Uzedy

Schizophrenia

Uzedy is used to treat schizophrenia in adults. It belongs to a class of medications called atypical antipsychotics. These medications work by helping to restore the balance of certain natural chemicals in the brain. It is used to manage symptoms such as hearing voices, seeing things that are not there, and feeling unusually suspicious or withdrawn.

Bipolar I Disorder

This medication is also used for the maintenance treatment of Bipolar I disorder in adults. It may be used in the following ways:

• Monotherapy: Used alone to help stabilize mood.
• Adjunctive therapy: Used in combination with other medications, such as lithium or valproate.

Uzedy is an extended-release injection, which means the medication is released slowly into the body over a period of one or two months. This delivery method is often used to help maintain consistent levels of the drug in the bloodstream and to provide an alternative for individuals who have difficulty taking a daily pill.

Mechanism of Action

Uzedy contains risperidone, a medication that belongs to a class of drugs known as atypical antipsychotics. While the exact way it works is not fully understood, it is believed to help manage symptoms by affecting the activity of neurotransmitters in the brain.

Neurotransmitters are natural chemicals that allow nerve cells to communicate with each other. Uzedy primarily targets two specific neurotransmitters:

• Dopamine: This chemical is involved in how the brain perceives reality, processes rewards, and controls movement.
• Serotonin: This chemical helps regulate mood, sleep, and social behavior.

By blocking certain receptors for these chemicals, the medication helps restore a more stable balance in the brain, which can improve thinking, mood, and behavior.

Extended-Release Technology

Unlike daily oral tablets, Uzedy is designed to release the medication slowly into the body over a long period. After it is injected under the skin (subcutaneously), the specialized delivery system forms a small reservoir that gradually releases risperidone into the bloodstream. This allows the medication to remain at a steady level in the body for either one or two months, depending on the prescribed dose.

Common Side Effects

The most frequently reported side effects of Uzedy include:

• Pain, redness, or swelling at the injection site
• Sleepiness or fatigue
• Dizziness
• Weight gain
• Dry mouth
• Constipation
• Nausea
• Restlessness or an inability to sit still (akathisia)
• Muscle stiffness or tremors

Serious Side Effects

Contact a healthcare provider immediately if you experience any of the following serious symptoms:

• Movement problems: Uncontrolled muscle movements in the face, tongue, or other body parts (tardive dyskinesia).
• Neuroleptic Malignant Syndrome (NMS): High fever, stiff muscles, confusion, sweating, or changes in pulse and blood pressure.
• Metabolic changes: High blood sugar (increased thirst or urination), high cholesterol, or significant weight gain.
• High prolactin levels: Breast enlargement or discharge, missed menstrual periods, or erectile dysfunction.
• Low white blood cell count: Fever or other signs of infection.
• Orthostatic hypotension: Feeling lightheaded or fainting when standing up too quickly.
• Seizures.
• Difficulty swallowing.
• Priapism: A painful or prolonged erection lasting more than four hours.

Boxed Warning: 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 the treatment of patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS)

NMS is a rare but potentially fatal condition associated with antipsychotic medication. Symptoms may include high fever, muscle stiffness, confusion, and changes in pulse or blood pressure. Immediate medical attention is required if these symptoms occur.

Tardive Dyskinesia

This condition involves involuntary, repetitive body movements, often in the face, tongue, or jaw. The risk increases with the duration of treatment and the total cumulative dose, though it can develop after short-term use. In some cases, the condition may be permanent.

Metabolic Changes

Antipsychotic medications can cause metabolic changes, including:

• High blood sugar (hyperglycemia) and diabetes mellitus.
• Changes in cholesterol and triglyceride levels (dyslipidemia).
• Significant weight gain.

Other Serious Precautions

• Orthostatic Hypotension: A sudden drop in blood pressure when standing up, which may lead to dizziness or fainting.
• Blood Cell Counts: Low white blood cell counts have been reported. Monitoring may be necessary for those with a history of low counts or pre-existing conditions.
• Seizures: Use with caution in individuals with a history of seizures or conditions that lower the seizure threshold.
• Hyperprolactinemia: Elevated levels of the hormone prolactin may occur, potentially leading to menstrual irregularities or breast enlargement.
• Cognitive and Motor Impairment: This medication may cause drowsiness and affect judgment or motor skills. Caution is advised when operating heavy machinery or driving.
• Body Temperature Regulation: Antipsychotics may disrupt the body's ability to reduce its core temperature. Caution is advised during strenuous exercise or exposure to extreme heat.

Pregnancy

Using Uzedy during the third trimester of pregnancy may cause complications in the newborn after delivery. These issues, known as extrapyramidal or withdrawal symptoms, can include:

• Agitation or jitteriness
• Feeding disorders
• Respiratory distress (difficulty breathing)
• Somnolence (excessive sleepiness)
• Muscle stiffness or limpness
• Tremors

If you become pregnant while using this medication, you should discuss the risks and benefits with your healthcare provider. There is a pregnancy exposure registry that monitors the health of infants born to individuals who took antipsychotic medications like Uzedy during pregnancy.

Breastfeeding

Risperidone, the active ingredient in Uzedy, is known to pass into breast milk. Infants exposed to the medication through breastfeeding may experience side effects, including:

• Excessive sleepiness
• Failure to thrive or feeding problems
• Jitteriness
• Involuntary muscle movements

The decision to breastfeed while using Uzedy should be made in consultation with a healthcare provider, weighing the mother's clinical need for the drug against the potential risks to the nursing infant.

Fertility

Uzedy may cause elevations in prolactin levels. High prolactin levels can lead to a loss of menstrual periods in females and may affect reproductive function or fertility in both males and females.

Dosage Forms

Uzedy is available as an extended-release injectable suspension. It is supplied in a single-dose prefilled syringe kit that includes the syringe and a safety needle.

This medication is designed for subcutaneous administration, which means it is injected into the fatty tissue just under the skin. It is administered by a healthcare professional in a clinical setting. Because it is an extended-release formulation, the medication is released slowly into the body after injection.

FDA Approval and Indications

The FDA approved Uzedy in 2023 as an extended-release subcutaneous injection for the treatment of schizophrenia in adults. It is designed to release risperidone over a period of one to two months, depending on the dosage prescribed.

Boxed Warning

Uzedy carries a boxed warning, which is the most serious warning required by the FDA. This warning states that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Uzedy is not approved for the treatment of patients with dementia-related psychosis.

Generic Availability

Currently, there is no generic version of Uzedy available in the United States. While other forms of risperidone are available as generics, the specific extended-release injectable formulation of Uzedy remains under patent protection.

Uzedy (risperidone) is an extended-release injectable antipsychotic used to treat schizophrenia. It is not a weight loss aid. Clinical studies of risperidone have shown that weight gain is a frequent side effect for many patients.

Weight Gain and Uzedy

Patients using Uzedy may experience significant increases in body weight. This effect is often linked to an increase in appetite or changes in how the body processes metabolism and blood sugar. Because weight gain can impact overall health, healthcare providers monitor weight and body mass index (BMI) regularly during treatment.

Monitoring and Management

If you are prescribed Uzedy, your healthcare team will likely perform the following:

• Establish a baseline weight before the first injection.
• Monitor weight and waist circumference at regular intervals.
• Check blood sugar (glucose) and cholesterol levels, as these can be affected by weight changes and the medication itself.

Patients are encouraged to follow a balanced diet and maintain regular physical activity to help manage potential weight changes. If you notice rapid or concerning weight gain, discuss management strategies with your doctor. Do not stop treatment without medical advice, as this can lead to a relapse of symptoms.