Infusion reactions are a common side effect of OCREVUS, 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 of OCREVUS 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.

OCREVUS can cause serious side effects including 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 include cold sores, shingles, genital sores, skin rash, pain, and itching. Signs of more serious herpes infection include: changes in vision, eye redness or eye pain, severe or persistent headache, stiff neck, and confusion. Signs of infection can happen during treatment or after you have received your last dose of OCREVUS. 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 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.
  
• Weakened immune system: OCREVUS taken before or after other medicines that weaken the immune system could increase your risk of getting infections.
  
• OCREVUS and COVID-19: As COVID-19 is caused by a new strain of coronavirus called SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), knowledge about how it may affect people with MS and those treated with OCREVUS is not currently available. Please speak with your doctor or healthcare team before stopping or delaying treatment. Please click here to review the latest updates.

See below for risk information about Progressive Multifocal Leukoencephalopathy (PML).

Progressive Multifocal Leukoencephalopathy (PML): PML is a rare brain infection that usually leads to death or severe disability, and has been reported with OCREVUS. 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  

• Do not receive OCREVUS if you have an active hepatitis B virus (HBV) infection.
• Do not receive OCREVUS if you have had a life-threatening allergic reaction to OCREVUS. Tell your healthcare provider if you have had an allergic reaction to OCREVUS or any of its ingredients in the past.

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.

Another possible serious side effect of OCREVUS is an increased risk of cancers (malignancies), including breast cancer.

Breast cancer in clinical trials for OCREVUS

In 3 main clinical trials, 6* out of 781 females (<1%) were diagnosed with breast cancer. There were no cases of breast cancer reported in the trial period for patients taking REBIF or placebo.

*2 relapsing MS and 4 PPMS patients.

The FDA recommends that patients taking OCREVUS should follow standard breast cancer screening guidelines.

What you can do

• Talk to your healthcare provider about the risk of breast cancer with OCREVUS and the risks and benefits of screening
• For example, the American Cancer Society recommends:
  
  • Age 40-44 – Annual mammogram if you and your healthcare provider feel it’s appropriate
    
  • Age 45-54 – Annual mammogram recommended
    
  • Age 55+ – Mammogram every 2 years or annually, depending on what you and your healthcare provider feel is appropriate
    
• Women under 40 with risk factors for breast cancer (genetic or environmental) should ask their HCP whether mammograms are advisable and how often to have them
  
• Other screening guidelines from federally recognized sources (eg, the US Preventive Services Task Force, the Centers for Disease Control and Prevention) may be used based on HCP preference

Inflammation of the colon, or colitis: Tell your healthcare provider about signs of colitis such as diarrhea, blood in stool, and stomach pain.

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?” in the Medication Guide.
• 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 not receive ‘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.
    
  • 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 OCREVUS, 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 OCREVUS so they can decide when your baby should be vaccinated.
    

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

You should talk to your healthcare provider before receiving OCREVUS if you:

• 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. Talk with your healthcare provider about what birth control method is right for you during this time.
  • Pregnancy Registry. There is a pregnancy registry for women who take OCREVUS during pregnancy. If you become pregnant while receiving OCREVUS, tell your healthcare provider right away. Talk to your healthcare provider about registering with the OCREVUS Pregnancy Registry. The purpose of this registry is to collect information about your health and your baby’s health. Your healthcare provider can enroll you in this registry by calling 1-833-872-4370 or visiting www.ocrevuspregnancyregistry.com.
    
• are breastfeeding or plan to breastfeed. It is not known if OCREVUS passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take OCREVUS.