(BPT) - Sponsored by Ferring Pharmaceuticals

Every year, about half a million Americans suffer from a serious and potentially deadly infection called Clostridioides difficile (C. diff) infection.^1,2 C. diff infection takes hold in the gut microbiome and people who suffer from the infection may experience debilitating symptoms, including diarrhea, fever, stomach pain, and inflammation of the colon.¹ Up to three in ten people who get a C. diff infection will get it again.^3,4,5,6 This is called a recurrence. After that first recurrence, up to six in ten people may get another C. diff infection.^3,4

The U.S. Food and Drug Administration (FDA) recently approved REBYOTA^™ (fecal microbiota, live - jslm), the only FDA-approved microbiome-based treatment to prevent recurrent C. diff infection, after you've taken antibiotics for recurrent C. diff infection. The treatment, produced by Ferring Pharmaceuticals, is a liquid mix of up to trillions of live microbes.⁷

'Having recurrent C. diff was the scariest thing that has ever happened in my life,' remembers Patricia, a C. diff infection patient. 'I'd never felt that sick before. To not be able to care for my children, to just be so weak and not want to leave the house, and then for it to go away and come back again, and then again - I lived my life in terror.'

While C. diff infection can affect anyone, older adults and people with a weakened immune system are more susceptible.¹ About 80 percent of recurrent C. diff infection patients wind up in the hospital for treatment each time, causing considerable healthcare, emotional and financial burdens for patients and their families.^5,8

'Until now, patients had few treatment options to help treat the devastating cycle of recurrent C. diff infections. The infection interrupts patients' lives, keeping them at home or in the hospital, and away from loved ones,' says Dr. Paul Feuerstadt, a professor at the Yale University School of Medicine. 'This new treatment option will bring hope to thousands of people experiencing this disease.'

For Patricia, this breakthrough couldn't come fast enough. She was referred by her doctor to a GI specialist to participate in a clinical trial for Ferring's investigational therapy.

'I wasn't scared, because the alternative of continuing to have C. diff, and living my life where one week out of the month I was unable to care for my kids or to leave my house was even scarier,' she says. 'Since my treatment more than three years ago, I haven't had a recurrence. I was so emotional to be able to finally hug my girls again after lying on the couch and isolating myself from them for so long. We were all excited.'

In clinical trials, REBYOTA was well-tolerated with generally expected and manageable side effects. Side effects were mostly mild to moderate in severity and the most common side effects were stomach pain, diarrhea, bloating, gas and nausea.

To learn more about C. diff infection and REBYOTA, talk to your doctor and visit REBYOTA.com.

INDICATION

REBYOTA (fecal microbiota, live - jslm) is indicated for the prevention of recurrence of Clostridioides difficile (C. diff) infection in individuals 18 years of age and older, following antibiotic treatment for recurrent C. diff infection.

Limitation of Use

REBYOTA is not indicated for the treatment of C. diff infection.

IMPORTANT SAFETY INFORMATION

• You should not receive REBYOTA if you have a history of a severe allergic reaction (e.g., anaphylaxis) to REBYOTA or any of its components.
• You should report to your doctor any infection you think you may have acquired after administration.
• REBYOTA may contain food allergens.
• Most common side effects may include stomach pain (8.9%), diarrhea (7.2%), bloating (3.9%), gas (3.3%), and nausea (3.3%).
• REBYOTA has not been studied in patients below 18 years of age.
• Clinical studies did not determine if adults 65 years of age and older responded differently than younger adults.

You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.FDA.gov/medwatch or call 1-800-332-1088.

Please visit REBYOTA.com for full Prescribing Information.

References:

1. Centers for Disease Control and Prevention. What Is C. Diff? 17 Dec. 2018. Available at: https://www.cdc.gov/cdiff/what-is.html.
2. 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.
3. Kelly, CP. Can we identify patients at high risk of recurrent Clostridium difficile infection? Clin Microbiol Infect. 2012;18(suppl 6):21-27.
4. Smits WK, Lyras D, Lacy DB, et al. Clostridium difficile infection. Nat Rev Dis Primers. 2016;2:16020.
5. Nelson WW, Scott TA, Boules M, et al. Health care resource utilization and costs of recurrent I infection in the elderly: a real-world claims analysis. J Manag Care Spec Pharm. 2021;27(7):828-838. Epub 2021 Mar 11.
6. Riddle DJ, Dubberke ER. Clostridium difficile infection in the intensive care unit. Infect Dis Clin North Am. 2009;23(3):727-743.
7. REBYOTA. Prescribing information. Parsippany, NJ: Ferring Pharmaceuticals Inc; 2022.
8. Feuerstadt P, Strong L, Dahdal DN, et al. Healthcare resource utilization and direct medical costs associated with index and recurrent Clostridioides difficile infection: a real-world data analysis. J Med Econ. 2020;23(6):603-609