Common Side Effects of Invega Sustenna (Paliperidone Palmitate)
The most common side effects of Invega Sustenna include extrapyramidal symptoms (EPS), injection site reactions, headache, insomnia, sedation, and prolactin-related effects, with EPS occurring in approximately 34% of patients during acute treatment phases.
Extrapyramidal Symptoms (Most Significant)
- EPS-related adverse events occur in approximately 34% of patients treated with paliperidone ER during acute and continuation treatment phases, which is notably higher than olanzapine (16%) 1
- Specific EPS manifestations include dyskinesia, akathisia, hypokinesia, tremor, and extrapyramidal disorder, each occurring in approximately 1% of patients during maintenance phases 1
- Acute dystonia can occur as early as one day after injection and may be severe enough to cause rhabdomyolysis, though this is rare 2
- Parkinsonism can develop, particularly with loading dose strategies, and may be severe and prolonged 3
Injection Site Reactions
- Injection site reactions occur at rates ranging from 4% to 10% depending on the dose regimen, compared with 2% for placebo 4
- These reactions are generally mild and do not typically require discontinuation 4
Common Neuropsychiatric Effects
- Headache occurs in 11-18% of patients treated with paliperidone ER 5
- Insomnia affects 4-14% of patients receiving paliperidone ER 5
- Sedation and somnolence are commonly reported, particularly at higher doses 6
- Dizziness occurs frequently and may be related to orthostatic effects 6
- Tremor is a frequently reported adverse event 6
Prolactin-Related Effects
- Prolactin-related adverse events occur in approximately 4% of patients during long-term treatment 5
- These effects are dose-dependent and more common at higher dosage strengths 4
Gastrointestinal Effects
Other Common Effects
- Akathisia (restlessness) is reported as a common adverse event 6
- Hypertonia (increased muscle tone) occurs in some patients 6
- Agitation and anxiety may develop during treatment 6
Dosing Considerations to Minimize Side Effects
- EPS and body weight gain may be more common at higher doses (156 mg and 234 mg), suggesting clinicians should use the lowest effective dose 4
- Deltoid injection produces approximately 28% higher maximum plasma concentrations compared with gluteal injection, which may influence side effect profiles 4
- Lower doses in elderly or frail patients can reduce the risk of severe EPS complications 3
Critical Safety Monitoring
- Patients developing EPS should be evaluated for potential rhabdomyolysis, particularly if dystonia is present, as creatine kinase levels can exceed 3000 unit/L 2
- Therapeutic drug monitoring using serum prolactin levels may be useful when plasma drug levels are unavailable, though this approach has limitations 3