paliperidone (injection)

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

What is paliperidone?

Paliperidone is an antipsychotic medicine that is used to treat schizophrenia in adults. 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 using 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;
• liver or kidney disease;
• seizures or epilepsy;
• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);
• diabetes (paliperidone may raise your blood sugar); or
• breast cancer.

Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

Using antipsychotic medicine in the last 3 months of pregnancy may cause breathing problems, feeding problems, or withdrawal symptoms in the newborn. However, you may have withdrawal symptoms or other problems if you stop using your medicine during pregnancy. If you get pregnant, tell your doctor right away. Do not stop using paliperidone without your doctor's advice.

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.

Follow your doctor's dosing instructions very carefully. Get your paliperidone injections regularly to get the most benefit.

Your doctor will need to check your progress while you are using paliperidone.

What happens if I miss a dose?

What happens if I overdose?

Overdose symptoms may include a headache with chest pain, fast or pounding heartbeats, and severe dizziness.

What should I avoid while using paliperidone?

While you are using paliperidone, you may be more sensitive to very hot conditions. Avoid becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise.

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.

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
• trouble swallowing;
• a seizure (convulsions);
• breast swelling (in women or men), nipple discharge;
• changes in menstrual periods;
• impotence, or penis erection that is painful or lasts 4 hours or longer;
• weight gain;
• fever, chills, sore throat, mouth sores, feeling light-headed;
• high blood sugar --increased thirst, increased urination, hunger, fruity breath odor; or
• severe nervous system reaction --very stiff (rigid) muscles, high fever, fast or pounding heartbeats, fainting.

Common side effects may include:

• dizziness, drowsiness;
• cold symptoms such as stuffy nose, sneezing, sore throat;
• feeling restless or anxious;
• muscle stiffness, tremors or shaking;
• uncontrolled muscle movements, trouble with walking, balance, or speech;
• abnormal movements of your eyes;
• weight gain;
• upset stomach, constipation;
• fast heart rate; or
• pain or tenderness 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 medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications 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 your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about paliperidone injection.