paliperidone (injection)

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

What is paliperidone?

Paliperidone is used in adults to treat schizophrenia. Paliperidone is also used alone or with other medicines to treat schizoaffective disorder in adults.

Paliperidone may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving paliperidone?

High doses or long-term use of paliperidone can cause a serious movement disorder that may not be reversible. The longer you use paliperidone, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

Before you receive your first injection, tell your doctor if you have never taken oral (by mouth) paliperidone or risperidone.

Tell your doctor if you have ever had:

• heart problems, or a heart attack;
• long QT syndrome (in you or a family member);
• high or low blood pressure, or fainting spells;
• low white blood cell (WBC) counts;
• a serious neurologic disorder caused by taking an antipsychotic medicine;
• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• seizures or epilepsy;
• an electrolyte imbalance (such as low blood levels of potassium or magnesium);
• diabetes (in you or a family member);
• cancer of the breast; or
• liver or kidney disease.

Using antipsychotic medicine in the last 3 months of pregnancy may cause serious problems in the newborn. Tell your doctor right away if you get pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of paliperidone on the baby.

How is paliperidone given?

Paliperidone is injected into a muscle. A healthcare provider will give you this injection.

Invega Sustenna is usually given only once per month, but the first two doses are given 1 week apart.

Invega Trinza is usually given once every 3 months, after you have used Invega Sustenna for at least 4 months in a row.

Invega Hafyera is usually given once every 6 months, after you have used Invega Sustenna for at least 4 months in a row or Invega Trinza for at least one cycle.

Remain under the care of a doctor while using paliperidone. Use paliperidone regularly for the best results.

Your doctor will need to check your progress on a regular basis.

What happens if I miss a dose?

What happens if I overdose?

Overdose symptoms may include drowsiness, feeling unsteady, fast or pounding heartbeats, and feeling like you might pass out.

What should I avoid while receiving paliperidone?

Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Follow your doctor's instructions about the type and amount of liquids you should drink.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

What are the possible side effects of paliperidone?

• tremors or shaking in your arms or legs;
• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement); or
• any new or unusual muscle movements you cannot control.

• low blood pressure, fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
• problems with thinking or feeling unsteady;
• trouble swallowing;
• seizure;
• breast swelling and tenderness, nipple discharge;
• high cholesterol, weight gain;
• fever, chills, sore throat, mouth sores, feeling light-headed;
• irregular blood cell counts;
• high blood sugar --increased thirst, increased urination, dry mouth, fruity breath odor;
• severe nervous system reaction --very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
• impotence, or erection that is painful or lasts longer than 4 hours; or
• changes in your menstrual periods.

Common side effects may include:

• headache, dizziness, drowsiness;
• cold symptoms such as stuffy nose, sneezing, sore throat;
• feeling restless or excited;
• muscle stiffness, tremors or shaking;
• uncontrolled muscle movements, problems with speech or walking;
• problems with balance or eye movement;
• weight gain;
• upset stomach, constipation;
• fast heart rate; or
• pain, bruising, swelling, or irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect paliperidone?

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Many drugs can affect paliperidone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all other medicines you use.

Where can I get more information?

Your doctor or pharmacist can provide more information about paliperidone injection.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2023 Cerner Multum, Inc. Version: 3.03. Revision date: 5/23/2023.