Paliperidone extended-release injection

What is this medicine?

PALIPERIDONE (pal ee PER i done) injection is given by a health care professional. The once-monthly injection (Invega Sustenna) is used for the treatment of schizophrenia or for schizoaffective disorder. The 3-month injection (Invega Trinza) is used for the treatment of schizophrenia.

How should I use this medicine?

This medicine is for injection into a muscle. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breast enlargement in both males and females

• breathing problems

• confusion

• fast, irregular heartbeat

• fever or chills, sore throat

• inability to keep still

• males: prolonged or painful erection

• missed menstrual periods

• pain, redness or irritation at site where injected

• problems with balance, talking, walking

• seizures

• signs and symptoms of high blood sugar such as being more thirsty or hungry or having to urinate more than normal. You may also feel very tired or have blurry vision

• signs and symptoms of low blood pressure like dizziness; feeling faint or lightheaded, falls; unusually weak or tired

• signs and symptoms of neuroleptic malignant syndrome like confusion; fast or irregular heartbeat; high fever; increased sweating; stiff muscles

• sudden numbness or weakness of the face, arm, or leg

• suicidal thoughts or other mood changes

• trouble swallowing

• uncontrollable movements of the arms, face, head, mouth, neck, or upper body

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• change in sex drive or performance

• cough

• drowsiness

• dry mouth

• headache

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• cisapride

• dronedarone

• fluconazole

• pimozide

• thioridazine

This medicine may also interact with the following medications:

• alcohol

• carbamazepine

• certain medicines for anxiety, depression, or psychotic disturbances

• certain medicines for blood pressure, heart disease, irregular heart beat

• certain medications for Parkinson's disease like levodopa, bromocriptine, ropinirole, and pramipexole

• certain medicines for sleep

• narcotic pain medicines

• other medicines that prolong the QT interval (cause an abnormal heart rhythm) like dofetilide

• rifampin

• St. John's Wort

What if I miss a dose?

Try to keep all appointments for your injections. This medicine is given either once every 4 weeks or once every 3 months depending on which type of injection your doctor has prescribed for you. Contact your health care provider for instructions if you miss an appointment.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• dementia

• diabetes or family history of diabetes

• heart disease

• high blood pressure

• history of irregular heartbeat

• history of low white blood cell count

• history of neuroleptic malignant syndrome

• history of stroke

• history of trouble controlling your muscles (tardive dyskinesia)

• kidney disease

• liver disease

• low blood pressure

• low levels of magnesium or potassium in the blood

• seizures

• stomach or intestine problems

• an unusual or allergic reaction to paliperidone, risperidone, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Your condition will be monitored carefully while you are receiving this medicine. It may be several weeks before you see the full effects. Do not stop this medicine except on the advice of your doctor or health care professional.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

This medicine may increase blood sugar. Ask your healthcare provider if changes in diet or medicines are needed if you have diabetes.

This drug can cause problems with controlling your body temperature. It can lower the response of your body to cold temperatures. If possible, stay indoors during cold weather. If you must go outdoors, wear warm clothes. It can also lower the response of your body to heat. Do not overheat. Do not over-exercise. Stay out of the sun when possible. If you must be in the sun, wear cool clothing. Drink plenty of water. If you have trouble controlling your body temperature, call your health care provider right away.