Risperidone Injection

IMPORTANT WARNING:

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 or use antipsychotics (medications for mental illness) such as risperidone have an increased risk of death during treatment.

Risperidone injection is not approved by the Food and Drug Administration (FDA) for the treatment of behavior problems 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 taking or receiving risperidone. For more information visit the FDA website: https://www.fda.gov/Drugs.

Talk to your doctor about the risks of receiving risperidone injection.

WHY is this medicine prescribed?

Risperidone injection is used to treat schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions). Risperidone injection may also be used alone or in combination with lithium (Lithobid) or valproate to treat people who have bipolar I disorder (manic depressive disorder; a disease that causes episodes of depression, episodes of severe mania, and other abnormal moods). Risperidone 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?

Risperidone extended-release (long-acting) injection (Risperdal Consta, Risvan, Rykindo) comes as a powder to be mixed with a liquid to be injected intramuscularly (into a muscle) by a healthcare provider. Risperidone extended-release injection (Perseris) comes as a powder to be mixed with a liquid to be injected subcutaneously (under the skin) by a healthcare provider. Risperidone extended-release injection (Uzedy) comes as a suspension (liquid) to be inject subcutaneously by a healthcare provider. If you have never received risperidone extended-release injection previously, your doctor will probably tell you to take risperidone tablets or oral solution by mouth before you receive your first injection.

Risperidone extended-release injection (Risperdal Consta) is usually injected intramuscularly once every 2 weeks into the buttocks or upper arm. Risperidone extended-release injection (Rykindo) is usually injected intramuscularly once every 2 weeks into the buttocks. Risperidone extended-release injection (Risvan) is usually injected intramuscularly once a month into the buttocks or upper arm. You may need to take risperidone tablets or another antipsychotic medication by mouth for the first 1 to 3 weeks after receiving your first injection of risperidone extended-release intramuscular injection. After at least 4 weeks of therapy, your doctor may increase your dose depending on your response to this medication.

Risperidone extended-release injection (Perseris) is usually injected subcutaneously once a month in your upper arm or abdomen. Risperidone extended-release injection (Uzedy) is usually injected subcutaneously once a month or once every 2 months in your upper arm or abdomen.

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

What SPECIAL PRECAUTIONS should I follow?

Before receiving risperidone injection,

• tell your doctor and pharmacist if you are allergic to risperidone, paliperidone (Invega), any other medications, or any of the ingredients in risperidone 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. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• The following nonprescription or herbal products may interact with risperidone: cimetidine (Tagamet HB), ranitidine (Zantac), and St. John's Wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start receiving risperidone injection. Do not start these medications while receiving risperidone injection without discussing with your healthcare provider.

• tell your doctor if you have 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 had or have ever had a stroke, a ministroke, heart disease, a heart attack, heart failure, irregular heartbeat, dyslipidemia (high cholesterol levels), seizures, difficulty swallowing, trouble keeping your balance, Parkinson's disease (PD; a disorder of the nervous system that causes difficulties with movement, muscle control, and balance), osteoporosis, or kidney or liver disease. Tell your doctor if you or anyone in your family has or has ever had diabetes and 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, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant or are breastfeeding. If you become pregnant while receiving risperidone injection, call your doctor. Risperidone may cause problems in newborns following delivery if it is taken during the last months of pregnancy.

• you should know that receiving risperidone 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 during your treatment with risperidone injection until you know how this medication affects you.

• you should know that alcohol can add to the drowsiness caused by this medication. Do not drink alcohol during your treatment with risperidone injection.

• 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 risperidone 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 risperidone 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 risperidone injection may make it harder for your body to cool down when it gets very hot or warm up when it gets very cold. Tell your doctor if you plan to do vigorous exercise or be exposed to extremely high or low temperatures.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

If you forget to keep an appointment to receive risperidone injection, call your doctor to schedule another appointment as soon as possible.

What SIDE EFFECTS can this medicine cause?

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

• constipation
• nausea
• heartburn
• stomach pain
• increased appetite
• fatigue
• weight change (gain or loss)
• headache
• blurred vision
• tiredness
• dry mouth
• acne
• dry skin
• increased saliva
• breast enlargement or discharge
• late or missed menstrual periods
• decreased sexual ability
• dizziness, feeling unsteady, or having trouble keeping your balance
• back, arm, or leg pain
• muscle stiffness, spasms, or pain
• pain, itching, hardness, or a lump in the place where the medication was injected

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

• seizures
• fever
• muscle stiffness
• confusion
• rash; itching; hives; swelling of the face, throat, lips, and eyes; difficulty swallowing or breathing
• fast or irregular heartbeat
• unusual movements of your face or body that you cannot control
• slow movements or shuffling walk
• falling
• painful erection of the penis that lasts for hours
• cough, chills and/or other signs of infection

Risperidone injection may cause other side effects. Call your doctor if you have any unusual problems while receiving 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.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to risperidone 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.