What is Zinplava - Bezlotoxumab used for?
Zinplava is a medicine used in adults who have infections due to a bacterium called Clostridium difficile, which causes severe diarrhea. It is used to prevent future episodes of diarrhea in patients who are taking antibiotics to treat C. difficile infection and who are at high risk of re-infection.
How is Zinplava used - Bezlotoxumab?
Zinplava is available as a concentrate to be transformed into a solution for infusion (drip) into a vein. It is given as a single infusion lasting about 1 hour. The recommended dose is 10 mg per kilogram of body weight.
The medicine can only be obtained with a prescription. For more information, see the package leaflet.
How does Zinplava - Bezlotoxumab work?
The bacterium C. difficile produces toxins that damage the mucous membrane of the intestine causing diarrhea, which can be serious. After an initial infection, some dormant forms of bacteria (spores) may persist in the body and eventually produce other toxins, which cause symptoms to return.
Bezlotoxumab is a monoclonal antibody (a type of protein) designed to bind to these toxins, blocking their action and thus preventing further damage and the occurrence of diarrhea.
What benefit has Zinplava - Bezlotoxumab shown during the studies?
Administered during antibiotic treatment, Zinplava was shown to be more effective than placebo (a dummy treatment) in preventing a new episode of diarrhea caused by C. difficile infection in 2 main studies involving a total of 655 patients. A new episode of diarrhea was defined as 3 or more soft stool evacuations in 24 hours or less.
In the first study, 17% of patients treated with Zinplava (67 of 386 patients) had a new episode of diarrhea within 12 weeks of treatment compared to 28% of patients who received a placebo (109 of 395). In the second study, the percentages were 16% (62 out of 395) for Zinplava and 26% (97 out of 378) for placebo. The effect was especially observed in patients at higher risk of recurrence of C. difficile infection (such as in older patients or those with a weakened immune system).
What are the risks associated with Zinplava - Bezlotoxumab?
The most common side effects with Zinplava (seen in more than 4 patients in 100) are malaise (nausea), diarrhea, fever and headache. Similar effects were observed in patients treated with placebo.
For the full list of all side effects reported with Zinplava and its limitations, see the package leaflet.
Why has Zinplava - Bezlotoxumab been approved?
Zinplava has been shown to be effective in preventing recurrence of C. difficile infection, particularly in patients at high risk of recurrence of infection (which occurs in approximately 15-35% of cases and is particularly difficult to treat) ). Zinplava is generally well tolerated with side effects similar to those seen in patients treated with placebo.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Zinplava's benefits are greater than its risks and recommended that it be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of Zinplava - Bezlotoxumab?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zinplava have been included in the summary of product characteristics and the package leaflet.
More information on Zinplava - Bezlotoxumab
The full EPAR for Zinplava can be found on the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Zinplava therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
