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Erzofri extended-release: Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx) Boxed warning
Strength:
39 mg/0.25 mL, 78 mg/0.5 mL, 117 mg/0.75 mL, 156 mg/mL, 234 mg/1.5 mL, 351 mg/2.25 mL
Other brand names:
Drug class:
Active ingredient:
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Erzofri extended-release

What is the most important information I should know about ERZOFRI?

ERZOFRI may cause serious side effects, including:

  • Increased risk of death in elderly people with dementia-related psychosis. ERZOFRI increases the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia).ERZOFRI is not for the treatment of people with dementia-related psychosis.

What is ERZOFRI?

ERZOFRI is a prescription medicine given by injection by a healthcare provider and used to treat:

  • schizophrenia in adults
  • schizoaffective disorder in adults either alone or with other medicines such as mood stabilizers or antidepressants

It is not known if ERZOFRI is safe and effective in children.

Who should not receive ERZOFRI?

Do not receive ERZOFRI if youare allergic to paliperidone, risperidone, or any of the ingredients in ERZOFRI. See the end of this Patient Information leaflet for a complete list of ingredients in ERZOFRI.

Before receiving ERZOFRI, tell your healthcare provider about all your medical conditions, including if you:

  • have never taken paliperidone or risperidone before
  • have had Neuroleptic Malignant Syndrome (NMS)
  • have or had heart problems, including a heart attack, heart failure, abnormal heart rhythm, or long QT syndrome
  • have or had low levels of potassium or magnesium in your blood
  • have or had uncontrolled movements of your tongue, face, mouth, or jaw (tardive dyskinesia)
  • have or had kidney or liver problems
  • have or had high blood sugar, diabetes or have a family history of diabetes
  • have or had high levels of total cholesterol, LDL cholesterol, or triglycerides, or low levels of HDL cholesterol
  • have Parkinson's disease or a type of dementia called Lewy Body Dementia
  • have or had problems with dizziness or fainting or are being treated for high blood pressure
  • have or had a low white blood cell count
  • have or had seizures or epilepsy

  • are pregnant or plan to become pregnant. It is not known if ERZOFRI will harm your unborn baby.

    • If you become pregnant during treatment with ERZOFRI, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.
    • Babies born to women who are treated with ERZOFRI during their third trimester of pregnancy may experience symptoms such as tremors, irritability, excessive sleepiness, eye twitching, muscle spasms, decreased appetite, difficulty breathing, or abnormal movement of arms and legs. Let your healthcare provider know if these symptoms occur.

  • are breastfeeding or plan to breastfeed. ERZOFRI can pass into your breast milk.

    • Talk to your healthcare provider about the best way to feed your baby if you receive ERZOFRI.

Tell your healthcare provider about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements. ERZOFRI and certain other medicines may affect each other causing possible serious side effects or affect the way each other works. Know the medicines you take. Keep a list of them to show to your healthcare provider or pharmacist when you get a new medicine.

How will I receive ERZOFRI?

  • Follow your ERZOFRI treatment schedule exactly as your healthcare provider tells you to.
  • Your healthcare provider will tell you how much ERZOFRI you will receive and when you will receive it.
  • ERZOFRI is given as an injection by your healthcare provider into the muscle (intramuscularly) of your arm or your buttocks 1 time every month. Your first ERZOFRI injection will be in your arm.
  • If you miss a dose of ERZOFRI, call your healthcare provider right away to schedule your next injection.

What should I avoid while receiving ERZOFRI?

  • Do notdrive, operate heavy machinery, or do other dangerous activities until you know how ERZOFRI affects you. ERZOFRI may affect your ability to make decisions, think clearly, or react quickly.
  • Avoid getting too hot or becoming dehydrated.
  • Do not exercise too much.
  • In hot weather, stay inside in a cool place if possible.
  • Stay out of the sun.
  • Do not wear too much clothing or heavy clothing.
  • Drink plenty of water.
  • Avoid alcohol during treatment with ERZOFRI.

What are the possible side effects of ERZOFRI?

ERZOFRI may cause serious side effects, including:

  • See " What is the most important information I should know about ERZOFRI"
  • Cardiovascular problems (including stroke) in elderly people with dementia-related psychosis that can lead to death.
  • Neuroleptic Malignant Syndrome (NMS), a serious condition that can lead to death.Call your healthcare provider right away or go to your nearest emergency room right away if you get any of the following signs or symptoms:
  • high fever
  • stiff muscles
  • confusion
  • sweating
  • changes in your breathing, pulse, heart rate, or blood pressure

  • Problems with your heartbeat.These heart problems can cause death. Call your healthcare provider right away if you get any of these symptoms:

    • passing out or feeling like you will pass out
    • dizziness
    • feeling as if your heart is pounding or missing beats
  • Uncontrolled body movements (tardive dyskinesia).ERZOFRI may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop taking ERZOFRI. Tardive dyskinesia may also start after you stop taking ERZOFRI.

  • Problems with your metabolism such as:

    • High blood sugar (hyperglycemia) and diabetes.Increases in blood sugar can happen in some people who are treated with ERZOFRI. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes such as being overweight, or a family history of diabetes, your healthcare provider should check your blood sugar before you start treatment and during your treatment with ERZOFRI.

      Call your healthcare provider if you get any of these symptoms of high blood sugar during treatment with ERZOFRI:

  • feel very thirsty
  • feel very hungry
  • feel sick to your stomach
  • need to urinate more than usual
  • feel weak or tired
  • feel confused, or your breath smells fruity
  • Increased fat levels (cholesterol and triglycerides) in your blood.Your healthcare provider may check your cholesterol and triglyceride levels during treatment with ERZOFRI.
  • Weight gain.You and your healthcare provider should check your weight regularly during treatment with ERZOFRI.
  • Decreased blood pressure (orthostatic hypotension) and fainting.You may feel lightheaded or faint when you rise too quickly from a sitting or lying position.
  • Falls.ERZOFRI may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position (orthostatic hypotension), and can slow your thinking and motor skills which may lead to falls that can cause fractures or other injuries.
  • Low white blood cell counts.Your healthcare provider may do blood tests during treatment with ERZOFRI.
  • Increased prolactin levels in your blood (hyperprolactinemia).ERZOFRI may cause a rise in the blood levels of a hormone called prolactin that may cause side effects including missed menstrual periods, a reversible reduction in fertility in females who are able to become pregnant, leakage of milk from the breasts, development of breasts in men, or problems with erection.
  • Sleepiness, drowsiness, feeling tired, difficulty thinking and doing normal activities.See " What should I avoid while receiving ERZOFRI?"
  • Seizures (convulsions).
  • Difficulty swallowingthat can cause food or liquid to get into your lungs.
  • Prolonged or painful erection lasting more than 4 hours (priapism).Call your healthcare provider or go to your nearest emergency room right away if you have an erection that lasts more than 4 hours.
  • Problems with control of your body temperature so that you feel too warm.See " What should I avoid while receiving ERZOFRI?"

The most common side effects of ERZOFRI include:

  • injection site reactions
  • sleepiness or drowsiness
  • dizziness
  • feeling restless or like you need to move
  • abnormal muscle movements including tremor (shaking), shuffling, uncontrolled involuntary movements, and abnormal movements of your eyes

Tell your healthcare provider if you have any side effect that bothers you or does not go away.

These are not all of the possible side effects of ERZOFRI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of ERZOFRI.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about ERZOFRI that is written for health professionals.

What are the ingredients in ERZOFRI?

Active ingredient: paliperidone palmitate

Inactive ingredients:citric acid monohydrate, dibasic sodium phosphate anhydrous, monobasic sodium phosphate monohydrate, polyethylene glycol 4000, polysorbate 20, sodium hydroxide, and water for injection.

Manufactured by: Shandong Luye Pharmaceutical Co., Ltd., No.15 Chuangye Road, Yantai, Shandong Province, China 264003

Manufactured for: Luye Innomind Pharma Shijiazhuang Co., Ltd., Shijiazhuang, Hebei Province, China 050000

For more information call 1-800-548-9765.

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 216352 · View the label on DailyMed

Revision date stated in the text: March 2025

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Erzofri extended-release

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Atypical Antipsychotic
Active ingredient Paliperidone palmitate
Dosage form Injection
Route Intramuscular
Marketing status listed in the FDA NDC Directory
Company (applicant) LUYE INNOMIND PHARMA
FDA approval NDA 216352New Drug Application (NDA) Approved July 26, 2024
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
39 mg/0.25 mL – 0.25 ml in 1 syringe, glass / 1 in 1 kit NDC 72526-105-11
78 mg/0.5 mL – 0.5 ml in 1 syringe, glass / 1 in 1 kit NDC 72526-106-11
117 mg/0.75 mL – 0.75 ml in 1 syringe, glass / 1 in 1 kit NDC 72526-107-11
156 mg/mL – 1 ml in 1 syringe, glass / 1 in 1 kit NDC 72526-108-11
234 mg/1.5 mL – 1.5 ml in 1 syringe, glass / 1 in 1 kit NDC 72526-109-11
351 mg/2.25 mL – 2.25 ml in 1 syringe, glass / 1 in 1 kit NDC 72526-110-11
351 mg/2.25 mL – 2.25 ml in 1 syringe, glass / 1 in 1 kit NDC 72526-110-21

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.