Ocrevus 300mg Injection is used to treat:

• Relapsing forms of multiple sclerosis (RMS): This includes clinically isolated syndrome, relapsing-remitting multiple sclerosis and active secondary progressive multiple sclerosis in eligible patients.

• Primary progressive multiple sclerosis (PPMS): It is used to treat primary progressive MS in eligible patients.

The treatment schedule and suitability of Ocrevus depend on the type and activity of MS and your overall health.

Ocrevus 300mg Injection contains Ocrelizumab, which targets CD20, a protein present on certain B cells.

These B cells are involved in the immune response that contributes to inflammation and damage in multiple sclerosis. Ocrelizumab binds to CD20 and helps remove these B cells from the circulation, reducing their involvement in the abnormal immune response.

special consideration.

• Other medicines that suppress or modify the immune system: Using Ocrevus close to other immunosuppressive or immune-modulating treatments may increase the risk of infections or other immune-related effects.

• Live or live-attenuated vaccines: These vaccines are not recommended during treatment with Ocrevus and until B-cell recovery after treatment.

• Non-live vaccines: Ocrevus may reduce the effectiveness of some non-live vaccines. Your doctor may recommend completing necessary vaccinations before starting treatment.

• Other multiple sclerosis medicines: Tell your doctor about any previous or current MS treatment before starting Ocrevus, particularly medicines that affect the immune system.

Always tell your doctor about all prescription medicines, over-the-counter medicines, supplements and vaccines you are receiving.

• Store Ocrevus 300mg Injection in a refrigerator at 2°C to 8°C.

• Keep the vial in the outer carton to protect it from light.

• Do not freeze.

• Do not shake.

• Ocrevus is intended for single use only.

• The diluted infusion should be prepared by a healthcare professional using appropriate aseptic technique.

Ocrevus 300mg Injection is given only by intravenous infusion under the supervision of a healthcare professional.

The initial treatment consists of:

• 300mg as the first infusion

• Another 300mg infusion two weeks later

After the initial treatment, the usual dose is 600mg as a single intravenous infusion every 6 months.

Before starting treatment, your doctor will assess you for active infections and may perform tests for hepatitis B virus (HBV), blood immunoglobulin levels and liver function.

A corticosteroid and an antihistamine are generally given before each infusion to reduce the risk and severity of infusion reactions. You may also receive a medicine to reduce fever.

You will be monitored during the infusion and for at least one hour afterwards. Infusion reactions can sometimes occur up to 24 hours after treatment.

If a planned infusion is missed, it should be given as soon as possible rather than waiting for the next scheduled date. Your doctor will reset the treatment schedule accordingly.

Common side effects

• Infusion reactions

• Upper respiratory tract infections

• Lower respiratory tract infections

• Skin infections

• Herpes infections

• Headache

• Fatigue

• Cough

• Back pain

• Pain or swelling in the arms or legs

• Fever

• Nausea

• Dizziness

Infusion reactions are particularly common with the first infusion and may include itching, rash, flushing, headache, dizziness, nausea, throat irritation or difficulty breathing.

Serious side effects

• Severe infusion reactions: Serious reactions can cause difficulty breathing, swelling of the throat or face, low blood pressure, rapid heartbeat or anaphylaxis.

• Serious infections: Ocrevus can increase susceptibility to bacterial, viral, fungal and other infections. Hepatitis B can also reactivate in people who have previously been infected.

• Progressive multifocal leukoencephalopathy (PML): This is a rare but serious infection of the brain caused by the JC virus that can lead to severe disability or death.

• Reduced immunoglobulin levels: Ocrevus can reduce levels of immunoglobulins, proteins that help the immune system fight infections.

• Liver injury: Clinically significant liver injury has been reported during treatment.

• Immune-mediated colitis: Rarely, inflammation of the intestine may cause persistent diarrhoea or other gastrointestinal symptoms.

• Cancer: An increased risk of malignancy, including breast cancer, may exist with Ocrevus.

Seek immediate medical attention for severe breathing difficulty, swelling, severe rash, persistent high fever, confusion, new neurological symptoms, severe diarrhoea or other symptoms that suggest a serious reaction or infection.

• Complete the recommended hepatitis B screening and other blood tests before starting Ocrevus.

• Tell your doctor if you currently have an infection. An Ocrevus infusion may need to be delayed until the infection has resolved.

• Keep your vaccination history up to date and discuss any required vaccines with your doctor before starting treatment.

• Do not receive live or live-attenuated vaccines during treatment unless your doctor specifically advises otherwise.

• Attend your scheduled blood tests so your doctor can monitor immunoglobulin levels and liver function when required.

• Inform your doctor immediately if you develop persistent cough, fever, painful skin lesions or other signs of infection.

• Report new neurological symptoms such as changes in vision, difficulty walking, weakness, confusion or problems with coordination promptly.

• Keep your doctor informed about previous medicines used to treat multiple sclerosis, particularly medicines that suppress or modify the immune system.

• Ocrevus treatment is given at long intervals, so keep track of your next scheduled infusion and attend appointments as advised.