WHAT IS CLOSTRIDIUM DIFFICILE (C. DIFF ) INFECTION?

C. diff bacteria cause inflammation of the colon, known as colitis. Symptoms of C. diff infection include²:

  • Diarrhea
  • Fever
  • Loss of appetite
  • Nausea
  • Abdominal pain/tenderness

C. DIFF  IS THE MOST COMMON CAUSE OF
HEALTHCARE-ASSOCIATED INFECTION IN US HOSPITALS³

  • ~500,000 CASES

    of C. diff infection have occurred in 1 year in the US³

  • ~29,000 DEATHS

    were associated with C. diff infection in 1 year in the US³

  • $4.8 BILLION

    in estimated C. diff infection–related costs for acute care facilities alone³

NEW GUIDELINES RECOMMEND ORAL VANCOMYCIN AS A FIRST‑LINE TREATMENT OPTION FOR ALL SEVERITIES OF C. DIFF INFECTION⁴

According to recent updates to the C. diff infection treatment guidelines from the Infectious Diseases Society of America and Society for Healthcare Epidemiology of America, oral vancomycin and fidaxomycin are now recommended as first‑line treatment in non-severe to severe cases of C. diff infection.⁴

In a recent white paper, Yoav Golan, MD, MS, FIDSA, of Tufts University School of Medicine, reviews these new guidelines and explains the reasons behind the update.

DOWNLOAD DR. GOLAN’S WHITE PAPER

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FIRVANQ

Learn about the only FDA‑approved
oral liquid vancomycin solution

ABOUT FIRVANQ™

IMPORTANT SAFETY INFORMATION
AND INDICATIONS

Indications

FIRVANQ™ is a glycopeptide antibacterial indicated in adults and pediatric patients less than 18 years of age for the treatment of:

  • Clostridium difficile-associated diarrhea
  • Enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains)

Contraindications

  • FIRVANQ™ is contraindicated in patients with known hypersensitivity to vancomycin.

Important Limitations of Use

  • Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin must be given orally for these infections.
  • Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of FIRVANQ™ and other antibacterial drugs, FIRVANQ™ should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

Warnings and Precautions

  • FIRVANQ™ must be given orally for treatment of C. difficile-associated diarrhea and staphylococcal enterocolitis. Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections.
  • Significant systemic absorption has been reported in some patients (e.g., patients with renal insufficiency and/or colitis) who have taken multiple oral doses of vancomycin hydrochloride for C. difficile-associated diarrhea. Some patients with inflammatory disorders of the intestinal mucosa also may have significant systemic absorption of vancomycin. Monitoring of serum concentrations of vancomycin may be appropriate in some instances, e.g., in patients with renal insufficiency and/or colitis or in those receiving concomitant therapy with an aminoglycoside antibacterial drug.
  • Nephrotoxicity has occurred following oral vancomycin hydrochloride therapy and can occur either during or after completion of therapy. The risk is increased in geriatric patients. In patients over 65 years of age, including those with normal renal function prior to treatment, renal function should be monitored during and following treatment with FIRVANQ™ to detect potential vancomycin induced nephrotoxicity.
  • Ototoxicity has occurred in patients receiving vancomycin. It may be transient or permanent. It has been reported mostly in patients who have been given high intravenous doses, who have an underlying hearing loss, or who are receiving concomitant therapy with another ototoxic agent, such as an aminoglycoside. Serial tests of auditory function may be helpful in order to minimize the risk of ototoxicity.
  • Use of FIRVANQ™ may result in the overgrowth of non-susceptible bacteria. If superinfection occurs during therapy, appropriate measures should be taken.
  • Prescribing FIRVANQ™ in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug resistant bacteria.
  • Hemorrhagic occlusive retinal vasculitis, including permanent loss of vision, occurred in patients receiving intracameral or intravitreal administration of vancomycin during or after cataract surgery. The safety and efficacy of vancomycin administered by the intracameral or intravitreal route have not been established by adequate and well controlled studies. Vancomycin is not indicated for prophylaxis of endophthalmitis.

Adverse Reactions

  • The most common adverse reactions (≥ 10%) were nausea (17%), abdominal pain (15%) and hypokalemia (13%).

To report SUSPECTED ADVERSE REACTIONS, contact CutisPharma, Inc. at 1‑800‑461‑7449, EXT 103; or FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.

This Important Safety Information does not include all the information needed to use FIRVANQ™ safely and effectively. See Full Prescribing Information for FIRVANQ™.

IMPORTANT SAFETY INFORMATION AND INDICATIONS

Indications

FIRVANQ™ is a glycopeptide antibacterial indicated in adults and pediatric patients less than 18 years of age for the treatment of:

  • Clostridium difficile-associated diarrhea
  • Enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains)

References: 1. FIRVANQ™ Prescribing Information. Wilmington, MA: CutisPharma, Inc; 2018. 2. Centers for Disease Control and Prevention (CDC). Clostridium difficile infection information for patients. https://www.cdc.gov/hai/organisms/cdiff/cdiff-patient.html. Accessed March 9, 2018. 3. Lessa FC, Mu Y, Bamberg WM, et al. Burden of Clostridium difficile infection in the United States. N Engl J Med. 2015;372(9);825-834. 4. McDonald LC, Gerding DN, Johnson S, et al. Clinical practice guidelines for Clostridium difficile infection in adults and children: 2017 update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA). [published online ahead of print February 15, 2018] Clin Infect Dis. doi:10.1093/cid/cix1085.