Uses

Ocrelizumab is used to treat certain forms of multiple sclerosis-MS (relapsing or primary progressive forms). It is not a cure for MS, but it is thought to help slow down nerve damage, reduce the number of relapses, and delay disability. Ocrelizumab belongs to a class of drugs known as monoclonal antibodies.

How To Use

Read the Medication Guide provided by your pharmacist before you start using ocrelizumab and each time you get an infusion. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection into a vein by a health care professional. It is given as directed by your doctor on a treatment schedule. The first 2 infusions are usually given 2 weeks apart. After that, an infusion is usually given once every 6 months. Follow your doctor's treatment schedule.

Ocrelizumab may cause very serious (rarely fatal) side effects called infusion reactions during or up to 24 hours after treatment. Your doctor or nurse will monitor you closely during your infusion and for at least 1 hour afterward. Your infusion may be slowed down or stopped depending on your symptoms. Tell your doctor or nurse right away if any of these side effects occur: rash, itching, trouble breathing, throat swelling/pain, tiredness, fever, fainting, flushing of the face, nausea, headache, dizziness, fast heartbeat. You should not receive ocrelizumab again if you had a life-threatening infusion reaction.

You may also be given additional medications before each treatment, including a corticosteroid (such as methylprednisolone), an antihistamine (such as diphenhydramine), and acetaminophen to help reduce the severity of an infusion reaction.

Side Effects

See also How to Use section.

Cold symptoms such as stuffy/runny nose or cough may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• severe diarrhea
• stomach/abdominal pain
• black/bloody stools

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infections (such as sore throat or cough that doesn't go away, fever, chills, herpes cold sores or genital sores, shingles).

Before treatment with this medication, your doctor will do blood tests to check for hepatitis B infection. If you have ever had hepatitis B, ocrelizumab may cause it to become active again and it could cause serious liver problems. Ask your doctor for more details.

This medication may rarely increase your risk of developing cancer, including breast cancer. Tell your doctor right away if you have symptoms such as unusual growths, a lump in the breast, nipple discharge. Ask your doctor for more details.

This medication may increase your risk of getting a rare but very serious (possibly fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Get medical help right away if you have any of these new or worsening side effects:

• clumsiness
• loss of coordination/balance
• weakness
• sudden change in your thinking (such as confusion, difficulty concentrating, memory loss)
• difficulty talking/walking
• seizure
• vision changes

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using ocrelizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• current/past/returning infections (including hepatitis B, herpes, tuberculosis)

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Ocrelizumab can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using ocrelizumab before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using ocrelizumab due to the risk of harm to an unborn baby. Discuss the use of reliable forms of birth control while using this medication and for 6 months after stopping treatment. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab)

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Lab and/or medical tests (such as blood tests to check for hepatitis B infection, breast cancer screening, immunoglobulin levels) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Not applicable. This medication is given in an infusion center and will not be stored at home.

Medical Alert

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).