Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should undergo fasting blood glucose testing. 1  It can help you think more clearly, feel less agitated, and behave more productively. Treatment failure was determined by an Event Monitoring Board (EMB) that was blinded to treatment assignment. Use Invega Sustenna (paliperidone injection) as ordered by your doctor. Some patients require continuation of antidiabetic treatment despite discontinuation of the suspect drug. There was a small increase in the risk of major birth defects (RR= 1.26, 95% CI 1.02–1.56) and of cardiac malformations (RR=1.26, 95% CI 0.88–1.81) in a subgroup of 1566 women exposed to the parent compound of paliperidone, risperidone, during the first trimester of pregnancy; however, there is no mechanism of action to explain the difference in malformation rates.There were no treatment-related effects on the offspring when pregnant rats were injected intramuscularly with paliperidone palmitate extended-release injectable suspension during the period of organogenesis at doses up to 250 mg/kg, which is 10 times MRHD of 234 mg paliperidone based on mg/mIn animal reproduction studies, there were no increases in fetal abnormalities when pregnant rats and rabbits were treated orally with paliperidone during the period of organogenesis with up to 8 times the MRHD of 12 mg based on mg/mAdditional reproduction toxicity studies were conducted with orally administered risperidone, which is extensively converted to paliperidone. †Patients successfully stabilized on INVEGA SUSTENNA Amenorrhea (2.5%) in females and no single potentially prolactin-related adverse reaction in males were observed with a rate greater than 2%. Paliperidone (9-hydroxy-risperidone) is the major metabolite of risperidone, which is approved for treatment of schizophrenia since 1994. © Janssen Pharmaceuticals, Inc. 2019. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including INVEGA SUSTENNANeonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. INDICATION. Patients should contact their healthcare provider or report to the emergency room if they experience the following signs and symptoms of NMS, including hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia Counsel patients on the signs and symptoms of tardive dyskinesia and to contact their healthcare provider if these abnormal movements occur Educate patients about the risk of metabolic changes, how to recognize symptoms of hyperglycemia (high blood sugar) and diabetes mellitus (e.g., polydipsia, polyuria, polyphagia, and weakness), and the need for specific monitoring, including blood glucose, lipids, and weight Educate patients about the risk of orthostatic hypotension, particularly at the time of initiating treatment, re-initiating treatment, or increasing the dose Advise patients with a pre-existing low WBC or a history of drug-induced leukopenia/neutropenia they should have their CBC monitored while taking INVEGA SUSTENNACounsel patients on signs and symptoms of hyperprolactinemia that may be associated with chronic use of INVEGA SUSTENNAAdvise patients of the possibility of painful or prolonged penile erections (priapism). If you have questions about side effects, call your doctor. The prespecified noninferiority margin was -15%.

Gluteal injections should be alternated between the two gluteal muscles.For patients who have never taken oral paliperidone or oral or injectable risperidone, it is recommended to establish tolerability with oral paliperidone or oral risperidone prior to initiating treatment with INVEGA SUSTENNAAdjustment of the maintenance dose may be made monthly. However, many people have no side effects or only have minor side effects. Weight Gain – Weight gain has been observed with atypical antipsychotic use. No studies have been conducted with oral paliperidone, INVEGA SUSTENNAA potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs, including paliperidone.Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Patients with risk factors for diabetes mellitus (e.g., obesity, family history of diabetes) who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. 50458-564-01, Although no cases of priapism have been reported in clinical trials with INVEGA SUSTENNADisruption of the body's ability to reduce core body temperature has been attributed to antipsychotic agents. 50458-563-03, Do not use INVEGA SUSTENNAThis Patient Information leaflet summarizes the most important information about INVEGA SUSTENNAYou can ask your healthcare provider or pharmacist for more information that is written for healthcare professionals.

as monotherapy . Invega Sustenna may also be used for purposes not listed in this medication guide. Schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers or antidepressants in adults. These are not all of the side effects that may occur. Injection site inflammatory reactions were greater and more advanced than reactions to the 1-month paliperidone palmitate extended-release injectable suspension. A total of 444 subjects were randomly assigned to either INVEGA SUSTENNAMaintenance Treatment – Monotherapy and as Adjunct to Mood Stabilizer or Antidepressant (SAff Study 1: SCA-3004)This study included a 13-week, open-label, flexible-dose (INVEGA SUSTENNAAfter the 13-week open-label flexible-dose INVEGA SUSTENNAA total of 334 subjects who met stabilization criteria for 12 consecutive weeks were randomized (1:1) to continue the same dose of INVEGA SUSTENNAThere was a statistically significant difference in time to relapse between the treatment groups in favor of INVEGA SUSTENNATable 16 summarizes the number of subjects with relapse in the overall population, by subgroup (monotherapy vs. adjunctive therapy), and by symptom type at the first occurrence of relapse.Store at room temperature (25°C, 77°F); excursions between 15°C and 30°C (between 59°F and 86°F) are permitted.