Ready
UZEDY® is rapidly absorbed after administration
Therapeutic levels are achieved within 6 to 24 hours after the first dose1*
FOR ADULTS LIVING WITH BD-1
RAPID ABSORPTION. SUSTAINED RELEASE.
Steady
UZEDY provides continuous therapeutic levels* with a 1-month dosing interval1
Uzedy
UZEDY monotherapy may provide sustained relapse prevention for patients
with BD-11
In the randomized, double-blind, placebo-controlled phase, patients receiving risperidone had delayed time to relapse vs placebo1†
*The threshold for therapeutic or clinically relevant plasma levels of risperidone is defined as levels ≥10 ng/mL.2
†In the open-label phase of the BD-1 monotherapy trial, 60% of patients (n=303) were judged to be stable on risperidone LAI and randomized to receive risperidone LAI vs placebo.1
MONOTHERAPY MAY PROVIDE DELAYED TIME TO RELAPSE1
UZEDY is an atypical antipsychotic indicated as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of BD-1 in adults1
The efficacy of UZEDY monotherapy for the treatment of BD-1 is based on the established efficacy of another risperidone LAI that was administered intramuscularly. UZEDY should only be administered subcutaneously.1
After the open-label phase of the BD-1 monotherapy trial1‡:
60% OF PATIENTS (n=303) WERE STABILIZED ON RISPERIDONE LAI
and randomized to
receive risperidone
LAI or placebo
In the randomized, double-blind, placebo-controlled phase1§:
PATIENTS RECEIVING RISPERIDONE HAD DELAYED TIME TO RELAPSE
vs placebo
Study Design: The efficacy of UZEDY as monotherapy for BD-1 was established based on a 24-month, multicenter, randomized, double-blind, placebo-controlled study of another risperidone LAI that was administered intramuscularly. Adults with BD-1 (N=501), as defined in the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition), entered a 26-week open-label phase. The starting dose of risperidone LAI was 25 mg and could be titrated up to 37.5 mg or 50 mg, or down to 12.5 mg, as needed. Patients who were stable on medication (n=303) were randomized to receive either the same dose of risperidone LAI intramuscularly or placebo. The primary endpoint in the double-blind phase was time to relapse, defined as any new mood episode (depression, mania, hypomania, or mixed).1
Results: Time to relapse was delayed in patients receiving another risperidone long-acting injection, given once every 2 weeks as monotherapy, compared with patients receiving placebo.1
‡At baseline, participants in the monotherapy trial had more manic episodes than depressive episodes.1
§The majority of relapses occurring during the randomized phase of the trial were due to manic rather than depressive symptoms.1
LAIs WITH BD-1 INDICATION
Features of LAI antipsychotics indicated for maintenance treatment of patients with BD-1
INDICATION
DOSING
SC INJECTION
INJECTION VOL.
READY TO USE||
(no reconstitution)
INJECTION SITES
UZEDY1
Monotherapy or adjunctive therapy to LIT or VAL for the maintenance treatment of BD-1 in adults
1 month
Yes
0.14 mL–0.28 mL
Yes
Abdomen, upper arm
Abilify Maintena®3
(US/EU)
Maintenance monotherapy treatment of BD-1 in adults
1 month
No
0.8 mL–2 mL
No
Deltoid/gluteal
Abilify
Asimtufii®4
(US)
Maintenance monotherapy treatment of BD-1 in adults
2 months
No
2.4 mL–3.2 mL
Yes
Gluteal
Risperdal Consta®5
(US/EU)
Monotherapy or adjunctive therapy to LIT or VAL for the maintenance treatment of BD-1¶
2 weeks
No
2.0 mL
No
Deltoid/gluteal
Rykindo®6
(US)
Monotherapy or adjunctive therapy to LIT or VAL for the maintenance treatment of BD-1 in adults
2 weeks
No
2.0 mL
No
Gluteal
Compare with
Abilify Maintena® (US/EU)
This information should not be construed to imply any difference in safety, efficacy, or other clinical outcome. All trademarks referenced are properties of their respective owners.
LAI, long-acting injectable; LIT, lithium; SC, subcutaneous; VAL, valproate.
¶Approved in the USA, may differ globally.
||No premixing or reconstitution required.
References: 1. UZEDY® (risperidone) extended-release injectable suspension Current Prescribing Information. Parsippany, NJ: Teva Neuroscience, Inc. 2. Data on file. Parsippany, NJ: Teva Neuroscience, Inc. 3. Abilify Maintena. Prescribing information. Otsuka Pharmaceutical Co., Ltd; 2025. 4. Abilify Asimtufii. Prescribing information. Otsuka Pharmaceutical Co., Ltd; 2023. 5. Risperdal Consta. Prescribing information. Janssen Pharmaceuticals, Inc; 2021. 6. Rykindo. Prescribing information. Shandong Luye Pharmaceutical Co., Ltd; 2023.
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SAFETY
See the safety data of UZEDY
in bipolar I disorder.
INDICATIONS AND USAGE
UZEDY (risperidone) extended-release injectable suspension for subcutaneous use is indicated in adults for the treatment of schizophrenia and as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder.
IMPORTANT SAFETY INFORMATION
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. UZEDY is not approved for use in patients with dementia-related psychosis and has not been studied in this patient population.
CONTRAINDICATIONS: UZEDY is contraindicated in patients with a known hypersensitivity to risperidone, its metabolite, paliperidone, or to any of its components. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone or paliperidone.
WARNINGS AND PRECAUTIONS
Cerebrovascular Adverse Reactions: In trials of elderly patients with dementia-related psychosis, there was a significantly higher incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, in patients treated with oral risperidone compared to placebo. UZEDY is not approved for use in patients with dementia-related psychosis.
Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptom complex, has been reported in association with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status including delirium, and autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. If NMS is suspected, immediately discontinue UZEDY and provide symptomatic treatment and monitoring.
Tardive Dyskinesia (TD): TD, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to predict which patients will develop the syndrome. Whether antipsychotic drug products differ in their potential to cause TD is unknown.
The risk of developing TD and the likelihood that it will become irreversible are believed to increase with the duration of treatment and the cumulative dose. The syndrome can develop, after relatively brief treatment periods, even at low doses. It may also occur after discontinuation. TD may remit partially or completely, if antipsychotic treatment is discontinued. Antipsychotic treatment, itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome, possibly masking the underlying process. The effect that symptomatic suppression has on the long-term course of the syndrome is unknown.
If signs and symptoms of TD appear in a patient treated with UZEDY, drug discontinuation should be considered. However, some patients may require treatment with UZEDY despite the presence of the syndrome. In patients who do require chronic treatment, use the lowest dose and the shortest duration of treatment producing a satisfactory clinical response. Periodically reassess the need for continued treatment.
Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. These metabolic changes include hyperglycemia, dyslipidemia, and body weight gain. While all of the drugs in the class have been shown to produce some metabolic changes, each drug has its own specific risk profile.
Hyperglycemia and diabetes mellitus (DM), in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, have been reported in patients treated with atypical antipsychotics, including risperidone. Patients with an established diagnosis of DM who are started on atypical antipsychotics, including UZEDY, should be monitored regularly for worsening of glucose control. Patients with risk factors for DM (e.g., obesity, family history of diabetes) who are starting treatment with atypical antipsychotics, including UZEDY, should undergo fasting blood glucose (FBG) testing at the beginning of treatment and periodically during treatment. Any patient treated with atypical antipsychotics, including UZEDY, should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics, including UZEDY, should undergo FBG testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic, including risperidone, was discontinued; however, some patients required continuation of antidiabetic treatment despite discontinuation of risperidone.
Dyslipidemia has been observed in patients treated with atypical antipsychotics.
Weight gain has been observed with atypical antipsychotic use. Monitoring weight is recommended.
Hyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors, risperidone elevates prolactin levels and the elevation persists during chronic administration. Risperidone is associated with higher levels of prolactin elevation than other antipsychotic agents.
Orthostatic Hypotension and Syncope: UZEDY may induce orthostatic hypotension associated with dizziness, tachycardia, and in some patients, syncope. UZEDY should be used with particular caution in patients with known cardiovascular disease, cerebrovascular disease, and conditions which would predispose patients to hypotension and in the elderly and patients with renal or hepatic impairment. Monitoring of orthostatic vital signs should be considered in all such patients, and a dose reduction should be considered if hypotension occurs. Clinically significant hypotension has been observed with concomitant use of oral risperidone and antihypertensive medication.
Falls: Antipsychotics, including UZEDY, may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other fall-related injuries. Somnolence, postural hypotension, motor and sensory instability have been reported with the use of risperidone. For patients, particularly the elderly, with diseases, conditions, or medications that could exacerbate these effects, assess the risk of falls when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy.
Leukopenia, Neutropenia, and Agranulocytosis have been reported with antipsychotic agents, including risperidone. In patients with a pre-existing history of a clinically significant low white blood cell count (WBC) or absolute neutrophil count (ANC) or a history of drug-induced leukopenia or neutropenia, perform a complete blood count (CBC) frequently during the first few months of therapy. In such patients, consider discontinuation of UZEDY at the first sign of a clinically significant decline in WBC in the absence of other causative factors. Monitor patients with clinically significant neutropenia for fever or other symptoms or signs of infection and treat promptly if such symptoms or signs occur. Discontinue UZEDY in patients with ANC < 1000/mm3) and follow their WBC until recovery.
Potential for Cognitive and Motor Impairment: UZEDY, like other antipsychotics, may cause somnolence and has the potential to impair judgement, thinking, and motor skills. Somnolence was a commonly reported adverse reaction associated with oral risperidone treatment. Caution patients about operating hazardous machinery, including motor vehicles, until they are reasonably certain that treatment with UZEDY does not affect them adversely.
Seizures: During premarketing studies of oral risperidone in adult patients with schizophrenia, seizures occurred in 0.3% of patients (9 out of 2,607 patients), two in association with hyponatremia. Use UZEDY cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.
Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Antipsychotic drugs, including UZEDY, should be used cautiously in patients at risk for aspiration.
Priapism has been reported during postmarketing surveillance for other risperidone products. A case of priapism was reported in premarket studies of UZEDY. Severe priapism may require surgical intervention.
Body temperature regulation: Disruption of the body’s ability to reduce core body temperature has been attributed to antipsychotic agents. Both hyperthermia and hypothermia have been reported in association with oral risperidone use. Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use UZEDY with caution in patients who experience these conditions.
ADVERSE REACTIONS
The most common adverse reactions with risperidone in patients with schizophrenia (≥5% and greater than placebo) were parkinsonism, akathisia, dystonia, tremor, sedation, dizziness, anxiety, blurred vision, nausea, vomiting, upper abdominal pain, stomach discomfort, dyspepsia, diarrhea, salivary hypersecretion, constipation, dry mouth, increased appetite, increased weight, fatigue, rash, nasal congestion, upper respiratory tract infection, nasopharyngitis, and pharyngolaryngeal pain.
The most common adverse reactions with risperidone in patients with bipolar disorder were weight increased (5% in monotherapy trial) and tremor and parkinsonism (≥10% in adjunctive therapy trial).
The most common injection site reactions with UZEDY (≥5% and greater than placebo) were pruritus and nodule.
DRUG INTERACTIONS
- Carbamazepine and other strong CYP3A4 inducers decrease plasma concentrations of risperidone.
- Fluoxetine, paroxetine, and other strong CYP2D6 inhibitors increase risperidone plasma concentration.
- Due to additive pharmacologic effects, the concomitant use of centrally-acting drugs, including alcohol, may increase nervous system disorders.
- UZEDY may enhance the hypotensive effects of other therapeutic agents with this potential.
- UZEDY may antagonize the pharmacologic effects of dopamine agonists.
- Concomitant use with methylphenidate, when there is change in dosage of either medication, may increase the risk of extrapyramidal symptoms (EPS)
USE IN SPECIFIC POPULATIONS
Pregnancy: May cause EPS and/or withdrawal symptoms in neonates with third trimester exposure. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including UZEDY, during pregnancy. Healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-288 or online at http://womensmentalhealth.org/clinicaland-research-programs/pregnancyregistry/.
Lactation: Infants exposed to risperidone through breastmilk should be monitored for excess sedation, failure to thrive, jitteriness, and EPS.
Fertility: UZEDY may cause a reversible reduction in fertility in females.
Pediatric Use: Safety and effectiveness of UZEDY have not been established in pediatric patients.
Renal or Hepatic Impairment: Carefully titrate on oral risperidone up to at least 2 mg daily before initiating treatment with UZEDY.
Patients with Parkinson’s disease or dementia with Lewy bodies can experience increased sensitivity to UZEDY. Manifestations and features are consistent with NMS.
Please see the full Prescribing Information for UZEDY, including Boxed WARNING.
