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Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-.
CASRN: 618109-00-5
Drug Levels and Effects
Summary of Use during Lactation
No published information is available on the use of darunavir during breastfeeding.
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
Gynecomastia has been reported among men receiving highly active antiretroviral therapy. Gynecomastia is unilateral initially, but progresses to bilateral in about half of cases. No alterations in serum prolactin were noted and spontaneous resolution usually occurred within one year, even with continuation of the regimen.[1-3] Some case reports and in vitro studies have suggested that protease inhibitors might cause hyperprolactinemia and galactorrhea in some male patients,[4,5] although this has been disputed.[6] The relevance of these findings to nursing mothers is not known. The prolactin level in a mother with established lactation may not affect her ability to breastfeed.
References
- 1.
- García-Benayas T, Blanco F, Martin-Carbonero L, et al. Gynecomastia in HIV-infected patients receiving antiretroviral therapy. AIDS Res Hum Retroviruses. 2003;19:739–41. [PubMed: 14585204]
- 2.
- Pantanowitz L, Evans D, Gross PD, et al. HIV-related gynecomastia. Breast J. 2003;9:131–2. [PubMed: 12603389]
- 3.
- Evans DL, Pantanowitz L, Dezube BJ, et al. Breast enlargement in 13 men who were seropositive for human immunodeficiency virus. Clin Infect Dis. 2002;35:1113–9. [PubMed: 12384846]
- 4.
- Hutchinson J, Murphy M, Harries R, et al. Galactorrhoea and hyperprolactinaemia associated with protease-inhibitors. Lancet. 2000;356:1003–4. [PubMed: 11041407]
- 5.
- Orlando G, Brunetti L, Vacca M. Ritonavir and saquinavir directly stimulate anterior pituitary prolactin secretion, in vitro. Int J Immunopathol Pharmacol. 2002;15:65–8. [PubMed: 12593790]
- 6.
- Montero A, Bottasso OA, Luraghi MR, et al. Galactorrhoea, hyperprolactinaemia, and protease inhibitors. Lancet. 2001;357:473–4. [PubMed: 11273087]
Substance Identification
Substance Name
Darunavir
CAS Registry Number
618109-00-5
Drug Class
Breast Feeding
Anti-Infective Agents
Anti-HIV Agents
Antiviral Agents
Anti-Retroviral Agents
HIV Protease Inhibitors
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- Review Darunavir: A comprehensive profile.[Profiles Drug Subst Excip Rela...]Review Darunavir: A comprehensive profile.Darwish IA, Al-Majed AA, Alsaif NA, Bakheit AH, Herqash RN, Alzaid A. Profiles Drug Subst Excip Relat Methodol. 2021; 46:1-50. Epub 2020 Aug 21.
- The Chiron Approach to (3<i>R</i>,3<i>aS</i>,6<i>aR</i>)-Hexahydrofuro[2,3-<i>b</i>]furan-3-ol, a Key Subunit of HIV-1 Protease Inhibitor Drug, Darunavir.[J Org Chem. 2021]The Chiron Approach to (3<i>R</i>,3<i>aS</i>,6<i>aR</i>)-Hexahydrofuro[2,3-<i>b</i>]furan-3-ol, a Key Subunit of HIV-1 Protease Inhibitor Drug, Darunavir.Ghosh AK, Markad SB, Robinson WL. J Org Chem. 2021 Jan 1; 86(1):1216-1222. Epub 2020 Dec 3.
- Review Practical Synthesis of the Bicyclic Darunavir Side Chain: (3<i>R</i>,3a<i>S</i>,6a<i>R</i>)-Hexahydrofuro[2,3-<i>b</i>]furan-3-ol from Monopotassium Isocitrate.[Org Process Res Dev. 2017]Review Practical Synthesis of the Bicyclic Darunavir Side Chain: (3<i>R</i>,3a<i>S</i>,6a<i>R</i>)-Hexahydrofuro[2,3-<i>b</i>]furan-3-ol from Monopotassium Isocitrate.Moore GL, Stringham RW, Teager DS, Yue TY. Org Process Res Dev. 2017 Jan 20; 21(1):98-106. Epub 2016 Dec 14.
- Asymmetric One-Pot Synthesis of (3R,3aS,6aR)-Hexahydrofuro[2,3-b]furan-3-ol: A Key Component of Current HIV Protease Inhibitors.[J Org Chem. 2017]Asymmetric One-Pot Synthesis of (3R,3aS,6aR)-Hexahydrofuro[2,3-b]furan-3-ol: A Key Component of Current HIV Protease Inhibitors.Sevenich A, Liu GQ, Arduengo AJ 3rd, Gupton BF, Opatz T. J Org Chem. 2017 Jan 20; 82(2):1218-1223. Epub 2017 Jan 4.
- Design of gem-difluoro-bis-tetrahydrofuran as P2 ligand for HIV-1 protease inhibitors to improve brain penetration: synthesis, X-ray studies, and biological evaluation.[ChemMedChem. 2015]Design of gem-difluoro-bis-tetrahydrofuran as P2 ligand for HIV-1 protease inhibitors to improve brain penetration: synthesis, X-ray studies, and biological evaluation.Ghosh AK, Yashchuk S, Mizuno A, Chakraborty N, Agniswamy J, Wang YF, Aoki M, Gomez PM, Amano M, Weber IT, et al. ChemMedChem. 2015 Jan; 10(1):107-15. Epub 2014 Oct 21.