Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Ocrevus (Ocrelizumab). If you are concerned about side effects, discuss the risks and benefits of Ocrevus (Ocrelizumab) with your doctor.

The following side effects have been reported by at least 1% of people taking Ocrevus (Ocrelizumab). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• Cold Sores
• flu-like symptoms (sudden lack of energy, Fever, cough, sore throat)
• runny nose
• trouble sleeping

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• buildup of mucus in the nose, throat, or chest
• red and inflamed eye
• Shingles
• signs of Depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• signs of infection (symptoms may include fever or chills, severe Diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
• signs of a serious skin reaction (such as skin rash; red skin; blistering of the lips, eyes, or mouth; skin peeling; fever; or joint pain)
• symptoms of hepatitis B (e.g., fever, feeling ill, loss of appetite, joint or muscle pain, abdominal pain, yellowing skin and eyes)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of an infusion reaction (e.g., itchy skin, rash, flushing, decreased blood pressure, shortness of breath, headache, nausea)
• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• symptoms of progressive multifocal leukencephalopathy (e.g., seizures, vision loss, trouble thinking clearly, difficulty walking)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Ocrevus (Ocrelizumab).

Each 15 mL vial contains 10 mL of Ocrevus (Ocrelizumab) for IV infusion. Nonmedicinal ingredients: sodium acetate, α,α-trehalose dehydrate, polysorbate 20, glacial acetic acid, and water for injection.

Do not take Ocrevus (Ocrelizumab) if you:

• are allergic to Ocrevus (Ocrelizumab) or any ingredients of the medication
• have a history of life-threatening infusion reaction to Ocrevus (Ocrelizumab)
• have active hepatitis B infection
• currently have any severe infection
• have a history of progressive multifocal leukoencephalopathy (PML)
• have a severely weakened immune system
• have active cancer

There may be an interaction between Ocrevus (Ocrelizumab) and any of the following:

• Azathioprine
• BCG (bacillus Calmette-Guérin)
• cancer medications (e.g., Carboplatin, Cyclophosphamide, Doxorubicin, Ifosfamide, Pimecrolimus, Vincristine)
• corticosteroids (e.g., budesonide, Dexamethasone, Hydrocortisone, fluticasone, Prednisone)
• Cyclosporine
• echinacea
• Fingolimod
• Glatiramer
• Hydroxyurea
• Imiquimod
• Leflunomide
• mycophenolate
• other monoclonal antibodies (e.g., Belimumab, eculizumab, Infliximab, Natalizumab, Rituximab)
• Roflumilast
• Romidepsin
• Tacrolimus
• Tofacitinib
• tretinoin
• vaccines

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Ocrevus (Ocrelizumab). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Ocrevus (Ocrelizumab).

Cancer: Ocrevus (Ocrelizumab) may increase the risk of cancer. Discuss any concerns you may have with your doctor.

Depression: People with MS may be more likely to develop symptoms of depression. If you have depression or have had it in the past, discuss with your doctor how Ocrevus (Ocrelizumab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Ocrevus (Ocrelizumab), and whether any special monitoring is needed. If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or thoughts of self-harm, or notice them in a family member who is taking Ocrevus (Ocrelizumab), contact your doctor as soon as possible.

Hypersensitivity reactions: A Anaphylaxis (severe allergic reaction) called hypersensitivity syndrome has occurred for some people with the use of Ocrevus (Ocrelizumab). This reaction involves a number of organs in the body and may be fatal if not treated quickly. Get immediate medical attention if you have symptoms of a severe allergic reaction, including fever, swollen glands, yellowing of the skin or eyes, or flu-like symptoms with skin rash or blistering.

Infusion reactions: Ocrevus (Ocrelizumab) can cause a hypersensitivity or infusion reaction. Symptoms of this type of reaction generally appear during the infusion of the medication and may include flushing, chest pain, shortness of breath, and a dramatic drop in blood pressure. These reactions can cause death if a health care provider is not informed immediately. If you experience any of these symptoms, or notice them happening to someone, let your nurse or doctor know immediately. You may be given medications before receiving your dose of Ocrevus (Ocrelizumab) to reduce the risk of an infusion reaction. Your doctor will probably have you remain at the clinic or hospital for an hour after your infusion to ensure that any infusion reaction can be quickly treated.

Progressive multifocal leukoencephalopathy (PML): There have been reports of PML after using Ocrevus (Ocrelizumab). PML is a rare disorder that causes nerve damage in the brain. If you experience memory loss, vision loss, trouble thinking, or difficulty walking, contact your doctor immediately.

Serious infections: Ocrevus (Ocrelizumab) can affect the way your body's natural defences work to fight infection. This makes the body more likely to develop infections due to bacteria, viruses, and fungi. This effect is increased if you are taking Ocrevus (Ocrelizumab) with other medications that reduce the body's ability to fight infection. For some people, these infections have been fatal. If you have a history of chronic or frequent infections, discuss with your doctor how Ocrevus (Ocrelizumab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Ocrevus (Ocrelizumab), and whether any special monitoring is needed.

Contact your doctor right away if you notice symptoms of a serious infection, such as fever, chills, headache, flu-like symptoms, feeling tired, cough, blood in the sputum, shortness of breath, night sweats, weight loss, nausea, vomiting, diarrhea, frequency or burning while passing urine, redness or swelling of skin or joint, cold sores, tooth pain, or new or worsening pain in any part of the body.

Vaccinations: It is not known how effective vaccines may be after treatment with Ocrevus (Ocrelizumab). Certain immunizations may be dangerous if given while receiving or shortly after receiving a treatment course of Ocrevus (Ocrelizumab). Before starting treatment with Ocrevus (Ocrelizumab), check with your doctor to ensure your immunizations are up to date.

Pregnancy: Ocrevus (Ocrelizumab) crosses the placenta and it is not known whether use of Ocrevus (Ocrelizumab) during pregnancy will affect the developing baby. Ocrevus (Ocrelizumab) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Ocrevus (Ocrelizumab), contact your doctor immediately.

Women who may become pregnant should use effective birth control when receiving Ocrevus (Ocrelizumab) and for at least 6 months after the course of treatment.

Breast-feeding: It is not known if Ocrevus (Ocrelizumab) passes into breast milk. If you are a breast-feeding mother and are taking Ocrevus (Ocrelizumab), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Ocrevus (Ocrelizumab) have not been established for children.