Is Glatiramer safe while breastfeeding?

Effects on the breastfed infant

Nine mothers received glatiramer acetate (dosage not stated) during pregnancy and postpartum for multiple sclerosis and breastfed their infants for an average of 3.6 months (range 1 to 12 months). No infections, signs of inadequate digestion or other important ill effects were reported in their breastfed infants during the neonatal period. Follow-up of the infants at 1 year or longer found no neurological or developmental deficits in the infants except for one otherwise normal infant with delayed language development who had been breastfed for 3 months.[ 8 ] Three mothers received glatiramer acetate (dosage not stated) for multiple sclerosis during pregnancy and postpartum. All of their infants were exclusively breastfed for 6 months and no noticeable problems were reported in any of them.[ 9 ] In data collected from 4 countries, 41 women received glatiramer acetate and 17 women received interferon during pregnancy and postpartum for treatment of multiple sclerosis. Of these, 63% breastfed (extent not stated) their infants for a mean of 8.8 months. No mention was made of adverse reactions in breastfed infants.[ 10 ] Among 1182 live birth pregnancies in the manufacturer s pharmacovigilance database, breastfeeding was reported for 14.3% of women (n = 169). During the first month after birth breastfeeding was reported in 10 mothers using 20 mg/mL daily and 64 using the 40 mg/mL three times weekly dosage regimen. Follow-up questionnaires were sent to patients or their healthcare providers at 1 and 12 months postpartum. Among 40 women who completed the 12-month questionnaires, 3 received the 20 mg/mL dose, 36 received the 40 mg/mL dose, and 1 received both doses. Of 27 women with known breastfeeding practices, exclusive breastfeeding for 4 or more months was reported for 17 (63.0%) respondents. Partial breastfeeding, defined as breastfeeding for less than 4 months or mixed breast and bottle feeding, was reported for ten (37.0%) mothers. The mean duration of exposure whil

Effects on milk supply

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

Levels in milk

Maternal Levels . In a manufacturer-sponsored study, healthy volunteers were given 60 mg of glatiramer acetate subcutaneously. Blood samples were obtained at 5, 15, 30, 60, 120, 240, and 360 minutes after injection. Glatiramer was undetectable ( 50 mcg/L) in the serum of 8 of 17 subjects; it was detectable for up to 30 minutes in 8 subjects and up to 360 minutes in one other. Assuming that milk levels equal peak serum levels, the authors estimated that in the worst-case scenario, an exclusively breastfed infant would receive a relative infant dose of 9% of the maternal weight-adjusted dosage in milk. However, the infant would be systemically exposed to a maximum of only 0.2% of the mother s dose when the poor oral bioavailability is considered.[ 7 ] Infant Levels. Relevant published information was not found as of the revision date.

Alternatives LactMed lists

• Immune Globulin
• Interferon Beta
• Methylprednisolone