TRADIPITANT CAP,ORAL
Clinical Criteria Summary
Indication & Patient Population
- Indicated for prevention of vomiting induced by motion in adults
- Clinical trials evaluated adults aged 18 to 75 years with a history of motion sickness
Dosing & Administration
- Recommended dosage is 85 mg or 170 mg administered as a single oral dose
- Administer approximately 60 minutes before an event expected to cause vomiting induced by motion
- Use the lowest effective dose; maximum dosage in a 24-hour period is a single dose of 85 mg or 170 mg
- Must be taken on an empty stomach, at least 1 hour prior to or 2 hours after a full meal
- Safety of taking more than 90 doses has not been established in clinical trials
Efficacy Criteria
- Demonstrates a significant reduction in the incidence of vomiting compared to placebo
- Efficacy observed across variable sea conditions, with pronounced benefit in rough seas (wave height ≥1m)
- Both dosing arms significantly reduced the incidence of vomiting and prevented more than one instance of vomiting compared to placebo
- Secondary endpoints regarding nausea and total symptom questionnaires favored tradipitant but did not reach statistical significance
Safety & Monitoring Requirements
- May cause somnolence and fatigue, which can impair abilities required for driving a motor vehicle or operating heavy machinery
- Most common adverse effects (>10% of patients) include somnolence, headache, and fatigue
- Mild treatment-emergent adverse events (fatigue, headache, somnolence) occur more frequently with tradipitant than placebo
- Advise breastfeeding women to monitor infants for somnolence
Contraindications & Precautions
- No boxed warnings or contraindications listed
- Avoid use in severe renal impairment
- Avoid use in patients with mild, moderate, or severe hepatic impairment
- Strong CYP3A4 inhibitors may increase tradipitant exposure and the risk of adverse reactions
- Concomitant use with other CNS depressants may increase impairment of mental alertness
Therapeutic Alternatives & Place in Therapy
- Consider for patients who have motion-induced vomiting that have not responded to adequate doses of scopolamine and antihistamines
- Environmental modifications (e.g., looking at a stable visual reference point, avoidance of reading while in motion, driving rather than being a passenger) should be utilized first
- Complementary treatments such as ginger and acupressure bands are well tolerated and may be beneficial
- Transdermal scopolamine or antihistamines are recommended for recurrent motion sickness despite environmental modification and complementary treatments