Info

🌱來自: fecal microbiota transplantation

Available Products of Fecal Microbiota Transplantation

• Potentially Practice-Changing

  Drug/Device Alert Updated 9 Dec 2022

  fecal microbiota, live-jslm (Rebyota) FDA approved for prevention of recurrence of Clostridioides difficile (CDI) in patients ≥ 18 years old who have completed antibiotic treatment for recurrent CDI

  • not indicated for treatment of C. difficile
  • fecal microbiota, live-jslm is from human fecal matter sourced from qualified donors
  • efficacy based on 2 randomized trials including 301 adults receiving fecal microbiota, live-jslm vs. placebo
    • CDI diarrhea defined as ≥ 3 unformed/loose stools in ≤ 24 hours for ≥ 2 consecutive days and a positive stool test for C. difficile toxin at time of diarrhea
    • treatment success defined as the absence of CDI diarrhea within 8 weeks of blinded treatment
    • overall estimated treatment success rate 70.6% vs. 57.5% (95% credible interval 2.3-24)
  • dosing and administration
    • thaw the product in a refrigerator for about 24 hours, do not thaw using heat source (such as hot water)
    • administer fecal microbiota, live-jslm 24-72 hours after the last dose of antibiotics for CDI
    • give 150 mL rectally once
    • see [product information][36] for preparation and administration instruction
  • adverse effects (in ≥ 3%) include abdominal distention/pain, diarrhea, flatulence, and nausea
  • References - [FDA Press Release 2022 Nov 30][37], [FDA Label 2022 Nov][38]

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title:Available Products of Fecal Microbiota Transplantation date: “2023-02-02” enableToc: false

Info

🌱來自: fecal microbiota transplantation

Available Products of Fecal Microbiota Transplantation

• Potentially Practice-Changing

  Drug/Device Alert Updated 9 Dec 2022

  fecal microbiota, live-jslm (Rebyota) FDA approved for prevention of recurrence of Clostridioides difficile (CDI) in patients ≥ 18 years old who have completed antibiotic treatment for recurrent CDI

  • not indicated for treatment of C. difficile
  • fecal microbiota, live-jslm is from human fecal matter sourced from qualified donors
  • efficacy based on 2 randomized trials including 301 adults receiving fecal microbiota, live-jslm vs. placebo
    • CDI diarrhea defined as ≥ 3 unformed/loose stools in ≤ 24 hours for ≥ 2 consecutive days and a positive stool test for C. difficile toxin at time of diarrhea
    • treatment success defined as the absence of CDI diarrhea within 8 weeks of blinded treatment
    • overall estimated treatment success rate 70.6% vs. 57.5% (95% credible interval 2.3-24)
  • dosing and administration
    • thaw the product in a refrigerator for about 24 hours, do not thaw using heat source (such as hot water)
    • administer fecal microbiota, live-jslm 24-72 hours after the last dose of antibiotics for CDI
    • give 150 mL rectally once
    • see [product information][36] for preparation and administration instruction
  • adverse effects (in ≥ 3%) include abdominal distention/pain, diarrhea, flatulence, and nausea
  • References - [FDA Press Release 2022 Nov 30][37], [FDA Label 2022 Nov][38]