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Invega Sustenna (Intramuscular)

Generic Name: paliperidone (Intramuscular route)

pal-ee-PER-i-done

Intramuscular route(Suspension, Extended Release)

Risk of death is increased in elderly patients with dementia-related psychosis treated with antipsychotic drugs. Paliperidone palmitate is not approved for use in patients with dementia-related psychosis .

Commonly used brand name(s)

In the U.S.

  • Invega Sustenna
  • Invega Trinza

Available Dosage Forms:

  • Suspension, Extended Release

Therapeutic Class: Antipsychotic

Chemical Class: Benzisoxazole

Uses For Invega Sustenna

Paliperidone injection is used to treat the symptoms of psychotic (mental) disorders, including schizophrenia. It may be used alone or in combination 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.

Before Using Invega Sustenna

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of paliperidone injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of paliperidone injection in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving paliperidone injection.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance 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.

  • Amifampridine
  • Amisulpride
  • Bepridil
  • Bromopride
  • Cisapride
  • Dronedarone
  • 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 required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acecainide
  • Ajmaline
  • Alfuzosin
  • Amiodarone
  • Amitriptyline
  • Amoxapine
  • Anagrelide
  • Apomorphine
  • Aripiprazole
  • Aripiprazole Lauroxil
  • Arsenic Trioxide
  • Artemether
  • Asenapine
  • Azimilide
  • Azithromycin
  • Bedaquiline
  • Bretylium
  • Buserelin
  • Chloroquine
  • Chlorpromazine
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clomipramine
  • Clozapine
  • Crizotinib
  • Cyclobenzaprine
  • Dabrafenib
  • Dasatinib
  • Degarelix
  • Delamanid
  • Desipramine
  • Deslorelin
  • Deutetrabenazine
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Donepezil
  • Droperidol
  • Efavirenz
  • Eliglustat
  • Erythromycin
  • Escitalopram
  • Fingolimod
  • Flecainide
  • Fluconazole
  • Fluoxetine
  • Foscarnet
  • Gatifloxacin
  • Gemifloxacin
  • Gonadorelin
  • Goserelin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Histrelin
  • Hydroquinidine
  • Hydroxychloroquine
  • Hydroxyzine
  • Ibutilide
  • Iloperidone
  • Imipramine
  • Ivabradine
  • Ketoconazole
  • Lapatinib
  • Leuprolide
  • Levofloxacin
  • Lopinavir
  • Lumefantrine
  • Mefloquine
  • Methadone
  • Metronidazole
  • Mifepristone
  • Moxifloxacin
  • Nafarelin
  • Nilotinib
  • Norfloxacin
  • Nortriptyline
  • Octreotide
  • Ofloxacin
  • Ondansetron
  • Oxymorphone
  • Panobinostat
  • Pasireotide
  • Pazopanib
  • Pimavanserin
  • Pitolisant
  • Posaconazole
  • Procainamide
  • Prochlorperazine
  • Promethazine
  • Propafenone
  • Protriptyline
  • Quetiapine
  • Quinidine
  • Quinine
  • Ranolazine
  • Remifentanil
  • Ribociclib
  • Salmeterol
  • Sematilide
  • Sevoflurane
  • Simeprevir
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sorafenib
  • Sotalol
  • Sulpiride
  • Sunitinib
  • Tacrolimus
  • Tedisamil
  • Telavancin
  • Telithromycin
  • Tetrabenazine
  • Tizanidine
  • Toremifene
  • Trazodone
  • Trifluoperazine
  • Trimipramine
  • Triptorelin
  • Vandetanib
  • Vardenafil
  • Vemurafenib
  • Vinflunine
  • Voriconazole
  • Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Carbamazepine
  • Paroxetine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Blood or bone marrow problems (eg, leukopenia, neutropenia) or
  • Breast cancer, prolactin-dependent or
  • Diabetes or
  • Dyslipidemia (high cholesterol or fats in the blood) or
  • Hyperglycemia (high blood sugar) or
  • Hyperprolactinemia (high prolactin in the blood) or
  • Neuroleptic malignant syndrome (NMS), history of or
  • Parkinson's disease or
  • Priapism (painful or prolonged erection of the penis) or
  • Seizures, history of—Use with caution. May make these conditions worse.
  • Bradycardia (slow heartbeat) or
  • Heart rhythm problems (eg, arrhythmia, QT prolongation), or history of or
  • Hypokalemia (low potassium in the blood) or
  • Hypomagnesemia (low magnesium in the blood)—Use with caution. May increase risk for more serious side effects.
  • Dehydration or
  • Dementia or
  • Heart attack, recent or history of or
  • Heart failure or
  • Heart or blood vessel disease or
  • Hypotension (low blood pressure) or
  • Hypovolemia (low amount of blood) or
  • Ischemic heart disease, history of or
  • Stroke, history of or
  • Trouble with swallowing—May cause side effects to become worse.
  • Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of paliperidone

This section provides information on the proper use of a number of products that contain paliperidone. It may not be specific to Invega Sustenna. Please read with care.

A nurse or other trained health professional will give you this medicine. This medicine is given as a shot into one of your muscles.

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

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Precautions While Using Invega Sustenna

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

Check with your doctor right away if you have any of the following symptoms while using this medicine: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, 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 any of the following symptoms while using this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

This medicine can cause changes in heart rhythm, such as a condition called 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 affect your blood sugar levels. Check with your doctor right away if you have increased thirst or increased urination. If you notice a change in the results of your urine or blood sugar tests, or if you have any questions, check with your doctor.

This medicine may increase the amount of cholesterol and fats in your blood. If this condition occurs, your doctor may give you some medicines that can lower the amount of cholesterol and fats in the blood.

This medicine may increase 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 an inability to have or keep 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 gets worse, check with your doctor.

Paliperidone injection can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, 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 with thinking, or trouble with controlling body movements, which may lead to falls, fractures or other injuries. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.

This medicine may make it more difficult for your body to cool itself down. Use care not to become overheated during exercise or hot weather since overheating may result in heat stroke. Also, use extra care not to become too cold while you are receiving risperidone injection. If you become too cold, you may feel drowsy, confused, or clumsy.

This medicine may increase your weight. Your doctor may need to check your weight on a regular basis while you are using this medicine. Talk to your doctor about ways to prevent weight gain.

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

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

Invega Sustenna Side Effects

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

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

More common
  • Anxiety
  • bladder pain
  • bloody or cloudy urine
  • body aches or pain
  • chills
  • cough
  • difficult, burning, or painful urination
  • difficulty with breathing
  • difficulty with swallowing
  • dry mouth
  • ear congestion
  • fever
  • frequent urge to urinate
  • headache
  • hyperventilation
  • inability to sit still
  • irregular heartbeats
  • irritability
  • loss of balance control
  • loss of voice
  • lower back or side pain
  • mask-like face
  • need to keep moving
  • nervousness
  • 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

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 aching or cramping
  • muscle pains 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

Other side effects not listed may also occur 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.

Side Effects (complete list)

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