Paliperidone Palmitate (pal-ee-PER-i-done PAL-mi-tate)

Treats schizophrenia and schizoaffective disorder.

Brand Name(s):

Invega Hafyera, Invega Sustenna, Invega Trinza

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot into one of your muscles. It is usually given in the arms or buttocks.
• A nurse or other health provider will give you this medicine.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: You must use this medicine on a fixed schedule. Call your doctor or pharmacist if you miss a dose.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how paliperidone works. Tell your doctor if you are using any of the following:
  • Bromocriptine, carbamazepine, levodopa, paroxetine, pramipexole, rifampin, ropinirole, St John's wort
  • Antibiotic medicine (including gatifloxacin, moxifloxacin)
  • Blood pressure medicine
  • Diuretic (water pill)
  • Medicine for heart rhythm problems (including amiodarone, procainamide, quinidine, sotalol)
  • Medicine for mental illness (including chlorpromazine, thioridazine)
  • Nitrate medicine
• Do not drink alcohol while you are using this medicine.
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, diabetes, Parkinson disease, dementia, trouble swallowing, or a history of breast cancer, seizures, or neuroleptic malignant syndrome. Tell your doctor if you have blood vessel or heart problems, low blood pressure, heart failure, heart rhythm problems, or a history of a heart attack or stroke.
• This medicine may cause the following:
  • Increased risk of stroke
  • Neuroleptic malignant syndrome (a nerve disorder that could be life-threatening)
  • Heart rhythm problem (including QT prolongation)
  • Tardive dyskinesia (a muscle disorder that could become permanent)
  • High blood sugar or high cholesterol levels
  • Low blood pressure
  • Increased levels of prolactin hormone
  • Increased risk of seizures
• This medicine may make you dizzy or drowsy, or may cause trouble with thinking or controlling body movements, which may lead to falls, fractures, or other injuries. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. You may also feel lightheaded when suddenly getting up from a lying or sitting position, so stand up slowly.
• This medicine lowers the number of white blood cells. This weakens your immune system, so you may get infections more easily. Wash your hands often. Avoid people who are sick.
• This medicine may change how your body regulates temperature. Avoid activities that could cause you to become very cold, hot, or dehydrated.
• Talk with your doctor before using this medicine if you plan to have children. Some women who use this medicine have become infertile (unable to have children).
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chills, cough, sore throat, body aches
• Difficulty swallowing (that can cause food or liquid to get into your lungs)
• Fast, slow, pounding, or uneven heartbeat
• Fever, confusion, sweating, muscle stiffness, loss of consciousness, trouble breathing
• Jerky muscle movements you cannot control (often in the face, tongue, or jaw)
• Lightheadedness, dizziness, fainting
• Numbness or weakness in your arm or leg, or on one side of your body
• Prolonged or painful erection, which lasts for more than 4 hours (in males)
• Sudden or severe headache, problems with vision, speech, or walking
• Tremors or seizures
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Anxiety, restlessness
• Mild headache
• Pain, itching, burning, swelling, or a lump under your skin where the shot was given
• Sleepiness or unusual drowsiness
• Swelling of the breasts or unusual milk production
• Weight gain

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088