Perseris (Intramuscular, Subcutaneous)

Risperidone injection is used to treat symptoms of psychotic (mental) disorders, like schizophrenia. Risperdal Consta® can be used alone or with other medicines (like lithium or valproate) to treat patients with bipolar disorder. This medicine should not be used to treat behavioral issues in older adults who have dementia.

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

It is very important for your doctor to check your progress during regular visits to ensure this medicine is working properly. Blood tests may be needed to look for unwanted effects.

This medicine may increase the risk of stroke in elderly patients with dementia. Tell your doctor right away if you experience confusion, difficulty speaking, slow speech, inability to speak, inability to move your arms, legs, or facial muscles, double vision, or headache while using this medicine.

Contact your doctor immediately 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 extreme tiredness. These could be signs of a serious condition called neuroleptic malignant syndrome (NMS).

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

This medicine may increase sugar levels in your blood. Contact your doctor immediately if you have blurred vision, dry mouth, flushed or 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 changes in your urine or blood sugar test results. If you have any questions, talk to your doctor.

Dizziness, lightheadedness, or fainting may occur, especially when you stand up suddenly from lying or sitting. Getting up slowly may help. If this problem continues or worsens, consult your doctor.

Risperidone injection can temporarily decrease the number of white blood cells in your blood, which may increase your chance of getting an infection. If possible, avoid contact with people who have infections. Contact your doctor immediately 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, difficulty thinking, or trouble controlling body movements, which could 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 make it harder for your body to cool down. Be careful not to overheat during exercise or in hot weather, as overheating may lead to heat stroke. Also, take extra care not to get too cold while receiving risperidone injection. If you become 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 taking this medicine.

Talk to your doctor before using this medicine with alcohol or other medications that affect the central nervous system (CNS). Using alcohol or other CNS-affecting medications with risperidone may worsen side effects, such as dizziness, poor concentration, drowsiness, unusual dreams, and sleep issues. Some examples of CNS-affecting medications include antihistamines or medications for allergies or colds, sedatives, tranquilizers, sleeping medications, antidepressants, anti-anxiety medications, prescription pain medications or narcotics, medications for attention deficit and hyperactivity disorder, seizure medications or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

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

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

Do not rub, massage, or place belts or waistbands on the injection site during treatment with Perseris™.

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

In deciding to use a drug, the chances of using the medicine must be weighed against the beneficial it will do. This is a decision you and your clinician will make. For this medication, the following should be considered:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this drug or any other medicines. Also inform 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 risperidone injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Elderly patients may be especially sensitive to the effects of risperidone. This may raise the chance of having side effects during treatment. This medication should not be used for behavioral issues in older adults with dementia.

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

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medicine during breastfeeding. Weigh the potential benefits against the potential risks before taking this medicine 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 clinician may want to change the dose, or other precautions may be necessary. When you are receiving this drug, it is especially essential that your healthcare professional know if you are using any of the drugs listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

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

Using this medicine with any of the following medicines is usually not advised, but may be required in some cases. If both medications are prescribed together, your doctor may change the dose or how frequently you use one or both of the drugs.

• Abiraterone Acetate
• Acecainide
• Adagrasib
• Ajmaline
• Amiodarone
• Amisulpride
• Amitriptyline
• Anagrelide
• Apalutamide
• Apomorphine
• Apomorphine Hydrochloride
• Aprindine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azimilide
• Azithromycin
• Bretylium
• Bromocriptine Mesylate
• Buprenorphine
• Bupropion
• Buserelin
• Carbamazepine
• Ceritinib
• Chloral Hydrate
• Chloroquine
• Chlorpromazine
• Citalopram
• Clarithromycin
• Clofazimine
• Clothiapine
• Clozapine
• Crizotinib
• Dabrafenib
• Darunavir
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Desvenlafaxine
• Deutetrabenazine
• Dexmedetomidine
• Dexmethylphenidate
• Dibenzepin
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Duloxetine
• Efavirenz
• Encainide
• Encorafenib
• Enflurane
• Entrectinib
• Enzalutamide
• Erythromycin
• Escitalopram
• Etrasimod
• Fedratinib
• Fenoldopam Mesylate
• Fexinidazole
• Fingolimod
• Flecainide
• Fluconazole
• Fluoxetine
• Formoterol
• Foscarnet
• Fosphenytoin
• Fostemsavir
• Gemifloxacin
• Gepirone
• Ginkgo Biloba
• Glasdegib
• Gonadorelin
• Goserelin
• Halofantrine
• Haloperidol
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Imipramine
• Inotuzumab Ozogamicin
• Itraconazole
• Ivabradine
• Ivosidenib
• Ketoconazole
• Lefamulin
• Lenvatinib
• Leuprolide
• Levofloxacin
• Linezolid
• Lithium
• Lofexidine
• Lorcainide
• Lumacaftor
• Macimorelin
• Mefloquine
• Methylphenidate
• Metronidazole
• Mirtazapine
• Mitotane
• Mobocertinib
• Moxifloxacin
• Nafarelin
• Nilotinib
• Nortriptyline
• Octreotide
• Olanzapine
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Ozanimod
• Pacritinib
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Phenobarbital
• Phenytoin
• Pimavanserin
• Pitolisant
• Ponesimod
• Posaconazole
• Pramipexole Dihydrochloride
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quizartinib
• Relugolix
• Remifentanil
• Ribociclib
• Rifampin
• Rifapentine
• Ropinirole Hydrochloride
• Rotigotine
• Selpercatinib
• Sematilide
• Serdexmethylphenidate
• Sertindole
• Sertraline
• Sevoflurane
• Simvastatin
• Siponimod
• Solifenacin
• Sotalol
• Spiramycin
• St John's Wort
• Sulfamethoxazole
• Sulpiride
• Sultopride
• Sunitinib
• Tacrolimus
• Tedisamil
• Telithromycin
• Terbinafine
• Tetrabenazine
• Tocilizumab
• Trazodone
• Triclabendazole
• Trifluoperazine
• Trimethoprim
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Zotepine
• Zuclopenthixol

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

• Cimetidine
• Lamotrigine
• Midodrine
• Ranitidine
• Ritonavir
• Valproic Acid

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this drug with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your clinician may change the dose or how frequently you use this drug, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical issues may affect the use of this drug. Make sure you inform your clinician if you have any other medical issues, especially:

• Allergic reaction to paliperidone (Invega®), history of—Should not be used in patients with this condition.

• Alzheimer's disease or
• Dehydration or
• Heart attack, recent or history of or
• Heart or blood vessel disease or
• Heart failure, history of or
• Heart rhythm issue, or a history of or
• Hypotension (low blood pressure) or
• Hypovolemia (low amount of blood) or
• Stroke, history of or
• Trouble with swallowing—May cause adverse effects to become worse.

• Blood or bone marrow problems or
• Bone issues (eg, osteodystrophy) or
• Breast cancer, prolactin-dependent or
• Diabetes 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 (sore or prolonged erection of the penis) or
• Seizures, history of—Use with caution. May make these conditions worse.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased since of slower removal of the medication from the body.

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

• Aggressive behavior
• agitation
• anxiety
• changes in vision, including blurred vision
• difficulty concentrating
• difficulty speaking or swallowing
• inability to move the eyes
• increase in amount of urine
• loss of balance control
• mask-like face
• memory problems
• muscle spasms of the face, neck, and back
• problems with urination
• restlessness or need to keep moving (severe)
• shuffling walk
• skin rash or itching
• stiffness or weakness of the arms or legs
• tic-like or twitching movements
• trembling and shaking of the fingers and hands
• trouble sleeping
• twisting body movements

Less common

• Back pain
• chest pain
• speech or vision problems
• sudden weakness or numbness in the face, arms, or legs

Rare

• Confusion
• dizziness
• drowsiness
• extreme thirst
• fast, shallow breathing
• fast, weak heartbeat
• headache
• increased thirst
• lip smacking or puckering
• loss of appetite
• muscle cramps
• pale, clammy skin
• poor coordination
• prolonged, painful, inappropriate erection of the penis
• puffing of the cheeks
• rapid or worm-like movements of the tongue
• shivering
• talking, feeling, and acting with excitement and activity that cannot be controlled
• uncontrolled chewing movements
• uncontrolled twisting movements of the neck, trunk, arms, or legs
• unusual bleeding or bruising
• unusual facial expressions or body positions

Incidence not known

• Abnormal growth filled with fluid or semisolid material
• accumulation of pus
• black, tarry stools
• bleeding gums
• bloating
• blood in the urine or stools
• bluish lips or skin
• break in the skin, especially associated with blue-black discoloration, swelling, or drainage of fluid
• change in mental status
• chills
• clumsiness
• cold sweats
• collection of blood under the skin
• constipation
• cough
• dark urine
• decrease in the frequency of urination
• decreased awareness or responsiveness
• decreased urine output
• deep, dark purple bruise
• depression
• diarrhea
• dry mouth
• fainting
• fast or irregular heartbeat
• fever
• flushed, dry skin
• fruit-like breath odor
• hives
• hostility
• inability to move the eyes
• increased blinking or spasms of the eyelid
• increased hunger
• indigestion
• irregular heartbeat, recurrent
• irritability
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• loss of consciousness
• low body temperature
• mimicry of speech or movements
• muscle ache, twitching, or weakness
• nausea
• nervousness
• nightmares
• painful urination
• pains in the stomach, side, or abdomen, possibly radiating to the back
• peculiar postures or movements, mannerisms, or grimacing
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid weight gain
• red irritated eyes
• red skin lesions, often with a purple center
• seizures
• severe constipation
• severe sleepiness
• severe vomiting
• shakiness
• small lumps under the skin
• sore throat
• sores on the skin
• sores, ulcers, or white spots in the mouth or on the lips
• sticking out of the tongue
• stomach pain
• swelling of the face, ankles, or hands
• swollen, red, tender area of infection
• tightness in the chest
• trouble breathing
• twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
• unexplained weight loss
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• vomiting
• weak or feeble pulse
• weight gain
• 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

• Heartburn
• increased dream activity
• increased length of sleep
• stuffy or runny nose

Less common

• Absent, missed, or irregular menstrual periods
• bleeding, blistering, burning, discoloration of the skin, infection, inflammation, itching, lumps, numbness, pain, rash, redness, soreness, stinging, swelling, tenderness, tingling, or warmth at the injection site
• body aches or pain
• breast swelling or soreness
• dandruff
• darkening of skin color
• decreased interest in sexual intercourse
• dry skin
• ear congestion
• inability to have or keep an erection
• increase in body movements
• increased watering of the mouth
• joint pain
• loss in sexual ability, desire, drive, or performance
• loss of voice
• oily skin
• pain or tenderness around the eyes and cheekbones
• sneezing
• stopping of menstrual bleeding
• toothache
• unusual breast milk production
• weight loss

Incidence not known

• Acne
• change in taste
• enlargement of the penis or testes
• growth of pubic hair
• loss or thinning of the hair
• loss of taste
• rapid increase in height
• sleepwalking

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.

In the U.S.

• Perseris
• Risperdal Consta
• Rykindo
• Uzedy

Available Dosage Forms:

• Suspension, Extended Release
• Powder for Suspension, Extended Release

Therapeutic Class: Antipsychotic

Chemical Class: Benzisoxazole

A nurse or other trained health professional will give you this medicine. It is given as a shot into one of your muscles or as shot under your skin (in the stomach area or upper arm only).

Perseris™ is given once a month. Risperdal Consta® is usually given every 2 weeks. Uzedy™ is given once a month or once every 2 months.

If you have never taken risperidone, your doctor will first give you an oral form of this medicine before starting treatment with Perseris™, Risperdal Consta®, or Uzedy™.

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.

Be sure to keep all appointments for the injections.

• What is the difference between Perseris and Risperdal Consta?
• What are the strongest sleeping pills?
• What drugs cause tardive dyskinesia?