• Invega Sustenna (paliperidone) is a long-acting prescription antipsychotic medicine used to treat schizophrenia or schizoaffective disorder in adults. It may take several weeks or longer to see your symptoms improve. It is given by injection once a month after your first two injections (given on the 1st and 8th day of treatment).
• Your hallucinations, delusions and disorganized thinking may improve in the first few weeks, but it can take several months to see the full benefit of your medicine.
• It’s important to keep receiving your medicine as prescribed by your doctor to help control your symptoms. Don't miss your appointments to see your doctor, discuss your progress, and have your scheduled injections.

While some patients may see certain symptoms improve in a few weeks, each person’s medical condition is unique and your response to treatment may be different. Symptoms may not completely disappear, but your symptoms should continue to improve as you receive your medicine over the long-term.

How is Invega Sustenna given?

• Invega Sustenna is given by a healthcare provider once a month as an injection into a muscle, but the first two doses are given one week apart.
• Initially, the first two doses are given one week apart (in the upper arm) to help reach therapeutic blood levels more quickly.
• After the first 2 doses, you’ll only need monthly injections because Invega Sustenna has a long duration of action. These injections can be given in your upper arm or buttock.
• Your doctor will determine which dose is best for your symptoms.

Schizophrenia medications are usually needed over the long-term to control your symptoms. Using a long-acting injectable medicine like Invega Sustenna can help you to remain on treatment without the burden of having to remember to take a daily pill.

It’s important that you stay on schedule with your Invega Sustenna injections. Keep all of your appointments so you can get your medication on time and discuss your progress with your doctor. If you must miss an appointment, contact your doctor to reschedule as soon as possible.

Onset of Efficacy: Study Results

Schizophrenia

Significant treatment effects with various doses of Invega Sustenna (when compared to placebo, an inactive treatment) were seen in studies in relapsed patients with acute schizophrenia. These studies measured effectiveness at 9 and 13 weeks after starting treatment. You can discuss these results with your healthcare provider for more information.

• In one 9-week and three 13-week short-term acute schizophrenia studies, Invega Sustenna was compared to an inactive placebo treatment.
• Patients received doses on day 1, 8, and 36 in the 9-week study and also on day 64 in the 13-week studies. Researchers determine effectiveness using the Positive and Negative Syndrome Scale (PANSS) total symptom severity score, a common scoring tool used in the study of schizophrenia.
• All doses (39 mg/4 weeks, 78 mg/4 weeks, 156 mg/4 weeks, 234 mg/4 weeks) were found to have a statistically significant, dose-related effect on the PANSS score when compared to placebo at 13 weeks. In the 9-week study, both the 78 mg/4 weeks and 156 mg/4 weeks were significant when compared to placebo.
• In the largest of the 13 week long studies, a significant change in PANSS total symptom severity score was seen by the 8th day in the groups receiving the 39 and 234 mg dose, and by day 22 for the group taking the 156 mg dose. These changes were maintained until the end of the study.

In a randomized, 13-week study (NCT #00590577) that looked at time to onset of effectiveness, 652 patients with schizophrenia received either placebo or paliperidone palmitate 234 mg on day 1 and then a randomized dose (39, 156, or 234 mg) or placebo on day 8, 36 and 64 via intramuscular injection. No oral antipsychotic supplementation was given. Efficacy was assessed using PANSS total scores.

• Onset of efficacy was defined as the first timepoint where the paliperidone palmitate group showed significant improvement in the Positive and Negative Syndrome Scale (PANSS) score compared to placebo.
• By day 8, paliperidone palmitate 234 mg (from the day 1 injection) was associated with greater improvement than placebo on mean PANSS total score (p=0.037).
• After the day 8 injection of 39, 156, or 234 mg, all paliperidone palmitate groups continued to show greater PANSS total score improvement than placebo when assessed at day 22 and day 36. The results suggest a dose-related effect.
• The percent of patients who responded to treatment (defined as a ≥30% reduction from baseline in PANSS total score) was significantly higher with paliperidone palmitate (in all dose groups) than with placebo by the day 36 timepoint.

Studies have also shown that patients receiving Invega Sustenna for up to one year have been able to maintain improvements in their symptoms and functional ability.

Bottom Line

• Invega Sustenna a long-acting prescription antipsychotic medicine used to treat schizophrenia or schizoaffective disorder in adults. It may take several weeks or longer to see your symptoms improve.
• Your hallucinations, delusions and disorganized thinking may improve in the first few weeks, but it can take several months to see the full benefit of your medicine.
• You should keep taking your medicine as prescribed by your doctor as part of your overall treatment plan to help control your symptoms.

This is not all the information you need to know about Invega Sustenna (paliperidone) for safe and effective use. Review the full Invega Sustenna information here, and discuss this information with your doctor or other health care provider.