Ocrevus (ocrelizumab) is a monoclonal antibody used for the treatment of a central nervous system (CNS) disorder called multiple sclerosis (MS).

It's not known exactly how Ocrevus works in people with MS, but it targets and binds to B-cells expressing CD20 on their surface, which results in their destruction via antibody-dependent cellular cytolysis and complement-mediate lysis. B cells are a type of white blood cell that contributes to the development and ongoing disease process involved in MS in a number of ways. The CD20 antigen is mainly found on the surface of B cells, which are also known as B lymphocytes, making it a good target for MS and certain other conditions affecting B cells.

Ocrevus was approved by the US Food and Drug Administration (FDA) in March 2017.

What is Ocrevus used for?

Ocrevus is a prescription medicine used to treat:

• relapsing forms of MS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
• primary progressive MS, in adults.

It is not known if it is safe and effective in children.

Ocrevus can cause serious side effects, including:

• Infusion reactions: Infusion reactions are a common side effect of this medication, which can be serious and may require you to be hospitalized. You will be monitored during your infusion and for at least 1 hour after each infusion for signs and symptoms of an infusion reaction. Tell your healthcare provider or nurse if you get any of these symptoms:
  • itchy skin
  • rash
  • hives
  • tiredness
  • coughing or wheezing
  • trouble breathing
  • throat irritation or pain
  • feeling faint
  • fever
  • redness on your face (flushing)
  • nausea
  • headache
  • swelling of the throat
  • dizziness
  • shortness of breath
  • fatigue
  • fast heart beat
    
    These infusion reactions can happen for up to 24 hours after your infusion. It is important that you call your healthcare provider right away if you get any of the signs or symptoms listed above after each infusion.
    If you get infusion reactions, your healthcare provider may need to stop or slow down the rate of your infusion.
• Infection:
  • Ocrevus increases your risk of getting upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes infections. Infections are a common side effect, which can be serious. Tell your healthcare provider if you have an infection or have any of the following signs of infection including fever, chills, or a cough that does not go away.
    • Signs of herpes infection include:
      • cold sores
      • shingles
      • genital sores
      • skin rash
      • pain
      • itching
    • Signs of a more serious herpes infection include:
      • changes in vision
      • eye redness or eye pain
      • severe or persistent headache
      • stiff neck
      • confusion
        
        Signs of infection can happen during treatment or after you have received your last dose of this medication. Tell your healthcare provider right away if you have an infection. Your healthcare provider should delay your treatment with Ocrevus until your infection is gone.
  • Hepatitis B virus (HBV) reactivation: Before starting treatment with this medication, 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 this medication.
  • Weakened immune system: Ocrevus taken before or after other medicines that weaken the immune system could increase your risk of getting infections.
• Progressive Multifocal Leukoencephalopathy (PML): PML is a rare brain infection that usually leads to death or severe disability, and has been reported with this medication. Symptoms of PML get worse over days to weeks. It is important that you call your healthcare provider right away if you have any new or worsening neurologic signs or symptoms that have lasted several days, including problems with:
  • thinking
  • eyesight
  • strength
  • balance
  • weakness on 1 side of your body
  • using your arms or legs
• Decreased immunoglobulins: Ocrevus may cause a decrease in some types of immunoglobulins. Your healthcare provider will do blood tests to check your blood immunoglobulin levels.

See "What are the possible side effects of Ocrevus?" below for more information about side effects.

• Ocrevus is given through a needle placed in your vein (intravenous (IV) infusion) in your arm.
• Before treatment, your healthcare provider will give you a corticosteroid medicine and an antihistamine to help reduce infusion reactions (make them less frequent and less severe). You may also receive other medicines to help reduce infusion reactions. See "What is the most important information to know about Ocrevus?"
• Your first full dose of Ocrevus will be given as 2 separate infusions, 2 weeks apart. Each infusion will last about 2 hours and 30 minutes.
• Your next doses of this medication will be given as 1 infusion every 6 months. These infusions will last about 2 hours to 3 hours and 30 minutes depending on the infusion rate prescribed by your healthcare provider.

The recommended dose of Ocrevus is:

• Starting dose: 300 mg IV infusion, followed two weeks later by a second 300 mg IV infusion
• Subsequent doses: 600 mg IV infusion every 6 months

See Full Prescribing Information for further details about Ocrevus dosing.

• Do not receive this medication if you have an active hepatitis B virus (HBV) infection.
• Do not receive this medication if you have had a life-threatening allergic reaction to it. Tell your healthcare provider if you have had an allergic reaction to Ocrevus or any of its ingredients in the past. See "What are the ingredients in Ocrevus?" below for a complete list of ingredients.

What should I tell my doctor before receiving Ocrevus?

Before receiving Ocrevus, tell your healthcare provider about all of your medical conditions, including if you:

• have or think you have an infection. See "What is the most important information I should know about Ocrevus?" above
• have ever taken, take, 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 ever had hepatitis B or are a carrier of the hepatitis B virus.
• have a history of inflammatory bowel disease or colitis.
• have had a recent vaccination or are scheduled to receive any vaccinations.
  • You should receive any required 'live' or 'live-attenuated' vaccines at least 4 weeks before you start treatment with Ocrevus. You should also not receive 'live' or 'live-attenuated' vaccines while you are being treated with it and until your healthcare provider tells you that your immune system is no longer weakened.
  • When possible, you should receive any 'non-live' vaccines at least 2 weeks before you start treatment with Ocrevus. If you would like to receive any non-live (inactivated) vaccines, including the seasonal flu vaccine, while you are being treated with this medication, talk to your healthcare provider.
  • If you have a baby and you received Ocrevus during your pregnancy, it is important to tell your baby's healthcare provider about receiving this medication so they can decide when your baby should be vaccinated.

If you miss a dose of Ocrevus, call your healthcare provider and reschedule your appointment to receive your missed dose as soon as possible. Do not wait until your next planned dose. After you receive your missed dose, reschedule your next dose for 6 months after your missed dose. Ocrevus doses must be separated by a minimum of 5 months.

Ocrevus may cause serious side effects, including:

• see "What is the most important information I should know about Ocrevus?" above
• risk of cancers (malignancies) including breast cancer. Follow your healthcare provider's instructions about standard screening guidelines for breast cancer.
• Inflammation of the colon, or colitis: Tell your healthcare provider if you have any symptoms of colitis, such as:
  • Diarrhea (loose stools) or more frequent bowel movements than usual
  • Stools that are black, tarry, sticky or have blood or mucus
  • Severe stomach-area (abdomen) pain or tenderness

These are not all the possible side effects of this medication. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider about other immunosuppressive or immune-modulating drugs that you have taken or are currently taking.