Last update Nov. 17, 2024

Dolutegravir (DTG), Dolutegravir Sodium

Compatible

Safe product and/or breastfeeding is the best option.

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.

During pregnancy and postpartum, combination antiretroviral therapy regimens that include dolutegravir (especially in association with emtricitabine and tenofovir alafenamide) seem safer and more effective in controlling viral load than those that do not (Chinula 2023), and can even be associated only with lamivudine. (Rohr 2024)


See below the information of this related product:

Alternatives

We do not have alternatives for Dolutegravir (DTG), Dolutegravir Sodium 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), Dolutegravir Sodium in other languages or writings:

Group

Dolutegravir (DTG), Dolutegravir Sodium belongs to this group or family:

Tradenames

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

  • Dovato™. Contains other elements than Dolutegravir (DTG), Dolutegravir Sodium in its composition
  • Juluca™. Contains other elements than Dolutegravir (DTG), Dolutegravir Sodium in its composition
  • Tivicay
  • Triumeq™. Contains other elements than Dolutegravir (DTG), Dolutegravir Sodium 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. 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)
  2. Rohr I, Hoeltzenbein M, Weizsäcker K, Weber C, Feiterna-Sperling C, Metz CK. Efficacy and safety of 2-drug regime dolutegravir/lamivudine in pregnancy and breastfeeding - clinical implications and perspectives. J Perinat Med. 2024 Sep 19;52(9):934-938. Abstract
  3. Chinula L, Ziemba L, Brummel S, McCarthy K, Coletti A, Krotje C, Johnston B, Knowles K, Moyo S, Stranix-Chibanda L, Hoffman R, Sax PE, Stringer J, Chakhtoura N, Jean-Philippe P, Korutaro V, Cassim H, Fairlie L, Masheto G, Boyce C, Frenkel LM, Amico KR, et al. Efficacy and safety of three antiretroviral therapy regimens started in pregnancy up to 50 weeks post partum: a multicentre, open-label, randomised, controlled, phase 3 trial. Lancet HIV. 2023 Jun;10(6):e363-e374. Abstract Full text (link to original source)
  4. 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. Abstract Full text (link to original source)
  5. 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)
  6. 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)
  7. 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)
  8. 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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