Longavo: Uses, Side Effects and Dosage

Serious warnings and precautions box

What LONGAVO is used for:

• LONGAVO is used to treat schizophrenia in adults.

How LONGAVO works:

LONGAVO belongs to a group of medicines called antipsychotic drugs, which affect the chemicals in the nerve cells (neurotransmitters). Antipsychotic medications affect dopamine and serotonin (chemicals found in the brain) that allow for the communication between your nerve cells. Exactly how this medication works is not known. However, it seems that LONGAVO corrects the balance of dopamine and serotonin in your body.

The ingredients in LONGAVO are:

Medicinal ingredient(s): Risperidone

Non-medicinal ingredients: Diblock mPEG-PDL copolymer, dimethyl sulfoxide, triblock PDL-PEG-PDL copolymer.

LONGAVO comes in the following dosage form(s):

LONGAVO extended release injectable suspension is available in a single-dose prefilled syringe in the following strengths:

• Monthly dosing: 50 mg / 0.14 mL, 75 mg / 0.21 mL, 100 mg /0.28 mL, 125 mg /0.35 mL.

Each strength is provided as a kit which includes: one prefilled single-dose syringe and one 21 gauge, 5/8-inch needle.

Do not use LONGAVO if:

• You are allergic to risperidone, paliperidone or any of the other non-medicinal ingredients in LONGAVO (see What are the ingredients in LONGAVO).

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take LONGAVO Talk about any health conditions or problems you may have, including if you:

• have had serious allergic reactions to other medications, including risperidone or paliperidone;
• have a history of stroke, mini-strokes, or high blood pressure. Medicines like LONGAVO can raise the risk of death in elderly people who have dementia;
• have neuroleptic malignant syndrome (a disorder that causes you to have high fever and stiffness in your muscles);
• have tardive dyskinesia (a disorder that causes you to have uncontrolled and repeated movements of the tongue, face or other body parts);
• have or are at risk for diabetes or high blood sugar or a family history of diabetes;

• are pregnant, think you may be pregnant or planning to become pregnant. If you become pregnant, talk to your healthcare professional right away;

• are breast-feeding or planning to breast-feed;
• have or have had prolonged and/or painful erections;
• have ever had blackouts or seizures;
• have a history of kidney or liver problems;

• have a history of:

  • problems with the heart and/or blood vessels;
  • any problems with the way your heart beats;
• are being treated for high blood pressure;
• are taking any medications that affect how your heart beats;
• have aspiration pneumonia (a type of infection in the lungs);
• are prone to hypotension (low blood pressure), have or have had a heart disease or heart disease treatment that makes you more likely to have low blood pressure or feeling dizzy or faint when you stand up from lying or sitting positions;

• are at risk for developing blood clots. Risk factors include:

  • family history of blood clots
  • being over the age of 65
  • smoking
  • being overweight
  • having a recent major surgery (such as hip or knee replacement);
• have had low white blood cell counts in your blood. Let your healthcare professional know right away if you develop a fever or infection while being treated with LONGAVO.
• have high levels of cholesterol or fats (triglycerides) in your blood;

• have a history of or are at risk of:

  • sleep apnea (a sleep disorder where your breathing is interrupted during sleep)
  • sleep walking
  • sleep-related eating disorder.
• have Parkinson’s disease;
• are taking or planning to take any other medicines (prescription, over-the-counter medicines, or natural health products;

• drink/drinks alcoholic beverages or use/uses drugs;

• have or have had breast cancer;
• have pituitary tumours;
• suffer from Alzheimer’s Disease;
• suffer from Lewy body dementia;
• are feeling thirsty and unwell;
• exercise strenuously. This kind of medication may interfere with your body’s ability to adjust to heat. You should avoid becoming overheated or dehydrated (for example with vigorous exercise or exposure to extreme heat) while taking LONGAVO.
• are planning to have an operation on the eye(s), such as cataract surgery [surgery to treat the cloudiness of the lens in your eye(s)]. Tell your eye healthcare professional you are taking any medicine

Other warnings you should know about:

• Elderly Patients with Dementia: Studies have shown that when TEVA-RISPERIDONE is taken by itself or taken together with furosemide (a “water pill”) by elderly patients who have dementia, it is linked to a higher rate of death.

• Tell your healthcare professional if you are taking furosemide. This drug can be used to treat:

  • swelling of parts of the body caused by the build-up of too much fluid.
  • some heart problems
  • high blood pressure

• In elderly patients with dementia, oral risperidone and other drugs that belong to the same

  group of drugs as TEVA-RISPERIDONE have also been linked to side effects that include:

  • a sudden change in mental state
  • sudden weakness or numbness of the face, arms or legs, especially on one side of the body
  • slurred speech
  • vision problems

If you have any of these symptoms, get medical help right away.

Blood Tests: Monitoring and Tests: Your healthcare professional may want to do blood tests if you are on certain medication to follow your progress. It is important that you do have your blood tested.

Driving and using machines: Do not drive or operate machinery until you know how to respond to LONGAVO. Some people experience drowsiness or blurred vision while taking LONGAVO.

Falls: Feeling sleepy, a fall in blood pressure when you stand up from sitting or lying down, vision and speech problems have been reported with the use of antipsychotic drugs. This can lead to falls that may cause fractures or other fall related injuries. Certain medications, diseases or conditions can make this worse.

Weight gain: Weight gain has been seen in patients who are taking antipsychotic drugs. Your healthcare professional may monitor your body weight when you are taking LONGAVO.

Blood tests: Your healthcare professional should do blood tests before you start taking LONGAVO. They will check your blood sugar levels, and for those with certain risk factors, the level of white blood cells in your blood. Your healthcare professional should continue to check your blood for as long as you are being treated with LONGAVO.

Dysphagia: Tell your healthcare professional if you have difficulty swallowing food or have problems with your food pipe (esophageal dysmotility) as there is a risk of pneumonia caused by inhaling food or liquid that gets into your lungs.

Severe Skin Reactions: in very rare cases, risperidone has been reported to cause skin reactions that can be serious or life-threatening. This includes skin conditions such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS). The following effects may be related to these skin reactions:

• Early warnings for patients:

  • fever
  • severe rash
  • swollen lymph glands
  • flu-like feeling
  • blisters and peeling skin that may start in and around the mouth, nose, eyes, and genitals and spread to other areas of the body

• Later developments:

  • yellow skin or eyes
  • shortness of breath
  • dry cough
  • chest pain or discomfort
  • feeling thirsty
  • urinating less often, less urine

Call your healthcare professional right away if you start to have any of the above symptoms while taking LONGAVO.

Neuroleptic Malignany Syndome (NMS): NMS is a potentially life-threatening reaction that has been reported with the use of antipsychotic drugs. Symptoms of NMS include:

• severe muscle stiffness or inflexibility with high fever,
• rapid or irregular heartbeat,
• sweating,
• state of confusion or reduced consciousness

Call your healthcare professional right away if you start to have any of these symptoms while taking LONGAVO.

Tardive Dyskinesia (TD): like other antipsychotic drugs, LONGAVO may cause potentially irreversible muscle twitching or unusual/abnormal movement of the face or tongue or other parts of your body.

Increased level of prolactin: LONGAVO can raise your levels of a hormone called “prolactin”. This is measured with a blood test. Symptoms may include:

• In men:

  • swelling in the breast
  • difficulty in getting or maintaining an erection or other sexual dysfunction

• In women:

  • discomfort in the breasts
  • leaking of milk from the breasts (even if not pregnant)
  • missing your menstrual period or other problems with your cycle

If you have high levels of prolactin and a condition called hypogonadism you may be at an increased risk of breaking a bone due to osteoporosis. This occurs in both men and women.

Effects on newborns: Do not take LONGAVO while you are pregnant or if you are planning on becoming pregnant unless you have talked to your healthcare professional about it.

If you take LONGAVO at any time while you are pregnant, or if you took it before you became pregnant, the following symptoms may happen in your newborn baby:

• shaking
• stiffness in their muscles and/or weakness
• sleepiness
• agitation
• breathing problems
• difficulty feeding

Get medical help right away if your newborn baby has any of these symptoms. In some cases, the newborn may experience symptoms that are severe and require the newborn to be hospitalized.

It is important for the healthcare professional to have all the above information before prescribing LONGAVO.

This list should be carefully reviewed by you/the caregiver and discussed with the healthcare professional.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may [also] interact with LONGAVO:

• other antipsychotic drugs
• drugs used to treat Parkinson’s disease such as carbidopa and levodopa
• drugs used to treat seizures such as carbamazepine, topiramate, phenytoin and phenobarbital
• drugs used to treat fungal infections such as itraconazole
• antidepressant drugs such as paroxetine and fluoxetine
• drugs used for heart rhythm disorders such as quinidine
• drugs used to treat infections such as rifampin
• drugs used to treat high or low blood pressure
• drugs that affect body salts (sodium, potassium, magnesium) such as furosemide (a “water pill”)
• drugs that increase the activity of the brain (psychostimulants) such as methylphenidate
• certain drugs used to treat HIV/AIDS such as ritonavir (NORVIR®)
• alcohol

Some drugs may increase or decrease the amount of risperidone in your blood. If you take other medicines with LONGAVO, your healthcare professional may need to change your dose.

Only take medications prescribed by your healthcare professional. Since LONGAVO works primarily in the brain, interference with other drugs that also work in the brain could occur.

DO NOT drink alcohol.

How to take LONGAVO:

• LONGAVO is given monthly by subcutaneous injection in the abdomen or upper arm by a healthcare professional. LONGAVO is not to be given by any other route.

Do not rub or massage the injection site after receiving your injection.

Usual dose:

If you have never taken any form of risperidone, your healthcare professional may give you oral risperidone before beginning treatment with LONGAVO.

LONGAVO can be given:

• Monthly: 50 mg /0.14 mL, 75 mg / 0.21 mL, 100 mg / 0.28 mL, 125 mg / 0.35 mL

Overdose:

Patients who have been given too much risperidone may experience the following symptoms:

• reduced consciousness
• sleepiness
• excessive trembling
• excessive muscle stiffness
• fast heart beat
• irregular heartbeat or other symptoms of an irregular heartbeat, such as light-headedness or fainting
• dizziness or light-headedness when standing up
• seizures (fits)

Missed dose:

If you miss an appointment, contact your healthcare professional right away to let them know you missed your injection. Your healthcare professional will advise you when to come next for your scheduled appointment.

Possible side effects from using LONGAVO:

These are not all the possible side effects you may have when taking LONGAVO. If you experience any side effects not listed here, tell your healthcare professional.

Common side effects may include:

• weight gain
• constipation
• feeling sleepy, drowsy
• lack of energy, fatigue
• pain in extremity
• back pain
• hard to fall asleep or stay asleep
• restlessness or difficulty staying still
• anxiety
• muscle pain
• muscle stiffness, spasms, tremors
• slowness of movement
• eye irritation

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting side effects

Storage:

Store LONGAVO in refrigerator at 2°C to 8°C in the original carton to protect from light. Allow LONGAVO kit to come to room temperature at 20°C to 25°C for at least 30 minutes before administration.

LONGAVO may be stored in unopened original packaging at room temperature 20°C to 25°C for up to 90 days. If unopened, LONGAVO may be returned to refrigerated storage within 90 days. Once the carton is opened, use LONGAVO immediately or discard.

Keep out of reach and sight of children.

If you want more information about LONGAVO:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (Drug Product Database: Access the database); the manufacturer’s website ([http://www.tevacanada.com); or by calling 1-800-268-4127 extension 3.

Date of Authorization: 2025-06-18