For non-infectious diarrhea in HIV patients on ART*
Effective October 2016, crofelemer (previously known as Fulyzaq)
is now available under the trade name Mytesi.
While the brand name is new, the drug itself remains unchanged.
FULYZAQ® is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART).
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.
The product information provided in this site is intended only for residents of the United States. The products discussed herein may have different product labeling in different countries.
Fulyzaq is manufactured for Napo Pharmaceuticals, Inc. by Patheon, Inc.
The botanical drug substance of FULYZAQ is extracted from Croton lechleri (the botanical raw material) that is sustainably harvested in South America.
2016 Napo Pharmaceuticals, Inc. All rights reserved NP-268-1
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