Ocrevus

Brand Name

Ocrevus

Common Name

ocrelizumab

In this drug factsheet:

• How does this medication work? What will it do for me?
• How should I use this medication?
• What form(s) does this medication come in?
• Who should NOT take this medication?
• What side effects are possible with this medication?
• Are there any other precautions or warnings for this medication?
• What other drugs could interact with this medication?

How does this medication work? What will it do for me?

Ocrelizumab belongs to the class of medications called selective immunomodulators. It is used to treat adults with active relapsing-remitting multiple sclerosis (RRMS).

Ocrelizumab has been granted a notice of compliance with conditions (NOC/c) by Health Canada for the treatment of early primary progressive multiple sclerosis (PPMS). This means that Health Canada has approved this medication to be marketed based on promising evidence of effectiveness, but additional results of studies are needed to verify its effectiveness. An NOC/c is used to allow access to products that are used to treat or prevent serious, life-threatening, or severely debilitating illness.

Multiple sclerosis (MS) is a disease that affects the nervous system. It is believed that MS is an autoimmune disease (a condition in which an individual's immune system starts reacting against his or her own tissues) and cannot be spread from person to person. For unknown reasons, the immune system sees the myelin sheath (a protective layer covering the nerves) as foreign and attacks it.

Ocrelizumab appears to affect the immune system by reducing the activity of the immune system attacking the myelin sheath and slowing down damage to the nerves.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

The first 2 treatments of ocrelizumab are given as 300 mg intravenous infusions (into the vein) 2 weeks apart. These doses are given over approximately 2½ hours.

After the first 2 doses, ocrelizumab is given as 600 mg intravenous infusions every 6 months.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important this medication be given exactly as recommended by your doctor. If you miss an appointment to receive ocrelizumab, contact your doctor as soon as possible to reschedule your appointment.

Unused vials should be stored in the fridge and diluted vials should be kept for no longer than 24 hours in the fridge or 8 hours at room temperature. This medication should be protected from light and moisture, and kept out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

Each 15 mL vial contains 10 mL of ocrelizumab 30 mg/mL for IV infusion. Nonmedicinal ingredients: sodium acetate trihydrate, α,α-trehalose dehydrate, polysorbate 20, glacial acetic acid, and water for injection.

Who should NOT take this medication?

Do not take this medication if you:

• are allergic to ocrelizumab or any ingredients of the medication
• have a history of life-threatening infusion reaction to ocrelizumab
• have active hepatitis B infection
• currently have any severe infection
• have a history of progressive multifocal leukoencephalopathy (PML)
• have a severely weakened immune system
• have active cancer

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• cold sores
• diarrhea
• flu-like symptoms (sudden lack of energy, fever, cough, sore throat)
• runny nose
• sinus infections (headache, facial pain, nasal congestion)
• trouble sleeping

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• abdominal pain
• blood or mucus in the stool
• buildup of mucus in the nose, throat, or chest
• genital sores
• red and inflamed eye
• shingles
• skin infection
• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
• symptoms of hepatitis B (e.g., fever, feeling ill, loss of appetite, joint or muscle pain, abdominal pain, yellowing skin and eyes)
• vision changes

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of heart problems (e.g., chest pain; fast, pounding, or uneven heartbeat)
• signs of an infusion reaction (e.g., itchy skin, rash, flushing, decreased blood pressure, shortness of breath, headache, nausea)
• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• signs of a serious skin reaction (such as skin rash; red skin; blistering of the lips, eyes, or mouth; skin peeling; fever; or joint pain)
• symptoms of progressive multifocal leukoencephalopathy (e.g., seizures, vision loss, trouble thinking clearly, difficulty walking)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Cancer: Ocrelizumab may increase the risk of cancer, including breast cancer for women. Discuss any concerns you may have with your doctor.

Depression: People with MS may be more likely to develop symptoms of depression. If you have depression or have had it in the past, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or thoughts of self-harm, or notice them in a family member who is taking this medication, contact your doctor as soon as possible.

Gastrointestinal inflammation: This medication, like other selective immunomodulators, has been linked to inflammation in the digestive tract. This often occurs between 6 and 12 weeks of treatment. Symptoms include lower abdominal pain and cramping, rectal bleeding, urgency with bowel movements, weight loss and blood in the stools. If you experience symptoms of gastrointestinal inflammation, speak to your doctor as soon as possible.

Hepatitis B reactivation: People who have hepatitis B infection that is dormant may experience the infection returning, causing further liver dysfunction or liver failure. If you have a history of hepatitis B infection, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this mediation, and whether any special monitoring is needed.

If you experience symptoms of worsening liver function, such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Hypersensitivity reactions: A severe allergic reaction called hypersensitivity syndrome has occurred for some people with the use of ocrelizumab. This reaction involves a number of organs in the body and may be fatal if not treated quickly. Get immediate medical attention if you have symptoms of a severe allergic reaction, including fever, swollen glands, yellowing of the skin or eyes, or flu-like symptoms with skin rash or blistering.

Infusion reactions: This medication can cause a hypersensitivity or infusion reaction. Symptoms of this type of reaction generally appear during the infusion of the medication and may include flushing, chest pain, shortness of breath, and a dramatic drop in blood pressure. These reactions can cause death if a health care provider is not informed immediately. If you experience any of these symptoms, or notice them happening to someone, let your nurse or doctor know immediately. You may be given medications before receiving your dose of ocrelizumab to reduce the risk of an infusion reaction. Your doctor will probably have you remain at the clinic or hospital for an hour after your infusion to ensure that any infusion reaction can be quickly treated.

Progressive multifocal leukoencephalopathy (PML): There have been reports of PML after using ocrelizumab. PML is a rare disorder that causes nerve damage in the brain. If you experience memory loss, vision loss, trouble thinking, or difficulty walking, contact your doctor immediately.

Serious infections: Ocrelizumab can affect the way your body's natural defences work to fight infection. This makes the body more likely to develop infections due to bacteria, viruses, and fungi. This effect is increased if you are taking ocrelizumab with other medications that reduce the body's ability to fight infection. For some people, these infections have been fatal. If you have a history of chronic or frequent infections, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Contact your doctor right away if you notice symptoms of a serious infection, such as fever, chills, headache, flu-like symptoms, feeling tired, cough, blood in the sputum, shortness of breath, night sweats, weight loss, nausea, vomiting, diarrhea, frequency or burning while passing urine, redness or swelling of skin or joint, cold sores, tooth pain, or new or worsening pain in any part of the body.

Vaccinations: It is not known how effective vaccines may be after treatment with this medication. Certain immunizations may be dangerous if given while receiving or shortly after receiving a treatment course of ocrelizumab. Before starting treatment with this medication, check with your doctor to ensure your immunizations are up to date. You should have your vaccinations completed at least 6 weeks before starting treatment with ocrelizumab.

Pregnancy: This medication crosses the placenta and it is not known whether use of this medication during pregnancy will affect the developing baby. Ocrelizumab should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

People who may become pregnant should use effective birth control when receiving ocrelizumab and for at least 6 months after the course of treatment.

Breast-feeding: It is not known if ocrelizumab passes into breast milk. If you are breast-feeding and taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

What other drugs could interact with this medication?

For a full list of interactions, use the Drug Interaction Checker available on the Drugs.com website.

If you are taking other medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Ocrevus