Invega Trinza: Uses, Side Effects and Dosage

Serious Warnings and Precautions

Increased Risk of Death in Elderly People with Dementia

Medicines like Invega Trinza can raise the risk of death in elderly people who have dementia. Invega Trinza is not approved for use in patients with dementia.

What is Invega Trinza used for?

Invega Trinza is given by your healthcare professional and is used in adults to treat symptoms of schizophrenia.

Not all people with schizophrenia have the same symptoms.

Some of the most common symptoms of schizophrenia may include:

• hallucinations (seeing, feeling, hearing or smelling things that are not there)
• delusions (believing things that are not true)
• paranoia (not trusting others and feeling very suspicious)
• avoiding family and friends and wanting to be alone

Invega Trinza is an injection that is given to you once every 3 months. Before you start taking this drug, you will first be given Invega Sustenna. Invega Sustenna contains the same medication as Invega Trinza and is given once a month. You will get this injection for at least 4 months. Once your symptoms are under control with Invega Sustenna, your healthcare professional will switch you to Invega Trinza. You will be given one injection every 3 months

How does Invega Trinza work?

Invega Trinza belongs to a group of medicines called antipsychotic drugs. Antipsychotic medications affect dopamine and serotonin (chemicals found in the brain) that allow for the communication between your nerve cells. Exactly how this medication works is not known. However, it seems that Invega Trinza corrects the balance of dopamine and serotonin in your body.

What are the ingredients in Invega Trinza?

Medicinal ingredients: Paliperidone (as paliperidone palmitate)

Non-medicinal ingredients: citric acid monohydrate, polyethylene glycol 4000, polysorbate 20, sodium dihydrogen phosphate monohydrate, sodium hydroxide, and water for injection

Invega Trinza comes in the following dosage forms:

Prolonged-Release Injectable Suspension in pre-filled syringes: 175 mg / 0.875 mL, 263 mg / 1.315 mL, 350 mg / 1.75 mL, and 525 mg / 2.625 mL.

Do not use Invega Trinza if:

• you or the person you are caring for has had an allergic reaction to:

  • paliperidone,
  • risperidone (paliperidone is a compound resulting from the breakdown of risperidone in the body) or
  • any of the other ingredients in Invega Trinza

Signs of an allergic reaction include:

• itching
• skin rash
• swelling of the face, lips or tongue
• shortness of breath

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Invega Trinza. Talk about any health conditions or problems you may have, including if you:

• are taking or planning to take any other medication (prescription, over-the-counter and natural health products)

  • are taking risperidone
• have had serious allergic reactions to other medications, including oral risperidone or oral paliperidone. Even if you have not had a reaction to oral paliperidone or risperidone before, it can occur very rarely after receiving injections of Invega Trinza.

• have a history of having:

  • stroke
  • mini-stroke
  • high cholesterol or
  • high blood pressure

Medicines like Invega Trinza can raise the risk of stroke/mini-stroke in elderly people with dementia.

• have or are at risk for diabetes or high blood sugar or have a family history of diabetes

• are pregnant, think you may be pregnant, or are planning to become pregnant

• are breast-feeding or are planning to breast-feed. Invega Trinza can pass into your breast milk. You should not breast-feed while taking this medication.
• have had or have prolonged and/or painful erection
• are prone to hypotension (low blood pressure), have or have had heart disease treatment that makes you more likely to have low blood pressure or feeling dizzy or faint when you stand up from lying or sitting positions

• have a history of:

  • heart problems
  • any problems with the way your heart beats
  • congenital long QT syndrome
• have low levels of potassium and/or magnesium in the blood
• are being treated for high blood pressure
• are taking any medications that affect how your heart beats
• have or have ever had blackouts or seizures
• have or have had low white blood cell count in your blood. Let your healthcare professional know right away if you develop a fever or infection while being treated with Invega Trinza
• have high levels of cholesterol or fats (triglycerides) in your blood

• have a history of or are at risk of:

  • sleep apnea (a sleep disorder where your breathing is interrupted during sleep)
  • sleep walking
  • sleep-related eating disorder
• have Parkinson’s disease or dementia with Lewy bodies (DLB)
• have or have had breast cancer
• have pituitary gland tumours

• drink alcoholic beverages or use drugs

• have a history of kidney problems
• have liver problems
• suffer from Alzheimer’s disease
• are feeling thirsty and unwell
• exercise strenuously. This kind of medication may interfere with your body’s ability to adjust to heat. You should avoid becoming overheated or dehydrated (for example with vigorous exercise or exposure to extreme heat) while taking Invega Trinza.
• have a fever or infection

• are at risk for developing blood clots. Risk factors include:

  • a family history of blood clots
  • being over the age over 65
  • smoking
  • being overweight
  • having a recent major surgery (such as hip or knee replacement)
  • not being able to move due to air travel or other reasons
  • taking oral birth control (“The Pill”)

• are planning to have surgery on your eye(s). During surgery to treat the cloudiness of the lens in your eye(s) (known as cataract surgery):

  • the pupil (the black circle in the middle of your eye) may not increase in size as needed
  • the iris (the coloured part of the eye) may become floppy during surgery. This may lead to eye damage.

Tell your eye doctor you are taking this medicine

Other warnings you should know about:

Elderly Patients with Dementia: Drugs that contain risperidone are similar to drugs that contain paliperidone (such as Invega Trinza). Studies have shown that when risperidone and furosemide (a “water pill”) are taken together by elderly patients who have dementia, it is linked to a higher rate of death.

• Tell your healthcare professional if you are taking furosemide. This drug can be used to treat:

  • swelling of parts of the body caused by the build-up of too much fluid
  • some heart problems
  • high blood pressure

• In elderly patients who have dementia, other drugs that belong to the same group of drugs as Invega Trinza have also been linked to side effects that include:

  • a sudden change in mental state
  • sudden weakness or numbness of the face, arms or legs, especially on one side of the body
  • slurred speech
  • vision problems

If you have any of these symptoms, get medical help right away.

Dysphagia: Tell your healthcare professional if you have difficulty swallowing food or have esophageal dysmotility (problems with your food pipe) as there is a risk of pneumonia caused by inhaling food or liquid that gets into your lungs.

Effects on newborns: You should not take Invega Trinza while you are pregnant or if you are planning on becoming pregnant unless you have talked to your healthcare professional about it.

If you took Invega Trinza at any time while you were pregnant or if you took it before you became pregnant, the following symptoms may happen in your newborn baby:

• shaking
• stiffness in their muscles and/or weakness
• sleepiness
• agitation
• breathing problems
• difficulty feeding

Get medical help right away if your newborn baby has any of these symptoms.

In some cases, babies born to a mother who took paliperidone while she was pregnant have had to be hospitalized after experiencing symptoms that were severe.

Driving and using machines: Do not drive or operate machinery until you know how you respond to Invega Trinza. Some people experience drowsiness or blurred vision while taking Invega Trinza.

Falls: Feeling sleepy, a fall in blood pressure when you stand up from sitting or lying down, vision and speech problems have been reported with the use of antipsychotic drugs. This can lead to falls that may cause fractures or other fall related-injuries. Certain medications, diseases or conditions can make this worse.

Weight gain: Weight gain has been seen in patients who are taking antipsychotic drugs. Your healthcare professional may monitor your body weight when you are taking Invega Trinza.

Blood tests: Your healthcare professional should do blood tests before you start taking Invega Trinza. They will check your blood sugar levels, and for those with certain risk factors, the level of white blood cells in your blood. Your healthcare professional should continue to do blood test for as long as you are being treated with Invega Trinza.

The following serious or life-threatening side effects have been reported with similar atypical antipsychotics drugs such as Invega Trinza:

• Neuroleptic Malignant Syndrome (NMS):

  • mental changes such as agitation, hallucinations, confusion, or other changes in mental status
  • coordination problems, uncontrolled muscle spasms, or muscle twitching (overactive reflexes)
  • restlessness
  • racing or fast heartbeat, high or low blood pressure
  • sweating or fever
  • nausea, vomiting, or diarrhea
  • stiff muscles

• Severe Skin Reactions: In very rare cases, skin reactions that can be serious or life-threatening have been reported. This includes skin conditions such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS). The following symptoms may be related to these skin reactions:

  • Early warnings for patients:

    • fever
    • severe rash
    • swollen lymph glands
    • flu-like feeling
    • blisters and peeling skin that may start in and around the mouth, nose, eyes, and genitals and spread to other areas of the body

  • Later developments:

    • yellow skin or eyes
    • shortness of breath
    • dry cough
    • chest pain or discomfort
    • feeling thirsty
    • urinating less often, less urine

Call your healthcare professional right away if you start to have any of the following symptoms while taking Invega Trinza.

Tardive Dyskinesia (TD): Invega Trinza, like other antipsychotic medications, can cause potentially irreversible muscle twitching or unusual/abnormal movement of the face or tongue or other parts of your body.

Increased levels of prolactin: Invega Trinza can raise your levels of a hormone called “prolactin”. This is measured with a blood test. Symptoms may include:

• In men:

  • swelling in the breast
  • difficulty in getting or maintaining an erection or other sexual dysfunction

• In women:

  • discomfort in the breasts
  • leaking of milk from the breasts (even if not pregnant)
  • missing your menstrual period or other problems with your cycle

If you have high levels of prolactin and a condition called hypogonadism, you may be at an increased risk of breaking a bone due to osteoporosis. This occurs in both men and women.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with Invega Trinza:

• DO NOT drink alcohol and only take medications prescribed by your healthcare professional.
• risperidone or oral paliperidone.
• drugs that can cause you to become sleepy or drowsy.
• dopamine agonists, such as levodopa (used to treat Parkinsons’s disease).
• carbamazepine (used to treat seizures).
• drugs that lower your blood pressure.
• psychostimulants such as methylphenidate.
• drugs used to treat abnormal heartbeats such as quinidine, procainamide, amiodarone and sotalol.
• drugs used to treat schizophrenia and other mental health problems such as chlorpromazine and thioridazine.
• antibiotics such as gatifloxacin and moxifloxacin.

This list is not complete and there may be other drugs that can interact with Invega Trinza.

How Invega Trinza is given:

Invega Trinza is a long-acting medicine. It will be given to you:

• by your healthcare professional
• as an injection into your muscle (intramuscularly) located on the uppermost part of your arm or in the upper outer side of your buttocks every 3 months.

Invega Trinza is designed to release medication slowly over time and provide a steady level of medication over the 3 months.

It is important for you to be treated first with Invega Sustenna (a once a month injection) for at least 4 months before you start taking Invega Trinza. This is so that your healthcare professional can decide if you can safely switch to Invega Trinza and what dose will work best for you.

It is important not to miss your scheduled dose. If you cannot keep your appointment with the healthcare professional, make sure you call them right away so another appointment can be made as soon as possible.

Usual adult dose:

Your healthcare professional has decided on the best dose for you. Your dose may be increased or decreased depending on:

• other health conditions you may have
• how you respond to the medication

Maintenance dose: (given either into your upper arm or buttocks)

Once every 3 months: 175 mg / 0.875 mL – 525 mg / 2.625 mL

Overdose:

Patients who have been given too much paliperidone may experience the following symptoms:

• feeling drowsy or sleepy
• a fast heart rate
• low blood pressure
• irregular heart beat or other symptoms of an irregular heartbeat, such as lightheadedness or fainting
• unusual movements of the face, body, arms or legs (such as excessive trembling or muscle stiffness)

Missed dose:

It is important not to miss your scheduled dose.

If you cannot keep your appointment with the healthcare professional, make sure you call them right away so another appointment can be made as soon as possible. Your healthcare professional or treatment team will decide what you should do next.

If you stop going for your injections, your symptoms may return. You should not stop this medicine unless told to do so by your healthcare professional.

What are possible side effects from using Invega Trinza?

These are not all the possible side effects you may feel when taking Invega Trinza. If you experience any side effects not listed here, tell your healthcare professional.

Side effects include:

• headache
• trouble falling asleep or waking up during the night or too early in the morning
• faster heart rate
• slow heart rate
• irregular heartbeat
• stomach ache
• constipation
• diarrhea
• nausea and vomiting
• lack of energy
• fatigue
• changes in weight (gain or loss)
• feeling restless
• dizziness
• abnormal or uncontrollable movements of the face or body, tremors (shaking), slowness of movement, muscle stiffness or spasms
• feeling sleepy
• rash
• high blood pressure
• urinary tract infection
• high blood triglycerides (a fat)
• feeling like you have the flu
• depression
• anxiety
• blurred vision
• dry mouth
• increased saliva
• decreased or increased appetite
• drooling
• itching
• low blood sugar (hypoglycemia).
• problems with the movement of your eyes

Since paliperidone (the ingredient in Invega Trinza) is a compound resulting from the breakdown of risperidone in the human body, any side effects that may occur after taking risperidone may also occur with Invega Trinza.

Serious side effects and what to do about them

Serious side effects and what to do about them

Serious side effects and what to do about them

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

Storage:

Store Invega Trinza:

• between 15–30°C in its original package

Keep out of reach and sight of children.

The expiry date for Invega Trinza is printed on the package. Do not use the medicine after this date.

If you want more information about Invega Trinza:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website Janssen Inc., www.janssen.com/canada, or by calling 1-800-567-3331 or 1-800-387-8781.

Toronto, Ontario M3C 1L9

All trademarks used under license.

Last Revised: September 28. 2023