• Ocrevus is a brand (trade) name for ocrelizumab which may be used to treat multiple sclerosis (MS).
• The way Ocrevus works in MS is by targeting a specific protein, called CD20, that exists on the surface of immature and mature B-lymphocytes. B lymphocytes are a type of white blood cell that are thought to contribute to the development of MS in several different ways, including secreting antibodies during an MS attack that causes inflammation which results in damage to the myelin coating around nerve cells in the brain and spinal cord. When Ocrevus binds to this protein, it causes B-cells to self-destruct or disintegrate.
• Ocrevus belongs to the class of medicines called CD20 monoclonal antibodies. It may also be called a targeted treatment, a biologic, or a monoclonal antibody.

• Ocrevus may be used to treat relapsing forms of MS which includes clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
• Ocrevus may also be used to treat primary progressive MS in adults.
• Ocrevus is not chemotherapy, it is a targeted treatment that works by binding to a protein called CD20 that is present on the surface of B-lymphocytes, which are a type of white blood cell. When Ocrevus binds to this protein, it causes B-cells to self-destruct or disintegrate.
• Research has shown that Ocrevus is effective at reducing the number of relapses per year in people with MS, increasing the percentage of people who remain relapse-free, and reducing the rate of disability progression. In one trial in people with early primary progressive MS, people taking Ocrevus were 24% less likely to have an increase in their disability than those taking placebo, which equates to delaying the need for a wheelchair by approximately seven years.
• Ocrevus only needs to be given once every six months, after an initial loading dose of two infusions two weeks apart.
• Ocrevus is expensive but most people do not pay the full cost. People with commercial or private insurance may be eligible for Ocrevus Co-Pay assistance and pay as little as $5 per treatment or up to $15 for a full year of Ocrevus. If you have Medicare your cost for a year of Ocrevus may range between $0 and $13,000. Almost half of people with Medicare pay $0. If you have Medicaid your cost for a year of Ocrevus may be between $0 and $30 but could vary depending on your state plan. If you are unable to afford Ocrevus, you may be able to apply for additional assistance through the Genentech Patient Foundation.
• PML is much less likely to occur in people taking Ocrevus compared with Tysabri.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Upper respiratory tract infections, infusion reactions, depression, pain, and other infections (such as herpes-virus associated infections and lower respiratory tract infections) are the most common side effects reported.
• Reactivation of hepatitis B has been reported in people who have a current or prior hepatitis B virus (HBV) infection before initiating treatment with Ocrevus. In some cases, this has resulted in severe and rapid liver disease, hepatic failure, and death. All patients should be tested for current or prior hepatitis B virus (HBV) infection before initiating treatment with Ocrevus.
• Do not give to people with an active HBV infection or those with a history of life-threatening reactions to Ocrevus.
• Ocrevus needs to be given by intravenous infusion by a healthcare professional. Provided you do not suffer any serious infusion reactions, Ocrevus is infused over at least 2.5 hours for the first two doses then over at least 2 hours for subsequent doses. An IV dose of 100mg methylprednisolone (or an equivalent corticosteroid) should be administered 30 minutes before each Ocrevus infusion to reduce the frequency and severity of infusion reactions, in addition to an antihistamine, such as diphenhydramine, administered 30 to 60 minutes before each infusion. A fever-lowering medication, such as acetaminophen may also be considered.
• If a life-threatening infusion reaction occurs, immediately stop and permanently discontinue Ocrevus and provide appropriate supportive treatment. For severe infusion reactions interrupt the infusion and administer appropriate supportive treatment. Restart the infusion only after all symptoms have resolved, then begin at half of the infusion rate and increase slowly if tolerated. For mild to moderate infusion reactions, reduce the infusion rate to half the rate and maintain the reduced rate for at least 30 minutes before increasing if the rate is tolerated.
• Observe patients for infusion reactions during the infusion and at least one hour after completion of the infusion. Inform patients that infusion reactions can occur up to 24 hours after the infusion.
• If a patient misses a dose of Ocrevus, then administer the dose as soon as possible, do not wait until the next scheduled dose. Once the missed dose has been administered reset the dosing schedule to administer the next dose 6 months after. Doses of Ocrevus must be separated by at least 5 months.
• Before every Ocrevus infusion check for active infections and delay treatment until the infection has resolved. Also, perform testing for quantitative serum immunoglobulins before administering Ocrevus. Seek immunological expert advice for those returning low serum immunoglobulins.
• Ocrevus costs $18,750 for one 300mg/10mL dose of Ocrevus intravenous solution. This price is for cash paying customers and is not valid with insurance plans. Most people do not pay this full amount because they either have insurance or are eligible for co-pay assistance.
• Ocrevus will suppress the immune system and will reduce a person's ability to fight infection. This ability will be further compromised if the person is also taking other drugs that suppress the immune system, such as chemotherapy agents, immune-modulating therapies, or other immunosuppressants. This immune-suppressing effect will persist for a few months after stopping Ocrevus treatment. Review all other immune-suppressing medications before initiating Ocrevus, and be aware of those with a long half-life whose effects may persist for weeks after discontinuation, such as natalizumab, teriflunomide, or mitoxantrone. Life-threatening and fatal infections have occurred in association with Ocrevus.
• Ocrevus will also reduce the immune response to live vaccines, such as MMR and varicella vaccines. All vaccines should be up to date before Ocrevus is even started. Administer all live or live-attenuated vaccines at least 4 weeks before initiating Ocrevus, and non-live vaccines at least 2 weeks before.
• Around a dozen cases of progressive multifocal leukoencephalopathy (PML) have been reported in people taking Ocrevus; at least 10 of these occurred in people who had previously been prescribed Tysabri or another MS agent such as Gilenya or Tecfidera. PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that often leads to death or severe disability. Posterior reversible encephalopathy syndrome (PRES) and respiratory effects have also been reported.
• Ocrevus can slightly increase a person's risk of developing cancer, such as breast cancer. Follow standard cancer screening guidelines.
• Ocrevus is not available as a generic.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• Before starting treatment with Ocrevus, and during treatment with Ocrevus, tell your health care provider if you think you have an infection or have symptoms of an infection such as a fever, chills, muscle aches, cough, shortness of breath, runny nose, sore throat, red or painful skin or sores on your body, tiredness, or pain during urination. Also, let them know if you have infections that keep coming back.
• Some vaccinations may need to be avoided during treatment with Ocrevus and for a few months after stopping it. Take care to avoid people who are unwell and protect yourself from injury.
• Your doctor will also test you for hepatitis B virus (HBV) infection before starting Ocrevus. This is because treating HCV may reactivate an underlying hepatitis B infection (HBV). Any underlying HBV infection should be treated before Ocrevus is started.
• Keep your appointments for your Ocrevus injection. If you miss an appointment, contact your doctor straight away to arrange another one. Ocrevus needs to be dosed every six months with at least five months between doses.
• Your first two infusions of Ocrevus will take 2.5 hours each and the subsequent infusions, 2 hours each, provider you don't suffer any serious infusion reactions. However, your actual appointment time will be longer because premedication with a corticosteroid and an antihistamine needs to be administered 30 to 60 minutes before giving Ocrevus, to lessen the risk of an infusion reaction happening.
• Infusion reactions, some serious, may occur while you are having an Ocrevus infusion and for up to 24 hours following. Symptoms may include itchy skin, a rash, hives, skin redness, bronchospasm, throat irritation, oropharyngeal pain, shortness of breath, throat edema, flushing, low blood pressure, fever, fatigue, headache, dizziness, nausea, a fast heartbeat, and anaphylaxis. Before Ocrevus is given, your healthcare provider will administer a corticosteroid, such as methylprednisolone, and an antihistamine, such as diphenhydramine to reduce the risk of these infusion reactions happening.
• Although Ocrevus is expensive if you have commercial or private insurance you may be eligible for Ocrevus Co-Pay assistance and pay as little as $5 per treatment or up to $15 for a full year of Ocrevus.
• There is limited data as to the effects of Ocrevus on a developing fetus. Use effective contraception while receiving Ocrevus and for 6 months after the last infusion. If you inadvertently become pregnant, see your doctor immediately and enroll on the pregnancy registry by calling 1-833-872-4370 or visiting www.Ocrevuspregnancyregistry.com. The effects of Ocrevus on a breastfeeding infant are also not known.
• Ocrevus may slightly increase your risk of developing cancer. Follow standard cancer screening guidelines.

• Ocrevus has some effect at reducing disability progression within about 12 weeks; however, it may take at least 6 months or possibly longer for the full effects to be seen.
• Trials of up to 96 weeks (almost 2 years) duration have shown that the number of patients with disability progression was significantly lower with Ocrevus compared with REBIF (interferon beta-1a) at 12 weeks (9.1% of those prescribed Ocrevus vs. 13.6% of those prescribed REBIF), and 24 weeks (6.9% vs. 10.5%)
• 82% to 83% of people taking Ocrevus were relapse-free after 24 weeks compared to 71% to 72% of those taking REBIF.
• People taking Ocrevus had 46% to 47% fewer relapses a year than people prescribed REBIF.
• The incidence of infusion reactions in Ocrevus-treated patients who received methylprednisolone (or an equivalent steroid) and possibly other pre-medication to reduce the risk of infusion reactions before each infusion was 34 to 40%, with the highest incidence with the first infusion. There were no fatal infusion reactions, but 0.3% of Ocrevus-treated MS patients experienced serious infusion reactions, some requiring hospitalization.

Medicines that interact with Ocrevus may either decrease its effect, affect how long it works, increase side effects, or have less of an effect when taken with Ocrevus. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Ocrevus interacts with over 300 medications; the majority of these interactions are considered moderate or major. Common medications that may interact with Ocrevus include:

• antineoplastics, such as capecitabine or cyclophosphamide
• biologics, such as adalimumab, etanercept, golimumab, or infliximab
• busulfan
• corticosteroids (such as prednisone or dexamethasone)
• herbals, such as brewer's yeast
• HIV medications, such as zidovudine
• immunosuppressants such as azathioprine, cyclosporine, or tacrolimus
• interferon
• live vaccines and some other vaccines, such as BCG, cholera, measles, hepatitis b vaccines, yellow fever, or live influenza vaccines (Ocrevus reduces the immune response to vaccination. Administer live or live-attenuated vaccines at least 4 weeks before Ocrevus initiation, and non-live vaccines at least 2 weeks before)
• probiotics, such as lactobacillus.

Ocrevus may have additive immune-suppressing effects when given with any other medications such as anticancer drugs, immune-modulating, or immunosuppressive therapies, which may increase a person's risk for infection. Take this into account when switching from drugs with prolonged immune effects, such as natalizumab, teriflunomide, fingolimod, or mitoxantrone.

Note that this list is not all-inclusive and includes only common medications that may interact with Ocrevus. You should refer to the prescribing information for Ocrevus for a complete list of interactions.