Okedi: Uses, Side Effects and Dosage

Serious Warnings and Precautions

Increased risk of death in elderly people with dementia.

Medicines like OKEDI can raise the risk of death in elderly people who have dementia. OKEDI is not approved for use in patients with dementia.

What is OKEDI used for?

OKEDI is given by your healthcare professional and is used in adults to treat symptoms of schizophrenia.

Not all people with schizophrenia have the same symptoms.

Some of the most common symptoms of schizophrenia may include:

• hallucinations (seeing, feeling, hearing or smelling things that are not there)
• delusions (believing things that are not true)
• paranoia (not trusting others and feeling very suspicious)
• avoiding family and friends and wanting to be alone

How does OKEDI work?

OKEDI belongs to a group of medicines called antipsychotic drugs. 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 OKEDI corrects the balance of dopamine and serotonin in your body.

What are the ingredients in OKEDI?

Medicinal ingredients: risperidone

Non-medicinal ingredients: poly (D,L-lactide-co-glycolide) acid copolymer (PLGA) with a 50:50 molar ratio of lactide to glycolide. The diluent is dimethyl sulfoxide (DMSO).

OKEDI comes in the following dosage forms:

• OKEDI is provided as a kit which includes two separate syringes. One syringe contains the medicinal ingredient and the delivery system in a powder form. The other syringe contains a

  • liquid that is used to dilute the powder. The contents of the syringes are mixed by a healthcare professional just prior to use.
• OKEDI is available in 75 mg and 100 mg strengths.

Do not use OKEDI if:

• you are allergic to risperidone, paliperidone, or to any other ingredients in OKEDI.

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

• are taking or planning to take any other medication (prescription, over-the-counter and natural health products), including any form of risperidone and paliperidone.
• have had serious allergic reactions to other medications, including oral risperidone or oral paliperidone. Even if you have not had a reaction to oral risperidone or oral paliperidone before, it can occur very rarely after receiving OKEDI injections.

• have a history of:

  • heart problems
  • any problems with the way your heart beats
  • congenital long QT syndrome
• are being treated for high blood pressure (hypertension).
• are taking any medications that affect how your heart beats.
• are prone to low blood pressure (hypotension), have or have had 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.
• have a history of stroke, mini-strokes, high cholesterol or high blood pressure. Medicines like OKEDI can raise the risk of stroke in elderly people who have dementia.
• have Parkinson’s disease or dementia with Lewy bodies (DLB).
• suffer from Alzheimer’s disease.
• have or 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 OKEDI.
• have high levels of cholesterol or fats (triglycerides) in your blood.
• have or are at risk for diabetes or high blood sugar or have a family history of diabetes.
• have or are at risk of aspiration pneumonia (a type of infection in the lungs).
• have or have had breast cancer.
• have pituitary gland tumours.
• have or have ever had blackouts or seizures.
• have or have had a prolonged and/or painful erection.
• exercise strenuously. OKEDI may interfere with your body’s ability to adjust to heat. Avoid becoming overheated or dehydrated (for example with vigorous exercise or exposure to extreme heat) while taking OKEDI.
• are feeling thirsty and unwell.
• have a history of kidney problems.
• have liver problems.
• have a history of suicide attempt.

• drink alcoholic beverages or use drugs.

• have, 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

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

  • a 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)
  • not being able to move due to air travel or other reasons
  • taking oral birth control (“The Pill”)
• are planning to have an operation on the eye(s), such as cataract surgery. Tell your eye doctor you are taking this medicine.

• are pregnant, think you may be pregnant or are planning to become pregnant. You should not use OKEDI during pregnancy, unless your healthcare professional decides the benefits outweigh the potential risks to your baby. If you become pregnant during your treatment with OKEDI, talk to your healthcare professional about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can enroll in this registry by calling 1-866-961-2388. The purpose of this registry is to collect information about the safety of antipsychotic medicines during pregnancy. Information about the registry can also be found at the website: http://womensmentalhealth.org/research/pregnancyregistry/atypicalantipsychotic/.

• are breast-feeding or planning to breast-feed. You should not breast-feed while taking this medication and for at least 12 weeks after the last injection.

Other warnings you should know about:

Elderly Patients with Dementia: Studies have shown that when 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 medicine can be used to treat:

  • swelling of parts of the body caused by the buildup of too much fluid
  • some heart problems
  • high blood pressure

In elderly patients with dementia, oral risperidone and other medicines that belong to the same group of medicines as OKEDI 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.

Driving and using machines: Do not drive or operate machinery until you know how you respond to OKEDI. Some people experience drowsiness, reduced consciousness and dizziness while taking OKEDI.

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

Blood tests: Your healthcare professional should do blood tests before you start taking OKEDI. 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 OKEDI.

Fall: 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 medicines. This can lead to falls that may cause fractures or other fall-related injuries. Certain medications, diseases or conditions can make this worse.

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.

The following serious or life-threatening side effects have been reported with the use of risperidone:

• Neuroleptic Malignant Syndrome (NMS):

  • mental changes such as agitation, hallucinations, confusion, or other changes in mental status
  • coordination problems, uncontrolled muscle spasms, or muscle twitching (overactive reflexes)
  • restlessness
  • racing or fast heartbeat, high or low blood pressure
  • sweating or fever
  • nausea, vomiting, or diarrhea
  • stiff muscles

• 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 symptoms 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 symptoms listed above while taking OKEDI.

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

Increased levels of prolactin: OKEDI 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: You should not take OKEDI while you are pregnant or if you are planning on becoming pregnant unless you have talked to your healthcare professional about it.

If you took OKEDI at any time while you were 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, babies born to a mother who took risperidone while she was pregnant have had to be hospitalized after experiencing symptoms that were severe.

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

The following may interact with OKEDI:

• Other antipsychotic medicines.
• Medicines used to treat depression (e.g., fluoxetine, paroxetine).
• Medicines used to treat heart rhythm problems (e.g., quinidine).
• Medicines used to treat bacterial infections (e.g., rifampin).
• Medicines used to treat fungal infections (e.g., ketoconazole).
• Medicines used to treat seizures (e.g., carbamazepine, phenytoin, phenobarbital).
• Medicines used to treat high or low blood pressure.
• Medicines used to treat Parkinson's disease (e.g., carbidopa, levodopa).
• Medicines that increase the activity of the brain (psychostimulants) (e.g., methylphenidate).
• Certain medicines used to treat HIV/AIDS (e.g., ritonavir).
• Medicines that affect body salts (sodium, potassium, magnesium) such as furosemide (a “water pill”).
• Medicines used to treat allergies.

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

Do NOT drink alcohol and only take medications prescribed by your healthcare professional. Since OKEDI works primarily in the brain, interference with other medicines that also work in the brain could occur.

How OKEDI is given:

OKEDI is a long-acting medicine. It will be given to you once every 4 weeks:

• by your healthcare professional
• as an injection into your muscle (intramuscularly) located on the uppermost part of your arm, or in the upper outer side of your buttocks. OKEDI should not be given by any other route.

If you have never taken any form of risperidone, your healthcare professional may give you oral risperidone before you start your treatment with OKEDI. This is to make sure you can tolerate OKEDI.

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

Usual dose:

• OKEDI may be started at a dose of 75 mg or 100 mg once every 4 weeks.
• To avoid a delayed dose, your healthcare professional may give you your next dose up to 3 days in advance of your 4-week appointment.

Overdose:

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

• reduced consciousness
• sleepiness
• excessive trembling
• excessive muscle stiffness
• fast heartbeat
• irregular heartbeat or other symptoms of an irregular heartbeat, such as light- headedness or fainting
• dizziness or light-headedness when standing up
• convulsions

If you think you, or a person you are caring for, have been given too much OKEDI, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms

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.

What are possible side effects from using OKEDI?

These are not all the possible side effects you may feel during your treatment with OKEDI. If you experience any side effects not listed here, tell your healthcare professional.

Side effects with OKEDI may include:

• weight gain, increased appetite
• nausea
• heartburn, indigestion, stomach ache, vomiting
• drooling
• constipation or diarrhea
• feeling sleepy or trouble sleeping (insomnia), abnormal dreams
• lack of energy, fatigue
• back pain
• headache
• dizziness
• high blood pressure
• restlessness or difficulty staying still
• uncontrollable movements of the face or body, rigid muscles
• forceful muscle contraction of the face, jaw and/or tongue
• depression
• anxiety
• muscle pain or stiffness
• pain, redness or swelling at the injection site
• bronchitis (inflammation of the airways leading up to the lungs)
• common cold symptoms such as runny or stuffy nose, or sore throat
• sinus infection
• slowness of movement
• eye irritation
• mania
• irritability
• trembling
• fast, slow or irregular heartbeat
• drop in blood pressure upon standing
• dry mouth
• itching
• bladder infection

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

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

OKEDI will be stored by your healthcare professional. It should be stored in its unopened original packaging at room temperature (15°C to 30°C).

Keep out of reach and sight of children.

If you want more information about OKEDI:

• 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 (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); or by calling the distributor at 1-800-361-4261.

Imported and distributed by:

Bausch Health, Canada Inc.

Laval, Québec, H7L 4A8

www.bauschhealth.ca

Last Revised: DEC 05, 2025