Paliperidone extended-release injection

What is this medicine?

PALIPERIDONE (pal ee PER i done) injection is either given as a once-monthly injection (Invega Sustenna) for the treatment of schizophrenia and schizoaffective disorder or as an injection every 3 months (Invega Trinza) 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

• change in blood sugar

• changes in vision

• confusion

• dark urine

• fast or irregular heartbeat

• feeling faint or lightheaded, falls

• fever or chills, sore throat

• increased thirst or hunger

• inner restlessness, unable to keep still

• men: prolonged or painful erection

• muscle pain, stiffness

• redness or swelling at the injection site

• trouble passing urine or change in the amount of urine

• unusual decrease in sweating

• unusual movements, spasms, tremor

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

• dofetilide

• dronedarone

• fluconazole

• pimozide

• quinidine

• 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

• certain medicines for chest pain

• 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)

• 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:

• chronic constipation or diarrhea

• dementia

• diabetes or family history of diabetes

• history of stroke

• irregular heartbeat or low blood pressure

• kidney disease

• liver disease

• stomach problems like adhesions, bowel disease, short gut, trouble swallowing

• 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 can reduce the response of your body to heat or cold. Dress warm in cold weather and stay hydrated in hot weather. If possible, avoid extreme temperatures like saunas, hot tubs, very hot or cold showers, or activities that can cause dehydration such as vigorous exercise.