What Is Uzedy, and Why Does It Matter?
Uzedy is a long-acting injectable form of risperidone, a medicine used to treat serious mental health conditions like schizophrenia and bipolar I disorder (BD-I). It's the first version of risperidone that's given as a shot under the skin (subcutaneous injection) that releases the medicine slowly and steadily over time.
The FDA has now approved Uzedy to treat adults with BD-I, either on its own or together with other medicines like lithium or valproate, to help maintain stable mood and prevent relapses. It was previously approved in 2023 for schizophrenia.
BD-I is a serious mental illness that causes extreme mood swings, including episodes of mania and depression. These mood changes can disrupt daily life, thinking, and behavior; are often hard to diagnose; and may happen with other mental health conditions. BD-I carries higher risks of suicide and heart disease, affecting about 1% of U.S. adults (over 3.4 million people). This once-monthly option may benefit patients who struggle to take daily pills, offering more consistent symptom control and reducing the risk of relapse.
Why Was It Approved?
The FDA has approved Uzedy based on studies with a long-acting risperidone injection (given in the muscle every two weeks) that has already been proven effective. Experts predict that Uzedy, given once a month under the skin, will offer similar benefits.
Studies showed that risperidone injection alone helped prevent new mood episodes like mania or depression better than a placebo.
In another study where it was added to other treatments like lithium or valproate, patients were less likely to have new mood episodes, compared with those who did not get the shot.
Common side effects included weight gain, shaking, stiffness, and restlessness. Some people also had reactions where they got the shot, like itching or small lumps.
What Do I Need to Know?
For BD-I, Uzedy is given once a month as a shot under the skin in your abdomen (belly area) or upper arm by a health care provider. The available doses for a once-monthly treatment plan are 50 mg, 75 mg, and 100 mg.
Before starting Uzedy, you'll need to try oral risperidone to make sure you can tolerate it. You should not take Uzedy if you're allergic to risperidone, paliperidone, or any of the ingredients in the shot.
Older patients with dementia-related psychosis have a higher risk of a stroke or mini-stroke. Rarely, a dangerous reaction called neuroleptic malignant syndrome can occur and requires medical care right away. Some people may get uncontrollable muscle movements (tardive dyskinesia), high blood sugar levels, or changes in cholesterol levels. It may cause dizziness or fainting when standing up from a lying or sitting position, especially in people with heart or circulation problems.
Use caution when driving or operating machines, as this medicine can cause drowsiness or slow reactions.
Uzedy can also raise levels of a hormone called prolactin, leading to missed periods, fertility problems, or breast changes in both men and women. In rare cases, prolonged painful erections (priapism) have been reported and needed medical attention right away.
Tell your health care provider about your medical history, especially if you have or have had seizures; heart, kidney, or liver issues; or low white blood cell counts. Also, let them know about all the medicines, supplements, and over-the-counter products you take to help avoid harmful interactions.
If you're pregnant or breastfeeding or plan to become pregnant, talk to your health care provider. Uzedy may cause problems for newborns if used late in pregnancy. It may also pass into breast milk.