Fulyzaq (crofelemer) is approved by the FDA for symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy.

For diarrhea related to antiretroviral therapy (ART) in adults with HIV

Fulyzaq may help

Fulyzaq is the only FDA-approved treatment that’s been studied specifically in adults with HIV/AIDS taking ART with noninfectious diarrhea

Diarrhea is a known side effect even in some of the newest ARTs.

Current treatment options have not been studied in patients with HIV.

In clinical studies, the most common adverse reactions associated with FULYZAQ—occurring in at least 3% 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).

Fulyzaq works differently from other medicines used to treat diarrhea and you only need to take 1 pill, twice a day

Fulyzaq is a plant-based medicine that restores the balance of water in the GI tract to control diarrhea.

In clinical trials, Fulyzaq demonstrated a proven safety profile over a 6-month period.

Indication

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% 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
Phone: 1-800-508-0024
Fax: 1-510-595-8183
Email: salix@medcomsol.com

Please see complete Prescribing Information for FULYZAQ. PDF

Salix obtained rights to crofelemer under license from Napo Pharmaceuticals, Inc.