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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 MS^1,2
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. ⁵Relapsing 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 cord^11,12

Produce antibodies that attack myelin and recruit other immune cells to attack myelin^13,14

May form structures with other immune cells in the brain that sustain the immune system attack on nerve cells in certain types of MS^15,16

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:

Relapsing forms of multiple sclerosis (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 OCREVUS is safe and 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: 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.

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.
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
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.

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 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.

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.

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

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.
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 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.

Please see additional Important Safety Information throughout and click here for full Prescribing Information and Medication Guide

¹ OCREVUS (ocrelizumab) Prescribing Information. Genentech, Inc. 2016.

² National Multiple Sclerosis Society. Treating PPMS. Available at
http://www.nationalmssociety.org/What-is-MS/Types-of-MS/Primary-progressive-MS/Treating-Primary-Progressive-MS.

³ MS International Federation. What is MS? Available at http://www.msif.org/about-ms/what-is-ms/.

⁴ National Institutes of Health-National Institute of Neurological Disorders and Stroke. (2015). Multiple Sclerosis: Hope Through Research. Available at: https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Hope-Through-Research/Multiple-Sclerosis-Hope-Through-Research.

⁵ Multiple Sclerosis International Federation. Types of MS. Available at https://www.msif.org/about-ms/types-of-ms/.

⁶ National Multiple Sclerosis Society. Types of MS. Available at http://www.nationalmssociety.org/What-is-MS/Types-of-MS.

⁷ Tullman MJ. Overview of the epidemiology, diagnosis, and disease progression associated with multiple sclerosis. Am J Manag Care. 2013;19(suppl 2):S15-S20.

⁸ Erbayat A, et al. (2013). Reliability of classifying multiple sclerosis disease activity using magnetic resonance imaging in a multiple sclerosis clinic. JAMA Neurol, 70(3):338-44.

⁹ Constant SL. (1999). B lymphocytes as antigen-presenting cells for CD4+ T cell priming in vivo. J Immunol, 162(10):5695-5703.

¹⁰ Crawford A, et al. (2006). Primary T cell expansion and differentiation in vivo requires antigen presentation by B cells. J Immunol, 176(6):3498-3506.

¹¹ Bar-Or A, et al. (2010). Abnormal B-cell cytokine responses a trigger of T-cell-mediated disease in MS? Ann Neurol, 67(4):452-461.

¹² Duddy M, et al. (2007). Distinct effector cytokine profiles of memory and naive human B cell subsets and implication in multiple sclerosis. J Immunol, 178(10):6092-6099.

¹³ Genain CP, et al. (1999). Identification of autoantibodies associated with myelin damage in multiple sclerosis. Nat Med, 5(2):170-175.

¹⁴ Storch MK, et al. (1998). Multiple sclerosis: in situ evidence for antibody- and complement-mediated demyelination. Ann Neurol, 43(4):465-471.

¹⁵ Serafini B, et al. (2004). Detection of ectopic B-cell follicles with germinal centers in the meninges of patients with secondary progressive multiple sclerosis. Brain Pathol, 14(2):164-174.

¹⁶ Magliozzi R, et al. (2010). A Gradient of neuronal loss and meningeal inflammation in multiple sclerosis. Ann Neurol, 68(4):477-493.

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Ocrevus® (ocrelizumab)