ONGENTYS SIDE EFFECTS
- Generic Name: opicapone capsules
- Brand Name: Ongentys
SIDE EFFECTS
The following clinically significant adverse reactions are discussed in more detail in other sections of the labeling:
- Cardiovascular Effects with Concomitant Use of Drugs Metabolized by Catechol-O-Methyltransferase (COMT)
- Falling Asleep During Activities of Daily Living and Somnolence
- Hypotension/Syncope
- Dyskinesia
- Hallucinations and Psychosis
- Impulse Control/Compulsive Disorders
- Withdrawal-Emergent Hyperpyrexia and Confusion
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 ONGENTYS was evaluated in 265 patients with Parkinson’s disease (PD) in two 14-15 week placebo-and active-controlled (Study 1) or placebo-controlled (Study 2) studies. All patients were taking a stable dose of levodopa and a DOPA decarboxylase inhibitor, alone or in combination with other PD medications. In Study 1 and Study 2, the mean age of patients was 63.6 years, 59% of patients were male, and 89% of patients were Caucasian. At baseline, the mean duration of PD was 7.6 years.
Adverse Reactions Leading To Discontinuation Of Treatment
In Study 1 and Study 2, a total of 8% of ONGENTYS 50 mg-treated patients and 6% of patients who received placebo discontinued due to adverse events. The most common adverse reaction leading to discontinuation was dyskinesia, reported in 3% of ONGENTYS 50 mg-treated patients and 0.4% of patients who received placebo.
Common Adverse Reactions
Adverse reactions that occurred in the pooled studies at an incidence of at least 2% and greater than placebo are presented in Table 1. The most common adverse reactions (incidence at least 4% and greater than placebo) were dyskinesia, constipation, blood creatine kinase increased, hypotension/syncope, and weight decreased.
Table 1: Adverse Reactions with an Incidence of at Least 2% in Patients Treated with ONGENTYS and Greater than on Placebo, in Pooled Study 1 and Study 2
| Adverse Reactions | ONGENTYS 50 mg N=265 % |
Placebo N=257 % |
| Nervous system disorders | ||
| Dyskinesia | 20 | 6 |
| Dizziness | 3 | 1 |
| Gastrointestinal disorders | ||
| Constipation | 6 | 2 |
| Dry mouth | 3 | 1 |
| Psychiatric disorders | ||
| Hallucination1 | 3 | 1 |
| Insomnia | 3 | 2 |
| Investigations | ||
| Blood creatine kinase increased | 5 | 2 |
| Weight decreased | 4 | 0 |
| Vascular disorders | ||
| Hypotension/syncope2 | 5 | 1 |
| Hypertension | 3 | 2 |
| 1 Includes hallucinations, hallucinations visual, hallucinations auditory, and hallucinations mixed 2 Includes hypotension, orthostatic hypotension, syncope, and presyncope |
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SRC: NLM .