Vanda Pharmaceuticals Inc.

Important Safety Information

In placebo-controlled clinical trials, somnolence (6%, 12%) and fatigue (6%, 8%) were adverse reactions reported in subjects who took a single dose of 85 mg or 170 mg NEREUS™, respectively. NEREUS™ may impair the mental and/or physical abilities required for driving a motor vehicle or operating heavy machinery. Concomitant use of other drugs that cause central nervous system depression and strong CYP3A4 inhibitors may increase this effect. If concomitant use is unavoidable, warn patients against driving and other activities requiring complete mental alertness.

Available data from clinical trials with NEREUS™ use in pregnant women are insufficient to inform a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

Lactation studies have not been conducted to assess the presence of tradipitant or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. Tradipitant has been found to be present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. Monitor breastfed infants for somnolence.

The safety and effectiveness of NEREUS™ have not been established in pediatric patients.

Tradipitant has not been studied in subjects with severe renal impairment (eGFR ≤ 29 mL/min/1.73m2). Avoid use of NEREUS™ in patients with severe renal impairment.

Tradipitant has not been studied in patients with any degree of hepatic impairment (Child-Pugh Class A to C). Avoid NEREUS™ in patients with mild, moderate, or severe hepatic impairment.