NORVEXA (tavorexin) film-coated tablets
COMPANY CORE DATA SHEET, version 4.0, 12 March 2026
Synthetic document: Norvexa, tavorexin and the company are invented.

1 COMPOSITION AND STRENGTHS
Each film-coated tablet contains 50 mg or 100 mg tavorexin.

2 INDICATIONS
Norvexa is indicated for the treatment of adults with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy.
Norvexa is indicated for the treatment of adults with active psoriatic arthritis who have had an inadequate response to at least one conventional DMARD.

3 DOSAGE AND ADMINISTRATION
The recommended dose is 100 mg once daily, taken with or without food.
Treatment should start at 50 mg once daily for the first 7 days, then 100 mg once daily.
In patients with moderate renal impairment (creatinine clearance 30 to 59 mL/min), the recommended dose is 50 mg once daily.
The maximum daily dose is 100 mg.
Tablets must be swallowed whole and must not be crushed or chewed.

4 CONTRAINDICATIONS
Hypersensitivity to tavorexin or to any of the excipients.
Severe hepatic impairment (Child-Pugh class C).
Pregnancy.
Concomitant use of strong CYP3A4 inhibitors, such as ketoconazole or clarithromycin.

5 WARNINGS AND PRECAUTIONS
Serious infections: serious and sometimes fatal infections have been reported. Do not start Norvexa in patients with an active serious infection. Interrupt treatment if a serious infection develops.
Hepatotoxicity: ALT elevations greater than 3 times the upper limit of normal occurred in 2.1% of patients. Monitor liver function tests at baseline and every 3 months.
Depression and suicidal ideation: advise patients to report new or worsening depression, suicidal thoughts or mood changes.
Contraception: women of childbearing potential must use effective contraception during treatment and for 4 weeks after the last dose.
Lymphopenia: do not start treatment in patients with an absolute lymphocyte count below 0.5 x 10^9/L.

6 ADVERSE REACTIONS
Very common (≥1/10): nausea, headache.
Common (≥1/100 to <1/10): diarrhoea, upper respiratory tract infection, fatigue, ALT increased.
Uncommon (≥1/1,000 to <1/100): herpes zoster, depression.

7 STORAGE
Store below 30°C. Store in the original package in order to protect from moisture.
