(pal" ee per' i done)

Brand Name(s): Erzofri^®, Invega Hafyera^®, Invega Sustenna^®, Invega Trinza^®

IMPORTANT WARNING:

Older adults with dementia (a brain disorder that affects the ability to remember, think clearly, communicate, and perform daily activities and that may cause changes in mood and personality) may have an increased risk of death during treatment. Older adults with dementia may also have an increased risk of stroke or ministroke during treatment.

Paliperidone extended-release (long-acting) injection is not approved by the Food and Drug Administration (FDA) for the treatment of behavior disorders in older adults with dementia.

Talk to your doctor about the risks of receiving paliperidone extended-release injection.

WHY is this medicine prescribed?

Paliperidone extended-release injections are used to treat schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions) and schizoaffective disorder (a mental illness that causes both a loss of contact with reality and mood problems [depression or mania]).Paliperidone extended-release injection is in a class of medications called atypical antipsychotics.It works by changing the activity of certain natural substances in the brain.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Paliperidone extended-release injections come as a suspension (liquid) to be injected intramuscularly (into a muscle) by a healthcare provider. Paliperidone extended-release injection is started only after you have been taking similar medicines by mouth and doing well. It is injected once a month. After 4 months, you may receive it every 3 or 6 months.

You will be given paliperidone extended-release injection in the butt or upper arm muscles.

Paliperidone extended-release injection may help control your symptoms but will not cure your condition. Continue to keep appointments to receive paliperidone extended-release injection even if you feel well. Talk to your doctor if you do not feel like you are getting better during your treatment with paliperidone extended-release injection.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before receiving paliperidone extended-release injection,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while receiving paliperidone injection. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• the following herbal product may interact with paliperidone injection: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start using paliperidone injection. Do not start any of these medications while receiving paliperidone injection without discussing with your healthcare provider.

• tell your doctor if you have a low level of potassium or magnesium in your blood, a low number of white blood cells, or if any other medication has ever caused a decrease in your white blood cells. Also tell your doctor if you have or have ever had seizures, a stroke, a ministroke, a heart attack, heart failure, an irregular heartbeat, long QT syndrome (condition that increases the risk of developing an irregular heartbeat that may cause fainting or sudden death), uncontrolled movements of your tongue, face, mouth, or jaw, trouble keeping your balance, Parkinson's disease (PD; a disorder of the nervous system that causes difficulties with movement, muscle control, and balance), Lewy body dementia (a condition in which the brain develops abnormal protein structures, and the brain and nervous system are destroyed over time), difficulty swallowing, dyslipidemia (high cholesterol levels), heart, liver, or kidney disease, or if you or anyone in your family has or has ever had diabetes. Tell your doctor if you have severe vomiting, diarrhea or signs of dehydration now, or if you develop these symptoms at any time during your treatment.

• tell your doctor if you are pregnant, if you plan to become pregnant, or if you are breastfeeding. If you become pregnant during your treatment with paliperidone extended-release injection, call your doctor.Paliperidone may cause problems in newborns following delivery if it is taken during the last months of pregnancy.

• you should know that receiving paliperidone extended-release injection may make you drowsy and may affect your ability to think clearly, make decisions, and react quickly. Do not drive a car or operate machinery at other times during your treatment with paliperidone extended-release injection until you know how this medication affects you.

• you should know that you may experience hyperglycemia (increases in your blood sugar) while you are receiving this medication, even if you do not already have diabetes.If you have schizophrenia, you are more likely to develop diabetes than people who do not have schizophrenia, and receiving paliperidone extended-release injection or similar medications may increase this risk.Tell your doctor immediately if you have any of the following symptoms during your treatment: extreme thirst, frequent urination, extreme hunger, blurred vision, or weakness. It is very important to call your doctor as soon as you have any of these symptoms, because high blood sugar can cause a serious condition called ketoacidosis. Ketoacidosis may become life-threatening if it is not treated at an early stage. Symptoms of ketoacidosis include dry mouth, nausea and vomiting, shortness of breath, breath that smells fruity, and decreased consciousness.

• you should know that paliperidone extended-release injection may cause dizziness, lightheadedness, fast or slow heartbeat, and fainting when you get up too quickly from a lying position, especially right after you receive your injection. If you feel dizzy or drowsy after you receive your injection, you will need to lie down until you feel better. During your treatment, you should get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

• you should know that paliperidone extended-release injection may make it harder for your body to cool down when it gets very hot.Tell your doctor if you plan to do vigorous exercise or be exposed to extreme heat. Be sure to drink plenty of water and call your doctor if you experience any of the following symptoms: feeling very hot, sweating heavily, not sweating even though it is hot, dry mouth, excessive thirst, or decreased urination.

• you should know that paliperidone extended-release injection may make it harder for your body to cool down when it gets very hot.Tell your doctor if you plan to do vigorous exercise or be exposed to extreme heat. Be sure to drink plenty of water and call your doctor if you experience any of the following symptoms: feeling very hot, sweating heavily, not sweating even though it is hot, dry mouth, excessive thirst, or decreased urination.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Paliperidone injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• pain, swelling, redness at injection site
• extreme tiredness
• dizziness, feeling unsteady, or having trouble keeping your balance
• restlessness or agitation
• headache
• dry mouth
• weight gain
• stomach pain or discomfort
• breast discharge
• missed menstrual period
• breast enlargement in males
• decreased sexual ability

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections, call your doctor immediately or get emergency medical treatment:

• rash, itching, hives; swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, and/or lower legs; difficulty swallowing or breathing
• falling
• irregular heartbeat
• confusion
• seizure or loss of consciousness
• muscle stiffness; unusual or uncontrolled movements of the mouth, tongue, face, head, neck, arms, and legs; uncontrollable shaking of the body; slow movements or shuffling walk
• painful erection of the penis that lasts for hours
• fever, cough, chills and/or other signs of infection

Paliperidone injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• drowsiness
• extreme tiredness
• increased or irregular heartbeat
• seizures
• slow movements or shuffling walk
• unusual or uncontrolled movements of the mouth, tongue, face, head, neck, arms, and legs

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Ask your pharmacist any questions you have about paliperidone extended-release injection.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2025. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: April 15, 2025.