For noninfectious diarrhea in adults living with HIV/AIDS who are on ART*

The efficacy of Mytesi 125-mg delayed-release tablets twice daily was evaluated in a randomized, double-blind, placebo-controlled (one month) and placebo-free (five month), multi-center study (the ADVENT trial). The study enrolled HIV-positive patients on stable ART with a history of diarrhea for 1 month or more.

A significantly larger proportion of patients in the Mytesi 125-mg twice daily group experienced clinical response compared with patients in the placebo group (p < 0.01).

  • *Indication

    MYTESI™ 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 MYTESI

    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%).

    Click to Read Full Prescribing Information

Baseline watery stools per week is the average of the combined treatment groups for patients on placebo (n=138) and patients on Mytesi 125-mg twice daily (n=134).

Source: MacArthur, et al. HIV Clinical Trials 2013; 14(6): 261-273

For product information, adverse event reports, and product complaint reports, please contact: 
Napo Pharmaceuticals     
email: napopharma@missionpharmacal.com        
phone: (844) 722-8256

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.

©2016 Napo Pharmaceuticals Inc. All rights reserved.

350a-g-1

  • *Indication

    MYTESI™ 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 MYTESI

    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%).

    Click to Read Full Prescribing Information

  • *Indication

    MYTESI™ 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 MYTESI

    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%).

    Click to Read Full Prescribing Information

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.

 

©2016 Napo Pharmaceuticals Inc. All rights reserved.

350a-g-1

For product information, adverse event reports, and product complaint reports, please contact: 
Napo Pharmaceuticals     
email: napopharma@missionpharmacal.com        
phone: (844) 722-8256

 

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.

 

©2016 Napo Pharmaceuticals Inc. All rights reserved.

350a-g-1

  • *Indication

    MYTESI™ 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 MYTESI

    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%).

    Click to Read Full Prescribing Information

  • *Indication

    MYTESI™ is an anti-diarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy.

    Important Safety Information about MYTESI

    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%).

    Click to Read Full Prescribing Information