Important Safety Information
OCREVUS is a prescription medicine that treats relapsing forms of multiple sclerosis (MS) — including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease — and primary progressive MS in adults. However, OCREVUS is not suitable for:
- Children — it hasn’t been confirmed to be safe or effective
- Adults who have an active hepatitis B virus (HBV) infection
- Adults who have had a life-threatening allergic reaction to OCREVUS
What is the most important information I should know about OCREVUS?
OCREVUS (ocrelizumab) is a monoclonal antibody that affects the actions of the body’s immune system. Monoclonal antibodies target and destroy only certain cells in the body, which can help protect healthy cells from becoming damaged.
Before receiving OCREVUS, you should talk to your doctor about all of your medical conditions. Especially 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
- Are pregnant or planning to become pregnant
OCREVUS Side Effects
Taking OCREVUS can increase your risk of infections — primarily when associated with infusions. Infusion reactions can be serious and may require hospitalization. You will be monitored during your infusion and for at least one hour after each infusion of OCREVUS for signs and symptoms of an infusion reaction. Tell your healthcare provider or nurse if you experience:
- Itchy skin
- Coughing or wheezing
- Trouble breathing
- Throat irritation or pain
- Feeling faint
- Redness on your face (flushing)
- Swelling of the throat
- Shortness of breath
- Fast heartbeat
OCREVUS may decrease the activity of your immune system and increase your risk for certain types of cancer — including breast cancer. Tell your doctor if you or anyone in your family have ever had cancer.
In addition to infusion reactions, 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 signs of an infection. 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 of PML have been seen with treatment in clinical trials, PML may occur. 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 one 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 HBV infection. If you have ever had hepatitis B virus infection, the virus may become active again during or after treatment with OCREVUS. This may cause serious liver problems — including liver failure or death. Your healthcare provider will monitor you if you are at risk for HBV reactivation during treatment and after you stop receiving OCREVUS.
Weakened Immune System
Taking OCREVUS before or after other medicines that weaken the immune system could increase your risk of getting infections. You should talk to your doctor before taking OCREVUS if you are taking any medication that weakens your immune system.
Tell your doctor if you experience any negative side effects. You are also encouraged to report such side effects to the Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088.
Females Who Can Become Pregnant
It is not known if OCREVUS can harm your unborn baby. You should use contraception during treatment and talk to your doctor whether or not you should take the medication. While it’s not known if OCREVUS passes into your breast milk, so you should talk to your doctor before breastfeeding or if you’re considering breastfeeding in the future. Talk to your doctor about the best way to feed your baby.
Tell your doctor about all the medicines you take — including prescription and over‐the‐counter medicines, vitamins, and herbal supplements. Keep a list of your medications to show your doctor and pharmacist when you get a new medicine.
Your doctor will determine the right dose of OCREVUS for you, the amount for each infusion, and how often you should receive it. Your infusion will be monitored by a physician or nurse to ensure treatment goes smoothly, and no signs of infection occur.