XERMELO Film-coated tablet Ref.[9179] Active ingredients: Telotristat

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Ipsen Pharma, 65 quai Georges Gorse, 92100, Boulogne-Billancourt, France

Product name and form

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.

Qualitative and quantitative composition

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
Hydroxypropylcellulose
Croscarmellose sodium
Magnesium stearate
Silica, colloidal anydrous

Film-coating:

Polyvinyl alcohol (partially hydrolysed) (E1203)
Titanium dioxide (E171)
Macrogol 3350 (E1521)
Talc (E553b)

Pack sizes and marketing

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.

Marketing authorization holder

Ipsen Pharma, 65 quai Georges Gorse, 92100, Boulogne-Billancourt, France

Marketing authorization dates and numbers

EU/1/17/1224/001
EU/1/17/1224/002

Date of first authorisation: 18 September 2017

Drugs

Drug Countries
XERMELO Austria, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States

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