FULYZAQ® is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy.
Important Safety Information about Fulyzaq
FULYZAQ® (crofelemer) delayed-release tablets should not be used for the treatment of infectious diarrhea. It is important that your healthcare provider considers infectious causes of diarrhea before you start taking FULYZAQ. If infectious causes are not considered, and you begin taking FULYZAQ based on a probable diagnosis of noninfectious diarrhea, there is a risk that you will not receive the appropriate treatments, and your disease may worsen.
FULYZAQ tablets should be swallowed whole. FULYZAQ tablets should not be crushed or chewed. You may take FULYZAQ with or without food. You should follow the instructions of your healthcare provider.
If you are pregnant, or planning to become pregnant, talk to your healthcare provider before taking FULYZAQ. The safety and effectiveness of FULYZAQ have not been established in people younger than 18 years of age.
In clinical studies, the most common adverse reactions associated with FULYZAQ—occurring in at least 3% of patients taking FULYZAQ—were upper respiratory tract infection, bronchitis (inflammation of the lining of the tubes which carry air to and from your lungs), cough, flatulence (intestinal gas passed through your rectum), and increased bilirubin (a waste product of the breakdown of red blood cells).
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.
For product information, adverse event reports, and product complaint reports, please contact:
Salix Product Information Call Center
Please see complete Prescribing Information for FULYZAQ.
Salix obtained rights to crofelemer under license from Napo Pharmaceuticals, Inc.