Paliperidone Injection

Studies have shown that 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) who take antipsychotics (medications for mental illness) such as paliperidone have an increased chance of death during treatment. Older adults with dementia may also have a greater chance of having a 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 the doctor who prescribed this medication if you, a family member, or someone you care for has dementia and is being treated with paliperidone extended-release injection. For more information visit the FDA website: https://www.fda.gov/Drugs.

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

Paliperidone extended-release injections (Invega Hafyera, Invega Sustenna, Invega Trinza) are used to treat schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions). Paliperidone extended-release injection (Invega Sustenna) is also used alone or with other medications to treat 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.

Paliperidone extended-release injections come as a suspension (liquid) to be injected into a muscle by a healthcare provider. There are three different types of paliperidone extended release injection products: Invega Sustenna, Invega Trinza, and Invega Hafyera.

Your doctor will start you with a single dose of paliperidone extended-release injection (Invega Sustenna). After you receive your first dose, you will receive a second dose usually 1 week after the first and then once every month after that.

After at least 4 months of treatment with paliperidone extended-release injection (Invega Sustenna) and you have responded to your treatment, your doctor may switch you to paliperidone extended-release injection (Invega Trinza). Paliperidone extended-release injection (Invega Trinza) is usually injected into a muscle by a healthcare provider once every 3 months.

After at least 4 months of treatment with paliperidone extended-release injection (Invega Sustenna) or after at least one 3-month injection of paliperidone extended-release injection (Invega Trinza) and you have responded to either treatment, your doctor may switch you to paliperidone extended-release injection (Invega Hafyera). Paliperidone extended-release injection (Invega Hafyera) is usually injected into a muscle by a healthcare provider once every 6 months.

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.

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

Before receiving paliperidone extended-release injection,

• tell your doctor and pharmacist if you are allergic to paliperidone, risperidone (Perseris Kit, Risperdal, Risperdal Consta), any other medications, or any of the ingredients in paliperidone extended-release injection. Ask your pharmacist for a list of the ingredients.
• 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.
• 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.

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

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
• 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
• seizure
• fever
• muscle stiffness
• falling
• irregular heartbeat
• confusion
• loss of consciousness
• unusual or uncontrolled movements of the mouth, tongue, face, head, neck, arms, and legs
• uncontrollable shaking of a part of the body
• slow movements or shuffling walk
• painful erection of the penis that lasts for hours
• 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).

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

Keep all appointments with your doctor.

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

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Invega Hafyera^®
• Invega Sustenna^®
• Invega Trinza^®