Crofelemer
Common name
N/A
ID
HD0133
Scientific name of the plant
Croton lechleri
Anatomical part for use
N/A
Human use
Gastrointestinal disorders
Summary
Crofelemer (USAN, trade name Mytesi) is a botanical drug for the treatment of diarrhea associated with anti-HIV drugs such as nucleoside analog reverse transcriptase inhibitors and protease inhibitors. Other possible uses include diarrhea in children, acute infectious diarrhea, and diarrhea in patients with irritable bowel syndrome. It is a purified oligomeric proanthocyanidin from "dragon's blood", the sap of the South American tree Croton lechleri.Crofelemer treats the symptoms of disease, but it is not used to treat infectious diarrhea (diarrhea caused by infection of the digestive system by a bacterium, virus or parasite).
It was initially developed by Napo Pharmaceuticals, which licensed it to Glenmark Pharmaceuticals in 140 emerging markets and to Salix Pharmaceuticals in the US, EU and some other markets. A Phase III clinical trial for diarrhea in HIV patients was completed in 2012, and the drug was approved by the US Food and Drug Administration (FDA) on 31 December 2012. (Source: Wiki)
Evidence Level
Level 0 (No convinced report of liver injury caused by herbal and dietary supplement)
Hepatotoxicity Description
During long term use of crofelemer in preregistration studies, serum
ALT
elevations occurred in 2.7% of treated subjects, but the background rate of serum enzyme elevations in this population was not defined in these open label studies. The elevations were generally mild and self-limited, rarely leading to dose reduction or discontinuation of therapy. There have been no reports of clinically apparent liver injury attributable to crofelemer, although it has had only limited wide scale use. (Source: LiverTox)
Common name
N/A
ID
HD0133
Scientific name of the plant
Croton lechleri
Anatomical part for use
N/A
Human use
Gastrointestinal disorders
Summary
Crofelemer (USAN, trade name Mytesi) is a botanical drug for the treatment of diarrhea associated with anti-HIV drugs such as nucleoside analog reverse transcriptase inhibitors and protease inhibitors. Other possible uses include diarrhea in children, acute infectious diarrhea, and diarrhea in patients with irritable bowel syndrome. It is a purified oligomeric proanthocyanidin from "dragon's blood", the sap of the South American tree Croton lechleri.Crofelemer treats the symptoms of disease, but it is not used to treat infectious diarrhea (diarrhea caused by infection of the digestive system by a bacterium, virus or parasite). It was initially developed by Napo Pharmaceuticals, which licensed it to Glenmark Pharmaceuticals in 140 emerging markets and to Salix Pharmaceuticals in the US, EU and some other markets. A Phase III clinical trial for diarrhea in HIV patients was completed in 2012, and the drug was approved by the US Food and Drug Administration (FDA) on 31 December 2012. (Source: Wiki)
Evidence Level
Level 0 (No convinced report of liver injury caused by herbal and dietary supplement)
Hepatotoxicity Description
During long term use of crofelemer in preregistration studies, serum ALT elevations occurred in 2.7% of treated subjects, but the background rate of serum enzyme elevations in this population was not defined in these open label studies. The elevations were generally mild and self-limited, rarely leading to dose reduction or discontinuation of therapy. There have been no reports of clinically apparent liver injury attributable to crofelemer, although it has had only limited wide scale use. (Source: LiverTox)