Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Ipsen Pharma, 65 quai Georges Gorse, 92100, Boulogne-Billancourt, France
Xermelo 250 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. White to off-white film-coated oval tablets (approximately 17 mm long by 7.5 mm wide) with ‘T-E’ debossed on one side and ‘250’ debossed on the other side. |
Each film-coated tablet contains telotristat etiprate equivalent to 250 mg telotristat ethyl.
Excipient with known effect: Each tablet contains 168 mg of lactose (as anhydrous).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Telotristat |
Both the prodrug (telotristat ethyl) and its active metabolite (telotristat) are inhibitors of L-tryptophan hydroxylases (TPH1 and TPH2, the rate limiting steps in serotonin biosynthesis). Serotonin plays a critical role in regulating several major physiological processes, including secretion, motility, inflammation, and sensation of the gastrointestinal tract, and is over-secreted in patients with carcinoid syndrome. Through inhibition of peripheral TPH1, telotristat reduces the production of serotonin, thus alleviating symptoms associated with carcinoid syndrome. |
| List of Excipients |
|---|
|
Tablet core: Lactose anhydrous Film-coating: Polyvinyl alcohol (partially hydrolysed) (E1203) |
PVC/PCTFE/PVC/Al blister.
The blisters are packaged in a carton.
Pack sizes of 90 and 180 tablets. Not all pack sizes may be marketed.
Ipsen Pharma, 65 quai Georges Gorse, 92100, Boulogne-Billancourt, France
EU/1/17/1224/001
EU/1/17/1224/002
Date of first authorisation: 18 September 2017
| Drug | Countries | |
|---|---|---|
| XERMELO | Austria, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
