Pronunciation: Riss-van
Generic name: risperidone
Dosage form: intramuscular injection
Drug class: Atypical antipsychotics

Medically reviewed by Carmen Pope, BPharm. Last updated on Apr 16, 2024.

What is Risvan?

Risvan (risperidone intramuscular) is an extended-release injectable, atypical, antipsychotic that is given by a healthcare provider once a month and may be used to treat schizophrenia in adults.

Risvan (risperidone) and its active metabolite, 9-hydroxy risperidone (paliperidone) block certain receptors in the brain, such as dopamine Type 2 (D2) and serotonin Type 2 (5HT2), affecting levels of some neurotransmitters, such as dopamine and serotonin, but the exact way they work in schizophrenia is unclear.

Risvan was FDA-approved on 29 March 2024.

What are the side effects of Risvan?

Get emergency medical help if you have signs of an allergic reaction to Risvan such as hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.

Risvan can cause serious side effects, such as Neuroleptic Malignant Syndrome, Tardive Dyskinesia, metabolic changes, reduced blood cell counts, low blood pressure, seizures, prolonged erections, or affect your thinking skills (see Warnings above).

Seek medical attention if you experience any of the following:

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking, or eye movement)
• breast swelling or tenderness (in men or women), nipple discharge, impotence, lack of interest in sex, missed menstrual periods
• severe nervous system reaction - very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out
• low white blood cells - sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, red or swollen gums, trouble swallowing, skin sores, cold or flu symptoms, cough, trouble breathing
• low levels of platelets in your blood - easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin
• high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor or
• an erection that is painful or lasts 4 hours or longer.

Common Risvan side effects affecting 5% or more people include:

• high blood prolactin levels and increased liver enzymes
• restlessness
• headache
• drowsiness, feeling tired
• increased weight
• pain at the injection site.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

Warnings and serious effects

Do not receive Risvan if you are allergic to risperidone, Risvan, paliperidone, or any of the inactive ingredients in the injection. Serious hypersensitivity reactions, including anaphylaxis, have been associated with risperidone.

Risvan should not be used in and had not been approved for, older adults with dementia-related psychosis. Using antipsychotics in this population is associated with an increased risk of death, and cerebrovascular events, such as a stroke or transient ischemic attack.

Risperidone products, such as Risvan have been associated with Neuroleptic Malignant Syndrome, a rare but life-threatening emergency associated with antipsychotics that block dopamine. Seek emergency medical help if you develop a high fever, muscle rigidity, confusion including delirium, an irregular or fast pulse, excessive sweating, or blood pressure changes.

Tardive Dyskinesia is a potentially irreversible, uncontrollable, movement disorder that has been associated with antipsychotics such as Risvan. Elderly women are most at risk. Tell your healthcare provider right away if you develop uncontrollable facial or limb movements, lip-smacking, or rapid blinking.

Risvan may decrease blood cell counts and increase your risk of developing metabolic changes, such as high blood sugar levels, diabetes, high cholesterol, high prolactin levels, reduced bone density, and weight gain. Your healthcare provider will monitor you for these.

May increase the risk of seizures. Tell your healthcare provider if you have a history of seizures.

You may develop low blood pressure while taking Risvan, especially when starting treatment or increasing the dose, which may cause you to feel faint or dizzy when standing. Be careful when going from lying or sitting to standing and keep well hydrated.

Risvan may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase this and other side effects.

Rarely, may cause painful or prolonged penile erections (priapism) and emergency medical attention should be sought.

While you are taking this medicine, you may be more sensitive to temperature extremes such as very hot or cold conditions. Avoid getting too cold, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise.

Risvan is not approved for use in children.

Before taking

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• an allergic reaction to risperidone or other risperidone products, Risvan, paliperidone, or any of the inactive ingredients in the injection
• heart disease, high or low blood pressure, heart rhythm problems, stroke or heart attack
• diabetes (or risk factors such as obesity or a family history of diabetes)
• low white blood cell (WBC) counts
• liver or kidney disease
• seizures
• breast cancer
• low bone mineral density
• trouble swallowing
• painful or prolonged erections
• tardive dyskinesia
• Parkinson's disease or
• if you are dehydrated.

Also tell your doctor if you are pregnant, intending to become pregnant, or breastfeeding.

Pregnancy

Taking antipsychotic medication, such as Risvan during the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles.

However, you may also have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant while taking it, do not stop taking it without your doctor's advice.

If you are pregnant, you or your healthcare provider can list your name on the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or online at http://womensmentalhealth.org/clinical-andresearch-programs/pregnancyregistry/, which will monitor the effects of Risvan on the unborn baby.

Risperidone products, such as Risvan, may temporarily affect a woman’s fertility (ability to have children).

Breastfeeding

Risvan can pass into breast milk and may cause side effects in the baby. If you are breastfeeding while receiving Risvan, tell your doctor if the baby has symptoms such as drowsiness, tremors, involuntary muscle movements, or does not seem to be putting on weight.

How is Risvan administered?

Risvan is administered by an intramuscular (IM) injection into your gluteal (buttock) or deltoid (shoulder) muscle.

• Your healthcare provider should initially give you oral risperidone tablets, to check that you can tolerate risperidone before they give you the long-acting injection.

The usual starting dose is 75mg or 100mg IM once a month. For patients switching from:

• 3 mg of oral risperidone per day, the recommended starting dose is 75 mg IM Risvan one day after the last oral risperidone dose
• 4 mg of oral risperidone per day, the recommended starting dose is 100 mg IM Risvan one day after the last oral risperidone dose.

Doses are given every month.

• It is not recommended to take oral risperidone once you start receiving IM Risvan.

What happens if I miss a dose?

If you miss an appointment for your Risvan dose, ring your healthcare provider right away to make a new appointment.

What happens if I overdose?

An overdose is unlikely because a healthcare provider administers Risvan.

Overdose symptoms may include severe drowsiness, fast heart rate, feeling light-headed, fainting, and restless muscle movements in your eyes, tongue, jaw, or neck. If you develop any of these symptoms seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What to avoid

Avoid driving or hazardous activity until you know how Risvan will affect you. Your reactions could be impaired.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or severe drowsiness can cause falls, fractures, or other injuries.

Avoid drinking alcohol. Dangerous side effects could occur.

Avoid getting too cold, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise.

What other drugs will affect Risvan?

Taking Risvan with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially:

• blood pressure medication
• carbamazepine
• clozapine
• paroxetine (Paxil) or
• levodopa.

Strong CYP2D6 inhibitors such as fluoxetine, bupropion, and duloxetine, may increase risperidone plasma concentrations.

Strong CYP3A4 inducers such as ketoconazole, ritonavir, grapefruit, and diltiazem, may decrease plasma risperidone concentrations.

This list is not complete. Other drugs may interact with Risvan, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Storage

Risvan should be stored at room temperature 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C and 30°C (between 59°F and 86°F) in the unopened original packaging.

Ingredients

Active: risperidone 75mg or 100mg

Inactive: Two-syringe mixing system. The first syringe contains a solvent syringe prefilled with the solvent dimethyl sulfoxide, a transparent and colorless solution. The second syringe is prefilled with risperidone and poly (lactide-coglycolide) acid co-polymer. The powder is white to white-yellowish in color.

Manufacturer

ROVI Pharma Industrial Services.

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Further information

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