Last update May 18, 2022

Bedaquiline Fumarate

Likely Compatibility

Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.

Bedaquiline is an antimycobacterial used in combination with at least three other antibacterials to treat multidrug-resistant pulmonary tuberculosis. Daily oral administration for 2 weeks followed by three times a week for 22 weeks. (Martidale, DrugBank, Janssen 2021, Mbuagbaw 2019)

Based on its pharmacokinetic data (very high plasma protein binding, very large volume of distribution and moderately high molecular weight), minimal excretion in breast milk was expected.

Perhaps its high lipophilicity and very long half-life (5.5 months) explain the high concentration found in breast milk and why the infant's plasma levels are similar (therapeutic) to those of the mother. (Court 2022)

The WHO and the manufacturer indicate its use in children older than 5 - 6 years of age and/or weighing more than 15 kg. (Janssen 2021, Mbuagbaw 2019)

It is advisable to monitor the appearance of nausea, abdominal pain, jaundice and abnormal liver enzymes in infants of mothers treated with bedaquiline. (Janssen 2021)

 

 


See below the information of this related product:

  • Maternal Tuberculosis (TBC) (Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.)

Alternatives

We do not have alternatives for Bedaquiline Fumarate.

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.
DONATE NOW

Other names

Bedaquiline Fumarate in other languages or writings:

Group

Bedaquiline Fumarate belongs to this group or family:

Tradenames

Main tradenames from several countries containing Bedaquiline Fumarate in its composition:

Pharmacokinetics

Variable Value Unit
Molecular weight 672 daltons
Protein Binding > 99.9 %
VD 2.34 l/Kg
pKa 13.61 -
Tmax 5 hours
T½ 3.960 hours
M/P ratio 10.76 -
Theoretical Dose 0.85 mg/Kg/d
Relative Dose 59.5 %

References

  1. DRUGBANK ONLINE. DrugBank.com 2006 - Consulted on Jan. 9, 2024 Full text (link to original source)
  2. Court R, Gausi K, Mkhize B, Wiesner L, Waitt C, McIlleron H, Maartens G, Denti P, Loveday M. Bedaquiline exposure in pregnancy and breastfeeding in women with rifampicin-resistant tuberculosis. Br J Clin Pharmacol. 2022 May 8. Consulted on May 18, 2022 Abstract
  3. Algharably EA, Kreutz R, Gundert-Remy U. Infant Exposure to Antituberculosis Drugs via Breast Milk and Assessment of Potential Adverse Effects in Breastfed Infants: Critical Review of Data. Pharmaceutics. 2023 Apr 13;15(4). pii: 1228. Abstract Full text (link to original source)
  4. Royal Pharmaceutical Society. Martindale: The Complete Drug Reference Medicines Complete. available online from: https://www.medicinescomplete.com 2022 Abstract
  5. Janssen. Bedaquiline (Sirturo). Drug Summary. 2021 Full text (in our servers)
  6. Mbuagbaw L, Guglielmetti L, Hewison C, Bakare N, Bastard M, Caumes E, Fréchet-Jachym M, Robert J, Veziris N, Khachatryan N, Kotrikadze T, Hayrapetyan A, Avaliani Z, Schünemann HJ, Lienhardt C. Outcomes of Bedaquiline Treatment in Patients with Multidrug-Resistant Tuberculosis. Emerg Infect Dis. 2019 May;25(5):936-943. Abstract Full text (link to original source)

Total visits

1,386

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 Amamanta of Spain

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