FULL PRESCRIBING INFORMATION: NORVEXA (tavorexin) tablets, for oral use
Synthetic document: Norvexa, tavorexin and the company are invented.

1 INDICATIONS AND USAGE
NORVEXA is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.

2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
The recommended dosage of NORVEXA is 100 mg orally once daily, with or without food. Initiate treatment at 50 mg once daily for the first 7 days, then increase to 100 mg once daily. Do not exceed 100 mg per day.
2.2 Dosage in Renal Impairment
The recommended dosage in patients with moderate renal impairment (CLcr 30 to 59 mL/min) is 50 mg once daily.
2.3 Administration
Swallow tablets whole. Do not crush or chew tablets.

3 DOSAGE FORMS AND STRENGTHS
Tablets: 50 mg and 100 mg tavorexin, film-coated.

4 CONTRAINDICATIONS
NORVEXA is contraindicated in patients with:
Known hypersensitivity to tavorexin or to any of the excipients in NORVEXA.
Severe hepatic impairment (Child-Pugh C).
Concomitant use of strong CYP3A4 inhibitors [see Drug Interactions (7.1)].

5 WARNINGS AND PRECAUTIONS
5.1 Serious Infections
Serious and sometimes fatal infections have been reported in patients receiving NORVEXA. Avoid use of NORVEXA in patients with an active, serious infection. Interrupt NORVEXA if a serious infection develops.
5.2 Hepatotoxicity
ALT elevations greater than 3 times the upper limit of normal (ULN) occurred in 2.1% of patients treated with NORVEXA. Monitor liver tests at baseline and every 6 months.
5.4 Embryo-Fetal Toxicity
Based on animal data, NORVEXA may cause fetal harm. Advise females of reproductive potential to use effective contraception during treatment and for 4 weeks after the last dose [see Use in Specific Populations (8.1)].
5.5 Lymphopenia
Do not initiate NORVEXA in patients with an absolute lymphocyte count less than 500 cells/mm3.

6 ADVERSE REACTIONS
The most common adverse reactions (incidence 10% or more) are nausea and headache. Adverse reactions reported in 1% to less than 10% of patients were diarrhea, upper respiratory tract infection, fatigue and ALT increased. Less common adverse reactions were herpes zoster and depression.

8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Based on findings from animal studies, NORVEXA may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus.

16 HOW SUPPLIED/STORAGE AND HANDLING
NORVEXA 50 mg tablets: pink, oval, debossed "NV50"; bottles of 30 (NDC 99999-150-30).
NORVEXA 100 mg tablets: white, oval, debossed "NV100"; bottles of 30 (NDC 99999-151-30).
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep in the original container to protect from moisture.
