Is Imiglucerase safe while breastfeeding?

Effects on the breastfed infant

A woman received imiglucerase 30 units/kg every 2 weeks during pregnancy and for 3 months while breastfeeding. The dose was then increased to 60 units/kg every 2 weeks because of disease progression, and she continued breastfeeding until the infant was 1 year old.[ 7 ] A woman receiving long-term therapy with imiglucerase 60 units/kg intravenously every 2 weeks became pregnant twice during therapy and breastfed both infants (extent not stated). Both infants developed normally during the observation periods of 13 and 33 months.[ 6 ] A woman with type 1 Gaucher s disease was exclusively breastfeeding her infant postpartum re-initiated intravenous imiglucerase 30 units/kg every 2 weeks beginning at 1 month postpartum. The infant was breastfed for about 9 months postpartum and was reportedly healthy when followed up to 3 years of age.[ 1 ] A woman with Gaucher s disease received imiglucerase 1800 units (30 units/kg) every 2 weeks during pregnancy and postpartum. Her infant was breastfed (extent not stated) and was followed by a pediatrician who determined that development was normal over 2 years.[ 8 ]

Effects on milk supply

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

Levels in milk

Maternal Levels . A woman on long-term imiglucerase therapy for Gaucher s disease was monitored after her usual dose of 60 units/kg intravenously every 2 weeks. At 6 months postpartum, milk samples were obtained and measured for beta-glucocerebrosidase activity, using milk from 10 mothers with galactorrhea as controls. The highest enzyme activity in milk was 16 nanomoles/hour/mL at 1 hour after the end of the infusion. Enzymatic activity decreased to the preinfusion level (0.008 nanomoles/hour/mL) in the samples of breastmilk taken about 5 hours after the end of the infusion and remained low for all samples taken over the first 24 hours after the dose. Breastmilk beta-glucocerebrosidase activity of the control subjects ranged from 0.067 to 0.214 nanomoles/hour/mL.[ 6 ] A woman with type 1 Gaucher s disease was exclusively breastfeeding her infant postpartum re-initiated intravenous imiglucerase 30 units/kg over 2 hours every 2 weeks at 1 month postpartum. Milk beta-glucocerebrosidase activity was measured at the time of her first postpartum dose, milk. Before the infusion activity was 2 nanomoles/hour/mL. Milk levels were 3 and 4 nanomoles/hour/mL immediately after and 30 minutes after the infusion, respectively. These values were much lower than the level of 42 nanomoles/hour/mL measured in the milk of a control mother without Gaucher s disease.[ 1 ] Infant Levels . Relevant published information was not found as of the revision date.

Alternatives LactMed lists

• Alglucerase
• Taliglucerase Alfa