IDStewardship

Brincidofovir (Tembexa)

Brincidofovir (Tembexa) photo

KEY POINTS

  • Brincidofovir (Tembexa) an orthopoxvirus nucleotide analog DNA polymerase inhibitor
  • Brincidofovir is a pro-drug that is converted intracellularly to cidofovir, which is subsequently phosphorylated to cidofovir diphosphate (the active compound). It inhibits orthopoxvirus DNA polymerase-mediated viral DNA synthesis. Incorporation of cidofovir into the growing viral DNA chain results in reductions in the rate of viral DNA synthesis.
  • Brincidofovir was FDA approved on 4 June 2021 for the treatment of smallpox (variola virus) disease in adult and pediatric patients, including neonates
    • The package insert states in limitations of use “not indicated for the treatment of diseases other than human smallpox disease”
      • Brincidovir has been studied for use against adenovirus, herpes simplex virus, cytomegalovirus, varicella zoster virus, ebola virus, and more
  • Available for oral only as 100 mg tablets and a 10 mg/mL suspension
    • Dose for adult and pediatric patients weighing 48 kg or more: 200 mg once weekly for two weeks (two doses total)
    • Dose for adult and pediatric patients weighing 10 kg or more but below 48 kg:  4 mg/kg using the oral suspension once weekly for two weeks (two doses total)
    • Pediatric patients less than 10 kg; 6 mg/kg oral suspension once weekly for two weeks (two doses total)
    • Avoid direct contact with broken or crushed tablets or oral suspension. If contact with skin or mucous membranes occurs, wash thoroughly with soap and water, and rinse eyes thoroughly with water
    • No renal or hepatic dose adjustments are listed in the package insert
  • Hepatic lab monitoring and pregnancy testing (for females) is necessary prior to starting brincidofovir
  • Holds an FDA Boxed Warning for increased risk of mortality when used for longer duration
  • Warnings include: hepatic transaminase and bilirubin elevation, diarrhea or other gastrointestinal adverse events, embryo-fetal toxicity, carcinogenicity, and male infertility
  • Other potential side effects include diarrhea, nausea, vomiting, and abdominal pain
  • Should not be co-administered with cidofovir
  • Has drug-drug interactions with OATP1B1 and 1B3 inhibitors, which can increase brincidofovir exposure
  • See package insert below for full prescribing details

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