Patient Medication Information: uses, side effects, how to take - Invega (Janssen, 3 mg, 6 mg, 9 mg)
What is INVEGA® used for?
INVEGA® is used in adults to treat the symptoms of schizophrenia and related psychotic disorders.
Not all people with schizophrenia and related psychotic disorders have the same symptoms.
Some of the most common symptoms of schizophrenia and related psychotic disorders 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
Related psychotic disorders may also include:
- mania (being very over-active and over-excited)
- depression (feeling sad, hopeless, helpless, tired, sleeping a lot or not enough)
How does INVEGA® work?
INVEGA® 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® corrects the balance of dopamine and serotonin in your body.
What are the ingredients in INVEGA® ?
Medicinal ingredients: Paliperidone
Non-medicinal ingredients: butylated hydroxytoluene, carnauba wax, cellulose acetate, ferric oxide red, ferric oxide yellow, hydroxyethyl cellulose, hypromellose, iron oxide black, polyethylene oxides, polyethylene glycol, povidone, propylene glycol, sodium chloride, stearic acid, and titanium dioxide.
Serious Warnings and Precautions
Increased Risk of Death in Elderly People with Dementia Medicines like INVEGA® can raise the risk of death in elderly people who have dementia. INVEGA® is not approved for use in patients with dementia.
The 3 mg tablets also contain lactose monohydrate and triacetin.
INVEGA® comes in the following dosage forms:
Tablets: 3 mg, 6 mg, and 9 mg
Do not use INVEGA® if:
you or the patient 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 ingredients in INVEGA®
Signs of an allergic reaction include:
- itching
- skin rash
- swelling of the face, lips or tongue
- shortness of breath
If you experience any of these symptoms or if these symptoms are experienced by the patient you are caring for, contact your doctor right away.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take INVEGA®. 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 risperidone
have a history of:
- stroke
- mini-stroke
- high cholesterol or
- high blood pressure
Medicines like INVEGA® can raise the risk of stroke/mini-stroke in elderly people who have dementia.
- have or are at a 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 planning to breast feed. INVEGA® can pass into your breast milk. You should not breast-feed while taking this medication.
- have had or have prolonged and/or painful erection
have a history of:
- heart problems
- any problems with the way your heart beats
- congenital long QT syndrome
- are being treated for high blood pressure
- are taking any medications that affect how your heart beats
- 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 or have ever had blackouts or seizures
- have or have had low white blood cell counts in your blood. Let your doctor know right away if you develop a fever or infection while being treated with INVEGA®
- have high levels of cholesterol or fats (triglycerides) in your blood
have or 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 a narrowing or blockage of your gastrointestinal tract (your esophagus, stomach, or large or small intestine)
- have diseases associated with diarrhea
- have Parkinson’s disease or Dementia with Lewy Bodies (DLB)
- have / had breast cancer
- have pituitary tumours
drink alcoholic beverages or use drugs
- suffer from lactose intolerance. INVEGA® contains lactose monohydrate
- 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®.
- 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 an operation on the 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®). 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 doctor 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® 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 doctor 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® while you are pregnant or if you are planning on becoming pregnant unless you have talked to your doctor about it.
If you took INVEGA® 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®. Some people experience drowsiness, or blurred vision while taking INVEGA®.
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 doctor may monitor your body weight when you are taking INVEGA®.
Blood tests: Your doctor should do blood tests before you start taking INVEGA®. They will check your blood sugar levels, and for those with certain risk factors, the level of white blood cells in your blood. Your doctor should continue to do blood test as long as you are being treated with INVEGA®.
The following serious or life-threatening side effects have been reported with similar atypical antipsychotics drugs such as INVEGA®:
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 doctor right away if you start to have any of the following symptoms while taking INVEGA®.
Tardive Dyskinesia (TD): INVEGA®, 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® 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 medications you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with INVEGA®:
- DO NOT drink alcohol and only take medications prescribed by your doctor. Since INVEGA® works primarily in the brain, interference with other drugs that also work in the brain could occur.
- Valproate (drugs used to treat seizures, manic-depression and migraines)
- Risperidone or injectable paliperidone palmitate. Taking either of these drugs together with INVEGA® can increase the amount of paliperidone in your body.
- INVEGA® can make you feel sleepy or drowsy. You should be careful when you take this drug with other drugs that can also cause you to become sleepy or drowsy.
- Since INVEGA® can lower blood pressure, care should be taken when this medicine is taken with other drugs that lower your blood pressure.
- Dopamine agonists, such as levodopa (used to treat Parkinson’s disease), may decrease the effect of INVEGA®. Also INVEGA® can affect how drugs used to treat Parkinson’s disease work.
- Carbamazepine (used to treat seizures) has been shown to decrease the levels of INVEGA® in your blood.
- INVEGA® should be used with caution with medicines that increase the activity of the central nervous system (psychostimulants such as methylphenidate).
How to take INVEGA®:
- Do not chew, crush or divide the tablets. Swallow the tablets whole with water or other liquids. The tablet shell does not dissolve completely. You may notice it in your stool. This is normal.
- Take / give INVEGA® exactly as directed by your doctor. It is important that you keep taking / giving it even after the symptoms have improved or disappeared. DO NOT change or stop INVEGA® without talking to your doctor.
Usual adult dose:
The doctor has decided on the best dose for you / the patient you are caring for. The dose will depend on:
- other health conditions you or the patient you are caring for may have
- how you or the patient you are caring for responds to the medication
Usual starting dose: 6 mg once a day (preferably in the morning)
Overdose:
| In case of drug overdose, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms. |
Patients who have taken or 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:
If you miss:
- one dose: take your next dose the following day
- two or more doses: contact your doctor
What are possible side effects from using INVEGA®?
These are not all the possible side effects you may feel when taking INVEGA®. If you experience any side effects not listed here, contact your healthcare professional.
Side effect include:
- headache
- feeling sleepy or less alert
- common cold symptoms
- sinus infection
- difficulty falling or staying asleep
- mania
- irritability
- depression
- anxiety
- faster heart rate, slowed heart rate, heartbeat irregularities
- lack of energy
- feeling restlessness
- feeling dizzy
- stuffy nose
- drop in blood pressure upon standing
- high blood pressure
- stomach ache
- dry mouth
- itching
- increased saliva
- being sick (vomiting)
- diarrhea
- uncontrollable movements of the face, eyes or body
- trembling
- slowness of movement, muscle stiffness or spasm
- weight gain, and increased appetite
- urinary tract infection
- feeling like you have the flu
- weight loss
- anemia
- high blood triglycerides (a fat)
- nightmares
- swelling of legs or other body area, increased liver transaminases in your blood, rash, a restless urge to move parts of your body
- fainting
- sensation the room is spinning
- sensation your heart is racing, variation in heart rate, heart rhythm changes
- decreased blood pressure
- decreased blood flow
- rigid muscles, muscle weakness, and joint swelling.
low blood sugar, diabetes or worsening of diabetes.
- high blood sugar has been reported; see your doctor if you experience symptoms such as excessive thirst or urination
- increased cholesterol
- loss of consciousness
- heartbeat irregularities
- joint stiffness
- vaginal discharge
- lack of bowel muscle movement that causes blockage (may occur very rarely)
- glaucoma (increased pressure within the eyeball), and problems with the movement of your eyes
Since paliperidone (the ingredient in INVEGA®) 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®.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
COMMON New or worsening constipation | ✓ | ||
| Dystonia: twisting movements that you cannot control, and can affect posture or the face, including eyes, mouth, tongue or jaw | ✓ | ||
UNCOMMON Skin rash on its own | ✓ | ||
| Severe allergic reactions: fever, difficulty swallowing or breathing, shortness of breath; drop in blood pressure; feeling sick to your stomach and throwing up; hives or rash; swelling of the face, lips, tongue or throat. | ✓ | ||
| Seizure (fits): loss of consciousness with uncontrollable shaking | ✓ | ||
| Dysphagia: difficulty swallowing that can cause food or liquid to get into your lungs | ✓ | ||
RARE Rhabdomyolysis (breakdown of damaged muscle): muscle tenderness, weakness, red-brown (tea-coloured) urine | ✓ | ||
| Leukopenia / Neutropenia (decreased white blood cells): infections, fatigue, fever, aches, pains, and flu-like symptoms | ✓ | ||
| Tardive Dyskinesia: Muscle twitching or unusual/abnormal movements of the face or tongue or other parts of your body | ✓ | ||
| Strokes and Transient Ischemic Attacks: sudden numbness or weakness of your arm, leg or face, especially if only on one side of the body; sudden confusion, difficulty speaking or understanding others; sudden difficulty in walking or loss of balance or coordination; suddenly feeling dizzy or sudden severe headache with no known cause | ✓ | ||
| Serious allergic reactions: symptoms include rash, swelling of your throat, itching or problems breathing. These may be signs of a serious allergic reaction | ✓ | ||
VERY RARE A state of confusion, reduced consciousness, high fever, or pronounced muscle stiffness | ✓ | ||
| Marked changes in body temperature (generally as a result of several factors together including extreme heat or cold) | ✓ | ||
| Priapism: long-lasting (greater than 4 hours in duration) and painful erection of the penis | ✓ |
| Blood clots: swelling, pain and redness in an arm or leg that can be warm to touch. You may develop sudden chest pain, difficulty breathing and heart palpitations. | ✓ | ||
| Catatonia: unable to move or respond while awake | ✓ | ||
UNKNOWN Pancreatitis (inflammation of the pancreas): severe upper abdominal pain, fever, rapid heartbeat, nausea, vomiting, tenderness when touching the abdomen | ✓ | ||
| Jaundice: yellowing of the skin and eyes, dark urine | ✓ | ||
| Life-threatening complications of uncontrolled diabetes such as shortness of breath, confusion and loss of consciousness | ✓ | ||
| Bruise easily, excessive bleeding | ✓ | ||
| Neuroleptic Malignant Syndrome (NMS): pronounced muscle stiffness or inflexibility with high fever, rapid or irregular heartbeat, sweating, state of confusion or reduced consciousness | ✓ | ||
| Severe skin reactions: 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, yellow skin or eyes, shortness of breath, dry cough, chest pain or discomfort, feeling thirsty, urinating less often, less urine | ✓ |
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
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Store INVEGA®:
- between 15–30oC in its original package.
- Protect from moisture.
Keep out of the sight and reach of children.
The expiry date for INVEGA® is printed on the package. Do not use the medicine after this date.
If you want more information about INVEGA®:
- 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 (www.janssen.com/canada), or by calling Janssen Inc. at: 1-800-567-3331 or 1-800-387-8781.
Toronto, Ontario M3C 1L9
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