Indikasjoner

Zinplava is a CDI antitoxin B indicated to prevent recurrence in adults at high risk for recurrence of CDI3

Despite treatment with antibiotics for CDI…

The risk of CDI recurrence remains a cause for concern1,2

Epidemiologic data from the US has shown that...

People who are at risk for CDI recurrence include

  • Age ≥65 years4–6
  • History of CDI in the past 6 months5–7
  • Recent antibiotic use6,8
  • Immunocompromised9
  • Severe CDI10
  • Inadequate immune response to toxins6,11

CDI antibiotics may not be enough to reduce the risk of CDI recurrence for high-risk patients8,12

  • While CDI antibiotics may target bacteria and resolve the infection, they may also perpetuate disruption of the gut microbiota and increase the risk for CDI recurrence due to persistent vegetative C difficile and germination of remaining spores.

An inadequate immune response to C difficile toxins is a contributing factor to CDI recurrence13

Role of the body’s adaptive immune response to C difficile toxins6

  • Most patients have an adequate immune response and are able to create antibodies against CDI toxins, which limits damage to the gut epithelium and helps prevent CDI recurrence.6
    • However, some patients are unable to mount an adequate immune response to toxins, which contributes to the recurrence risk.6

ZINPLAVA: CDI antitoxin B that may prevent recurrence in adults at high risk for recurrence of CDI3

Now, you have an option to prevent CDI recurrence in high-risk patients

Non-antibiotic mechanism of action targets toxin B3,14

  • ZINPLAVA is a selective, fully human monoclonal antibody that binds with high affinity to toxin B.3

ZINPLAVA enhances the immune response against toxin B3

  • Neutralizes toxin B activity.

Referanser

  • 1.

    McFarland LV, Surawicz CM, Greenberg RN, et al. A randomized placebo-controlled trial of Saccharomyces boulardii in combination with standardantibiotics for Clostridium difficile disease. JAMA. 1994;271(24):1913–1918.

  • 2.

    McFarland LV, Elmer GW, Surawicz CM. Breaking the cycle: treatment strategies for 163 cases of recurrent Clostridium difficile disease. Am Coll Gastroenterol. 2002;97(7):1769–1775.

  • 3.

    SPC Zinplava september 2017, avsnitt 4.1, 4.2, 4.8, 5.1.

  • 4.

    Lessa FC, Mu Y, Bamberg WM, et al. Burden of Clostridium difficile infection in the United States. N Engl J Med. 2015;372:825–834. doi:10.1056/NEJMoa1408913.

  • 5.

    Debast SB, Bauer MP, Kuijper EJ. European Society of Clinical Microbiology and Infectious Diseases: update of the treatment guidance document for Clostridium difficile infection. Clin Microbiol Infect. 2014;20(2):1–26.

  • 6.

    Gupta SB, Mehta V, Dubberke ER, et al. Antibodies to toxin B are protective against Clostridium difficile infection recurrence. Clin Infect Dis. 2016;63(6):730–734. doi:10.1093/cid/ciw364.

  • 7.

    Kelly CP, LaMont JT. Clostridium difficile—more difficult than ever. N Engl J Med. 2008;359:1932–1940. doi:10.1056/NEJMra0707500.

  • 8.

    Bagdasarian N, Rao K, Malani PN. Diagnosis and treatment of Clostridium difficile in adults: a systematic review. JAMA. 2015;313(4):398–408.doi:10.1001/jama.2014.17103.

  • 9.

    Huang AM, Marini BL, Frame D, Aronoff DM, Nagel JL. Risk factors for recurrent Clostridium difficile infection in hematopoietic stem cell transplantrecipients. Transpl Infect Dis. 2014;16(5):744–750.

  • 10.

    Eyre DW, Walker AS, Wyllie D, et al. Predictors of first recurrence of Clostridium difficile infection: implications for initial management. Clin Infect Dis. 2012;55(S2):S77–S87.

  • 11.

    Kelly CP. Can we identify patients at high risk of recurrent Clostridium difficile infection? Clin Microbiol Infect. 2012;18(6):21–27.

  • 12.

    Britton RA, Young VB. Role of the intestinal microbiota in resistance to colonization byClostridium difficile. Gastroenterology. 2014;146:1547–1553.

  • 13.

    Bauer MP, Nibbering PH, Poxton IR, et al. Humoral immune response as predictor of recurrence in Clostridium difficile infection. Clin Microbiol Infect. 2014;20(12):1323–1328. doi:10.1111/1469-0691.12769.

  • 14.

    Orth P, Xiao L, Hernandez LD, et al. Mechanism of action and epitopes of Clostridium difficile toxin-B-neutralizing antibody bezlotoxumab revealed by x-ray crystallography. J Biol Chem. 2014;289(26):18008–18021. doi:10.1074/jbc.M114.560748.

 
INFC-1247832-0003 May 2018