Last update May 10, 2021

Tenofovir Disoproxil Fumarate (TDF)

Very Low Risk

Safe. Compatible. Minimal risk for breastfeeding and infant.

Tenofovir disoproxil fumarate (TDF) is the pro-drug of Tenofovir. It is a nucleoside analog reverse transcriptase inhibitor (NRTI) with antiviral activity used to treat human immunodeficiency virus (HIV-1) and Hepatitis B virus (HBV).
Indicated in the treatment of AIDS and chronic hepatitis B and pre-exposure HIV prophylaxis.
Oral administration once a day for months or years.
Its use is authorized in HIV treatment from two years of age and, off-label, in children under 2 years.

It is excreted in breastmilk in clinically insignificant amounts (Erturk 2019, Mugwanya 2016, Palombi 2016, Benaboud 2011).
No problems have been observed in infants whose mothers take it (Kapito 2021, Marcellin 2016, Ganne 2013, Gouraud 2012, Pan 2012), except for some cases of mild diarrhea (Mugwanya 2016).
There was also no involvement of markers of bone mineralization (Floridia 2016 and 2016) or growth rates at 6 and 12 months (Liotta 2016).
Plasma tenofovir levels in these infants were undetectable or very low (Waitt 2017 and 2018, Mugwanya 2016, Palombi 2016, Gouraud 2012).

After administration in the form of an intravaginal gel, concentrations in plasma and breastmilk and in the infant's plasma were undetectable or very low and the side effects in the infants were mild or non-existent. (Noguchi 2016).

Several medical associations and experts consider the use of this medication to be safe during breastfeeding (Hu 2019, Wong 2018, Mugwanya 2017, Seidman 2017, Mofenson 2017, UNICEF 2016).


See below the information of these related products:

  • Maternal Aids ( Poorly safe. Evaluate carefully. Use safer alternative or interrupt breastfeeding 3 to 7 T ½ (elimination half-lives). Read the Comment.)
  • Maternal Hepatitis B Infection ( Safe. Compatible. Minimal risk for breastfeeding and infant.)

Alternatives

We do not have alternatives for Tenofovir Disoproxil Fumarate (TDF) since it is relatively safe.

Suggestions made at e-lactancia are done by APILAM team, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it.

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

Tenofovir Disoproxil Fumarate (TDF) is also known as


Tenofovir Disoproxil Fumarate (TDF) in other languages or writings:

Group

Tenofovir Disoproxil Fumarate (TDF) belongs to this group or family:

Tradenames

Main tradenames from several countries containing Tenofovir Disoproxil Fumarate (TDF) in its composition:

  • Atripla™. Contains other elements than Tenofovir Disoproxil Fumarate (TDF) in its composition
  • Descovy™. Contains other elements than Tenofovir Disoproxil Fumarate (TDF) in its composition
  • Leuzan
  • Mivuten™. Contains other elements than Tenofovir Disoproxil Fumarate (TDF) in its composition
  • Ricovir
  • Symtuza™. Contains other elements than Tenofovir Disoproxil Fumarate (TDF) in its composition
  • Telavir™. Contains other elements than Tenofovir Disoproxil Fumarate (TDF) in its composition
  • Tenof
  • Tenozet
  • Tribuss™. Contains other elements than Tenofovir Disoproxil Fumarate (TDF) in its composition
  • Trivenz™. Contains other elements than Tenofovir Disoproxil Fumarate (TDF) in its composition
  • Truvada™. Contains other elements than Tenofovir Disoproxil Fumarate (TDF) in its composition
  • Vemlidy
  • Vidara
  • Virakam
  • Viread
  • Viread (Виреад)
  • Viread (韦瑞德)

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 25 - 40 %
Molecular weight 636 daltons
Protein Binding 7 %
VD 1.2 ± 0.4 l/Kg
pKa 3,75 -
Tmax 1.0 ± 0.4 hours
T1/2 12 - 18 hours
M/P ratio 0,02 - 0,08 -
Theoretical Dose 0,0009 – 0,003 mg/Kg/d
Relative Dose 0,02 – 0,06 %
Ped.Relat.Dose 0,01 – 0,04 %

References

  1. Kapito-Tembo AP, Bauleni A, Wesevich A, Ongubo D, Hosseinipour MC, Dube Q, Mwale P, Corbett A, Mwapasa V, Phiri S. Growth and Neurodevelopment Outcomes in HIV-, Tenofovir-, and Efavirenz-Exposed Breastfed Infants in the PMTCT Option B+ Program in Malawi. J Acquir Immune Defic Syndr. 2021 Jan 1;86(1):81-90. Abstract
  2. Hu X, Wang L, Xu F. Guides concerning tenofovir exposure via breastfeeding: A comparison of drug dosages by developmental stage. Int J Infect Dis. 2019 Oct;87:8-12. Abstract
  3. Erturk US, Mete B, Ozaras R, Saltoglu N, Balkan II, Mert A, Kacmaz B, Saglam O, Guney B, Sayman OA, Tabak F. The determination of tenofovir level in breast milk of nursing mothers under tenofovir therapy. AASLD Abstracts, poster 431. Hepatology 2018;68 (Suppl 1):256A-7A. Poster 431. doi:10.1002/hep.30257. Full text (link to original source) Full text (in our servers)
  4. 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)
  5. Wong GL, Seto WK, Wong VW, Yuen MF, Chan HL. Review article: long-term safety of oral anti-viral treatment for chronic hepatitis B. Aliment Pharmacol Ther. 2018 Abstract
  6. 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
  7. Mammas IN, Spandidos DA. The innovation of the subspecialty of Paediatric Virology: An interview with Research Professor of Molecular Virology Anna Kramvis. Exp Ther Med. 2017 Abstract Full text (link to original source) Full text (in our servers)
  8. 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
  9. Mofenson LM, Baggaley RC, Mameletzis I. Tenofovir disoproxil fumarate safety for women and their infants during pregnancy and breastfeeding. AIDS. 2017 Abstract
  10. 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)
  11. 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
  12. Floridia M, Liotta G, Andreotti M, Galluzzo CM, Amici R, Jere H, Sagno JB, Marazzi MC, Buonomo E, Scarcella P, Mancinelli S, Vella S, Giuliano M, Palombi L. Levels of bone markers in a population of infants exposed in utero and during breastfeeding to tenofovir within an Option B+ programme in Malawi. J Antimicrob Chemother. 2016 Abstract
  13. 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)
  14. 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)
  15. UNICEF. Updates on HIV and Infant Feeding: The Duration of Breastfeeding, and Support from Health Services to Improve Feeding Practices Among Mothers Living with HIV. Guideline. 2016 Abstract Full text (link to original source) Full text (in our servers)
  16. 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)
  17. Liotta G, Floridia M, Andreotti M, Jere H, Sagno JB, Marazzi MC, Buonomo E, Scarcella P, Mancinelli S, Vella S, Giuliano M, Palombi L. Growth indices in breastfed infants pre and postnatally exposed to tenofovir compared with tenofovir-unexposed infants. AIDS. 2016 Abstract
  18. Marcellin P, Zoulim F, Hézode C, Causse X, Roche B, Truchi R, Pauwels A, Ouzan D, Dumortier J, Pageaux GP, Bourlière M, Riachi G, Zarski JP, Cadranel JF, Tilliet V, Stern C, Pétour P, Libert O, Consoli SM, Larrey D. Effectiveness and Safety of Tenofovir Disoproxil Fumarate in Chronic Hepatitis B: A 3-Year, Prospective, Real-World Study in France. Dig Dis Sci. 2016 Abstract Full text (link to original source) Full text (in our servers)
  19. Noguchi LM, Montgomery ET, Biggio JR, Hendrix CW, Bogen DL, Hillier SL, Dai JY, Piper JM, Marzinke MA, Dezzutti CS, Isaacs SK, Schwartz JL, Watts DH, Beigi RH. Detectable Tenofovir Levels in Breast-Feeding Infants of Mothers Exposed to Topical Tenofovir. Antimicrob Agents Chemother. 2016 Abstract
  20. Mofenson LM. Tenofovir Pre-exposure Prophylaxis for Pregnant and Breastfeeding Women at Risk of HIV Infection: The Time is Now. PLoS Med. 2016 Abstract
  21. Floridia M, Liotta G, Andreotti M, Galluzzo CM, Jere H, Sagno JB, Mancinelli S, Amici R, Marazzi MC, Vella S, Giuliano M, Palombi L. Serum Phosphate and Creatinine Levels in the First Year of Life in Infants Born to HIV-Positive Mothers Receiving Tenofovir-Based Combination Regimens During Pregnancy and Prolonged Breastfeeding in an Option B+ Program in Malawi. J Acquir Immune Defic Syndr. 2016 Abstract
  22. Society for Maternal-Fetal Medicine (SMFM)., Dionne-Odom J, Tita AT, Silverman NS. #38: Hepatitis B in pregnancy screening, treatment, and prevention of vertical transmission. Am J Obstet Gynecol. 2016 Jan;214(1):6-14. Abstract Full text (link to original source) Full text (in our servers)
  23. Fouquet A, Jambon AC, Canva V, Bocket-Mouton L, Gottrand F, Subtil D. [Hepatitis B and pregnancy. Part 2. Nine practical issues about delivery and neonatal care]. J Gynecol Obstet Biol Reprod (Paris). 2016 Abstract
  24. Visvanathan K, Dusheiko G, Giles M, Wong ML, Phung N, Walker S, Le S, Lim SG, Gane E, Ngu M, Hardikar W, Cowie B, Bowden S, Strasser S, Levy M, Sasaduesz J. Managing HBV in pregnancy. Prevention, prophylaxis, treatment and follow-up: position paper produced by Australian, UK and New Zealand key opinion leaders. Gut. 2016 Feb;65(2):340-50. Abstract
  25. 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)
  26. Sogni P. [Pregnancy and viral hepatitis B and C]. Presse Med. 2015 Abstract
  27. Morrison S, John-Stewart G, Egessa JJ, Mubezi S, Kusemererwa S, Bii DK, Bulya N, Mugume F, Campbell JD, Wangisi J, Bukusi EA, Celum C, Baeten JM; Partners PrEP Study Team.. Rapid Antiretroviral Therapy Initiation for Women in an HIV-1 Prevention Clinical Trial Experiencing Primary HIV-1 Infection during Pregnancy or Breastfeeding. PLoS One. 2015 Abstract
  28. Salado-Rasmussen K, Theilgaard ZP, Chiduo MG, Bygbjerg IC, Gerstoft J, Lüneborg-Nielsen M, Lemnge M, Katzenstein TL. Nevirapine, sodium concentration and HIV-1 RNA in breast milk and plasma among HIV-infected women receiving short-course antiretroviral prophylaxis. PLoS One. 2015 Abstract
  29. 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)
  30. WHO. Guidelines on post-exposure prophylaxis for HIV and the use of co-trimoxazole prophylaxis for HIV-related infections among adults, adolescents and children: recommendations for a public health approach. Guideline. 2014 Full text (link to original source) Full text (in our servers)
  31. Mirochnick M, Taha T, Kreitchmann R, Nielsen-Saines K, Kumwenda N, Joao E, Pinto J, Santos B, Parsons T, Kearney B, Emel L, Herron C, Richardson P, Hudelson SE, Eshleman SH, George K, Fowler MG, Sato P, Mofenson L; HPTN 057 Protocol Team.. Pharmacokinetics and safety of tenofovir in HIV-infected women during labor and their infants during the first week of life. J Acquir Immune Defic Syndr. 2014 Abstract
  32. 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)
  33. Ganne-Carrie N, Causse X, Zarski JP et al. Efficacy and safety results of tenofovir DF (TDF) treatment from the first trimester in HBV pregnant women in real-life clinical practice. Hepatology. 2013;58 (Suppl 1):664A-5A 2013 Full text (link to original source) Full text (in our servers)
  34. Pan CQ, Mi LJ, Bunchorntavakul C, Karsdon J, Huang WM, Singhvi G, Ghany MG, Reddy KR. Tenofovir disoproxil fumarate for prevention of vertical transmission of hepatitis B virus infection by highly viremic pregnant women: a case series. Dig Dis Sci. 2012 Abstract
  35. A Gouraud, A Millaret, N Bernard, M Bruel, N Paret, J Descotes, T Vial Centre de Pharmacovigilance de Lyon. Tenofovir exposure through breast feeding: serum concentrations in neonates and clinical follow-up. Fundam Clin Pharmacol. 2012;26 (Suppl 1):9. Abstract 11-O017. 2012 Full text (link to original source) Full text (in our servers)
  36. Bateman C. Mothers and babies: widening the HIV safety net. S Afr Med J. 2011 Abstract
  37. 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)
  38. Pol S, Corouge M, Fontaine H. Hepatitis B virus infection and pregnancy. Clin Res Hepatol Gastroenterol. 2011 Abstract
  39. Bositis CM, Gashongore I, Patel DM. Updates to the World Health Organization's Recommendations for the Use of Antiretroviral Drugs for Treating Pregnant Women and Preventing HIV Infection in Infants. Med J Zambia. 2010 Abstract

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