Imiglucerase

Drug Levels and Effects:




Summary of Use during Lactation:


Because imiglucerase 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 imiglucerase. 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 imiglucerase or alglucerase (the placenta-derived form of the enzyme) 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.

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 ascontrols. 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 thecontrolsubjects ranged from 0.067 to 0.214 nanomoles/hour/mL.[4]

One woman received 60 units/kg of alglucerase intravenously. Alglucerase appeared in breastmilk in levels above the baselinecontrolvalues at 12, 6, 12, 24 and 48 hours postinfusion. Concentrations ranged between 67 and 187 mg/L above baseline.[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.[4]


Possible Effects on Lactation:


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


Alternate Drugs to Consider:


Alglucerase


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. 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
5. Esplin J, Greenspoon JS, Cheng E et al. Alglucerase infusions in pregnant type 1 Gaucher patients. Blood. 1993;82:509a. Abstract.
6. Aporta Rodriguez R, Escobar Vedia JL 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:

Imiglucerase

CAS Registry Number:

143003-46-7

Drug Class:


  • Enzymes

  • Enzyme Replacement Therapy


  • Administrative Information:




    LactMed Record Number:


    787


    Last Revision Date:


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