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C1 Esterase Inhibitor use while Breastfeeding

Drugs containing C1 Esterase Inhibitor: Berinert, Cinryze

C1 Esterase Inhibitor Levels and Effects while Breastfeeding

Summary of Use during Lactation

C1 esterase inhibitor [human] is a serine proteinase inhibitor derived from human plasma that is used in treating hereditary angioedema. Breastmilk levels of C1 esterase inhibitor have not been measured after exogenous administration in humans. Because of its large molecular weight, amounts in milk are expected to be small. Any C1 esterase inhibitor in breastmilk is probably destroyed in the infant's gastrointestinal tract and not absorbed, except perhaps in neonates. An international consensus panel states that human plasma-derived C1 esterase inhibitor is considered to be the therapy of choice for both treatment and prophylaxis of maternal hereditary angioedema during lactation.[1]

Drug Levels

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

Three patients with hereditary angioedema received C1 esterase inhibitor concentrate on 12 occasions to relieve abdominal edematous episodes during breastfeeding. No adverse reactions were reported.[2]

In a case series spanning 12 years, 21 mothers with hereditary angioedema breastfed their infants for a median duration of 4.8 months (range 1 to 34 months) while receiving C1 esterase inhibitor concentrate as needed. No side effects occurred tin the breastfed infants.[3]

A pregnant woman with severe hereditary angioedema required 500 IU of C1 inhibitor concentrate every 2 days to maintain her pregnancy. Postpartum, she received 500 IU on demand while breastfeeding. She used 88 vitals during her 6-month breastfeeding (extent not stated) period. No side effects or viral transmission were reported and or virus anti-C1-INH antibodies were not detected.[4] A woman with hereditary angioedema received C1 inhibitor concentrate 1000 units every week during pregnancy. Postpartum she used 500 units as needed. She and her breastfed infant were reportedly healthy.[5]

Effects on Lactation and Breastmilk

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

References

1. Caballero T, Farkas H, Bouillet L et al. International consensus and practical guidelines on the gynecologic and obstetric management of female patients with hereditary angioedema caused by C1 inhibitor deficiency. J Allergy Clin Immunol. 2012;129:308-20. PMID: 22197274

2. Czaller I, Visy B, Csuka D et al. The natural history of hereditary angioedema and the impact of treatment with human C1-inhibitor concentrate during pregnancy: a long-term survey. Eur J Obstet Gynecol Reprod Biol. 2010;152:44-9. PMID: 20541309

3. Martinez-Saguer I, Rusicke E, Aygoren-Pursun E et al. Characterization of acute hereditary angioedema attacks during pregnancy and breast-feeding and their treatment with C1 inhibitor concentrate. Am J Obstet Gynecol. 2010;203:131.e1-7. PMID: 20471627

4. Farkas H, Csuka D, Toth F et al. Successful pregnancy outcome after treatment with C1-inhibitor concentrate in a patient with hereditary angioedema and a history of four miscarriages. Eur J Obstet Gynecol Reprod Biol. 2012;165:366-7. PMID: 22884590

5. Baccioglu A , Kalpaklioglu AF. Successful pregnancy outcome after treatment with C1-inhibitor concentrate in a patient with hereditary angioedema. Allergy Eur J Allergy Clin Immunol. 2014;69:493-4. Abstract.

C1 Esterase Inhibitor Identification

Substance Name

C1 Esterase Inhibitor

CAS Registry Number

80295-38-1

Drug Class

Complement C1 Inactivator Proteins

Administrative Information

LactMed Record Number

969

Last Revision Date

20160401

Disclaimer

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