Last update Sept. 23, 2023

Human plasma protease C1 inhibitor (C1 esterase inhibitor) (N,O-glycosylated recombinant protein expressed in the mammary gland of transgenic rabbits), glycoformα

Compatible

Safe substance and/or breastfeeding is the best option.

Complement esterase inhibitor C1, a plasma glycoprotein, is an endogenous complement blocker that is prepared from human plasma, in which it is found naturally. Indicated in acute attacks of hereditary angioedema (HAE) of moderate to severe intensity in pediatric and adult patients. Its molecular weight is 105,000 daltons and its T ½ is between 40 and 90 hours.

Conestat alfa is a recombinant analogue of the human C1 esterase inhibitor (rhC1-INH) produced by recombinant DNA technology. It is indicated for treatment of acute angioedema attacks in patients aged 2 years and above with hereditary angioedema (HAE) due to C1 esterase inhibitor deficiency. Its molecular weight is 67,000 daltons and its T ½ is 2 to 2.5 hours.

Administration by infusion or slow intravenous injection.

Since the last update we have not found published data on its excretion in breastmilk.

Its very high molecular weight make it highly unlikely that significant quantities will pass into breast milk. (Hale, AEMPS 2021)

Due to its protein nature it would be digested and inactivated in the gastrointestinal tract, not being absorbed as such but in the form of loose amino acids, which is why its oral bioavailability is practically zero. (Hale)

No problems have been seen in nursing infants whose mothers were treated with this drug. (Battle 2022, Staubach 2021, Andarawewa 2021, Baccioglu 2014, Martinez 2010)

Several medical societies and expert consensus consider the use of this medication to be safe during breastfeeding.(Maurer 2022, Jakes 2021)

Expert authors consider C1 esterase inhibitor to be the drug of first choice for the treatment of hereditary angioedema during pregnancy and lactation. (Yeich 2023, Bouillet 2015)

 

Alternatives

  • Tranexamic Acid (Safe substance and/or breastfeeding is the best option.)

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

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Other names

Human plasma protease C1 inhibitor (C1 esterase inhibitor) (N,O-glycosylated recombinant protein expressed in the mammary gland of transgenic rabbits), glycoformα is Complement C1 Esterase Inhibitor in Chemical name.

Is written in other languages:

Human plasma protease C1 inhibitor (C1 esterase inhibitor) (N,O-glycosylated recombinant protein expressed in the mammary gland of transgenic rabbits), glycoformα is also known as

Group

Human plasma protease C1 inhibitor (C1 esterase inhibitor) (N,O-glycosylated recombinant protein expressed in the mammary gland of transgenic rabbits), glycoformα belongs to this group or family:

Tradenames

Main tradenames from several countries containing Human plasma protease C1 inhibitor (C1 esterase inhibitor) (N,O-glycosylated recombinant protein expressed in the mammary gland of transgenic rabbits), glycoformα in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. ≈ 0 %
Molecular weight 67.000 - 105.000 daltons
VD 0.04 l/Kg
Tmax 0.3 ± 0.1 hours
T½ Conestat: 2.5; C1 Inhib: 20-60 hours

References

  1. Hale TW. Medications & Mothers' Milk. 1991- . Springer Publishing Company. Available from https://www.halesmeds.com Consulted on April 10, 2024 Full text (link to original source)
  2. Yeich A, Elhatw A, Ashoor Z, Park K, Craig T. Safety of medications for hereditary angioedema during pregnancy and lactation. Expert Opin Drug Saf. 2023 Jan;22(1):17-24. Consulted on Sept. 22, 2023 Abstract
  3. Maurer M, Magerl M, Betschel S, Aberer W, Ansotegui IJ, Aygören-Pürsün E, Banerji A, Bara NA, Boccon-Gibod I, Bork K, Bouillet L, Balle Boysen H, Brodszki N, Busse PJ, Bygum A, Caballero T, Cancian M, Castaldo A, Cohn DM, Csuka D, Farkas H, Gompels M, et al. The international WAO/EAACI guideline for the management of hereditary angioedema - the 2021 revision and update. Allergy. 2022 Jan 10. Abstract Full text (link to original source) Full text (in our servers)
  4. Batlle AR, do Carmo APP, Galao N, Grumach AS. Management of hereditary angioedema type I and homozygous MTHFR mutation during pregnancy. Allergol Immunopathol (Madr). 2021 Jul 1;49(4):1-3. Abstract
  5. Jakes AD, Thorne I, Guly J, Kiani-Alikhan S, Banerjee A. Case report: Hereditary angioedema in pregnancy. Obstet Med. 2021 Sep;14(3):177-180. Abstract Full text (link to original source)
  6. Staubach-Renz P. Subcutaneous C1-esterase inhibitor therapy throughout pregnancy and breastfeeding in a patient with hereditary angioedema: A case report. Allergy 2021;76:421. Abstract Full text (link to original source) Full text (in our servers)
  7. Andarawewa S, Aygören-Pürsün E. Subcutaneous C1-Inhibitor Concentrate for prophylaxis during pregnancy and lactation in a patient with C1-INH-HAE. Clin Case Rep. 2021 Feb 6;9(3):1273-1275. Abstract Full text (link to original source)
  8. Évora F, Rodolfo A. Hereditary Angioedema: A Gynecology and Obstetrics Perspective. Cureus. 2021 Nov 24;13(11):e19861. Abstract Full text (link to original source)
  9. AEMPS-CSL Behring GmbH. Inhibidor de la C1 esterasa humano (Berinert). Ficha técnica. 2021 Full text (in our servers)
  10. CSL Behring. C1 Esterase Inhibitor (Berinert). Drug Summary. 2020 Full text (in our servers)
  11. EMA. Conestat alfa (Ruconest). Drug Summary. 2015 Full text (in our servers)
  12. EMA. Conestat alfa (Ruconest) Ficha técnica. 2015 Full text (in our servers)
  13. Bouillet L, Lehmann A, Gompel A, Boccon-Gibod I, Launay D, Fain O; CREAK.. Traitements des angiœdèmes héréditaires : recommandations du centre de référence national des angiœdèmes (consensus 2014 de Bordeaux). [Hereditary angiœdema treatments: Recommendations from the French national center for angiœdema (Bordeaux consensus 2014)]. Presse Med. 2015 Abstract
  14. Baccioglu A, Kalpaklioglu AF. Successful pregnancy outcome after treatment with C1-inhibitor concentrate in a patient with hereditary angioedema. Allergy 2014;69 (Suppl 99):493-4. Poster 1364 Abstract Full text (link to original source) Full text (in our servers)
  15. Martinez-Saguer I, Rusicke E, Aygören-Pürsün E, Heller C, Klingebiel T, Kreuz W. Characterization of acute hereditary angioedema attacks during pregnancy and breast-feeding and their treatment with C1 inhibitor concentrate. Am J Obstet Gynecol. 2010 Aug;203(2):131.e1-7. Abstract

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