Is Tenofovir Disoproxil Fumarate compatible with breastfeeding? Do we have alternatives for Tenofovir Disoproxil Fumarate?

Tenofovir Disoproxil Fumarate

June 9, 2018 (Very Low Risk)

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 (Mugwanya 2016, Palombi 2016, Benaboud 2011).
No problems have been observed in infants whose mothers were taking it (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 (Wong 2018, Mugwanya 2017, Seidman 2017, Mofenson 2017, UNICEF 2016).


See below the information of these related products:

Alternatives

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

Very Low Risk

Compatible. Not risky for breastfeeding or infant.

Low Risk

Moderately safe. Mild risk possible. Follow up recommended. Read the Comment.

High Risk

Poorly safe. Evaluate carefully. Use a safer alternative. Read the Comment.

Very High Risk

Not recommended. Cessation of breastfeeding or alternative.

Synonyms

  • Tenofovir
  • Tenofovir Alafenamide
  • Tenofovir Alafenamide Fumarate

Writings

  • τενοφοβίρη (Greek)
  • нофовир Дизопроксил Фумарат (Cyrillic)
  • テノホビル ジソプロキシルフマル酸塩 (Japanese)
  • C19 H30 N5 O10 P, C4 H4 O4 (Molecular formula)
  • 9-{(R)-2-[(Bis{[(isopropoxycarbonyl)oxy]methoxy}phosphinyl)methoxy]propyl}adenine fumarate (1:1) (Chemical name)
  • TDF (Abbreviation)
  • J05AF07 (ATC Code/s)

Drug trade names

References

  1. 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. 2018Abstract
  2. 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. 2018Abstract
  3. Mofenson LM, Baggaley RC, Mameletzis I. Tenofovir disoproxil fumarate safety for women and their infants during pregnancy and breastfeeding. AIDS. 2017Abstract
  4. 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. 2017Abstract
  5. 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. 2017Abstract Full text (link to original source) Full text (in our servers)
  6. 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. 2017Abstract
  7. Mofenson LM. Tenofovir Pre-exposure Prophylaxis for Pregnant and Breastfeeding Women at Risk of HIV Infection: The Time is Now. PLoS Med. 2016Abstract
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  9. 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. 2016Abstract Full text (link to original source) Full text (in our servers)
  10. 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. 2016Abstract
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  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. 2016Abstract
  13. 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. 2016Abstract
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