Nereus

Tradipitant · Capsule · Oral

Prescription (Rx)

Uses

1 INDICATIONS AND USAGE NEREUS is indicated for the prevention of vomiting induced by motion in adults. NEREUS is a substance P/neurokinin 1 (NK1) receptor antagonist indicated for the prevention of vomiting induced by motion in adults. ( 1 )

Dosage and administration

The recommended dosage of NEREUS is 85 mg or 170 mg as a single oral dose approximately 60 minutes before an event expected to cause vomiting induced by motion. The safety of NEREUS for the prevention of vomiting induced by motion in adults for more than 90 doses has not been established in clinical trials. ( 2.1 ) The maximum dosage in a 24-hour period is a single dose of 85 mg or 170 mg. ( 2.1 ) Administer on an empty stomach, at least 1 hour prior to or 2 hours after a full meal. ( 2.1 ) 2.1 Recommended Dosage and Administration The recommended dosage of NEREUS is 85 mg or 170 mg as a single oral dose. Use the lowest effective dose. The safety of NEREUS for the prevention of vomiting induced by motion in adults for more than 90 doses has not been established in clinical trials [see Adverse Reactions (6.1) ] . Administer NEREUS orally approximately 60 minutes before an event expected to cause vomiting induced by motion. The maximum dosage in a 24-hour period is a single dose of 85 mg or 170 mg. Administer NEREUS on an empty stomach, at least 1 hour prior to or 2 hours after a full meal [see Clinical Pharmacology (12.3) ] .

Dosage forms and strengths

Capsules: 85 mg, supplied as a white opaque body capsule with “VANDA 85mg” printed on the black opaque cap. Capsules: 85 mg ( 3 )

Contraindications

None. None. ( 4 )

Warnings and precautions

Effects on the Ability to Drive or Operate Machinery: May impair 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. ( 5.1 , 7.1 ) 5.1 Effects on the Ability to Drive or Operate Machinery 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 [see Adverse Reactions (6.1) ] . 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 [see Drug Interactions (7.1) ] . If concomitant use is unavoidable, warn patients against driving and other activities requiring complete mental alertness.

Side effects

Most common adverse reactions (incidence ≥5%) are: somnolence, headache, and fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Vanda Pharmaceuticals Inc. at 1-844-GO-VANDA (1-844-468-2632) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of a single 85 mg or 170 mg dose of NEREUS was evaluated in adult subjects with a history of motion sickness in two randomized, double-blind, placebo-controlled trials, Study 1 and Study 2 [see Clinical Studies (14) ] . Additional safety data for the 170 mg dose of NEREUS were obtained from a randomized, double-blind, placebo-controlled trial, Study 3 (NCT03772340). Adverse reactions reported in at least 5% of subjects treated with a single NEREUS 85 mg or 170 mg dose and at a higher frequency than subjects who received placebo, are shown in Table 1 . Table 1: Adverse Reactions a in Adult Subjects with a History of Motion Sickness in Single-Dose, Placebo-Controlled Studies Among Subjects Receiving NEREUS a Reported in at least 5% of subjects and at a higher frequency than placebo. b NEREUS was administered as a single 85 mg dose approximately 60 minutes prior to a boat trip and without food. c NEREUS was administered as a single 170 mg dose approximately 60 minutes prior to a boat trip and without food. Studies 1 and 2 Studies 1, 2, and 3 Adverse Reaction NEREUS 85 mg b N=227 n (%) Placebo N=228 n (%) NEREUS 170 mg c N=289 n (%) Placebo N=291 n (%) Somnolence 14 (6) 9 (4) 36 (12) 17 (6) Headache 16 (7) 12 (5) 28 (10) 17 (6) Fatigue 14 (6) 6 (3) 24 (8) 6 (2) In a 12-month randomized, open-label study, 382 subjects with a history of motion sickness were instructed to administer NEREUS 85 mg (N=199) or 170 mg (N=183) as a single dose 60 minutes before a travel event of at least 60 minutes in duration expected to induce symptoms of motion sickness. Subjects were allowed to take up to 90 doses during the study. The median exposure was 18 doses and the majority of subjects (69%) did not take more than 30 doses. Most subjects (95%) did not take more than 8 doses in any 30-day period. Adverse reactions were consistent with those observed in Study 1, Study 2, and Study 3.

Drug interactions

Strong CYP3A4 Inhibitors: May increase tradipitant exposure and the risk of adverse reactions. ( 7.1 ) 7.1 Effects of Other Drugs on NEREUS Strong CYP3A4 Inhibitors Tradipitant is a CYP3A4 substrate. Strong CYP3A4 inhibitors may increase tradipitant exposure, which may increase the risk of adverse reactions to NEREUS.

Use in specific populations

Lactation: Monitor breastfed infants for somnolence. ( 8.2 ) 8.1 Pregnancy Risk Summary 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. In animal reproduction studies, no adverse developmental effects were observed with oral administration of tradipitant to pregnant rats during organogenesis through lactation or to pregnant rabbits during organogenesis at doses up to approximately 3.3 and 1.4 times the exposure to tradipitant at the maximum recommended human dose (MRHD), respectively. The background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In a combined fertility and embryo-fetal development study in pregnant rats, tradipitant was administered at oral doses of 10, 100, or 1000 mg/kg (approximately 1.4, 1.9, and 2.2 times the exposure to tradipitant at the MRHD) during the periods of mating and organogenesis, through gestation day 17. No adverse effects on maternal performance or embryo-fetal development were observed at any tested dose. In an embryo-fetal development study in pregnant rabbits, tradipitant was administered at oral doses 30, 175, or 1000 mg/kg/day (approximately 0.2, 0.4, and 1.4 times the exposure to tradipitant at the MRHD) during the period of organogenesis, from gestation day 7 to 19. No adverse effects on maternal performance or embryo-fetal development were observed at any tested dose. In a pre- and post-natal development study in pregnant rats, tradipitant was administered at oral doses of 100, 300, or 1000 mg/kg/day (approximately 2.3, 2.4, and 3.3 times the exposure to tradipitant at the MRHD) from gestation day 6 through lactation day 20. No maternal toxicity or developmental effects on the offspring were observed at any tested dose. 8.2 Lactation Risk Summary 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 is present in rat milk (see Data ) . 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 developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for NEREUS and any potential adverse effects on the breastfed child from NEREUS or the underlying maternal condition. Data Tradipitant was excreted in milk of lactating rats that received tradipitant at 100, 300, or 1000 mg/kg (2.3, 2.4, and 3.3 times the exposure to tradipitant at the MRHD) during pregnancy from gestation day 6 through lactation day 20. Serum concentrations of tradipitant and its major metabolites in pups were approximately 1% to 3% of maternal serum concentrations on lactation day 4 and up to 1% of those in the dams on lactation day 11. 8.4 Pediatric Use The safety and effectiveness of NEREUS have not been established in pediatric patients. 8.5 Geriatric Use Of the total number of NEREUS-treated subjects in controlled clinical studies for vomiting induced by motion, 69 (13%) were 65 years of age and older, while 4 (0.8%) were 75 years of age and older [see Adverse Reactions (6.1) and Clinical Studies (14) ] . No overall differences in safety or effectiveness were observed between subjects 65 years of age and older and younger adult subjects, and other reported clinical experience has not identified differences in responses between geriatric and younger adult subjects, but greater sensitivity of some older individuals cannot be ruled out. 8.6 Renal Impairment The recommended dosage of NEREUS in patients with mild and moderate renal impairment (estimated glomerular filtration rate (eGFR) of at least 30 mL/minute/1.73m 2 ) is the same as in patients with normal renal function. Tradipitant has not been studied in subjects with severe renal impairment (eGFR ≤ 29 mL/min/1.73m 2 ) [see Clinical Pharmacology (12.3) ] . Avoid use of NEREUS in patients with severe renal impairment. 8.7 Hepatic 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.

Pregnancy

8.1 Pregnancy Risk Summary 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. In animal reproduction studies, no adverse developmental effects were observed with oral administration of tradipitant to pregnant rats during organogenesis through lactation or to pregnant rabbits during organogenesis at doses up to approximately 3.3 and 1.4 times the exposure to tradipitant at the maximum recommended human dose (MRHD), respectively. The background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In a combined fertility and embryo-fetal development study in pregnant rats, tradipitant was administered at oral doses of 10, 100, or 1000 mg/kg (approximately 1.4, 1.9, and 2.2 times the exposure to tradipitant at the MRHD) during the periods of mating and organogenesis, through gestation day 17. No adverse effects on maternal performance or embryo-fetal development were observed at any tested dose. In an embryo-fetal development study in pregnant rabbits, tradipitant was administered at oral doses 30, 175, or 1000 mg/kg/day (approximately 0.2, 0.4, and 1.4 times the exposure to tradipitant at the MRHD) during the period of organogenesis, from gestation day 7 to 19. No adverse effects on maternal performance or embryo-fetal development were observed at any tested dose. In a pre- and post-natal development study in pregnant rats, tradipitant was administered at oral doses of 100, 300, or 1000 mg/kg/day (approximately 2.3, 2.4, and 3.3 times the exposure to tradipitant at the MRHD) from gestation day 6 through lactation day 20. No maternal toxicity or developmental effects on the offspring were observed at any tested dose.

Pediatric use

7.1 Effects of Other Drugs on NEREUS Strong CYP3A4 Inhibitors Tradipitant is a CYP3A4 substrate. Strong CYP3A4 inhibitors may increase tradipitant exposure, which may increase the risk of adverse reactions to NEREUS. 8.4 Pediatric Use The safety and effectiveness of NEREUS have not been established in pediatric patients.

Geriatric use

8.5 Geriatric Use Of the total number of NEREUS-treated subjects in controlled clinical studies for vomiting induced by motion, 69 (13%) were 65 years of age and older, while 4 (0.8%) were 75 years of age and older [see Adverse Reactions (6.1) and Clinical Studies (14) ] . No overall differences in safety or effectiveness were observed between subjects 65 years of age and older and younger adult subjects, and other reported clinical experience has not identified differences in responses between geriatric and younger adult subjects, but greater sensitivity of some older individuals cannot be ruled out.

Description

(tradipitant) is a substance P/neurokinin-1 (NK-1) receptor antagonist designated by the chemical name, as {2-[1-(3,5-Bistrifluoromethylbenzyl)-5-pyridin-4-yl-1H-[1,2,3]triazol-4- yl]-pyridin-3-yl}-(2-chlorophenyl)-methanone, with molecular formula C 28 H 16 C l F 6 N 5 O, and molecular weight 587.9. The chemical structure for tradipitant is: Tradipitant is a white to off-white crystalline powder. It is practically insoluble in water, soluble in methanol, and slightly soluble in isopropyl alcohol and simulated gastric fluid. NEREUS is supplied as white opaque body capsules with “VANDA 85mg” printed in white on the black opaque cap for oral administration, each containing 85 mg tradipitant. Inactive ingredients are croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. The capsule contains FD&C blue No 1, FD&C red No 40, and FD&C yellow No 6, gelatin, and titanium dioxide. Chemical Structure

Mechanism of action

12.1 Mechanism of Action Tradipitant is a selective, high-affinity antagonist of human substance P/neurokinin 1 (NK1) receptors. Tradipitant does not have affinity for NK2 and NK3 receptors, serotonin (5-HT3), dopamine (D2), cholinergic, or histamine (H1) receptors. Tradipitant has been shown in animal models to inhibit drug induced emesis. Human Positron Emission Tomography (PET) studies with tradipitant have shown that tradipitant crosses the blood brain barrier and occupies brain NK-1 receptors. The exact mechanism by which tradipitant exerts its therapeutic effect is not fully established.

How supplied

(tradipitant) capsules 85 mg are supplied as white opaque body with “VANDA 85mg” printed in white on the black opaque cap and packaged as 36-count in an HDPE bottle with child-resistant cap and a 2-g desiccant pouch, as 60-count in an HDPE bottle with child resistant cap and a 2-g desiccant canister, and as a 2-count in blister pack. NDC 43068-585-02 Bottles of 36 NDC 43068-585-01 Bottles of 60 NDC 43068-585-03 Blister pack of 2 Store NEREUS capsules at controlled room temperature, 25°C (77°F); excursions permitted to 15°C to 30°C (59° - 86°F) [See USP Controlled Room Temperature]. Protect NEREUS capsules from exposure to light and moisture.

Patient information

Effects on the Ability to Drive or Operate Machinery Advise patients NEREUS may cause somnolence and/or fatigue and impair the mental and/or physical abilities required for driving a motor vehicle or operating heavy machinery and to avoid concomitant use of other drugs with NEREUS as it may increase this effect [see Drug Interactions (7.1) ] . If concomitant use is unavoidable, warn patients against driving and other activities requiring complete mental alertness [see Warnings and Precautions (5.1) ] . Administration Information Advise the patient: Take NEREUS approximately 60 minutes before an event expected to cause vomiting induced by motion. The maximum dosage in a 24-hour period is a single dose of 85 or 170 mg. Administer NEREUS on an empty stomach, at least 1 hour prior to or 2 hours after a full meal [see Clinical Pharmacology (12.3) ] . Lactation Advise breastfeeding women using NEREUS to monitor infants for somnolence and to seek medical care if they notice this sign [see Use in Specific Populations (8.2) ] . Distributed By: Vanda Pharmaceuticals Inc. Washington, D.C. 20037 USA

Label text from the FDA structured product label by Vanda Pharmaceuticals Inc. (revised Jul 16, 2026). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Tradipitant in 1 product

Nereus NDC products (1)

NDC	Strength & form	Labeler	Type
43068-585	Tradipitant 85 mg/1 Capsule	Vanda Pharmaceuticals Inc.	NDA

Frequently asked questions

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Nereus is listed by 1 labeler in the FDA NDC directory, including Vanda Pharmaceuticals Inc..