Ocrevus: Uses, Side Effects and Dosage

What OCREVUS is used for:

• OCREVUS is a prescription medicine used to treat adults with active Relapsing Remitting Multiple Sclerosis (RRMS) and Primary Progressive Multiple Sclerosis (PPMS).

• OCREVUS is also used to treat children aged 10 years of age and older with Relapsing Remitting Multiple Sclerosis (RRMS)

• In Multiple Sclerosis (MS), your immune system mistakenly attacks the protective insulation (called ‘myelin’) around your nerves in the central nervous system (brain and spinal cord), causing inflammation.
• When the inflammation causes you to have symptoms, this is often called a “relapse” or “attack”. In Relapsing Remitting MS (RRMS), people will have repeated attacks (relapses) of physical symptoms followed by periods of recovery. Symptoms vary from patient to patient but usually involve physical problems such as difficulty walking, vision and balance problems.
• Symptoms may disappear completely after the relapse is over, but over time, some problems may remain between relapses that can interfere with your daily activities.
• Patients with Primary Progressive MS (PPMS) have symptoms that continuously get worse from the start of the disease. Occasionally relapses occur in PPMS.

What is a Notice of Compliance with Conditions (NOC/c)?

A Notice of Compliance with Conditions (NOC/c) is a type of approval to sell a drug in Canada.

Health Canada only gives an NOC/c to a drug that treats, prevents, or helps identify a serious or life-threatening illness. The drug must show promising proof that it works well, is of high quality, and is reasonably safe. Also, the drug must either respond to a serious medical need in Canada, or be much safer than existing treatments.

Drug makers must agree in writing to clearly state on the label that the drug was given an NOC/c, to complete more testing to make sure the drug works the way it should, to actively monitor the drug’s performance after it has been sold, and to report their findings to Health Canada.

How OCREVUS works:

OCREVUS is a humanized monoclonal antibody. Monoclonal antibodies are proteins which bind to a unique site (called an antigen) on cells. OCREVUS binds to an antigen, called CD20, which is present at high levels on certain cells of your immune system. OCREVUS works on your immune system so that it may not attack your nervous system as much.

The ingredients in OCREVUS are:

Medicinal ingredient(s): ocrelizumab

Non-medicinal ingredients: glacial acetic acid, polysorbate 20, sodium acetate trihydrate, trehalose dihydrate, and water for injection

OCREVUS comes in the following dosage form(s):

Single use vial. Each vial contains 300 mg of ocrelizumab in 10 mL at a concentration of 30 mg/mL. One vial is packaged in each carton.

Do not use OCREVUS if:

• You are allergic to ocrelizumab or any of the other ingredients of this medicine (listed above) or component of the container.
• You have a history of life-threatening infusion reactions to OCREVUS (see Other Warnings you should know about).
• You have severe, active infections (see Other warnings you should know about).
• You have active Hepatitis B virus (HBV) infection (see Other warnings you should know about).
• You have or have had confirmed progressive multifocal leukoencephalopathy (PML) (see Other warnings you should know about).
• You have been told that you have severe problems with your immune system.
• You have cancer.

If you are not sure, talk to your doctor before you are given OCREVUS.

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

• think you have an infection. Your doctor will wait until the infection is resolved before giving you OCREVUS.
• have ever had a type of liver disease called hepatitis B or are a carrier of the hepatitis B virus. This is because medicines similar to OCREVUS can cause the hepatitis B virus to become active again. Before your OCREVUS treatment, your doctor will check if you are at risk of having hepatitis B infection by a blood test. Patients who have had hepatitis B or are carriers of the hepatitis B virus will have a blood test and will be monitored by a doctor for signs of hepatitis B infection. This is because the virus could become active and may result in serious liver problems.
• have ever had an allergic reaction to ocrelizumab or any of the other ingredients in OCREVUS.
• have ever taken, are taking, or plan to take medicines that affect your immune system, or other treatments for MS. These medicines could increase your risk of getting an infection.
• have depression or a history of depression.
• have a history of heart disease, heart attack or stroke.
• have had a recent vaccination or are scheduled to receive any vaccinations. You should receive any required vaccines at least 6 weeks before you start treatment with OCREVUS. You should not receive certain vaccines (called ‘live’ or ‘live attenuated’ vaccines) while you are being treated with OCREVUS and until your healthcare provider tells you that your immune system is no longer weakened.

• are pregnant, think that you might be pregnant, or plan to become pregnant. It is not known if OCREVUS will harm your unborn baby. You should use birth control (contraception) during treatment with OCREVUS and for 6 months after your last infusion of OCREVUS.

• are breastfeeding or plan to breastfeed. OCREVUS can be used during breastfeeding starting a few days after birth. Talk to your healthcare provider about the best way to feed your baby if you take OCREVUS.
• have cancer or if you have had cancer in the past. Your doctor may decide to delay your treatment with OCREVUS.
• have a history of liver problems.

If any of the above apply to you (or you are not sure), talk to your doctor before you are given OCREVUS.

Other warnings you should know about:

Infusion reactions

• Infusion reactions are the most common side effect of OCREVUS treatment and can be serious and require you to be hospitalized.
• Tell your doctor or nurse straight away if you experience any of these signs or symptoms during or after each infusion: itchy skin, trouble breathing, nausea, shortness of breath, rash, throat irritation or pain, headache, fatigue, hives, feeling faint, swelling of the throat, fast heartbeat, tiredness, fever, dizziness, coughing or wheezing, redness on your face (flushing).
• Infusion reactions can happen during the infusion or up to 24 hours after the infusion.
• To reduce the risk of infusion reaction, your doctor or nurse will give you other medicines before each infusion of OCREVUS and you will be closely monitored during the infusion and for at least one hour after the infusion has been given.
• If you get infusion reactions, your doctor or nurse may need to stop or slow down the rate of your infusion.

Infections

• OCREVUS may increase your risk of getting upper respiratory tract infections, lower respiratory tract infections, and herpes infections.
• Tell your doctor or nurse straight away if you have any of these signs of infection during or after OCREVUS treatment: fever and/or chills, cough which does not go away, herpes (such as cold sore, shingles or genital sores). If you have an active infection, your doctor will delay your treatment with OCREVUS until your infection is gone.
• Progressive multifocal leukoencephalopathy (PML): Tell your doctor or nurse straight away if you or your care-giver think your MS is getting worse or if you notice any new symptoms. This is because of a very rare and life-threatening brain infection, called ‘progressive multifocal leukoencephalopathy’ (PML), can cause symptoms similar to those of MS. PML can occur in patients taking OCREVUS. Tell your partner or caregiver about your OCREVUS treatment. They might notice symptoms of PML that you do not, such as memory lapses, troubles thinking, difficulty walking, sight loss, changes in the way you talk, weakness on one side of your body, strength, or using your arms or legs.
• Hepatitis B virus (HBV) reactivation: Before starting treatment with OCREVUS, your healthcare provider will do blood tests to check for hepatitis B viral infection. If you have ever had hepatitis B virus infection, the hepatitis B virus may become active again during or after treatment with OCREVUS. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure or death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop receiving OCREVUS.

Vaccinations

• Tell your doctor or nurse if you have recently been given, or might be given in the near future, any sort of vaccine.
• While you are being treated with OCREVUS, you should not be given some types of vaccine, called ‘live’ or ‘live attenuated’ vaccines (for example BCG for tuberculosis or vaccines against yellow fever).
• Talk to your doctor before you receive any non-live (inactivated) vaccines, including the seasonal flu vaccine. While you are being treated with OCREVUS, responses to non-live vaccines may be decreased. However, the impact on the effectiveness of the vaccine is not known.
• Your doctor will check if you need any vaccinations before you start treatment with OCREVUS. Any vaccinations should be given at least 6 weeks before you start treatment with OCREVUS.
• If you were pregnant while taking OCREVUS, talk to your doctor before vaccinating your newborn.

Weakened immune system

OCREVUS taken before or after other medicines that weaken the immune system could increase your risk of getting infections. If you have another disease which affects the immune system, you may not be able to receive OCREVUS.

Decreased immunoglobulins

OCREVUS may cause a decrease in some types of immunoglobulins (proteins in your blood that help your immune system fight infection). Your healthcare provider will do blood tests to check your blood immunoglobulin levels.

Depression and suicide

If you develop depression, depressed mood, or suicidal thoughts, contact your doctor right away. Symptoms could include, irritability (getting upset easily), depression (feeling unusually sad, feeling hopeless or bad about yourself), nervousness, anxiety, sleeping a lot more or a lot less than usual, feel tired or sleepy all the time, or thoughts of hurting yourself or suicide.

Others

Heart diseases and serious skin reactions can occur in patients taking other medicines like OCREVUS. Contact your doctor if you develop a wide-spread redness or blistering of the skin and the inside of the mouth.

Children and adolescents

The safety and efficacy of OCREVUS have been established in children 10 years of age and older with RRMS.

The safety and efficacy of OCREVUS in children under 10 years of age have not been studied. Therefore, Health Canada has not authorized an indication for children under 10 years old.

Pregnancy

• Tell your doctor or nurse before being given OCREVUS if you are pregnant, think that you might be pregnant or are planning to have a baby. This is because OCREVUS may cross the placenta and affect your baby.
• Do not use OCREVUS if you are pregnant unless you have discussed this with your doctor. Your doctor will consider the benefit of you taking OCREVUS against the risk to your baby.

Contraception for females

If you are able to become pregnant (conceive), you must use contraception:

• during treatment with OCREVUS and
• for 6 months after your last infusion of OCREVUS.

Breastfeeding

OCREVUS can be used during breastfeeding starting a few days after birth.

Driving and using machines

It is not known whether OCREVUS can affect you being able to drive or use any tools or machines. Your doctor will tell you whether your MS may affect your ability to drive or use tools and machines safely.

Risk of cancers (malignancies) including breast cancer

An increased risk of malignancy, including breast cancer, may exist with OCREVUS. Follow your doctor’s instructions about standard screening guidelines for breast cancer. Your doctor will monitor you if you have known risk factors for malignancies and/are being actively monitored for the recurrence of a malignancy and may consider delaying treatment with OCREVUS.

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 OCREVUS:

Tell your doctor if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor if:

• you have ever taken, are taking or are planning to take medicines which affect your immune system - such as chemotherapy, immuno-suppressants or other treatments for MS. These medicines could affect your ability to fight infections in combination with OCREVUS.
• you are taking medicines for high blood pressure. This is because some people have a decrease in their blood pressure while being given OCREVUS. Your doctor may ask you to stop taking these medicines for 12 hours before each OCREVUS infusion.
• you have recently been given, or might be given in the near future, any sort of vaccine.

If any of the above apply to you (or you are not sure), talk to your doctor before you are given OCREVUS.

How to take OCREVUS:

Medicines you will receive before you are given OCREVUS

Before you are given OCREVUS, you will receive other medicines to prevent or reduce possible side effects, such as infusion reactions.

You will receive corticosteroids before each infusion and antihistamines and you may also receive medicines to reduce fever.

How OCREVUS is given

• OCREVUS will be given to you by a doctor or a nurse. It will be given as an infusion into a vein (called an intra-venous infusion or ‘IV’ infusion).
• You will be closely monitored while you are being given OCREVUS and for at least 1 hour after the infusion has been given. This is in case you experience any side effects such as infusion reactions. The infusion may be slowed, temporarily stopped or permanently stopped if you have an infusion reaction, depending on how serious it is (see Other warnings you should know about and Possible side effects from using OCREVUS for information about infusion reactions).

Usual dose:

Adults:

You will be given a total dose of 600 mg of OCREVUS every 6 months.

• The first dose of OCREVUS will be a 300 mg infusion, followed 2 weeks later by a second 300 mg infusion. Each infusion will last about 2 hours and 30 minutes or longer.
• The following doses of OCREVUS will be given as one single 600 mg infusion. Each infusion will either last about 3 hours and 30 minutes or about 2 hours depending on the infusion rate prescribed by your healthcare professional.

Children (aged 10 years of age and older):

You will be given OCREVUS based on your body weight:

If you weigh between 25 and 35 kg:

• The first dose of OCREVUS will be a 150 mg infusion, followed 2 weeks later by a second 150 mg infusion. Each infusion will last about 2 hours and 30 minutes.
• The following doses of OCREVUS will be given as one single dose of 300 mg infusion every 6 months. Each infusion will last about 2 hours and 30 minutes.

If you weigh 35 kg or more:

• The first dose of OCREVUS will be a 300 mg infusion, followed 2 weeks later by a second 300 mg infusion. Each infusion will last about 2 hours and 30 minutes.
• The following doses of OCREVUS will be given as one single dose of 600 mg infusion every 6 months. Each infusion will last about 3 hours and 30 minutes.

Overdose:

Missed dose:

• If you miss an infusion of OCREVUS, talk to your doctor to arrange to have it as soon as possible. Do not wait until your next planned infusion.
• To get the full benefit of OCREVUS, it is important that you receive each infusion when it is due.

Possible side effects from using OCREVUS:

Like all medicines, OCREVUS can cause side effects, although not everybody gets them.

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

Most side effects are mild to moderate but some may be serious. The following side effects have been reported with OCREVUS:

Infusion reactions

• Infusion reactions are the most common side effect of OCREVUS treatment. In most cases, they were mild reactions but some serious reactions can happen.
• Tell your doctor or nurse right away if you experience any signs or symptoms of an infusion reaction during the infusion or up to 24 hours after the infusion.

• To reduce the risk of infusion reactions, your doctor or nurse will give you other medicines before

  • each infusion of OCREVUS. Your doctor or nurse will also monitor you during the infusion and for at least one hour after the infusion has been given.

Immune

• Inflammation of the large bowel (colitis): Tell your healthcare professional if you have any symptoms of colitis, such as:

  • diarrhea (loose stools) or more frequent bowel movements than usual
  • stools that have blood or mucus
  • stomach-area (abdomen) pain.

Liver Damage

• OCREVUS may cause liver damage. Your healthcare provider will do blood tests to check your liver before you start OCREVUS and while you take OCREVUS if needed. Tell your healthcare provider right away if you have any symptoms of liver damage, such as:

  • yellowing of the skin and eyes (jaundice)
  • nausea
  • vomiting
  • unusual darkening of the urine
  • feeling tired or weak.

Infections

• You might get infections more easily with OCREVUS. These infections are usually mild infections but serious infections can happen.
• Tell your doctor or nurse straight away if you have any of these signs of infection during or after OCREVUS treatment.

• Signs of serious herpes infection include:

  • changes in vision
  • severe or persistent headache
  • confusion
  • eye redness or eye pain
  • stiff neck.

• The following infections have been seen in patients treated with OCREVUS in MS.

  Very common: may affect more than 1 in 10 people

  • upper respiratory tract infection
  • common cold
  • flu.

Common: may affect up to 1 in 10 people

• sinus infection
• bronchitis (bronchial tube inflammation)
• infection of the stomach and bowel (gastroenteritis)
• respiratory tract infection
• viral infection
• herpes infection (cold sore or shingles)
• red and inflamed eye (conjunctivitis)
• skin infection (cellulitis).

Uncommon: may affect up to 1 in 100 people

• genital sores.

• Other side effects

  Common: may affect up to 1 in 10 people

• problems sleeping
• cough
• a build-up of thick mucus in the nose, throat or chest.

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:

OCREVUS will be stored by the healthcare professionals at the hospital or clinic under the following conditions:

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the outer carton and the vial label after ‘EXP’. The expiry date refers to the last day of that month.
• Store in a refrigerator (2° - 8°C). Do not freeze. Keep the vials in the outer carton in order to protect from light.

OCREVUS must be diluted before it is given to you. Dilution will be done by a healthcare professional. It is recommended that the product is used immediately after dilution. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the healthcare professional and would normally not be longer than 24 hours at 2° - 8°C and 8 hours at room temperature.

Do not throw away any medicines via wastewater. This measure will help protect the environment.

If you want more information about OCREVUS:

• 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 (www.rochecanada.com); or by calling 1-888-762-4388.

Date of Authorization: 2026-10-23

OCREVUS^® Registered trademark of F. Hoffmann-La Roche AG, used under license

All other trademarks are the property of their respective owners.

Hoffmann-La Roche Limited

Mississauga, ON L5N 5M8