Ocrevus® (ocrelizumab)

About OCREVUS

OCREVUS® (ocrelizumab) is a therapeutic monoclonal antibody that represents a different scientific approach to treating MS. It targets a type of immune cell called a CD20-positive B cell that plays a key role in the disease. OCREVUS is approved by the FDA to treat relapsing or primary progressive forms of multiple sclerosis (MS). OCREVUS is given once every six months by an intravenous (IV) infusion.1

  • FIRST AND ONLY approved disease-modifying therapy for primary progressive multiple sclerosis (PPMS), a highly disabling form of MS1,2
  • FIRST AND ONLY medicine approved to treat two types of MS: relapsing forms of MS (RMS) and PPMS1
  • FIRST AND ONLY approved MS treatment to target CD20-positive B cells1

About Multiple Sclerosis

MS is a chronic neurological disease for which there is no cure, and over time will lead to some level of disability in most people.3,4 The cause of MS is unknown. In people with MS, the immune system attacks the insulation around nerve cells in the brain, spinal cord and/or optic nerves, causing inflammation and potentially debilitating symptoms.4 The majority of people living with MS either have a relapsing form or PPMS at the time of diagnosis. 5 Relapsing forms of MS are characterized by episodes of new or worsening symptoms (relapses) followed by periods of recovery.6 PPMS is a highly disabling form of MS characterized by steadily worsening symptoms, usually without periods of improvement/remission.6

  • APPROXIMATELY 400,000

    people in the US are living with MS7

  • 20-40

    age range in which MS is commonly diagnosed4

  • RMS occurs at least

    2x

    as frequently in women as in men4

People with all forms of MS experience disease activity – inflammation in the nervous system and permanent loss of nerve cells in the brain, spinal cord or optic nerves – even when their clinical symptoms aren’t apparent or don’t appear to be getting worse.8

Disease activity causes lesions in the brain, which can be measured with magnetic resonance imaging (MRI).8

Most people with MS continue to experience disease activity and worsening disability. An important goal of treating MS is to slow the progression of disability.6

About B Cells

T cells have long been believed to be the culprit in MS. Pioneering science has shown B cells may also play a key role in MS in several ways:

Activate other immune cells to attack the insulation and support around nerve cells (myelin)9,10

Release chemicals that stimulate inflammatory activity in the brain and spinal cord11,12

Produce antibodies that attack myelin and recruit other immune cells to attack myelin13,14

May form structures with other immune cells in the brain that sustain the immune system attack on nerve cells in certain types of MS15,16

How OCREVUS May Work (Proposed Mechanism of Action)1

OCREVUS is a humanized monoclonal antibody that is designed to target CD20-positive B cells.

Although the exact way OCREVUS works is not known, it is thought to work in MS by decreasing certain B cells which have the CD20 protein on its surface. Since the CD20 protein is not found on all B cells, other B cells may still be available to help your body fight infection and other illnesses.

OCREVUS Efficacy in MS1

The FDA approval of OCREVUS is based on positive results from three Phase III studies (OPERA I and OPERA II in RMS; ORATORIO in PPMS).

In RMS, OCREVUS was proven superior to Rebif,® a commonly used treatment, over two years:

For PPMS, in a clinical study compared with a placebo, OCREVUS was the first and only treatment to:

Study-Specific Safety in MS1

In the OPERA I and OPERA II studies, OCREVUS adverse reactions in at least 5% of RMS patients and higher than Rebif were:

In the ORATORIO study, OCREVUS adverse reactions in at least 5% of PPMS patients and higher than placebo were:

What it Treats

What is OCREVUS?

OCREVUS is a prescription medicine used to treat adults with relapsing or primary progressive forms of multiple sclerosis.

It is not known if OCREVUS is safe or effective in children.

Who should not receive OCREVUS?

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.

Important Safety Information

What is the most important information I should know about OCREVUS?

OCREVUS can cause serious side effects, including:

  • Infusion reactions: OCREVUS can cause infusion reactions that can be serious and 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.
  • Infection:
    • OCREVUS increases your risk of getting upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes infections. Tell your healthcare provider if you have an infection or have any of the following signs of infection including fever, chills, a cough that does not go away, or signs of herpes (such as cold sores, shingles, or genital sores). These signs can happen during treatment or after you have received your last dose of OCREVUS. If you have an active infection, your healthcare provider should delay your treatment with OCREVUS until your infection is gone.
    • Progressive Multifocal Leukoencephalopathy (PML): Although no cases have been seen with OCREVUS treatment, PML may happen with OCREVUS. PML is a rare brain infection that usually leads to death or severe disability. Tell your healthcare provider right away if you have any new or worsening neurologic signs or symptoms. These may include problems with thinking, balance, eyesight, weakness on 1 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.
    • Weakened immune system: OCREVUS taken before or after other medicines that weaken the immune system could increase your risk of getting infections.

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

  • have ever taken, take, or plan to take medicines that affect your immune system, or other treatments for MS.
  • have ever had hepatitis B or are a carrier of the hepatitis B virus.
  • 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. 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.

What are the possible side effects of OCREVUS?

OCREVUS may cause serious side effects, including:

  • Risk of cancers (malignancies) including breast cancer. Follow your healthcare provider’s instructions about standard screening guidelines for breast cancer.

Most common side effects include infusion reactions and infections.

These are not all the possible side effects of OCREVUS.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

For more information, go to www.OCREVUS.com or call 1-844-627-3887

For additional safety information, please see the full Prescribing Information and Medication Guide.