Pronunciation:

ris-PER-i-done

Brand Names:

• Perseris
• Risperdal Consta
• Rykindo
• Uzedy

Dosage Forms:

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

Warnings:

Warning: Increased Mortality in Elderly Patients with Dementia-Related PsychosisElderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. RisperiDONE is not approved for the treatment of patients with dementia-related psychosis and has not been studied in this population .

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. RisperiDONE is not approved for use in patients with dementia-related psychosis .

Classifications:

Therapeutic—

Antipsychotic

Chemical—

Benzisoxazole

Uses of This Medicine:

Risperidone injection is used to treat the symptoms of psychotic (mental) disorders, including schizophrenia. Risperdal Consta® may be used alone or together with other medicines (eg, lithium or valproate) to treat patients with bipolar 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 This Medicine:

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.

Children—

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.

Older adults—

Elderly patients may be especially sensitive to the effects of risperidone. This may increase the chance of having side effects during treatment. This medicine should not be used for behavioral problems 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 problems, 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 medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other 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.

• 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 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.

• 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
• 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 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.

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

Other interactions—

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

• Ethanol

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:

• 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 problem, 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 side effects to become worse.

• Blood or bone marrow problems or
• Bone problems (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 (painful 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 because of slower removal of the medicine from the body.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

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

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

Check with your doctor right away if you have difficulty with breathing, fast heartbeat, 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 the arms and legs.

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 increased urination, nausea, sweating, trouble breathing, unexplained weight loss, unusual tiredness or weakness, or vomiting. If you have diabetes, you may notice a change in the results of your urine or blood sugar tests. If you have any questions, check with your doctor.

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

Risperidone 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 immediately if you think you are getting an infection or if you get 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. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

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 receiving this medicine.

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.

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.

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

Avoid rubbing, massaging, or placing belts or waistbands on the injection site during treatment with Perseris™.

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.

Side Effects of This Medicine:

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.