Positively Aware Mytesi

Mytesi

crofelemer

Anti-diarrheal approved for use in those with HIV/AIDS and on antiretroviral therapy
Non-HIV Drug

Standard Dose

One 125 mg delayed-release tablet taken twice a day, with or without food. The tablet should be swallowed whole and not crushed or chewed.

Mytesi (crofelemer) is the first, and only, anti-diarrheal indicated for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy. Currently, what is typically recommended is for the patient to take medication(s) with food and/or use Imodium (loperamide) for symptomatic diarrhea.

Mytesi approval was based on a randomized, placebo-controlled study of 374 HIV-positive patients who had about 3 watery stools per day and were on anti-HIV medicines. At study entry, patients experienced an average of approximately 20 watery stools per week. To be considered a responder, watery stools had to be decreased to two or fewer per week, which occurred in 18% of Mytesi-treated patients vs. 8% of placebo-treated patients at 4 weeks. In an open label extension phase of the study, about 50% of the patients reported two or fewer watery stools per week at 3 months, an effect which was maintained until study end at 6 months. These findings suggest that it may take some time to achieve the optimal effect. Mytesi appears to work best in those who have tried and failed non-prescription anti-diarrheals, have had diarrhea for more than two years, have more than two watery bowel movements per day, and whose bowel movements tend to be “pourable” (not clumpy). Mytesi was less effective in African Americans in this clinical study.

Manufacturer

Napo Pharmaceuticals
mytesi.com
(844) 722-8256

AWP

$802.22/60 tablets

Potential Side Effects and Toxicity

More Information