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XERMELO Film-coated tablet (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Xermelo 250 mg film-coated tablets.

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, ...

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.

Therapeutic indications

Xermelo is indicated for the treatment of carcinoid syndrome diarrhoea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy.

Posology and method of administration

Posology The recommended dose is 250 mg three times daily (tid). Available data suggest that clinical response is usually achieved within 12 weeks of treatment. It is recommended to reassess the benefit ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Hepatic enzymes elevations Elevations in hepatic enzymes were observed in clinical studies (see section 4.8). Laboratory monitoring of hepatic enzymes prior to and during telotristat therapy is recommended ...

Interaction with other medicinal products and other forms of interaction

Effect of other medicinal products on Xermelo Short acting octreotide Concomitant administration of short-acting octreotide with Xermelo significantly decreased the systemic exposure of telotristat ethyl ...

Fertility, pregnancy and lactation

Women of childbearing potential Women of childbearing potential should be advised to use adequate contraception during treatment with telotristat. Pregnancy There are no data from the use of telotristat ...

Effects on ability to drive and use machines

Telotristat has minor influence on the ability to drive and use machines. Fatigue may occur following administration of telotristat (see section 4.8).

Undesirable effects

Summary of the safety profile The most commonly reported adverse reactions in patients treated with telotristat were abdominal pain (26%), gamma-glutamyl transferase increased (11%) and fatigue (10%). ...

Overdose

Symptoms There is limited clinical experience with telotristat overdose in humans. Gastrointestinal disorders including nausea, diarrhoea, abdominal pain and vomiting have been reported in healthy subjects ...

Pharmacodynamic properties

Pharmacotherapeutic group: Other alimentary tract and metabolism products: Various alimentary tract and metabolism products ATC code: A16AX15 Mechanism of action Both the prodrug (telotristat ethyl) and ...

Pharmacokinetic properties

The pharmacokinetics of telotristat ethyl and its active metabolite have been characterised in healthy volunteers and patients with carcinoid syndrome. Absorption After oral administration to healthy volunteers, ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeat dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development. ...

List of excipients

Tablet core: Lactose anhydrous Hydroxypropylcellulose Croscarmellose sodium Magnesium stearate Silica, colloidal anydrous Film-coating: Polyvinyl alcohol (partially hydrolysed) (E1203) Titanium dioxide ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 48 months.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

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.

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

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

Marketing authorization number(s)

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

Date of first authorization / renewal of the authorization

Date of first authorisation: 18 September 2017

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