Indications & Important Safety Information
What is OCREVUS ZUNOVO?
OCREVUS ZUNOVO 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 ZUNOVO is safe and effective in children.
Who should not receive OCREVUS ZUNOVO?
Do not receive OCREVUS ZUNOVO if you:
- have an active hepatitis B virus (HBV) infection.
- have had a life-threatening administration reaction to ocrelizumab
- have had a life-threatening allergic reaction to ocrelizumab, hyaluronidase, or any of the ingredients of OCREVUS ZUNOVO. Tell your healthcare provider if you have had an allergic reaction to OCREVUS ZUNOVO or any of its ingredients in the past.
What is the most important information I should know about OCREVUS ZUNOVO? OCREVUS ZUNOVO can cause serious side effects, including:
- Injection reactions: Injection reactions are a common side effect of OCREVUS ZUNOVO, which can be serious and may require you to be hospitalized. You will be monitored for signs and symptoms of an injection reaction when you receive OCREVUS ZUNOVO. This will happen during all injections for at least 1 hour after your first injection, and for at least 15 minutes after all injections following the first injection.
- Infection:
- Infections are a common side effect. OCREVUS ZUNOVO increases your risk of getting upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes infections. Serious infections can happen with OCREVUS ZUNOVO, which can be life-threatening or cause death. Tell your healthcare provider right away if you have an infection or are experiencing any signs of infection. Your healthcare provider should delay your treatment with OCREVUS ZUNOVO until your infection is gone.
- Hepatitis B virus (HBV) reactivation: If you have ever had hepatitis B virus infection, the hepatitis B virus may become active again during or after treatment with ocrelizumab. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure or death.
- Weakened immune system: OCREVUS ZUNOVO taken before or after other medicines that weaken the immune system could increase your risk of getting infections.
- Progressive Multifocal Leukoencephalopathy (PML): PML is a rare brain infection that usually leads to death or severe disability and has been reported with ocrelizumab. Symptoms of PML get worse over days to weeks.
- Decreased immunoglobulins: OCREVUS ZUNOVO may cause a decrease in some types of immunoglobulins. Your healthcare provider will do blood tests to check your blood immunoglobulin levels.
What are the possible side effects of OCREVUS ZUNOVO? OCREVUS ZUNOVO may cause serious side effects, including:
- Risk of cancers (malignancies) including breast cancer: Follow your healthcare provider’s instructions about standard screening guidelines for breast cancer.
- Inflammation of the colon, or colitis: Tell your healthcare provider if you have any symptoms of colitis, such as diarrhea, blood in stool, and severe stomach pain or tenderness.
- The most common side effects of OCREVUS ZUNOVO include: injection reactions, respiratory tract infections, and skin infections.
These are not all the possible side effects of OCREVUS ZUNOVO.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Genentech at (888) 835-2555.
For more information, go to www.OCREVUS.com or call 1-844-627-3887.
For additional safety information, please see the full Prescribing Information and Medication Guide.