2024-12-04T08:01:00

(BPT) - Every year, nearly half a million people in the U.S. suffer from a serious and potentially deadly infection called Clostridioides difficile or C. diff.1,2 C. diff is a bacteria that can overwhelm good bacteria in the gut and cause an infection. Symptoms may include constant diarrhea, stomach pains, and fever.1 Even when treated with antibiotics, a C. diff infection can come back again and again.1

Imagine having C. diff and needing to be close to a bathroom almost constantly – it can make even the simplest task like going to the grocery store difficult.1 That's what happened to Heather, a 37-year-old newlywed from Arizona.

Heather recalls her fear when she began going through a vicious cycle of symptoms right before her wedding. "I had dreamed of being this beautiful princess bride, and suddenly I was sick all the time. It was devastating."

Heather was initially treated with antibiotics, but her infection returned. This is common for some C. diff sufferers. Up to three in 10 people who have C. diff get it again, which is known as a recurrence.2,3 After a first recurrence, up to six in 10 people may develop a subsequent recurrence. 4,5

When Heather visited her doctor for a follow-up, she learned about an option called REBYOTA, the first and only single-dose microbiome-based therapy approved by the U.S. Food and Drug Administration (FDA) to prevent recurrent C. diff infection in individuals 18 years of age and older following antibiotic treatment for recurrent C. diff infection. REBYOTA is delivered directly where it's needed, the gut microbiome.

"I went in, and my nurse administered REBYOTA. It only took about 15 minutes, and then I was able to get up and drive myself home," she said.

A few days after the administration, Heather started to notice a difference.

"I was so surprised. The number of times I was rushing to the bathroom decreased, and each day I felt incrementally better," she said. "After being sick for so long, I was finally starting to feel like myself again."

More than six months later, Heather remains free of C. diff symptoms. She even felt well enough to go to the Phoenix State Fair with her husband. "We were there from morning until night, and I didn't have to worry about being close to a bathroom. It was something I never thought would be possible when I was sick," she said. Individual results may vary.

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 click to see the full Prescribing Information.

References:

  1. Centers for Disease Control and Prevention. About C. Diff? 6 Mar. 2024. Available at: https://www.cdc.gov/c-diff/about/index.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. Cornely OA, Miller MA, Louie TJ, Crook DW, Gorbach SL. Treatment of first recurrence of Clostridium difficile infection: fidaxomicin versus vancomycin. Clin Infect Dis. 2012;55(suppl 2):S154-S161.
  4. Kelly CP. Can we identify patients at high risk of recurrent Clostridium difficile infection? Clin Microbiol Infect. 2012;18(suppl 6):21-27.
  5. Smits WK, Lyras D, Lacy DB, Wilcox MH, Kuijper EJ. Clostridium difficile infection. Nat Rev Dis Primers. 2016;2:16020.

Photo by Julian Dufort

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