b'PATIENT INFORMATIONOCREVUS TM(oak-rev-us)(ocrelizumab)injection, for intravenous useWhat is the most important information I should know What is OCREVUS?about OCREVUS? OCREVUS is a prescription medicine used to treat adults with OCREVUS can cause serious side effects, including: relapsing or primary progressive forms of multiple sclerosis.Infusion reactions: OCREVUS can cause infusion reactions thatIt is not known if OCREVUS is safe or effective in children. can be serious and require you to be hospitalized. You will bemonitored during your infusion and for at least 1 hour after eachWho should not receive OCREVUS?infusion of OCREVUS for signs and symptoms of an infusion Do not receive OCREVUS if you have an active hepatitis B virus reaction. Tell your healthcare provider or nurse if you get any of(HBV) infection.these symptoms: Do not receive OCREVUS if you have had a life threatening allergicitchy skinrednessonyourface(ushing) reaction to OCREVUS. Tell your healthcare provider if you have had rashnausea an allergic reaction to OCREVUS or any of its ingredients in the past.hivesheadache See "What are the ingredients in OCREVUS?" for a complete list oftirednessswelling of the throat ingredients in OCREVUS. coughing or wheezingdizziness Before receiving OCREVUS, tell your healthcare provider about all of trouble breathingshortness of breath your medical conditions, including if you: throat irritation or painfatigue have or think you have an infection. See "What is the mostfeeling faintfast heartbeat important information I should know about OCREVUS?" feverhave ever taken, take, or plan to take medicines that affect your These infusion reactions can happen for up to 24 hours after yourimmune system, or other treatments for MS. These medicines could infusion. It is important that you call your healthcare provider rightincrease your risk of getting an infection.away if you get any of the signs or symptoms listed above after each infusion. If you get infusion reactions, your healthcare provider may have ever had hepatitis B or are a carrier of the hepatitis B virus.need to stop or slow down the rate of your infusion.have had a recent vaccination or are scheduled to receive anyInfection: vaccinations. You should receive any required vaccines at leastOCREVUS increases your risk of getting upper respiratory tract6 weeks before you start treatment with OCREVUS. You should infections, lower respiratory tract infections, skin infections, andnot receive certain vaccines (called \'live\' or \'live attenuated\' herpes infections. Tell your healthcare provider if you have anvaccines) while you are being treated with OCREVUS and until yourinfection or have any of the following signs of infection includinghealthcare provider tells you that your immune system is no longerAfever, chills, a cough that does not go away, or signs of herpesweakened. 1(such as cold sores, shingles, or genital sores). These signs can are pregnant, think that you might be pregnant, or plan to become happen during treatment or after you have received your lastpregnant. It is not known if OCREVUS will harm your unborn baby.dose of OCREVUS. If you have an active infection, your healthcareYou should use birth control (contraception) during treatment with provider should delay your treatment with OCREVUS until yourOCREVUS and for 6 months after your last infusion of OCREVUS. infection is gone.are breastfeeding or plan to breastfeed. It is not known if OCREVUS passes into your breast milk. Talk to your healthcare provider about Progressive Multifocal Leukoencephalopathy (PML): AlthoughD no cases have been seen with OCREVUS treatment in clinicalthe best way to feed your baby if you take OCREVUS. trials, PML may happen with OCREVUS. PML is a rare brainTell your healthcare provider about all the medicines you take, infection that usually leads to death or severe disability. Tell yourincluding prescription and over-the-counter medicines, vitamins, and healthcare provider right away if you have any new or worseningherbal supplements.neurologic signs or symptoms. These may include problems withHow will I receive OCREVUS?thinking, balance, eyesight, weakness on 1 side of your body, OCREVUS is given through a needle placed in your vein strength, or using your arms or legs. (intravenous infusion) in your arm. Hepatitis B virus (HBV) reactivation: Before starting treatment Before treatment with OCREVUS, your healthcare provider will give with OCREVUS, your healthcare provider will do blood tests toyou a corticosteroid medicine and an antihistamine to help reduce check for hepatitis B viral infection. If you have ever had hepatitisinfusion reactions (make them less frequent and less severe). You B virus infection, the hepatitis B virus may become active againmay also receive other medicines to help reduce infusion reactions. during or after treatment with OCREVUS. Hepatitis B virusSee What is the most important information I should know about becoming active again (called reactivation) may cause seriousOCREVUS?liver problems including liver failure or death. Your healthcare provider will monitor you if you are at risk for hepatitis B virusYourrstfulldoseofOCREVUSwillbegivenas2separateinfusions,reactivation during treatment and after you stop receiving2weeksapart.Eachinfusionwilllastabout2hoursand30minutes.OCREVUS.Your next doses of OCREVUS will be given as one infusion every Weakened immune system: OCREVUS taken before or after6months.Theseinfusionswilllastabout3hoursand30minutes.other medicines that weaken the immune system could increase your risk of getting infections.U.S. BLA 761053: OcrelizumabGenentech, Inc.Regional (Multiple Sclerosis): clean-label-text'