Ocrevus

The first two treatments of Ocrevus (Ocrelizumab) are given as 300 mg intravenous infusions (into the vein) 2 weeks apart. These doses are given over approximately 2½ hours.

After the first 2 doses, Ocrevus (Ocrelizumab) is given as intravenously as 600 mg every 6 months, infused over at least 3½ hours.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important Ocrevus (Ocrelizumab) be given exactly as recommended by your doctor. If you miss an appointment to receive Ocrevus (Ocrelizumab), contact your doctor as soon as possible to reschedule your appointment.

Store Ocrevus (Ocrelizumab) at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

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.