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Mytesi® (crofelemer)

Mytesi® (crofelemer)

RedHill Biopharma announced in June 2018 that it has entered into a co-promotion agreement with Napo Pharmaceuticals, Inc. granting RedHill exclusive U.S. rights to co-promote Mytesi® (crofelemer 125 mg delayed-release tablets) for the approved indication in people living with HIV/AIDS with respect to certain gastroenterologists and primary care physicians. In July 2018 RedHill initiated promotion of Mytesi® to certain gastroenterologists and primary care physicians in the U.S.

Mytesi® is an anti-diarrheal indicated for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART).

Important Safety Information
Mytesi (crofelemer) is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). Mytesi is not indicated for the treatment of infectious diarrhea. Rule out infectious etiologies of diarrhea before starting Mytesi. If infectious etiologies are not considered, there is a risk that patients with infectious etiologies will not receive the appropriate therapy and their disease may worsen. In clinical studies, the most common adverse reactions occurring at a rate greater than placebo were upper respiratory tract infection (5.7%), bronchitis (3.9%), cough (3.5%), flatulence (3.1%), and increased bilirubin (3.1%).

See full Prescribing Information at www.Mytesi.com. Crofelemer, the active ingredient in Mytesi, is a botanical (plant-based) drug extracted and purified from the red bark sap of the medicinal Croton lechleri tree in the Amazon rainforest. Napo has established a sustainable harvesting program for crofelemer to ensure a high degree of quality and ecological integrity.

To submit adverse event reports or product complaint reports, contact Napo Pharmaceuticals, Inc. at napopharma@missionpharmacal.com or (844) 722-8256. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/Safety/MedWatch/default.htm or call 1-800-FDA-1088 (1-800-332-1088).