SUMMARY OF PRODUCT CHARACTERISTICS
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.
Synthetic document: Norvexa, tavorexin and the company are invented.

1. NAME OF THE MEDICINAL PRODUCT
Norvexa 50 mg film-coated tablets
Norvexa 100 mg film-coated tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg or 100 mg tavorexin.

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

4.2 Posology and method of administration
The recommended dose is 100 mg once daily. Treatment should be initiated at 50 mg once daily for the first 7 days, followed by 100 mg once daily. The maximum daily dose is 100 mg.
Renal impairment: in patients with moderate renal impairment (creatinine clearance 30 to 59 mL/min), the recommended dose is 50 mg once daily.
Method of administration: for oral use. The tablets must be swallowed whole and must not be crushed or chewed. Norvexa can be taken with or without food.

4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Severe hepatic impairment (Child-Pugh class C) (see section 4.4).
Pregnancy (see section 4.6).
Concomitant use of strong CYP3A4 inhibitors, e.g. ketoconazole or clarithromycin (see section 4.5).

4.4 Special warnings and precautions for use
Serious infections: serious and sometimes fatal infections have been reported. Norvexa must not be initiated in patients with an active serious infection. Treatment should be interrupted if a serious infection develops.
Hepatotoxicity: ALT elevations greater than 3 times the upper limit of normal were observed in 2.1% of patients. Liver function tests should be monitored at baseline and every 3 months.
Depression and suicidal ideation: patients should be advised to report new or worsening depression, suicidal thoughts or mood changes.
Women of childbearing potential: women of childbearing potential must use effective contraception during treatment and for 4 weeks after the last dose.
Lymphopenia: treatment must not be initiated in patients with an absolute lymphocyte count below 0.5 x 10^9/L.

4.8 Undesirable effects
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.
Reporting of suspected adverse reactions: healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

6.4 Special precautions for storage
Do not store above 30°C. Store in the original package in order to protect from moisture.
