• To reduce recurrence of Clostridium difficile infection (CDI) in patients 18 years of age or older who are receiving antibacterial drug treatment of CDI and are at a high risk for CDI recurrence

• Diagnosis of Clostridium difficile infection (CDI) confirmed by documentation of positive Clostridium difficile test

AND

• Will receive or is currently receiving concomitant antibacterial drug treatment for CDI (e.g. metronidazole, vancomycin, fidaxomicin)

AND

• Member has had at least two episodes of CDI recurrence (3 episodes) in the previous 6 months and has been treated with appropriate treatment for CDI (see general information), including a pulsed vancomycin regimen

• Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.

• Zinplava is the only medication approved to reduce the recurrence of CDI.
• Approximately 35% of CDI patients experience recurrence after the initial treatment and resolution of diarrhea. Of those who have a primary recurrence, 40% will have another CDI episode, and after 2 recurrences, the chances of an additional episode increases to as high as 65%.
• Recurrent episodes of CDI are treated with metronidazole, vancomycin, or fidaxomicin. The first recurrence should be treated with the same treatment as the initial episode. The second recurrence should be treated with vancomycin in a pulsed regimen and the third recurrence with a pulsed regimen and consideration for fecal microbiata transplant.
• Metronidazole: 500 mg orally 3 times per day for 10 - 14 days
• Vancomycin: 125 mg orally 4 times per day for 10 days
• Fidaxomicin: 200 mg orally twice daily for 10 days
• Pulsed Vancomycin: 10 days course of vancomycin at 125 mg four times per day, followed 125 mg daily pulsed every 3 days for 10 doses
  
  

Vial: 1,000 mg/40 mL (25 mg/mL)

1. Zinplava Prescribing Information. Whitehouse Station, NJ: Merck & Co., Inc; October 2016. Available at http://www.merck.com. Accessed November 2, 2016.
2. Antimicrobial Drugs Advisory Committee. Bezlotoxumab injection briefing document (BLA 761046). Published June 9, 2016. Available at http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/anti-infectivedrugsadvisorycommittee/ucm505291.pdf. Accessed November 10, 2016.
3. Antimicrobial Drugs Advisory Committee. Bezlotoxumab injection briefing document (BLA 761046). Published June 9, 2016. Available at http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/anti-infectivedrugsadvisorycommittee/ucm505290.pdf. Published June 9, 2016. Accessed November 9, 2016.
4. Cohen SH, Gerding DN, Johnson S et al. Clinical practice guidelines for Clostridium difficile infection in adults: 2010 update by the society for healthcare epidemiology of America (SHEA) and the infectious diseases society of America (IDSA). Infect Control Hosp Epidemiol. 2010 May;31(5):431-55. doi: 10.1086/651706.
5. Surawicz CM, Brandt LJ, Binion DG et al. Guidelines for diagnosis, treatment, and prevention of Clostridium difficile infections. Am J Gastroenterol. 2013 Apr;108(4):478-98; quiz 499. doi: 10.1038/ajg.2013.4. Epub 2013 Feb 26.
6. Zar FA, Bakkanagari SR, Moorthi KM, Davis MB. A comparison of vancomycin and metronidazole for the treatment of Clostridium difficile-associated diarrhea, stratified by disease severity. Clin Infect Dis 2007;45(3):302-7.
7. Lessa FC, Mu Y, Bamber WM et al. Burden of Clostridium difficile infection in the United States. N Engl J Med. 2015 Feb 26;372(9):825-34. doi: 10.1056/NEJMoa1408913.