Tradipitant
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
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 ] .
Avoid use of NEREUS in patients with severe renal impairment.
Dosing in liver impairment
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.
Preparation and administration
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 ] . 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 ] .
Drug interactions
Check interactions
Add the patient's other drugs. Matches come from both FDA labels: by name, drug class, and enzyme or transporter pathway.
- Tradipitant
Label text (2 paragraphs)
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.
Contraindications
None. None. ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for tradipitant. Check the label's hepatic warnings.
Pregnancy and lactation
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.
Breastfeeding (LactMed)
No information is available on the use of tradipitant during breastfeeding. Because tradipitant is more than 96% bound to plasma proteins, the amount in milk is likely to be low. If the mother requires tradipitant, it is not a reason to discontinue breastfeeding. Monitor the infant for sedation.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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