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Mytesi Is a Novel, First-in-Class Antisecretory Agent
Mytesi is FDA-approved for symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy (ART).
Mytesi has a novel mechanism of action that modulates chloride secretion in the gastrointestinal tract, reducing excessive chloride and accompanying water flow and relieving watery diarrhea.
Mytesi Is a Novel, First-in-Class Antisecretory Agent
Mytesi is FDA-approved for symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy (ART).
Mytesi has a novel mechanism of action that modulates chloride secretion in the gastrointestinal tract, reducing excessive chloride and accompanying water flow and relieving watery diarrhea.
Indication
Mytesi (crofelemer) is an antidiarrheal drug indicated for symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS who are on antiretroviral therapy (ART).
Important Safety Information
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 (6%), bronchitis (4%), cough (4%), flatulence (3%), and increased bilirubin (3%).
JAG-G-0001
Indication
CANALEVIA-CA1 is conditionally approved for the treatment of chemotherapy-induced diarrhea (CID) in dogs.
IMPORTANT SAFETY INFORMATION
APPROVAL
Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-552.
CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. It is a violation of Federal Law to use this product other than as directed in the labeling.
SAFETY
For oral use in dogs only. Not for use in humans. Keep Canalevia®-CA1 (crofelemer delayed-release tablets) in a secure location out of reach of children and other animals. Consult a physician in case of accidental ingestion by humans. Do not use in dogs that have a known hypersensitivity to crofelemer. Prior to using Canalevia-CA1, rule out infectious etiologies of diarrhea. Canalevia-CA1 is a conditionally approved drug indicated for the treatment of chemotherapy-induced diarrhea in dogs. The most common adverse reactions included decreased appetite, decreased activity, dehydration, abdominal pain, and vomiting.
CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Use only as directed. It is a violation of Federal law to use this product other than as directed in the labeling. Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-552.
BXD-025-1022
