Perseris: Uses, Side Effects and Dosage

What is PERSERIS used for?

• PERSERIS is used to treat schizophrenia in adults.

How does PERSERIS work?

PERSERIS belongs to a group of medicines called antipsychotic drugs, which affect the chemicals that allow nerve cells to talk to each other (neurotransmitters). These chemicals are called dopamine and serotonin. PERSERIS seems to work by changing the balance of dopamine and serotonin in your body.

What are the ingredients in PERSERIS?

Medicinal ingredients: Risperidone

Non-medicinal ingredients: 80:20 Poly(D,L-lactide-co-glycolide) carboxylic acid end group, and N-methyl-2-pyrrolidone (NMP).

PERSERIS comes in the following dosage forms:

PERSERIS is supplied in two separate syringes. One syringe contains the medicinal ingredient 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.

PERSERIS is available in strengths of 90 mg and 120 mg.

Do not use PERSERIS if:

• You are allergic to risperidone, paliperidone, or any of the nonmedicinal ingredients of PERSERIS (see What are the ingredients in PERSERIS).

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

• 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

Serious Warnings and Precautions

Increased Risk of Death in Elderly people with Dementia: Medicines like PERSERIS can raise the risk of death in elderly people who have dementia.

PERSERIS is not approved for use in patients with dementia.

• before, it can occur very rarely after receiving injections of PERSERIS
• have a history of stroke, mini-strokes, high cholesterol or high blood pressure. Medicines like PERSERIS can raise the risk of stroke in elderly people who have dementia.
• have or are at risk for diabetes or high blood sugar or have 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

• are breast-feeding or planning to breast-feed
• have or have had prolonged and/or painful erection
• have or have ever had blackouts or seizures
• have a history of kidney or liver problems
• have a history of problems with your heart and/or blood vessels
• are being treated for high blood pressure (hypertension)
• 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
• are taking any medications that affect how your heart beats
• have aspiration pneumonia (a type of infection in the lungs)
• have had low white blood cell counts in your blood. Let your doctor know right away if you develop a fever or infection while being treated with PERSERIS

• 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”)
• have Parkinson’s disease
• have Lewy body dementia
• have or have had breast cancer
• have pituitary tumours
• suffer from Alzheimer's disease
• are feeling thirsty and unwell
• exercise strenuously. PERSERIS 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 PERSERIS

• drink alcoholic beverages or use drugs

• are planning to have an operation on the eye(s), such as cataract surgery. Tell your eye doctor you are taking this medicine

Other warnings you should know about:

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

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 doctor may monitor your body weight when you are taking PERSERIS.

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

Dysphagia: Tell your doctor 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 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:

• fever
• severe rash
• swollen lymph glands
• flu-like feeling
• yellow skin or eyes
• shortness of breath
• dry cough
• chest pain or discomfort
• feeling thirsty
• urinating less often, less urine

Neuroleptic Malignant Syndrome (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 doctor right away if you start to have any of these symptoms while taking PERSERIS.

Tardive Dyskinesia (TD): like other antipsychotic drugs, PERSERIS 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: PERSERIS 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 PERSERIS while you are pregnant or if you are planning on becoming pregnant unless you have talked to your doctor about it.

If you take PERSERIS 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 doctor to have all the above information before prescribing PERSERIS. This list should be carefully reviewed by you/the caregiver and discussed with the doctor.

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 PERSERIS:

• 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
• 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®)

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

DO NOT drink alcohol and only take medications prescribed by your doctor. Since PERSERIS works primarily in the brain, interference with other drugs that also work in the brain could occur.

How to take PERSERIS:

PERSERIS is given once a month as an injection by a healthcare professional only, into the subcutaneous tissue of the abdomen or back of the upper arm. PERSERIS is not to be given by any other route.

Do not rub or massage the injection site after receiving your injection. Be aware of the placement of any belts, waistbands, sleeves, cuffs or other parts of clothing.

Usual dose:

If you have never taken any form of risperidone, your doctor may give you oral risperidone before beginning treatment with PERSERIS.

PERSERIS may be started at a dose of 90 mg, or 120 mgonce monthly.

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 doctor right away to let them know you missed your injection. Your doctor will advise you when to come next for your scheduled appointment.

What are possible side effects from using PERSERIS?

These are not all the possible side effects you may feel when taking PERSERIS. If you experience any side effects not listed here, contact your healthcare professional.

Common side effects may include:

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

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

Reporting Side Effects

Storage:

Store in the refrigerator at 2° to 8°C. Allow PERSERIS kit to come to room temperature, 20°C to 25°C, for at least 15 minutes before mixing. PERSERIS may be stored in its unopened original packaging at room temperature, 15°C to 25°C, for up to 7 days before use. After removal from the refrigerator, use PERSERIS within 7 days or discard.

Keep out of reach and sight of children.

If you want more information about PERSERIS:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.perseris.ca, or by calling 1-844-457-8729

10 Carlson Court, Suite 701

Etobicoke, Ontario M9W 6L2

Canada

Last Revised: May 25, 2023

PERSERIS™ is a trademark of Indivior UK Limited. All rights reserved