Paliperidone (Invega® and generic forms), Invega Sustenna®, and Invega Trinza® belongs to a group of medications called “atypical antipsychotics” or “second-generation antipsychotics.”

What is this medication used for?

Paliperidone was first developed to treat psychotic illnesses such as schizophrenia. Paliperidone is not approved by Health Canada for use in children and adolescents.

When potential benefits outweigh risks, paliperidone may be prescribed “off-label” for treatment of schizophrenia and other psychotic disorders, management of acute mania in bipolar disorder, and irritability associated with autism spectrum disorder. Learn more about off-label medication use: http://bit.ly/KMH-off-label-use

Tell your doctor or pharmacist if you:

• Have allergies or bad reactions to a medication
• Take (or plan to take) other prescription or non-prescription medications, including natural medicines. Some medications interact with paliperidone. Your doctor may adjust medication doses or monitor for side effects
• Have a history of kidney or liver disease, seizures, bowel obstruction, trouble urinating, low white blood cell count, glaucoma or sleep apnea
• Have a history (or family history) of diabetes, heart disease, arrhythmia or “familial long QT syndrome”
• Miss a menstrual period, are pregnant, breastfeeding or planning a pregnancy
• Use alcohol or drugs. Taking paliperidone together with certain substances may cause a bad reaction. Learn more at www.DrugCocktails.ca

When will the medication start to work?

It may take 1 to 2 weeks before the benefits of paliperidone become noticeable. It can take up to 6 weeks to see the full benefits of the medication. You (or your family members) may notice clearer thoughts, less moodiness, anger, irritability, or explosive behaviour. If you experience seeing, hearing or feeling things that are not there, this may also decrease or stop entirely.

It is important that you continue taking paliperidone regularly even if you are feeling well, as it can prevent symptoms from returning. Talk with your doctor if

you feel paliperidone treatment has not been helpful or side effects are too bothersome. Your doctor may recommend switching you to a different medication.

This medication is not addictive. Do not stop taking it before talking to your doctor.

How do I take this medication?

There are three forms of paliperidone: sustained-release (SR) tablets and two long-acting injections (Invega Sustenna® and Invega Trinza®). Paliperidone tablets are usually taken once daily in the evening, at the same time(s) each day with or without food.

Paliperidone SR tablets should be swallowed whole with fluids. Do not crush, chew or divide the SR tablets. Usually, you will start with a low dose and slowly increase this dose over several days or weeks, based on how you tolerate it.

For the long-acting injection, a doctor or nurse will give this into a large muscle every 4 weeks, following 2 initial loading doses given 7 days apart (Invega Sustenna®) or every 3 months (Invega Trinza®). You may be able to stop taking the oral tablet after the first injection, or you may be asked to continue taking it by mouth for a few weeks until the injection starts to take effect.

Possible common or serious side effects:

Side effects may be more common when starting a medication or after a dose increase. Talk to your doctor, nurse or pharmacist if any side effect concerns you.

• Dizziness, drowsiness, headache or dry mouth
• Feelings of agitation or restlessness
• Stomach ache or constipation
• Fast or irregular heartbeat
• Increased appetite or weight gain
• Increased blood glucose or cholesterol levels

Contact your doctor immediately if you experience:

• Unexplained rash, seizure, fever or excessive sweating
• Fainting, feeling lightheaded or difficulty with balance
• Feelings of restlessness or severe abdominal pain
• Excessive snoring or periods of not breathing during sleep (sleep apnea)
• Signs of infection (fever, sore throat, flu-like symptoms)
• Breast tenderness or swelling (males and females)
• Frequent urination accompanied by excessive thirst
• Shaking, muscle spasm/stiffness, pain or weakness
• Unusual movements of fingers, toes, neck, lips or tongue
• Thoughts of hurting yourself, suicide, increased hostility or worsening symptoms

What precautions should my doctor and I be aware of when taking this medication?

• When you take this medication, your body may have difficulty maintaining a normal body temperature. Drink enough fluids to avoid becoming dehydrated. Avoid doing a lot of physical activity on hot days.
• While taking this medication, if you feel dizzy, drowsy or slowed down, do not drive a car or operate heavy machinery. Alcohol could make this worse. Try to avoid alcohol while taking paliperidone.
• Paliperidone can cause a rare side effect called “tardive dyskinesia.” Symptoms include involuntary movements of the lips, tongue, toes, hands or neck. Stopping or switching this medication at first signs will decrease the chances this side effect will continue. These movements may become permanent without a medication change.
• Paliperidone can cause a rare side effect called “neuroleptic malignant syndrome.” Symptoms include severe muscle stiffness, high fever, sweating, increased or irregular heartbeat and increased blood pressure.

What special instructions should I follow while using this medication?

• Keep all appointments with your doctor and the lab. Your doctor may order lab tests to check how you are responding and monitor for side effects.
• Try to keep a healthy, well-balanced diet and exercise regularly. Some people may gain weight as a result of increased appetite.
• Do not allow anyone else to use your medication.

What should I do if I forget to take a dose of this medication?

If you take paliperidone SR tablets once daily in the evening and forget to take a dose, take it as soon as you remember before going to sleep. If you remember after waking in the morning, skip the missed dose and continue regularly with your next scheduled dose. DO NOT double your next dose to try to ‘catch up’.

If you are receiving a paliperidone long-acting injection and you miss your dose, contact your doctor to receive your next injection.

How do I store this medication?

Keep this medication in the original container, stored at room temperature away from moisture and heat and protected from light. Keep this medication out of reach and sight of children.

How does this medication work?

Like other antipsychotics, paliperidone affects actions of the brain chemicals dopamine and serotonin. The exact way that paliperidone improve symptoms of schizophrenia, bipolar disorder and other conditions is not known.

How well does the medication work in children and adolescents?

Evidence supports the use of paliperidone in children and adolescents. Paliperidone has been been shown to be better than placebo (an inactive pill) for adolescents with schizophrenia, as well as children and adolescents with manic episodes associated with bipolar disorder. Paliperidone has not been studied in children and adolescents for treatment of irritability associated with autism. However, it is sometimes prescribed when patients have experienced side effects with other treatments.

How long should I take the medication for?

This depends on the symptoms you have, how frequently they occur, and how long you have had them. Most people will need to take paliperidone for several months. This allows time for symptoms to stabilize and for function to improve. Your doctor will discuss the benefits and risks of taking paliperidone with you. At this time, you can also discuss how long you might need to take this medication.

If you have schizophrenia and you tolerate paliperidone well, you may be asked to take paliperidone on an ongoing basis. Continuing treatment will significantly decrease the chances that your symptoms will return. Do not increase, decrease, or stop taking this medication without talking with your doctor. If you stop taking paliperidone suddenly, it is possible that your symptoms may return or you may have a bad reaction.

TIP: Use the Kelty Mental Health Antipsychotic Monitoring Form for Children and Adolescents to help measure your progress on this medication. https://bit.ly/ap_monitoring

Also see the Kelty Mental Health document Atypical Antipsychotics & Metabolic Monitoring. https://bit.ly/ap_info