Velaglucerase alfa and Breastfeeding

Summary of use during lactation

No information is available on the clinical use of velaglucerase during breastfeeding. Velaglucerase is a synthetic form of beta-glucocerebrosidase, which is a normal component of human milk, but has an identical amino acid sequence to the normal enzyme. Studies with other forms of the enzyme have found very low levels of the enzyme in breastmilk. Absorption by the infant is unlikely because it is probably destroyed in the infant's gastrointestinal tract.[1,2] A limited amount of data support the safety of breastfeeding with alglucerase (the placenta-derived form of the enzyme) and imiglucerase (another biosynthetic form of the enzyme). An international panel of clinicians from 9 centers that treat Gaucher's disease reported that, breastfeeding complications were less frequent in mothers who were treated with alglucerase or imiglucerase postpartum than in untreated mothers with Gaucher's disease. Consider limiting the duration of breastfeeding to about 6 months to avoid excessive bone loss in the nursing mother.[2,3]

Drug levels in milk and infant serum

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

Effects in breastfed infants

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

Effects on lactation and breastmilk

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

Alternative drugs to consider

Alglucerase, Imiglucerase, Taliglucerase Alfa

References

1. Belmatoug N. Considerations for pregnant patients with Gaucher disease: Challenges for the patient and physician. Clin Ther 2009;31 (Suppl. C):S192-S3. doi:10.1016/S0149-2918(09)80019-2
2. Zimran A, Morris E, Mengel E, et al. The female Gaucher patient: The impact of enzyme replacement therapy around key reproductive events (menstruation, pregnancy and menopause). Blood Cells Molec Dis 2009;43:264-88.19502088 PubMed
3. Granovsky-Grisaru S, Belmatoug N, vom Dahl, S, et al. The management of pregnancy in Gaucher disease. Eur J Obstet Gynecol Reprod Biol 2011;156:3-8.21269752 PubMed