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, Ireland, Israel, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States |
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