reg;®
Table 3: Percentage of Patients Experiencing Common (≥ 2%) Adverse Reactions in Short-Term Adjunctive Study 3
Adverse Reaction Term All Doses of INTUNIV ®
(N=302) a Placebo (N=153)
Headache 21% 13%
Somnolence b 18% 7%
Insomnia c 12% 6%
Fatigue 10% 3%
Abdominal pain d 10% 3%
Dizziness 8% 4%
Decreased appetite 7% 4%
Nausea 5% 3%
Diarrhea 4% 1%
Hypotension e 3% 0%
Affect lability 2% 1%
Bradycardia 2% 0%
Constipation 2% 0%
Dry mouth 2% 0%
a: The morning and evening dose groups of INTUNIV are combined. b: The somnolence term includes somnolence, sedation, and hypersomnia. c: The insomnia term includes insomnia, initial insomnia, and middle insomnia. d: The abdominal pain term includes abdominal pain, abdominal pain upper, and abdominal pain lower. e: The hypotension term includes hypotension, orthostatic hypotension, and decreased blood pressure. ®
Effects on Blood Pressure and Heart Rate
In the monotherapy pediatric, short-term, controlled trials (Studies 1 and 2), the maximum mean changes from baseline in systolic blood pressure, diastolic blood pressure, and pulse were −5 mmHg, −3 mmHg, and −6 bpm, respectively, for all dose groups combined (generally one week after reaching target doses of 1 mg/day, 2 mg/day, 3 mg/day or 4 mg/day). These changes were dose dependent. Decreases in blood pressure and heart rate were usually modest and asymptomatic; however, hypotension and bradycardia can occur. Hypotension was reported as an adverse reaction for 7% of the INTUNIV group and 3% of the placebo group. This includes orthostatic hypotension, which was reported for 1% of the INTUNIV group and none in the placebo group. In the adjunctive trial, hypotension (3%) and bradycardia (2%) were observed in patients treated with INTUNIV as compared to none in the placebo group. In long-term, open label studies, (mean exposure of approximately 10 months), maximum decreases in systolic and diastolic blood pressure occurred in the first month of therapy. Decreases were less pronounced over time. Syncope occurred in 1% of pediatric subjects in the clinical program. The majority of these cases occurred in the long-term, open-label studies. ®®®
Other Adverse Reactions Observed in Clinical Studies
Table 4 includes additional adverse reactions observed in short-term, placebo-controlled and long-term, open-label clinical studies not included elsewhere in section 6.1, listed by organ system.
Table 4: Other adverse reactions observed in clinical studies
Body System
Adverse Reaction
Cardiac
Atrioventricular block, sinus arrhythmia
Gastrointestinal
Dyspepsia, stomach discomfort, vomiting
General
Asthenia, chest pain
Immune System &nb |
