DIFICID: targeted therapy for the treatment of Clostridium difficile-associated diarrhea (CDAD)

The persons depicted are models used for illustrative purposes only.

DIFICID is an antibacterial drug that treats Clostridium difficile (klos-TRID-e-uhm dif-uh-SEEL)-associated diarrhea (CDAD) (pronounced see-dad) in adults 18 years of age and older. DIFICID is a tablet taken by mouth, two times a day for 10 days, with or without food.

Indication and Important Safety Information

Indication

  • DIFICID® (fidaxomicin) is an antibacterial drug for the treatment of Clostridium difficile-associated diarrhea (CDAD) in adults 18 years of age or older

Contraindication

  • DIFICID should not be used by patients who are allergic to fidaxomicin (the main ingredient of DIFICID)

Warnings and Precautions

  • DIFICID should not be taken for systemic infections (infections that affect multiple organs and/or the body as a whole)
  • Serious allergic reactions (swelling under the skin, shortness of breath, itching, and rash) have been reported by patients taking DIFICID. If you have a serious allergic reaction, stop taking DIFICID
  • Only take DIFICID for an infection that your healthcare professional has determined is caused by C. difficile. Taking DIFICID when you do not have a C. difficile infection will not provide benefit and can increase the likelihood that bacteria will develop resistance and will not be treatable by DIFICID or other antibacterial drugs in the future

Adverse Reactions

  • The most common side effects reported in clinical trials were nausea (11%), vomiting (7%), abdominal pain (6%), bleeding in the gastrointestinal tract (4%), decrease in the number of red blood cells (2%), and a low number of neutrophils (type of white blood cell) (2%)

Please see full Prescribing Information for DIFICID.

To report SUSPECTED ADVERSE REACTIONS, contact Cubist Pharmaceuticals at 1-877-CUBIST-6 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.