Paliperidone (Intramuscular)

Paliperidone injection is used to treat symptoms of psychotic (mental) disorders, including schizophrenia. Invega Trinza® and Invega Hafyera™ are used if patients have been treated with Invega Sustenna® for at least 4 months. Invega Hafyera™ is also used if patients have been treated with Invega Trinza® for at least 3 months. Invega Sustenna® can be used alone or with other medicines to treat schizoaffective disorder. This medicine should not be used to treat behavioral problems in older adults who have dementia.

This medicine is to be given only by or under the direct supervision of your doctor.

It is very important for your doctor to check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for any unwanted effects.

This medicine may increase your risk of having a stroke. This is more likely in people who already have heart or blood vessel disease. Check with your doctor right away if you have confusion, difficulty speaking, slow speech, inability to speak or move your arms, legs, or facial muscles, double vision, or headache.

Check with your doctor right away if you have difficulty breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, seizures, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of your arms and legs.

This medicine can cause changes in heart rhythm, including QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Call your doctor right away if you have any symptoms of heart rhythm problems, such as dizziness, feeling faint, or a fast, pounding, or irregular heartbeat.

This medicine may increase the amount of sugar in your blood. Check with your doctor right away if you have blurred vision, dry mouth, flushed, dry skin, increased hunger, increased thirst or urination, nausea, sweating, trouble breathing, unexplained weight loss, unusual tiredness or weakness, or vomiting. If you have diabetes, you may notice a change in your urine or blood sugar test results. If you have any questions, check with your doctor.

This medicine may increase the amount of cholesterol and fats in your blood. If this happens, your doctor may prescribe medicines to lower the cholesterol and fats in your blood.

This medicine may raise prolactin blood levels if used for a long time. Check with your doctor if you have breast swelling or soreness, unusual breast milk production, absent, missed, or irregular menstrual periods, stopping of menstrual bleeding, loss in sexual ability, desire, drive, or performance, decreased interest in sexual intercourse, or difficulty having or keeping an erection.

Dizziness, lightheadedness, or fainting may occur, especially when you suddenly get up from a lying or sitting position. Getting up slowly may help. If this problem continues or worsens, check with your doctor.

Paliperidone injection can temporarily lower your white blood cell count, increasing your chance of getting an infection. If possible, avoid people with infections. Check with your doctor right away if you think you are getting an infection, or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine may cause drowsiness, trouble thinking, or trouble controlling body movements, which may lead to falls, fractures, or other injuries. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine may cause difficulty swallowing, which can lead to food or liquid getting into your lungs, and a prolonged or painful erection that lasts more than 4 hours. Talk to your doctor if you have any concerns about this.

This medicine may make it harder for your body to cool itself down. Be careful not to overheat during exercise or hot weather, as overheating can lead to heat stroke. Also, take extra care not to get too cold while receiving paliperidone injection. If you get too cold, you may feel drowsy, confused, or clumsy.

This medicine may cause weight gain. Your doctor may need to check your weight regularly while you are receiving this medicine. Talk to your doctor about ways to prevent weight gain.

Check with your doctor before using this medicine with alcohol or other medications that affect the central nervous system (CNS). Using alcohol or other medications that affect the CNS with paliperidone may worsen the side effects of this medicine, including dizziness, poor concentration, drowsiness, unusual dreams, and trouble sleeping. Some examples of medications that affect the CNS are antihistamines or medications for allergies or colds, sedatives, tranquilizers, sleeping medications, medications for depression, medications for anxiety, prescription pain medications or narcotics, medications for attention deficit and hyperactivity disorder, medications for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

If you plan to have children, talk with your doctor before using this medicine. Some women using this medicine have become infertile (unable to have children).

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks of the medicine compared to its benefits. Here are some important points to think about:

Allergies

Let your doctor know if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, inform your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how age affects the use of paliperidone injection in children. It is not recommended to use Invega Trinza® or Invega Hafyera™ in this group. Safety and effectiveness have not been established.

Geriatric

Studies have not shown any specific problems in older adults that would limit the use of paliperidone injection. However, older patients are more likely to have age-related kidney issues, which may require caution and a dose adjustment for those receiving paliperidone injection.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits against the possible risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could happen. If you are receiving this medicine, it is crucial that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are important and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bepridil
• Bromopride
• Cisapride
• Dronedarone
• Levoketoconazole
• Mesoridazine
• Metoclopramide
• Pimozide
• Piperaquine
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be needed in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Acecainide
• Adagrasib
• Ajmaline
• Alfuzosin
• Amiodarone
• Amisulpride
• Amitriptyline
• Amoxapine
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Artemether
• Asenapine
• Atazanavir
• Azimilide
• Azithromycin
• Bedaquiline
• Bretylium
• Buprenorphine
• Buserelin
• Carbamazepine
• Ceritinib
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clothiapine
• Clozapine
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexmedetomidine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Droperidol
• Efavirenz
• Encorafenib
• Entrectinib
• Enzalutamide
• Erythromycin
• Escitalopram
• Etrasimod
• Fexinidazole
• Fingolimod
• Flecainide
• Fluconazole
• Fluoxetine
• Formoterol
• Foscarnet
• Fosphenytoin
• Fostemsavir
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Inotuzumab Ozogamicin
• Ivabradine
• Ivosidenib
• Ketoconazole
• Lapatinib
• Lefamulin
• Lenvatinib
• Leuprolide
• Levofloxacin
• Lofexidine
• Lopinavir
• Lumacaftor
• Lumefantrine
• Macimorelin
• Mefloquine
• Methadone
• Metronidazole
• Mifepristone
• Mirtazapine
• Mitotane
• Mobocertinib
• Moxifloxacin
• Nafarelin
• Nilotinib
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxymorphone
• Ozanimod
• Pacritinib
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Phenobarbital
• Phenytoin
• Pimavanserin
• Pitolisant
• Ponesimod
• Posaconazole
• Primidone
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Relugolix
• Remifentanil
• Ribociclib
• Rifampin
• Selpercatinib
• Sematilide
• Sertraline
• Sevoflurane
• Simeprevir
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• St John's Wort
• Sulpiride
• Sunitinib
• Tacrolimus
• Tedisamil
• Telavancin
• Telithromycin
• Tetrabenazine
• Tipranavir
• Toremifene
• Trazodone
• Triclabendazole
• Trifluoperazine
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Zuclopenthixol

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used at or around mealtime, as interactions may occur. Consuming alcohol or tobacco with certain medicines can also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical conditions may affect how you can use this medicine. Be sure to tell your doctor about any other medical issues, especially:

• Blood or bone marrow problems (e.g., leukopenia, neutropenia) or
• Breast cancer that depends on prolactin or
• Diabetes or
• Dyslipidemia (high cholesterol or fats in the blood) or
• Hyperglycemia (high blood sugar) or
• Hyperprolactinemia (high prolactin levels in the blood) or
• Neuroleptic malignant syndrome (NMS), history of or
• Priapism (painful or prolonged erection) or
• Seizures, history of—Use with caution. May worsen these conditions.

• Bradycardia (slow heartbeat) or
• Heart rhythm problems (e.g., arrhythmia, QT prolongation), or history of or
• Hypokalemia (low potassium) or
• Hypomagnesemia (low magnesium)—Use with caution. May increase risk for more serious side effects.

• Dehydration or
• Dementia or
• Recent heart attack or history of or
• Heart failure or
• Heart or blood vessel disease or
• Hypotension (low blood pressure) or
• Hypovolemia (low blood volume) or
• Ischemic heart disease, history of or
• Stroke, history of or
• Difficulty swallowing—Use with caution. May cause side effects to become worse.

• Kidney disease—Invega Hafyera™ is not recommended for patients with this condition.

• Mild kidney disease—Use with caution. The effects may be stronger because the medicine is removed from the body more slowly.

• Moderate to severe kidney disease—Use is not recommended for patients with this condition.

• Lewy body dementia or
• Parkinson's disease—Use with caution. Patients with these conditions may be more sensitive to the effects of this medicine.

Along with its necessary effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do, they may need medical attention.

Check with your doctor or nurse right away if any of the following side effects occur:

More common

• Anxiety
• bladder pain
• bloody or cloudy urine
• body aches or pain
• chills
• cough
• deep or fast breathing with dizziness
• difficult, burning, or painful urination
• difficulty with breathing
• difficulty with swallowing
• dry mouth
• ear congestion
• fever
• frequent urge to urinate
• headache
• inability to sit still
• irregular heartbeat
• irritability
• loss of balance control
• loss of voice
• lower back or side pain
• mask-like face
• need to keep moving
• nervousness
• numbness of the feet, hands, and around the mouth
• restlessness
• runny or stuffy nose
• shaking
• shuffling walk
• slowed movements
• slurred speech
• sneezing
• sore throat
• stiffness of the arms and legs
• tic-like (jerky) movements of the head, face, mouth, and neck
• trembling and shaking of the fingers and hands
• trouble with sleeping
• twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
• unusual tiredness or weakness

Less common

• Blurred vision
• difficulty with speaking
• dizziness
• drooling
• inability to move the eyes
• increase in body movements
• increased blinking or spasms of the eyelid
• loss of balance control
• muscle trembling, jerking, or stiffness
• pounding in the ears
• slow or fast heartbeat
• sticking out of the tongue
• uncontrolled movements, especially of the face, neck, and back
• uncontrolled twisting movements of the neck, trunk, arms, or legs
• unusual facial expressions

Incidence not known

• Change in mental status
• chest tightness
• decrease in the amount and frequency of urination
• difficulty speaking
• hives, itching, skin rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• loss of bladder control
• pale color of the skin
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• seizures
• severe constipation
• severe vomiting
• stomach pain
• swollen tongue
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

Less common

• Back pain
• constipation
• diarrhea
• difficulty with moving
• dry mouth
• increased weight
• lack or loss of strength
• muscle pains, cramps, or stiffness
• nausea
• nightmares
• pain and swelling in the joints
• pain in the arms or legs
• tearing of the skin
• toothache
• upper abdominal or stomach pain
• vomiting

Incidence not known

• Sleepwalking

Other side effects not listed may also happen in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Invega Hafyera
• Invega Sustenna
• Invega Trinza

Available Dosage Forms:

• Suspension, Extended Release

Therapeutic Class: Antipsychotic

Chemical Class: Benzisoxazole

A nurse or other trained health professional will give you this medicine in a medical facility. It is given as a shot into one of your muscles, usually in the arms or buttocks.

This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

When you receive the first dose of Invega Sustenna®, you will need to get a second dose 1 week later. After that, you will only need to get a dose once a month. You will receive Invega Trinza® once every 3 months and Invega Hafyera™ once every 6 months.

• What drugs cause tardive dyskinesia?
• How long does Invega Sustenna take to work?
• Can you drink alcohol while taking Invega Sustenna?
• Invega Sustenna vs Invega Trinza vs Invega Hafyera. What's the difference?
• How to transition to Invega Trinza from Invega Sustenna?
• How do you give an Invega Sustenna injection?
• How to transition to Invega Hayfera from Invega Trinza or Invega Sustenna?
• How is Invega Trinza administered?
• How often is Invega Trinza given?

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