Last update Dec. 21, 2022

J05AF05

Compatible

Safe substance and/or breastfeeding is the best option.

Antiretroviral, Lamivudine is a nucleoside reverse transcriptase inhibitor (NRTI) with antiviral activity against HIV-1 and hepatitis B virus. Indicated for the treatment of HIV infection and AIDS and chronic hepatitis B. Administration together with other oral antiretrovirals in one or two daily doses.

Although it is concentrated in breast milk, it reaches a low, clinically insignificant concentration. (Aebi 2022, Ramírez 2018, Waitt 2018 & 2017, Palombi 2016 & 2012, Corbett 2014, Shapiro 2013 & 2005, Pirillo 2015, Mirochnick 2009, Giuliano 2007, Moodley 1998)

No problems have been observed in infants whose mothers have taken it. (Palombi 2012, Bae 2008)

The plasma levels of these infants were undetectable or very low, less than 5% - 10% of maternal plasma levels. (Aebi 2022, Waitt 2018 & 2017, Palombi 2016, Pirillo 2015, Corbett 2014, Shapiro 2013 & 2005, Palombi 2012, Mirochnick 2009) 

The emergence of resistance to treatment due to subtherapeutic levels received by infants may be of concern. (Inzaule 2016)

Authorized use in newborns and infants.

Several medical societies and expert authors consider the use of this medication to be safe during breastfeeding. (Panel 2022, WHO 2016, Terrault 2016, Ehrhardt 2015, Pandhi 2014, Hirnschall 2013)


See below the information of these related products:

Alternatives

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.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

J05AF05 is Lamivudine (3TC) in ATC Code/s.

Is written in other languages:

Group

J05AF05 belongs to this group or family:

Tradenames

Main tradenames from several countries containing J05AF05 in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 86% ± 16% %
Molecular weight 229 daltons
Protein Binding < 40 %
VD 1.3 ± 0.4 l/Kg
pKa 14.29 -
Tmax 1 - 1.5 hours
5 - 7 hours
M/P ratio 3.7 (2.8 - 4.7) -
Theoretical Dose 0.2 (0.12 - 0.24) mg/Kg/d
Relative Dose 4.9 (3 - 6) %
Ped.Relat.Dose 2.5 - 5 %

References

  1. Panel on Treatment of HIV During Pregnancy and Prevention of Perinatal Transmission. Recommendations for the Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States. Department of Health and Human Services. 2023 Consulted on June 16, 2023 Abstract Full text (link to original source)
  2. Aebi-Popp K, Kahlert CR, Crisinel PA, Decosterd L, Saldanha SA, Hoesli I, Martinez De Tejada B, Duppenthaler A, Rauch A, Marzolini C; Swiss Mother and Child HIV Cohort Study (SHCS).. Transfer of antiretroviral drugs into breastmilk: a prospective study from the Swiss Mother and Child HIV Cohort Study. J Antimicrob Chemother. 2022 Nov 28;77(12):3436-3442. Consulted on Dec. 16, 2022 Abstract Full text (link to original source)
  3. Waitt C, Olagunju A, Nakalema S, Kyohaire I, Owen A, Lamorde M, Khoo S. Plasma and breast milk pharmacokinetics of emtricitabine, tenofovir and lamivudine using dried blood and breast milk spots in nursing African mother-infant pairs. J Antimicrob Chemother. 2018 Abstract Full text (link to original source)
  4. Ramírez-Ramírez A, Sánchez-Serrano E, Loaiza-Flores G, Plazola-Camacho N, Rodríguez-Delgado RG, Figueroa-Damián R, Domínguez-Castro M, López-Martínez M, Flores-García Z, Hernández-Pineda J. Simultaneous quantification of four antiretroviral drugs in breast milk samples from HIV-positive women by an ultra-high performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) method. PLoS One. 2018 Jan 19;13(1):e0191236. Abstract Full text (link to original source)
  5. Waitt C, Diliiy Penchala S, Olagunju A, Amara A, Else L, Lamorde M, Khoo S. Development, validation and clinical application of a method for the simultaneous quantification of lamivudine, emtricitabine and tenofovir in dried blood and dried breast milk spots using LC-MS/MS. J Chromatogr B Analyt Technol Biomed Life Sci. 2017 Abstract Full text (link to original source)
  6. Kobbe R, Schalkwijk S, Dunay G, Eberhard JM, Schulze-Sturm U, Hollwitz B, Degen O, Teulen M, Colbers A, Burger D. Dolutegravir in breast milk and maternal and infant plasma during breastfeeding. AIDS. 2016 Nov 13;30(17):2731-2733. No abstract available. Abstract Full text (link to original source)
  7. Terrault NA, Bzowej NH, Chang KM, Hwang JP, Jonas MM, Murad MH; American Association for the Study of Liver Diseases.. AASLD guidelines for treatment of chronic hepatitis B. Hepatology. 2016 Jan;63(1):261-83. Abstract Full text (link to original source)
  8. Inzaule SC, Weidle PJ, Yang C, Ndiege K, Hamers RL, Rinke de Wit TF, Thomas T, Zeh C. Prevalence and dynamics of the K65R drug resistance mutation in HIV-1-infected infants exposed to maternal therapy with lamivudine, zidovudine and either nevirapine or nelfinavir in breast milk. J Antimicrob Chemother. 2016 Jun;71(6):1619-26. Abstract Full text (link to original source)
  9. WHO - World Health Organization Consolidated Guidelines on the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection: Recommendations for a Public Health Approach. Guideline. 2016 Abstract Full text (link to original source) Full text (in our servers)
  10. Palombi L, Pirillo MF, Marchei E, Jere H, Sagno JB, Luhanga R, Floridia M, Andreotti M, Galluzzo CM, Pichini S, Mwenda R, Mancinelli S, Marazzi MC, Vella S, Liotta G, Giuliano M. Concentrations of tenofovir, lamivudine and efavirenz in mothers and children enrolled under the Option B-Plus approach in Malawi. J Antimicrob Chemother. 2016 Abstract Full text (link to original source) Full text (in our servers)
  11. Pirillo MF, Scarcella P, Andreotti M, Jere H, Buonomo E, Sagno JB, Amici R, Mancini MG, Leone P, Ceffa S, Mancinelli S, Marazzi MC, Vella S, Palombi L, Giuliano M. Hepatitis B virus mother-to-child transmission among HIV-infected women receiving lamivudine-containing antiretroviral regimens during pregnancy and breastfeeding. J Viral Hepat. 2015 Mar;22(3):289-96. Abstract
  12. Ehrhardt S, Xie C, Guo N, Nelson K, Thio CL. Breastfeeding while taking lamivudine or tenofovir disoproxil fumarate: a review of the evidence. Clin Infect Dis. 2015 Abstract Full text (link to original source) Full text (in our servers)
  13. Corbett AH, Kayira D, White NR, Davis NL, Kourtis AP, Chasela C, Martinson F, Phiri G, Musisi B, Kamwendo D, Hudgens MG, Hosseinipour MC, Nelson JA, Ellington SR, Jamieson DJ, van der Horst C, Kashuba A; BAN Study Team.. Antiretroviral pharmacokinetics in mothers and breastfeeding infants from 6 to 24 weeks post-partum: results of the BAN Study. Antivir Ther. 2014;19(6):587-95. Abstract Full text (link to original source)
  14. Pandhi D, Ailawadi P. Initiation of antiretroviral therapy. Indian J Sex Transm Dis. 2014 Abstract Full text (link to original source) Full text (in our servers)
  15. Shapiro RL, Rossi S, Ogwu A, Moss M, Leidner J, Moffat C, Lockman S, Moyo S, Makhema J, Essex M, Capparelli E. Therapeutic levels of lopinavir in late pregnancy and abacavir passage into breast milk in the Mma Bana Study, Botswana. Antivir Ther. 2013;18(4):585-90. Abstract Full text (link to original source)
  16. Hirnschall G, Harries AD, Easterbrook PJ, Doherty MC, Ball A. The next generation of the World Health Organization's global antiretroviral guidance. J Int AIDS Soc. 2013 Abstract Full text (link to original source) Full text (in our servers)
  17. Palombi L, Pirillo MF, Andreotti M, Liotta G, Erba F, Sagno JB, Maulidi M, Ceffa S, Jere H, Marchei E, Pichini S, Galluzzo CM, Marazzi MC, Vella S, Giuliano M. Antiretroviral prophylaxis for breastfeeding transmission in Malawi: drug concentrations, virological efficacy and safety. Antivir Ther. 2012;17(8):1511-9. Abstract Full text (link to original source)
  18. Mirochnick M, Thomas T, Capparelli E, Zeh C, Holland D, Masaba R, Odhiambo P, Fowler MG, Weidle PJ, Thigpen MC. Antiretroviral concentrations in breast-feeding infants of mothers receiving highly active antiretroviral therapy. Antimicrob Agents Chemother. 2009 Mar;53(3):1170-6. Abstract Full text (link to original source)
  19. Rezk NL, White N, Bridges AS, Abdel-Megeed MF, Mohamed TM, Moselhy SS, Kashuba AD. Studies on antiretroviral drug concentrations in breast milk: validation of a liquid chromatography-tandem mass spectrometric method for the determination of 7 anti-human immunodeficiency virus medications. Ther Drug Monit. 2008 Oct;30(5):611-9. Abstract Full text (link to original source)
  20. Bae WH, Wester C, Smeaton LM, Shapiro RL, Lockman S, Onyait K, Thior I, Essex M. Hematologic and hepatic toxicities associated with antenatal and postnatal exposure to maternal highly active antiretroviral therapy among infants. AIDS. 2008 Aug 20;22(13):1633-40. Abstract Full text (link to original source)
  21. Giuliano M, Guidotti G, Andreotti M, Pirillo MF, Villani P, Liotta G, Marazzi MC, Mancini MG, Cusato M, Germano P, Loureiro S, Ceffa S, Regazzi M, Vella S, Palombi L. Triple antiretroviral prophylaxis administered during pregnancy and after delivery significantly reduces breast milk viral load: a study within the Drug Resource Enhancement Against AIDS and Malnutrition Program. J Acquir Immune Defic Syndr. 2007 Mar 1;44(3):286-91. Abstract Full text (link to original source)
  22. Shapiro RL, Holland DT, Capparelli E, Lockman S, Thior I, Wester C, Stevens L, Peter T, Essex M, Connor JD, Mirochnick M. Antiretroviral concentrations in breast-feeding infants of women in Botswana receiving antiretroviral treatment. J Infect Dis. 2005 Sep 1;192(5):720-7. Epub 2005 Jul 27. Abstract Full text (link to original source)
  23. Moodley J, Moodley D, Pillay K, Coovadia H, Saba J, van Leeuwen R, Goodwin C, Harrigan PR, Moore KH, Stone C, Plumb R, Johnson MA. Pharmacokinetics and antiretroviral activity of lamivudine alone or when coadministered with zidovudine in human immunodeficiency virus type 1-infected pregnant women and their offspring. J Infect Dis. 1998 Nov;178(5):1327-33. Abstract Full text (link to original source) Full text (in our servers)

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