FDA approves oral vancomycin for C difficile and MRSA GI infections

  • CutisPharma
  • CutisPharma news release
  • 29/01/2018

  • Jenny Blair, MD
  • Clinical Essentials
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Takeaway

  • An oral vancomycin solution (Firvanq; CutisPharma) is now FDA-approved and is targeted for launch on April 2, 2018.
  • Firvanq is indicated for the treatment of Clostridium difficile-associated diarrhea and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains (MRSA).

Why this matters

  • A premixed oral vancomycin solution could save time and improve access.

Key details

  • Firvanq will come in 25 and 50 mg/mL strengths and in 150 and 300 mL sizes.
  • It will replace CutisPharma’s oral vancomycin solution compounding kit, FIRST.
  • Vancomycin is bactericidal; it works primarily by inhibiting cell-wall biosynthesis. 
  • Intravenous formulations of vancomycin can also be administered orally.
  • Some conditions can raise the risk for systemic vancomycin absorption via the oral route, including high doses, prolonged administration, and severe gastrointestinal (GI) infection or inflammation.
  • Common adverse reactions include nausea, abdominal pain, vomiting, diarrhea, fever, and hypokalemia. 
  • Nephrotoxicity was noted in 5% of study patients in prescription insert; other serious reactions include ototoxicity and reversible neutropenia. 
  • There are no available data on Firvanq's safety in pregnancy, but older data have not linked vancomycin use in the second and third trimesters with adverse pregnancy-related outcomes.