Generic Name: ocrelizumab
Dosage Form: Injection
Date of Approval: March 28, 2017
Treatment for: Multiple Sclerosis
FDA Approves Ocrevus
The U.S. Food and Drug Administration (FDA) has approved Ocrevus (ocrelizumab), a humanized monoclonal antibody designed to selectively target CD20-positive B cells as the first and only medicine for both relapsing and primary progressive forms of multiple sclerosis.
About Ocrevus (ocrelizumab)
Ocrevus is a humanized monoclonal antibody designed to selectively target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. This nerve cell damage can lead to disability in people with MS. Based on preclinical studies, Ocrevus binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, and therefore important functions of the immune system may be preserved.
Ocrevus is administered by intravenous infusion every six months. The first dose is given as two 300 mg infusions given two weeks apart. Subsequent doses are given as single 600 mg infusions.
Ocrevus U.S. Indication
Ocrevus is a prescription medicine used to treat adults with relapsing or primary progressive forms of multiple sclerosis.
It is not known if Ocrevus is safe or effective in children.
Who should not receive Ocrevus?
Do not receive Ocrevus if you are a patient that has an active hepatitis B virus (HBV) infection. Do not receive Ocrevus if you are a patient that has had a life threatening allergic reaction to Ocrevus. Patients should tell their healthcare provider if they have had an allergic reaction to Ocrevus or any of its ingredients in the past.
What is the most important information about Ocrevus?
Ocrevus can cause serious side effects, including:
- Infusion Reactions: Ocrevus can cause infusion reactions that can be serious and require a patient to be hospitalized. A patient will be monitored during the infusion and for at least 1 hour after each infusion of Ocrevus for signs and symptoms of an infusion reaction. Patients should tell their healthcare provider or nurse if they get any of these symptoms: itchy skin, rash, hives, tiredness, coughing or wheezing, trouble breathing, throat irritation or pain, feeling faint, fever, redness on the 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 the infusion. It is important that patients call their healthcare provider right away if they get any of the signs or symptoms listed above after each infusion. If a patient gets infusion reactions, the healthcare provider may need to stop or slow down the rate of the infusion.
- Ocrevus increases a patient’s risk of getting upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes infections. Patients should tell their healthcare provider if they have an infection or have any of the following signs of infection including fever, chills, a cough that does not go away, or signs of herpes (such as cold sores, shingles, or genital sores). These signs can happen during treatment or after a patient has received their last dose of Ocrevus. If a patient has an active infection, their healthcare provider should delay treatment with Ocrevus until the infection is gone.
- Progressive Multifocal Leukoencephalopathy (PML): Although no cases have been seen with Ocrevus treatment, PML may happen with Ocrevus. PML is a rare brain infection that usually leads to death or severe disability. Patients should tell their healthcare provider right away if they have any new or worsening neurologic signs or symptoms. These may include problems with thinking, balance, eyesight, weakness on one side of the body, strength, or using arms or legs.
- Hepatitis B virus (HBV) reactivation: Before starting treatment with Ocrevus, a patient’s healthcare provider will do blood tests to check for hepatitis B viral infection. If a patient has 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. A healthcare provider will monitor a patient if they are at risk for hepatitis B virus reactivation during treatment and after they stop receiving Ocrevus.
- Weakened immune system: Ocrevus taken before or after other medicines that weaken the immune system could increase a patient’s risk of getting infections.
Before receiving Ocrevus
Before receiving Ocrevus, patients should tell their healthcare provider about all of their medical conditions, including if they:
- have ever taken, take, or plan to take medicines that affect the 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. A patient should receive any required vaccines at least 6 weeks before they start treatment with Ocrevus. A patient should not receive certain vaccines (called ‘live’ or ‘live attenuated’ vaccines) while being treated with Ocrevus and until their healthcare provider tells them that their immune system is no longer weakened.
- are pregnant, think that they might be pregnant, or plan to become pregnant. It is not known if Ocrevus will harm an unborn baby. Patients should use birth control (contraception) during treatment with Ocrevus and for 6 months after the last infusion of Ocrevus.
- are breastfeeding or plan to breastfeed. It is not known if Ocrevus passes into the breast milk. Patients should talk to their healthcare provider about the best way to feed their baby if the patient takes Ocrevus.
Ocrevus side effects
Ocrevus may cause serious side effects, including:
- Risk of cancers (malignancies) including breast cancer. Patients should follow their healthcare provider’s recommendations about standard screening guidelines for breast cancer.
Most common side effects include infusion reactions and infections.
These are not all the possible side effects of Ocrevus.
Patients should call their doctor for medical advice about side effects. Side effects may also be reported to the FDA at 1-800-FDA-1088.