Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS 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.
5 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.
Like all medications, Nereus can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: