175 mg, 263 mg, 350 mg, 525 mg solution for injection, depot suspension
paliperidone
What TREVICTA is and what it is used for
TREVICTA contains the active substance paliperidone, which is an antipsychotic drug and is used as a maintenance treatment for the symptoms of schizophrenia in adult patients.
If you have responded well to treatment with paliperidone palmitate for injection given once a month, your doctor may start treatment with TREVICTA.
Schizophrenia is a disease with “positive” and “negative” symptoms. Positive symptoms mean the presence of symptoms that normally do not occur. For example, a person with schizophrenia may hear voices or see things that are not there (called hallucinations), believe things that are not true (called delusions), or feel unusually suspicious of others. Negative symptoms mean a lack of behaviors or feelings that normally occur. For example, a person with schizophrenia may appear withdrawn, emotionally depleted, and may have difficulty speaking clearly and logically. People with this disorder may also feel depressed, anxious, burdened with guilt, or tense.
TREVICTA can help relieve the symptoms of your disease and prevent your symptoms from coming back.
What you need to know before you use TREVICTA
Do not use TREVICTA
- if you are allergic to paliperidone or any of the other ingredients of this medicine (listed in section 6).
- if you are allergic to any other antipsychotic drug, including the substance risperidone.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using TREVICTA.
This medicine has not been studied in elderly patients with dementia. However, elderly patients with dementia who are treated with other similar types of medicine may have an increased risk of having a stroke or dying (see section 4).
All medicines can cause side effects and some of the side effects caused by this medicine can worsen the symptoms of other medical conditions. It is therefore important that you consult your doctor about any of the following conditions that could worsen during treatment with this medicine:
- if you have Parkinson’s disease
- if you have ever been diagnosed with the neuroleptic malignant syndrome, a condition where symptoms include fever and muscle stiffness
- if you have ever had involuntary jerking movements of the face, tongue, or other parts of the body ( tardive dyskinesia )
- if you know that you have had low levels of white blood cells in the past (this may or may not have been caused by other medicines)
- if you are diabetic or have a predisposition to diabetes
- if you have had breast cancer or a tumor in the pituitary gland of the brain
- if you have heart disease or are being treated for a heart disease that can cause your blood pressure to become low
- if you have low blood pressure when you stand up or sit up quickly
- if you have previously had seizures
- if you have kidney problems
- if you have liver problems
- if you have prolonged and/or painful erections
- if you have disturbances in the regulation of body temperature or have an elevated body temperature
- if you have an abnormally high level of the hormone et prolactin in your blood or if you have a tumor that may be prolactin dependent
- if you or someone in your family has had blood clots, antipsychotic medicines have been associated with the formation of blood clots
If you have any of these conditions, talk to your doctor as he/she may want to adjust your dose or monitor you for some time.
In very rare cases, a dangerously low level of a certain type of white blood cell needed to fight infection in the blood has been seen in patients taking this medicine. Your doctor may check your levels of white blood cells.
Even if you have previously tolerated oral paliperidone or risperidone, allergic reactions may rarely occur after you receive an injection of TREVICTA. Seek immediate medical attention if you develop a rash, swelling of the throat, itching, or breathing problems as these may be signs of a serious allergic reaction.
This medicine may cause weight gain. Significant weight gain can hurt your health. Your doctor should check your body weight regularly.
Your doctor should watch for signs of high blood sugar because diabetes mellitus or worsening of existing diabetes has been seen in patients using this medicine. In patients with existing diabetes, blood sugar should be checked regularly.
Because this medicine can reduce the urge to vomit, there is a risk that it may mask the body’s normal response to toxic substances or other medical conditions.
During cataract surgery, it may happen that pupil one (the black circle in the center of the eye) does not increase in size as much as needed. In addition, you can get reduced muscle tension in the iris (the colored part of the eye) during the operation and this can lead to eye damage. If you have eye surgery planned, you must inform your eye doctor that you are using this medicine.
Children and young people
Do not use this medicine in children and adolescents under 18 years of age. It is not known whether it is safe and effective in these patients.
Other medicines and TREVICTA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Taking this medicine with carbamazepine (used for epilepsy and as a mood stabilizer) may require a change in your dose of this medicine.
As this medicine primarily has an effect on the brain, the use of other medicines that also work in the brain may cause a worsening of side effects such as drowsiness or other effects on the brain, e.g. other medicines to treat mental conditions, opioids, antihistamines, and sleeping pills.
As this medicine can lower blood pressure et, caution should be taken when the medicine is used together with other medicines that lower blood pressure et.
This medicine can reduce the effect of medicines for Parkinson’s disease and leg cramps (eg levodopa ).
This medicine can cause abnormal ECGs in that it takes longer than usual for an electrical impulse to travel to a certain part of the heart (the condition is called ‘QT prolongation). Other drugs that cause such an effect include certain drugs used to treat heart arrhythmias or to treat infections, as well as other antipsychotic drugs.
If you have had seizures in the past, this medicine may increase your risk of having them. Other drugs that cause such an effect include certain drugs used to treat depression or to treat infection, as well as other antipsychotic drugs.
TREVICTA should be used with caution with drugs that increase activity in the central nervous system (psychostimulants, eg methylphenidate).
TREVICTA with alcohol
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. You should not use this medicine during pregnancy unless you have discussed this with your doctor. In newborn babies whose mothers have taken paliperidone during the last trimester (the last three months of pregnancy), the following symptoms may occur: tremors, stiff and weak muscles, sleepiness, agitation, breathing problems, and difficulty eating. If your child develops any of these symptoms, you should contact your doctor.
This medicine can be passed from mother to baby through breast milk, which may be harmful to the baby. You should therefore not breastfeed while using this medicine.
Driving ability and use of machinery
Dizziness, extreme tiredness, and vision problems may occur during treatment with this medicine (see section 4). This must be taken into account in situations where full vigilance is required, e.g. when driving a car or operating machinery.
TREVICTA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is almost “sodium-free”.
How to use TREVICTA
This medicine is given to you by your doctor or other healthcare professional. The doctor will let you know when you need the next injection. You mustn’t miss a scheduled dose. If you cannot come to a scheduled visit with the doctor, you should immediately contact him or her to get a new appointment as soon as possible.
You will receive an injection of TREVICTA in either the upper arm or the buttock once every 3 months.
Depending on your symptoms, the doctor may increase or decrease the amount of medicine you receive when it is time for the next scheduled injection.
Patients with kidney problems
If you have mild kidney problems, your doctor will determine which dose of TREVICTA is appropriate based on the dose of paliperidone palmitate for injection once a month that you have received. If you have moderate or severe kidney problems, this medicine should not be used.
Older
Your doctor will decide your dose of this medicine if you have impaired kidney function.
If you have been given too much TREVICTA
You will be given this medicine by trained healthcare professionals, so it is unlikely that you will be given too much.
Patients who have received too much paliperidone may experience the following symptoms:
drowsiness or sleepiness, fast heartbeat, low blood pressure, abnormal EKG (electrical monitoring of the heart), or slow or abnormal movements of the face, body, arms, or legs.
If you stop using TREVICTA
If you stop taking your injections, your symptoms of schizophrenia may get worse. You should not stop using this medicine unless your doctor tells you to.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you:
- get blood clots, especially in the legs (symptoms are swelling, pain, and redness of the legs), which can travel through the blood vessels to the lungs and cause chest pain and breathing difficulties. If you experience any of these symptoms, seek medical attention immediately.
- have dementia and experience a sudden mental change or sudden weakness or numbness in the face, arms, or legs, especially on one side, or slurred speech, even for a short period. This could be a sign of a stroke.
- experience fever, muscle stiffness, sweating, or reduced level of consciousness (a condition known as ‘neuroleptic malignant syndrome). Immediate medical treatment may be needed.
- are a man and experience persistent or painful erections. This is called priapism. Immediate medical treatment may be required.
- experience involuntary rhythmic movements of the tongue, mouth, and face.
Treatment with paliperidone may need to be discontinued. - suffer from a severe allergic reaction with fever, swelling of the mouth, face, lips, or tongue, shortness of breath, itching, skin rash, and sometimes a drop in blood pressure (a so-called anaphylactic reaction ). Even if you have previously tolerated risperidone taken by mouth or paliperidone took by mouth, allergic reactions may rarely occur after injection of paliperidone.
- have eye surgery planned, you must inform your eye doctor that you are using this medicine. During cataract surgery, it can happen that you get reduced muscle tension in the iris (the colored part of the eye) during the operation (so-called “floppy iris syndrome”) and this can lead to eye damage.
- know that you have dangerously low levels of a certain type of white blood cell that is needed to protect you against infection in the blood.
The following side effects may occur:
Very common (may affect more than 1 in 10 users):
- difficulty falling asleep or staying asleep without interruption.
Common (may affect up to 1 in 10 users):
- cold symptoms, urinary tract infection, flu-like symptoms
- TREVICTA can increase your levels of a hormone called ‘prolactin’ in a blood test (this may or may not cause symptoms). Symptoms of high prolactin levels in men can include swollen breasts, difficulty getting or maintaining an erection, or other sexual dysfunction. In women, symptoms may include breast discomfort, milk leakage, missed periods, or other problems with the menstrual cycle.
- high blood sugar, weight gain, weight loss, decreased appetite
- irritability, depression, anxiety
- restlessness
- parkinsonism: this condition can include decreased or weakened body movements, feeling of tight or stiff muscles (making your movements jerky), and sometimes even a feeling that movement stops and then start again. Other signs of parkinsonism include a slow shuffling gait, tremors at rest, increased saliva production and/or drooling, and a lack of facial expression.
- restlessness, feeling sleepy or less alert
- dystonia: a condition involving slow or sustained involuntary muscle contractions. Dystonia can affect any part of the body (and lead to abnormal posture) but often affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or jaw.
- dizziness
- dyskinesia: this is a condition involving involuntary muscle movements and may include repetitive, spastic, or distorted movements or jerks
- tremors _
- headache
- fast heartbeat
- high blood pressure
- cough, nasal congestion
- abdominal pain, vomiting, nausea, constipation, diarrhea, poor digestion, toothache
- increased liver transaminases in the blood
- bone or muscle pain, back pain, joint pain
- absence of menstruation, milk leakage from the breasts
- fever, weakness, fatigue
- reaction at the injection site, including itching, pain, or swelling.
Uncommon (may affect up to 1 in 100 users):
- pneumonia, trachea ( bronchitis ), respiratory tract infection, sinusitis, cystitis, ear infection, strep throat, nail fungus, skin infection
- decrease in the number of white blood cells, decrease in the type of white blood cells that help protect you against infection, decrease in the number of platelets ( blood cells that stop bleeding), anemia
- allergic reaction
- diabetes or worsening of diabetes, increased amount of insulin (a hormone that regulates blood sugar levels) in the blood
- increased appetite
- loss of appetite leading to malnutrition and low body weight
- high level of triglycerides in the blood (a type of blood fat), increased cholesterol level in the blood
- sleep disturbance, excited mood (mania), decreased sex drive, nervousness, nightmares
- tardive dyskinesia (involuntary twitching movements of the face, tongue, or other parts of the body). Tell your doctor right away if you experience involuntary rhythmic movements of the tongue, mouth, or face. Treatment with this medicine may need to be discontinued.
- fainting, a restless need to move parts of the body, dizziness when standing up, trouble paying attention, trouble speaking, loss of taste or abnormal sense of taste, decreased sensation in the skin to touch and pain, tingling or pricking, or numbness in the skin
- blurred vision, an eye infection or “red eyes”, dry eyes
- the feeling of spinning ( vertigo ), ringing in the ears, ear pain
- disturbance in the conduction of impulses between the upper and lower parts of the heart, abnormal electrical conduction in the heart, prolonged QT interval from the heart, fast heart rate when standing up, slow heart rate, an abnormal electrical signal in the heart ( electrocardiogram or EKG ), a fluttering or pounding feeling in the chest (palpitations)
- low blood pressure, low blood pressure when standing up (as a result, some people taking this medicine may feel weak, dizzy, or faint when they sit or stand up suddenly)
- shortness of breath, blood congestion in the airways, wheezing and wheezing, sore throat, nosebleeds
- abdominal pain, stomach or intestinal infection, difficulty swallowing, dry mouth, greatly increased gas formation
- increased gamma‑GT (a liver enzyme called gamma-glutamyltransferase) in the blood, increased levels of liver enzymes in the blood
- rash ( hives ), itching, rash, hair loss, eczema, dry skin, skin redness, acne
- increase in CK (creatine phosphokinase) in the blood, an enzyme that is sometimes released when muscles are broken down
- muscle spasms, joint stiffness, muscle weakness, neck pain
- urinary incontinence, frequent urges, pain when urinating
- erectile dysfunction, ejaculation disorder, missed periods or other problems with the menstrual cycle (women), breast development in men, sexual dysfunction, breast pain
- swelling of the face, mouth, eyes, or lips, swelling of the body, arms, or legs
- an increase in body temperature
- change in the way of walking
- chest pain, chest discomfort, feeling unwell
- skin calluses
- case.
Rare (may affect up to 1 in 1,000 users):
- eye infection
- skin inflammation caused by mites, accumulation under the skin
- increase in eosinophils (a type of white blood cell ) in the blood
- insufficient secretion of a hormone that regulates urine volume
- sugar in the urine
- life-threatening complications of uncontrolled diabetes
- low blood sugar
- excessive water drinking
- confusion
- immobility and lack of responsiveness when awake (catatonia)
- sleepwalking
- lack of emotions
- inability to orgasm
- neuroleptic malignant syndrome (confusion, decreased or loss of consciousness, high fever, and severe muscle stiffness), problems with blood vessels in the brain, including sudden reduction of blood supply to the brain ( stroke or mini-stroke), lack of response to stimuli, loss of consciousness, low level of consciousness, seizures, balance disorder
- abnormal coordination
- glaucoma (increased pressure inside the eyeball)
- trouble moving the eyes, eye-rolling, hypersensitivity to light, increased tear flow, red eyes
- atrial fibrillation (an abnormal heart rhythm), irregular heart rhythm
- blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the legs). If you experience any of these symptoms, seek medical attention immediately.
- flushing (feeling of heat and redness in the skin)
- difficulty breathing during sleep ( sleep apnea )
- pulmonary stasis
- crackling breathing sounds
- inflammation of the pancreas, swollen tongue, fecal incontinence, very hard stools
- chapped lips
- drug rash, thickening of the skin, dandruff
- joint swelling
- inability to urinate
- breast discomfort, enlargement of the mammary glands, breast enlargement
- vaginal discharge
- very low body temperature, chills, feeling thirsty
- withdrawal symptoms
- accumulation of was caused by infection at the injection site, deep skin infection, a cyst at the injection site, and bruising at the injection site.
Frequency not known (cannot be estimated from available data):
- dangerously low levels of a certain type of white blood cell needed to protect you against infection in the blood
- severe allergic reactions characterized by fever, swollen mouth, face, lip, or tongue, shortness of breath, itching, rash, and sometimes a drop in blood pressure
- dangerously excessive intake of water
- sleep-related eating disorder
- coma resulting from uncontrolled diabetes
- head shaking
- blood clots in the lungs that can cause chest pain and difficulty breathing. If you experience any of these symptoms, seek medical attention immediately.
- rapid, shallow breathing, pneumonia due to inhalation of food, voice disturbance
- reduced oxygen flow to parts of the body (due to reduced blood flow)
- blockage in the bowel, lack of bowel muscle movements causing constipation
- yellowing of the skin and eyes (jaundice)
- serious or life-threatening rash with blisters and peeling skin that may start in and around the mouth, nose, eyes, or genitals and spread to other parts of the body ( Stevens-Johnson syndrome or toxic epidermal necrolysis )
- severe allergic reaction with swelling that may involve the throat and lead to breathing difficulties
- skin discoloration, flaky itchy scalp or skin
- abnormal posture
- newborn babies, whose mothers have taken TREVICTA during pregnancy, may experience side effects from the drug and/or withdrawal symptoms such as irritability, stiff and/or persistent muscle contractions, tremors, sleepiness, breathing problems, and difficulty eating.
- priapism (prolonged erection of the penis which may require surgical treatment)
- lowered body temperature
- dead skin cells at the injection site, and a wound at the injection site.
How to store TREVICTA
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is paliperidone.
Each pre-filled syringe of TREVICTA 175 mg contains 273 mg of paliperidone palmitate.
Each pre-filled syringe of TREVICTA 263 mg contains 410 mg of paliperidone palmitate.
Each pre-filled syringe of TREVICTA 350 mg contains 546 mg of paliperidone palmitate.
Each pre-filled syringe of TREVICTA 525 mg contains 819 mg of paliperidone palmitate.
Other ingredients are:
Polysorbate 20
Polyethylene glycol 4000
Citric acid monohydrate
Sodium dihydrogen phosphate monohydrate
Sodium hydroxide (for pH adjustment)
Appearance and package sizes of the medicine
TREVICTA is a white to off-white solution for injection, depot suspension, in a pre-filled syringe that your doctor or nurse should shake vigorously to resuspend the suspension before it is injected.
Each pack contains 1 pre-filled syringe and 2 needles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Janssen‑Cilag International NV
Turnhoutseweg 30
B‑2340 Beerse
Belgium
Manufacturer
Janssen Pharmaceutica NV
Turnhoutseweg 30
B‑2340 Beerse
Belgium