OCREVUS Safety Information
Before starting any treatment, it's important to understand how it works, possible side effects, and potential risks. Be sure to have a conversation with your doctor about whether OCREVUS is right for you.
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 or effective in children.
- 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. See “What are the ingredients in OCREVUS?” in the Medication Guide for a complete list of ingredients in OCREVUS.
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
- coughing or wheezing
- trouble breathing
- throat irritation or pain
- feeling faint
- redness on your face (flushing)
- swelling of the throat
- shortness of breath
- 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.
OCREVUS can cause serious side effects including 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, or a cough that does not go away. Signs of herpes include cold sores, shingles, genital sores and, if more serious, a severe or persistent headache, confusion, change in vision, eye redness, or eye pain. 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 in clinical trials, 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.
OCREVUS Treatment and Breast Cancer
One possible side effect of OCREVUS is an increased risk of cancers, including breast cancer.
Breast cancer in clinical trials for OCREVUS
In three main clinical trials, 6* out of 781 patients (<1%) were diagnosed with breast cancer. There were no cases of breast cancer reported in the trial period for patients taking REBIF or placebo.
*2 relapsing MS and 4 PPMS patients.
The FDA recommends that patients taking OCREVUS should follow standard breast cancer screening guidelines.
What you can do
- Talk to your healthcare provider about the risk of breast cancer with OCREVUS and the risks and benefits of screening
- For example, the American Cancer Society recommends:
- Women under 40 with risk factors for breast cancer (genetic or environmental) should ask their HCP whether mammograms are advisable and how often to have them
- Other screening guidelines from federally recognized sources (eg, the US Preventive Services Task Force, the Centers for Disease Control and Prevention) may be used based on HCP preference
Before receiving OCREVUS, tell your healthcare provider about all of your medical conditions, including if you:
- have or think you have an infection. See “What is the most important information I should know about OCREVUS?”
- have ever taken, take, or plan to take medicines that affect your immune system, or other treatments for MS. These medicines could increase your risk of getting an infection.
- 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.
- 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 are pregnant or planning to become pregnant talk to your doctor about vaccinations for your baby, as some precautions may be needed.
- 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.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Pregnancy & Family Planning
You should talk to your healthcare provider before receiving OCREVUS if you are pregnant, think you might be pregnant, or are planning 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 to your doctor about vaccinations for your baby, as some precautions may be needed
Breastfeeding while on OCREVUS
It is not known if OCREVUS passes into your breast milk. If you are breastfeeding or plan to breastfeed, talk to your healthcare provider about the best way to feed your baby if you take OCREVUS.