Last update Dec. 19, 2022

Dolutegravir (DTG)

Very Low Risk

Safe. Compatible. Minimal risk for breastfeeding and infant.

Dolutegravir is an HIV integrase inhibitor. It is used in combination with other antiretrovirals (tenofovir + emtricitabine or lamivudine) for the treatment of HIV infection and AIDS. Oral administration.

It is excreted in breast milk in clinically insignificant amounts (Aebi 2022, Dickinson 2021, Waitt 2019, Gini 2018, Kobbe 2016) and no problems have been observed in infants whose mothers have taken it.  (Malaba 2022, Kobbe 2016)

Plasma levels in these infants were very low, less than 10% of maternal plasma levels. (Aebi 2022, Dickinson 2021, Waitt 2019, Gini 2018, Kobbe 2016)

Authorized use in children over 4 weeks old and weighing at least 3 kg.

Several medical societies and expert authors consider the use of this medication to be safe during breastfeeding. (Panel 2022)


See below the information of this related product:

Alternatives

We do not have alternatives for Dolutegravir (DTG) 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

Dolutegravir (DTG) is also known as


Dolutegravir (DTG) in other languages or writings:

Group

Dolutegravir (DTG) belongs to this group or family:

Tradenames

Main tradenames from several countries containing Dolutegravir (DTG) in its composition:

  • Dovato™. Contains other elements than Dolutegravir (DTG) in its composition
  • Juluca™. Contains other elements than Dolutegravir (DTG) in its composition
  • Tivicay
  • Triumeq™. Contains other elements than Dolutegravir (DTG) in its composition
  • Zevuvir

Pharmacokinetics

Variable Value Unit
Molecular weight 419 daltons
Protein Binding 98.9 %
VD 0.25 l/Kg
pKa 10.1 -
Tmax 2 - 3 hours
14 hours
M/P ratio 0.04 -
Theoretical Dose 0.02 mg/Kg/d
Relative Dose 1.0 (0.8 - 1.3) %

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. Malaba TR, Nakatudde I, Kintu K, Colbers A, Chen T, Reynolds H, Read L, Read J, Stemmet LA, Mrubata M, Byrne K, Seden K, Twimukye A, Theunissen H, Hodel EM, Chiong J, Hu NC, Burger D, Wang D, Byamugisha J, Alhassan Y, Bokako S, et al. 72 weeks post-partum follow-up of dolutegravir versus efavirenz initiated in late pregnancy (DolPHIN-2): an open-label, randomised controlled study. Lancet HIV. 2022 Aug;9(8):e534-e543. Consulted on Dec. 19, 2022 Abstract Full text (link to original source)
  3. 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)
  4. Dickinson L, Walimbwa S, Singh Y, Kaboggoza J, Kintu K, Sihlangu M, Coombs JA, Malaba TR, Byamugisha J, Pertinez H, Amara A, Gini J, Else L, Heiberg C, Hodel EM, Reynolds H, Myer L, Waitt C, Khoo S, Lamorde M, Orrell C; DolPHIN-1 Study Group.. Infant Exposure to Dolutegravir Through Placental and Breast Milk Transfer: A Population Pharmacokinetic Analysis of DolPHIN-1. Clin Infect Dis. 2021 Sep 7;73(5):e1200-e1207. Abstract Full text (link to original source)
  5. Waitt C, Orrell C, Walimbwa S, Singh Y, Kintu K, Simmons B, Kaboggoza J, Sihlangu M, Coombs JA, Malaba T, Byamugisha J, Amara A, Gini J, Else L, Heiburg C, Hodel EM, Reynolds H, Mehta U, Byakika-Kibwika P, Hill A, Myer L, Lamorde M, et al. Safety and pharmacokinetics of dolutegravir in pregnant mothers with HIV infection and their neonates: A randomised trial (DolPHIN-1 study). PLoS Med. 2019 Sep 20;16(9):e1002895. Abstract Full text (link to original source)
  6. Gini J, Penchala SD, Amara A, Challenger E, Egan D, Waitt C, Lamorde M, Orrell C, Myer L, Khoo S, Else LJ. Validation and clinical application of a novel LC-MS method for quantification of dolutegravir in breast milk. Bioanalysis. 2018 Nov 19. Abstract Full text (link to original source)
  7. 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)

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