Last update Dec. 21, 2022

J05AF09

Compatible

Safe substance and/or breastfeeding is the best option.

Antiretroviral. It 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 hepatitis B (HB). Administration together with other oral antiretrovirals in one daily dose.

Although it is concentrated in breast milk, it reaches a low, clinically insignificant concentration in breast milk (Aebi 2022, Waitt 2018 & 2017, Mugwanya 2016, Benaboud 2011), much lower (2% to 4%) than the dose used in newborns and infants. (Mugwanya 2016)

No problems have been observed in infants whose mothers were taking it, except for mild diarrhea in 4% of cases. (Mugwanya 2016)

The plasma levels of these infants were undetectable or very low, less than 20% of maternal plasma levels. (Aebi 2022, Waitt 2018 y 2017, Mugwanya 2016) 

Authorized use in newborns and infants. The dosage in infants older than 3 months is 6 mg/kg/day and half from birth to that age. (Ribera 2011)

Its use in breastfeeding mothers is considered safe for both HIV and HB treatment and pre-exposure prophylaxis. (Mugwanya 2017, Seidman 2017)


See below the information of this related product:

Alternatives

We do not have alternatives for J05AF09 since it is relatively safe.

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

J05AF09 is Emtricitabine (FTC) in ATC Code/s.

Is written in other languages:

Group

J05AF09 belongs to this group or family:

Tradenames

Main tradenames from several countries containing J05AF09 in its composition:

  • Atripla™. Contains other elements than J05AF09 in its composition
  • Biktarvy™. Contains other elements than J05AF09 in its composition
  • Complera™. Contains other elements than J05AF09 in its composition
  • Descovy™. Contains other elements than J05AF09 in its composition
  • Emtenef™. Contains other elements than J05AF09 in its composition
  • Emtriva
  • Eviplera™. Contains other elements than J05AF09 in its composition
  • Landtricib
  • Odefsey™. Contains other elements than J05AF09 in its composition
  • Padviram™. Contains other elements than J05AF09 in its composition
  • Previd™. Contains other elements than J05AF09 in its composition
  • Remivir™. Contains other elements than J05AF09 in its composition
  • Simplir™. Contains other elements than J05AF09 in its composition
  • Symtuza™. Contains other elements than J05AF09 in its composition
  • Tenriltab (Тенрилтаб)™. Contains other elements than J05AF09 in its composition
  • Trastiva™. Contains other elements than J05AF09 in its composition
  • Tribuss™. Contains other elements than J05AF09 in its composition
  • Trivenz™. Contains other elements than J05AF09 in its composition
  • Truvada™. Contains other elements than J05AF09 in its composition

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 75 - 93 %
Molecular weight 247 daltons
Protein Binding < 4 %
VD 0.8 l/Kg
pKa 5.47 -
Tmax 1 - 2 hours
10 hours
M/P ratio 3.9 (2.3 - 5.5) -
Theoretical Dose 0.12 (0.1 - 0.2) mg/Kg/d
Relative Dose 4.0 (2.4 - 5.6) %
Ped.Relat.Dose 2 - 4 %

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. Puthanakit T, Thepnarong N, Chaithongwongwatthana S, Anugulruengkitt S, Anunsittichai O, Theerawit T, Ubolyam S, Pancharoen C, Phanuphak P. Intensification of antiretroviral treatment with raltegravir for pregnant women living with HIV at high risk of vertical transmission. J Virus Erad. 2018 Apr 1;4(2):61-65. Abstract Full text (link to original source) Full text (in our servers)
  4. 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)
  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. Seidman DL, Weber S, Cohan D. Offering pre-exposure prophylaxis for HIV prevention to pregnant and postpartum women: a clinical approach. J Int AIDS Soc. 2017 Abstract Full text (link to original source) Full text (in our servers)
  7. Mugwanya KK, John-Stewart G, Baeten J. Safety of oral tenofovir disoproxil fumarate-based HIV pre-exposure prophylaxis use in lactating HIV-uninfected women. Expert Opin Drug Saf. 2017 Abstract Full text (link to original source)
  8. Mugwanya KK, Hendrix CW, Mugo NR, Marzinke M, Katabira ET, Ngure K, Semiyaga NB, John-Stewart G, Muwonge TR, Muthuri G, Stergachis A, Celum CL, Baeten JM. Pre-exposure Prophylaxis Use by Breastfeeding HIV-Uninfected Women: A Prospective Short-Term Study of Antiretroviral Excretion in Breast Milk and Infant Absorption. PLoS Med. 2016 Abstract Full text (link to original source) Full text (in our servers)
  9. 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)
  10. Ribera E, Tuset M, Martín M, del Cacho E. Características de los fármacos antirretrovirales. [Characteristics of antiretroviral drugs]. Enferm Infecc Microbiol Clin. 2011 May;29(5):362-91. Abstract
  11. Benaboud S, Pruvost A, Coffie PA, Ekouévi DK, Urien S, Arrivé E, Blanche S, Théodoro F, Avit D, Dabis F, Tréluyer JM, Hirt D. Concentrations of tenofovir and emtricitabine in breast milk of HIV-1-infected women in Abidjan, Cote d'Ivoire, in the ANRS 12109 TEmAA Study, Step 2. Antimicrob Agents Chemother. 2011 Abstract Full text (link to original source) Full text (in our servers)

Total visits

1,332

Help us improve this entry

How to cite this entry

Do you need more information or did not found what you were looking for?

   Write us at elactancia.org@gmail.com

e-lactancia is a resource recommended by Academy of Breastfeeding Medicine - 2015 of United States of America

Would you like to recommend the use of e-lactancia? Write to us at corporate mail of APILAM