Mytesi® (crofelemer 125 mg delayed-release tablets) is an FDA approved anti-secretory anti-diarrheal with a novel mechanism of action (MOA). Crofelemer, the active ingredient in Mytesi®, is a botanical drug substance extracted and purified from latex from the bark of Croton lechleri, a tree that is sustainably harvested in the Amazon rainforest. The mechanism of action of Mytesi® does not affect gut motility, peristalsis or intestinal transit time. Mytesi® is the first oral prescription pharmaceutical approved under the FDA’s botanical guidance.
Mytesi® is indicated for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral therapy (ART).
The recommended dose of Mytesi® is one 125 mg delayed-release tablet taken orally two times a day.
Important Safety Information
Mytesi® (crofelemer 125 mg delayed-release tablets) is approved for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy. Rule out infectious etiologies of diarrhea before starting Mytesi® in order to avoid the risk of potential worsening of disease due to delay of appropriate therapy. The most common adverse events (incidence ≥ 3%) reported in Mytesi® clinical trials were upper respiratory tract infection, bronchitis, cough, flatulence, and increased billirubin.
Please see further details and complete Prescribing Information available at Mytesi.com