www.uzedyhcp.com Open in urlscan Pro
45.60.124.67  Public Scan

Form analysis
0 forms found in the DOM

Text Content

skip-to-mainskip-to-main-menuskip-to-sub-menuskip-to-footer-menuskip-to-sitemap

 * 100%

 * 
   panel-contrast
 * 
   panel-grayscale
 * 
   panel-animation
 * 
   panel-default
 * 
   panel-normalization-font
 * 
   panel-white-cursor
 * 
   panel-black-cursor
 * 
   panel-statement
 * 
   feedback-menu

 * powered by Allyable(opens in a new tab)
 * 
   English

 * Prescribing Information
 * Important Safety Information
 * Shared Solutions
   Request A Rep Patient Site
   


 * The Difference with Uzedy
   Features of UZEDY Companion Survey
 * Efficacy & Safety
   Study Design Pivotal Trial Data Safety Data
 * Administration & Dosing
   Administration & Storage Dosing & PK Data
 * Support & Resources
   Teva Shared Solutions® Hospital Inpatient Free Trial Program Resources


Back To Top


HELP PATIENTS
ESCAPE THE SPIRAL
OF SCHIZOPHRENIA RELAPSE WITH UZEDY

UZEDY is a long-acting formulation of risperidone for subcutaneous injection.1

See the Difference

UZEDY significantly reduced the risk of relapse vs placebo in a phase 3
study.1,2

See the Data


UZEDY IS AN LAI THAT CLINICIANS AND PATIENTS AGREE ON2*


CLINICIAN AND PATIENT ATTITUDES TOWARD UZEDY WERE ASSESSED IN A COMPANION
SURVEY2

92 %

of patients reported they were satisfied With UZEDY2

96%

of clinicians reported they were satisfied with UZEDY2

70%

of patients who had previously used a long-acting injectable (LAI) indicated
that the clinical trial medication provided a better injection experience than
their previous LAI2

90%

of patients chose UZEDY when given the option to continue taking the clinical
trial medication or return to their previous medication2

Data were collected from 63 patients, 24 physicians, and 25 nurses in a
prospective, cross-sectional companion survey assessing the perceptions
regarding ease of use and satisfaction with UZEDY. The survey was administered
after a minimum of 2 experiences prescribing, administering, or receiving
UZEDY.2

*See companion study information.

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.


INDICATION AND USAGE

UZEDY (risperidone) extended-release injectable suspension for subcutaneous use
is indicated for the treatment of schizophrenia in adults.


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 upon 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 (≥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 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
1-866-961-2388 or online at
http://womensmentalhealth.org/clinical-and-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.


 * Legal Notice
 * Privacy Notice
 * Site Map
 * Cookie Settings

© 2023 Teva Neuroscience, Inc.

RIS-40626 July 2023

This site is intended for US Healthcare Professionals only.



YOU ARE ABOUT TO LEAVE THIS SITE

You are about to leave UZEDYHCP.com and enter a website operated by a third
party.

Would you like to continue?

No Yes
This site uses cookies to personalize content, save your preferences, provide
social media features, enable personalized advertising and track the site's
performance as described in our Privacy Notice in the footer of this site.
Please review your Cookie Settings to confirm your choices before continuing to
browse this site. You can make changes at any time by accessing the Cookie
Settings link in the footer of this site, orclicking here.



 * YOUR PRIVACY


 * STRICTLY NECESSARY COOKIES


 * PERFORMANCE COOKIES


 * TARGETING COOKIES


 * FUNCTIONAL COOKIES

YOUR PRIVACY

This site uses cookies to personalize content, save your preferences, provide
social media features, enable personalized advertising and track the site's
performance as described in our Privacy Notice. Please review your Cookie
Settings to confirm your choices before continuing to browse this site.

Privacy Policy

STRICTLY NECESSARY COOKIES

Always Active

These cookies are necessary for the website to function and cannot be switched
off in our systems. They are usually only set in response to actions made by you
which amount to a request for services, such as setting your privacy
preferences, logging in or filling in forms. You can set your browser to block
or alert you about these cookies, but some parts of the site will not then work.

PERFORMANCE COOKIES

Performance Cookies


These cookies allow us to count visits and traffic sources so we can measure and
improve the performance of our site. They help us to know which pages are the
most and least popular and see how visitors move around the site. All
information these cookies collect is aggregated and therefore may be
non-directly identifiable. If you do not allow these cookies we will not know
when you have visited our site, and will not be able to monitor its performance.

TARGETING COOKIES

Targeting Cookies


These cookies may be set through our site by our advertising partners. They may
be used by those companies to build a profile of your interests and show you
relevant adverts on other sites. They do not store directly personal
information, but are based on uniquely identifying your browser and internet
device. If you do not allow these cookies, you will experience less targeted
advertising.

FUNCTIONAL COOKIES

Functional Cookies


These cookies enable the website to provide enhanced functionality and
personalisation. They may be set by us or by third party providers whose
services we have added to our pages. If you do not allow these cookies then some
or all of these services may not function properly.

Back Button


COOKIE LIST

Filter Button
Consent Leg.Interest
checkbox label label
checkbox label label
checkbox label label

Clear
checkbox label label
Apply Cancel
Confirm My Choices
Allow All


back-to-top