XERMELO- telotristat ethyl tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

telotristat ethyl (UNII: 8G388563M7) (telotristat - UNII:381V4FCV2Z)

Available from:

TerSera Therapeutics LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Xermelo is indicated for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy. Xermelo is contraindicated in patients with a history of a hypersensitivity reaction to telotristat. Reactions have included angioedema, rash and pruritis. Risk Summary There are no human data with Xermelo use in pregnant women to inform a drug-associated risk. In animal reproduction studies, no effects on embryo-fetal development were observed with the administration of oral telotristat ethyl to rats during organogenesis at doses up to 750 mg/kg/day (approximately 9 times the exposure at the RHD [recommended human dose]). Treatment of pregnant rabbits with oral telotristat ethyl during organogenesis produced maternal toxicity and post-implantation loss at doses of 250 mg/kg/day or higher (approximately 15 times the exposure at the RHD), and reduced fetal weight at 500 mg/kg/day (approximately 33 times the exposure at the RHD). In a pr

Product summary:

How Supplied 250 mg tablet: white to off-white coated oval tablet with “T-E” debossed on one side and “250” debossed on the other side. Xermelo is dispensed in a monthly case for a total of 28 days of therapy. Each monthly case contains four weekly packs. Each weekly pack contains 21 tablets. Storage Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Authorization status:

New Drug Application

Summary of Product characteristics

XERMELO- TELOTRISTAT ETHYL TABLET
TERSERA THERAPEUTICS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
XERMELO SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR XERMELO.
XERMELO (TELOTRISTAT ETHYL) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2017
RECENT MAJOR CHANGES
Contraindications (4)
9/2022
Warnings and Precautions, Constipation (5.1)
9/2022
INDICATIONS AND USAGE
Xermelo is a tryptophan hydroxylase inhibitor indicated for the
treatment of carcinoid syndrome diarrhea
in combination with somatostatin analog (SSA) therapy in adults
inadequately controlled by SSA therapy.
(1)
DOSAGE AND ADMINISTRATION
The recommended dosage of Xermelo in adult patients is 250 mg three
times daily for patients whose
diarrhea is inadequately controlled by a SSA therapy. (2)
Take Xermelo with food. (2)
When short-acting octreotide is used in combination with Xermelo,
administer short-acting octreotide at
least 30 minutes after administering Xermelo. (2, 7.3)
Discontinue Xermelo if severe constipation develops. (2, 5.1)
DOSAGE FORMS AND STRENGTHS
Tablets: 250 mg telotristat ethyl (3)
CONTRAINDICATIONS
History of hypersensitivity to telotristat. (4)
WARNINGS AND PRECAUTIONS
Constipation: Xermelo reduces bowel movement frequency; monitor
patients for constipation, and/or
severe persistent or worsening abdominal pain. Discontinue Xermelo if
constipation or abdominal pain
develops. (5.1)
ADVERSE REACTIONS
Most common adverse reactions (≥5%) are nausea, headache, increased
GGT, depression, flatulence,
decreased appetite, peripheral edema, and pyrexia. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TERSERA THERAPEUTICS
LLC AT 1-844-334-
4035 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
DRUG INTERACTIONS
CYP3A4 Substrates (e.g., midazolam) and CYP2B6 Substrates (e.g.,
bupropion, efavirenz): Efficacy of
concomitant drugs may be decreased; monitor patients’ response and
consider increasing the dosage of
the concomitant drug, if necessary. (7.1)
S