Velaglucerase alfa

Drug Levels and Effects:




Summary of Use during Lactation:


No data exist on the use of velaglucerase during breastfeeding. Because it is an enzyme, it is likely to be destroyed in the infant's gastrointestinal tract and not absorbed systemically.[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:


Maternal Levels.

One woman received 60 units/kg of alglucerase intravenously. Alglucerase appeared in breastmilk in levels above the baseline control values at 2, 6, 12, 24 and 48 hours postinfusion. Concentrations ranged between 69 and 187 ng/L above baseline.[4]

In one patient taking imiglucerase 60 units/kg every 2 weeks, the imiglucerase level in breastmilk was elevated above baseline at 1 hour afer the end of the infusion and was at baseline by 5 hours after the dose.[5]

Infant Levels.

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


Effects in Breastfed Infants:


One woman received alglucerase 30 international units/kg intravenously every 2 weeks during pregnancy and lactation. Her breastfed infant reportedly grew and developed normally.[6]

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.[5]


Possible Effects on Lactation:


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


Alternate Drugs to Consider:


Alglucerase,Imiglucerase


References:


1. Belmatoug N. Considerations for pregnant patients with Gaucher disease: challenges for the patient and physician. Clin Ther. 2009;31 (Suppl. C):S192-3.
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. PMID:19502088
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. PMID:21269752
4. Esplin J, Greenspoon JS, Cheng E et al. Alglucerase infusions in pregnant type 1 Gaucher patients. Blood. 1993;82:509a. Abstract.
5. Sekijima Y, Ohashi T, Ohira S et al. Successful pregnancy and lactation outcome in a patient with Gaucher disease receiving enzyme replacement therapy, and the subsequent distribution and excretion of imiglucerase in human breast milk. Clin Ther. 2010;32:2048-52. PMID:21118740
6. Aporta Rodriguez R, Escobar Vedia JL, Navarro Castro AM et al. Alglucerase enzyme replacement therapy used safely and effectively throughout the whole pregnancy of a Gaucher disease patient. Haematologica. 1998;83:852-3. PMID:9825582
7. Mrsic M, Fumic K, Potocki R, Stern-Padovan R. Successful pregnancy of enzyme replacement therapy with Cerezyme . Clin Ther. 2007;29 (Suppl C):S84. Abstract.



Substance Identification:




Substance Name:

Velaglucerasealfa

CAS Registry Number:

884604-91-5

Drug Class:


  • Enzymes

  • Enzyme Replacement Therapy


  • Administrative Information:




    LactMed Record Number:


    803


    Last Revision Date:


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