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