 colostrum samples that underwent Holder pasteurization found that IgG amounts decreased by 34 to 40%. Specific IgG subclasses decreased by different amounts, with Holder pasteurization having little effect on IgG4.[3] None of the studies measured IgG activity.

Maternal / infant drug levels

No information is available on the clinical use of galcanezumab during breastfeeding. Because galcanezumab is a large protein molecule with a molecular weight of about 147,000, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant’s gastrointestinal tract. Until more data become available, galcanezumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. Galcanezumab is a human immunoglobulin G4 (IgG4) antibody. Holder pasteurization (62.5 degrees C for 30 minutes) decreases the concentration of endogenous immunoglobulin G in mature milk by 60 to 79%.[1][2] A study of 67 colostrum samples that underwent Holder pasteurization found that IgG amounts decreased by 34 to 40%. Specific IgG subclasses decreased by different amounts, with Holder pasteurization having little effect on IgG4.[3] None of the studies measured IgG activity.

Possible effects of Galcanezumab on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Galcanezumab

None listed