Tradipitant

Nereus

85MG capsuleÉtats-UnisCommercialiséAutorisé le 30 déc. 2025

Contenu en anglais

Indications

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 )

Contre-indications

None. None. ( 4 )

Mises en garde et précautions d’emploi

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 )

5.1Effects 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.

Interactions

Strong CYP3A4 Inhibitors: May increase tradipitant exposure and the risk of adverse reactions. ( 7.1 )

Mises en garde et précautions d’emploi

5.1Effects on the Ability to Drive or Operate Machinery

If concomitant use is unavoidable, warn patients against driving and other activities requiring complete mental alertness.

Grossesse et allaitement

8.1Pregnancy 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.

Effets indésirables

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 .

6.1Clinical 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.

Nereus

Indications

Contre-indications

Mises en garde et précautions d’emploi

5.1Effects on the Ability to Drive or Operate Machinery

Interactions

Deux médicaments dans une même question ?

Nereus

Indications

Contre-indications

Mises en garde et précautions d’emploi

5.1Effects on the Ability to Drive or Operate Machinery

Interactions

Deux médicaments dans une même question ?

7.1Effects of Other Drugs on

Grossesse et allaitement

8.1Pregnancy Risk Summary

Effets indésirables

6.1Clinical Trials Experience

Conditionnements

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