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Bookshelf ID: NBK591116PMID: 37094049
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Drugs and Lactation Database (LactMed®) [Internet]. Bethesda (MD): National Institute of Child Health and Human Development; 2006-.
CASRN: 1809010-50-1
Drug Levels and Effects
Summary of Use during Lactation
Berotralstat is a plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema. No information is available on the excretion of berotralstat into breastmilk. Because berotralstat is about 99% bound to plasma proteins, the amounts in milk are likely to be very low. If berotralstat is required by the mother, it is not a reason to discontinue breastfeeding. Until more data become available, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.
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
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.
Alternate Drugs to Consider
Substance Identification
Substance Name
Berotralstat
CAS Registry Number
1809010-50-1
Disclaimer: Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.
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- Oral berotralstat for the prophylaxis of hereditary angioedema attacks in patients in Japan: A phase 3 randomized trial.[Allergy. 2021]Oral berotralstat for the prophylaxis of hereditary angioedema attacks in patients in Japan: A phase 3 randomized trial.Ohsawa I, Honda D, Suzuki Y, Fukuda T, Kohga K, Morita E, Moriwaki S, Ishikawa O, Sasaki Y, Tago M, et al. Allergy. 2021 Jun; 76(6):1789-1799. Epub 2020 Dec 23.
- Review A review of oral kallikrein inhibitor berotralstat for hereditary angioedema.[Drugs Today (Barc). 2022]Review A review of oral kallikrein inhibitor berotralstat for hereditary angioedema.Gao Y, Hwang J, Hwang G, Craig T. Drugs Today (Barc). 2022 Feb; 58(2):59-67.
- Oral once-daily berotralstat for the prevention of hereditary angioedema attacks: A randomized, double-blind, placebo-controlled phase 3 trial.[J Allergy Clin Immunol. 2021]Oral once-daily berotralstat for the prevention of hereditary angioedema attacks: A randomized, double-blind, placebo-controlled phase 3 trial.Zuraw B, Lumry WR, Johnston DT, Aygören-Pürsün E, Banerji A, Bernstein JA, Christiansen SC, Jacobs JS, Sitz KV, Gower RG, et al. J Allergy Clin Immunol. 2021 Jul; 148(1):164-172.e9. Epub 2020 Oct 21.
- Review Orladeyo (Berotralstat): A Novel Oral Therapy for the Prevention of Hereditary Angioedema.[Ann Pharmacother. 2022]Review Orladeyo (Berotralstat): A Novel Oral Therapy for the Prevention of Hereditary Angioedema.Powell J, Piszczatoski C, Rubido E. Ann Pharmacother. 2022 Apr; 56(4):488-493. Epub 2021 Jul 20.
- Berotralstat - Drugs and Lactation Database (LactMed®)Berotralstat - Drugs and Lactation Database (LactMed®)
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