Ocrevus® 300 mg concentrate for solution for infusion – patient leaflet, side effects, dosage

1. What Ocrevus is and what it is used for

What Ocrevus is

Ocrevus contains the active substance ‘ocrelizumab’. It is a type of protein called a ‘monoclonal antibody’. Antibodies work by attaching to specific targets in your body.

What Ocrevus is used for

Ocrevus is used to treat adults with:

• Relapsing forms of multiple sclerosis (RMS)
• Early primary progressive multiple sclerosis (PPMS)

Ocrevus is used to treat children and adolescents (aged 10 years and older) with relapsing‑remitting multiple sclerosis (RRMS).

What is Multiple Sclerosis

Multiple Sclerosis (MS) affects the central nervous system, especially the nerves in the brain and spinal cord. In MS, the immune system (the body’s defence system) works incorrectly and attacks a protective layer (called myelin sheath) around nerve cells and causes inflammation. Breakdown of the myelin sheath stops the nerves working properly.

Symptoms of MS depend on which part of the central nervous system is affected and can include problems with walking and balance, weakness, numbness, double vision and blurring, poor coordination and bladder problems.

• In relapsing forms of MS, the patient has repeated

  attacks of symptoms (relapses). The symptoms can appear suddenly within a few hours, or slowly over several days. The symptoms disappear or improve between relapses but damage may build up and lead to permanent disability.

• In primary progressive MS, the symptoms generally

  continue to worsen from the start of the disease.

How does Ocrevus work

Ocrevus attaches to specific B cells, which are a type of white blood cells that are part of the immune system and play a role in MS. Ocrevus targets and removes those specific B cells. This reduces inflammation and attacks on the myelin sheath, reduces the chance of having a relapse and slows the progression of your disease.

• In Relapsing forms of MS (RMS), Ocrevus helps to

  significantly reduce the number of attacks (relapses) and significantly slow down the progression of the disease. Ocrevus also significantly increases the chance of a patient having no evidence of disease activity (brain lesions, relapses and worsening of disability).

• In Primary Progressive MS (PPMS), Ocrevus helps to

  slow down the progression of the disease and reduce deterioration in walking speed.

2. What you need to know before you are given Ocrevus

You must not be given Ocrevus:

• if you are allergic to ocrelizumab or any of the other

  ingredients of this medicine (listed in section 6). ● if you currently have an infection.

• if you have been told that you have severe problems with

  your immune system.

• if you have cancer.

If you are not sure, talk to your doctor before you are given Ocrevus.

Warnings and precautions

Talk to your doctor before you are given Ocrevus if any of the following apply to you. Your doctor may decide to delay your treatment with Ocrevus, or may decide you cannot receive Ocrevus if:

• you have an infection. Your doctor will wait until the

  infection is resolved before giving you Ocrevus. ● you have ever had hepatitis B or are a carrier of the

  hepatitis B virus. This is because medicines like Ocrevus can cause the hepatitis B virus to become active again. Before your Ocrevus treatment, your doctor will check if you are at risk of hepatitis B infection. Patients who have had hepatitis B or are carriers of the hepatitis B virus will have a blood test and will be monitored by a doctor for signs of hepatitis B infection.

• you have cancer or if you have had cancer in the past. Your

  doctor may decide to delay your treatment with Ocrevus.

Effect on the immune system:

• Diseases that affect your immune system: if you have

  another disease which affects the immune system. You may not be able to receive Ocrevus.

• Medicines that affect your immune system: if you have

  ever taken, are taking or are planning to take medicines that affect the immune system – such as chemotherapy, immunosuppressants or other medicines used to treat MS. Your doctor may decide to delay your treatment with Ocrevus or may ask you to stop such medicines before starting treatment with Ocrevus. See under ‘Other medicines and Ocrevus’, below for more information.

  Infusion-related reactions

  • Infusion‑related reactions are the most common side effect

    of Ocrevus treatment.

  • Tell your doctor or nurse straight away if you have any

    infusion-related reaction (see section 4 for a list of infusion‑related reactions). Infusion‑related reactions can happen during the infusion or up to 24 hours after the infusion. ● To reduce the risk of infusion‑related reaction, your doctor

    will give you other medicines before each infusion of Ocrevus (see section 3) and you will be closely monitored during the infusion and for at least one hour after the infusion has been given.

Infections

• Talk to your doctor before you are given Ocrevus if you

  think you have an infection. Your doctor will wait until the infection is resolved before giving you Ocrevus. ● You might get infections more easily with Ocrevus. This is

  because the immune cells that Ocrevus targets also help to fight infection.

• Before you start treatment with Ocrevus and before

  subsequent infusions, your doctor may ask you to have a blood test to verify your immune system because infections may occur more frequently in case of severe problems with your immune system.

• If you are treated with Ocrevus for primary progressive

  multiple sclerosis, and you have swallowing difficulties, Ocrevus may increase the risk of severe pneumonia. ● Tell your doctor or nurse straight away if you have

  any of these signs of infection during or after Ocrevus treatment:

  ‑ fever or chills

  ‑ cough that does not go away

  ‑ herpes (such as cold sore, shingles or genital sores). ● Tell your doctor or nurse straight away if you think

  your MS is getting worse or if you notice any new symptoms. This is because of a very rare and life‑threatening brain infection, called ‘progressive multifocal leukoencephalopathy’ (PML), which can cause symptoms similar to those of MS. PML can occur in patients taking Ocrevus.

• Tell your partner or carer about your Ocrevus treatment.

  They might notice symptoms of PML that you do not, such as memory lapses, trouble thinking, difficulty walking, sight loss, changes in the way you talk, which your doctor may need to investigate.

Vaccinations

• Tell your doctor if you have recently been given any vaccine

  or might be given a vaccine in the near future. ● While you are being treated with Ocrevus, you should not

  be given live or live attenuated vaccines (for example BCG for tuberculosis or vaccines against yellow fever). ● Your doctor may recommend that you are given a seasonal

  influenza vaccine.

• Your doctor will check if you need any vaccinations before

  you start treatment with Ocrevus. Any vaccinations should be given at least 6 weeks before you start treatment with Ocrevus.

Children and adolescents

Ocrevus is not intended to be used in children under 10 years old. This is because it has not yet been studied in this age group.

Other medicines and Ocrevus

Tell your doctor if you are taking, have recently taken or might take any other medicines.

In particular tell your doctor if:

• you have ever taken, are taking or are planning to take

  medicines that affect the immune system – such as chemotherapy, immunosuppressants or other medicines used to treat MS. The effect on the immune system of these medicines with Ocrevus could be too strong. Your doctor may decide to delay your treatment with Ocrevus or may ask you to stop such medicines before starting treatment with Ocrevus.

• you are taking medicines for high blood pressure. This is

  because Ocrevus may lower blood pressure. Your doctor may ask you to stop taking your blood pressure medicines for 12 hours before each Ocrevus infusion.

If any of the above apply to you (or you are not sure), talk to your doctor before you are given Ocrevus.

Pregnancy

• If you are pregnant, think you may be pregnant or are

  planning to have a baby, ask your doctor for advice before taking this medicine. This is because Ocrevus may cross the placenta and affect your baby.

• Do not use Ocrevus if you are pregnant unless you have

  discussed this with your doctor. Your doctor will consider the benefit of you taking Ocrevus against the risk to your baby. ● Talk to your doctor before vaccinating your baby.

Contraception for females

Females who could become pregnant must use contraception: ● during treatment with Ocrevus and

• for 4 months after your last infusion of Ocrevus.

Breast-feeding

Ocrevus can be used during breastfeeding. Talk to your doctor about the best way to feed your baby if you are given Ocrevus.

Driving and using machines

It is not known whether Ocrevus can affect your ability to drive or use tools or machines.

Your doctor will tell you whether your MS may affect your ability to drive or use tools and machines safely.

Ocrevus contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium‑free’. Medicinal product will be prepared for administration with sodium‑containing solution and this should be considered in relation to the total sodium intake of the patient from all sources per day.

Ocrevus contains polysorbate

This medicine contains 2 mg of polysorbate 20 in each vial, which is equivalent to 0.2 mg/mL. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

3. How Ocrevus is given

Ocrevus will be given to you by a doctor or nurse who is experienced with this treatment.

• It will be given as a drip into a vein, this is called an

  ‘intravenous’ or ‘IV’ infusion.

• You will be closely monitored during your Ocrevus infusion

  and for at least 1 hour afterwards. This is in case you have any side effects related to the infusion. The infusion may be slowed, paused or stopped if you have any side effects related to the infusion. This will depend on how severe your reaction is, see sections 2 and 4 for information about side effects related to the infusion

  Medicines you will have before you are given Ocrevus

  Before you are given Ocrevus, you will receive other medicines to prevent or reduce possible side effects such as infusion‑related reactions (see sections 2 and 4 for information about infusion‑related reactions).

  You will receive a corticosteroid and an anti‑histamine before each infusion and you may also receive medicines to reduce fever.

  How much and how often you will be given Ocrevus

  Adults

  You will be given a total dose of 600 mg of Ocrevus every 6 months.

  • The first 600 mg dose of Ocrevus will be given as 2 separate

    infusions (300 mg each), given 2 weeks apart. Each infusion will last about 2 hours 30 minutes.

  • The next 600 mg doses of Ocrevus will be given as a single

    infusion. Depending on the rate of the subsequent infusion, each infusion will either last about 3 hours 30 minutes or 2 hours.

Children and adolescents (aged 10 years and older)

The dose depends on body weight:

Children and adolescents with body weight below 35 kg: ● Will be given a dose of 300 mg of Ocrevus every 6 months. ● The first 300 mg dose of Ocrevus will be given as 2 separate

infusions (150 mg each), given 2 weeks apart. Each infusion will last about 2 hours 30 minutes.

• The next 300 mg doses of Ocrevus will be given as a single

  infusion. Each infusion will last about 2 hours 30 minutes. ● Children who start on a 300 mg dose and subsequently

  reach a stable body weight of 35 kg or more should be switched to the 600 mg dose. The first 600 mg dose will be given as 2 separate infusions (300 mg each), given 2 weeks apart. The next 600 mg doses will be given as a single infusion.

Children and adolescents with body weight equal to or above 35 kg:

• Will be given a dose of 600 mg of Ocrevus every 6 months. ● The first 600 mg dose of Ocrevus will be given as 2 separate

  infusions (300 mg each), given 2 weeks apart. Each infusion will last about 2 hours 30 minutes.

• The next 600 mg doses of Ocrevus will be given as a single

  infusion. Each infusion will last about 3 hours 30 minutes.

If you miss an infusion of Ocrevus

• If you miss an infusion of Ocrevus, talk to your doctor to

  arrange to have it as soon as possible. Do not wait until your next planned infusion.

• To get the full benefit of Ocrevus, it is important that you

  receive each infusion when it is due.

If you stop Ocrevus treatment

• It is important to continue your treatment for as long as you

  and your doctor decide that it is helping you.

• Some side effects can be related to having low B cells. After

  you stop Ocrevus treatment, you may still experience side effects until your B‑cells return to normal. Your blood B‑cells will gradually increase to normal levels. This can take from six months to two and a half years, or up to several years in rare cases.

• Before you start any other medicines, tell your doctor when

  you had your last Ocrevus infusion.

If you have any further questions on the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported with Ocrevus:

Serious side effects:

Infusion-related reactions

• Infusion‑related reactions are the most common side effect

  of Ocrevus treatment (very common: may affect more than 1 in 10 people). In most cases these are mild reactions but some serious reactions can happen.

• Tell your doctor or nurse straight away if you

  experience any signs or symptoms of an infusion-related reaction during the infusion or up to 24 hours after the infusion. Symptoms can include, but are not limited to:

  ‑ itchy skin

  ‑ rash

  ‑ hives

  ‑ redness of the skin

  ‑ throat irritation or pain

  ‑ shortness of breath

  ‑ swelling of the throat

  ‑ flushing

  ‑ low blood pressure

  ‑ fever

  ‑ feeling tired

  ‑ headache

  ‑ feeling dizzy

  ‑ feeling sick (nausea)

  ‑ fast heart beat.

• If you have an infusion‑related reaction, you will be given

  medicines to treat it and the infusion may need to be slowed down or stopped. When the reaction has stopped, the infusion may be continued. If the infusion‑related reaction is life‑threatening, your doctor will permanently stop your treatment with Ocrevus.

Infections

• You might get infections more easily with Ocrevus. The

  following infections have been seen in patients treated with Ocrevus in MS:

  ‑ Very common (may affect more than 1 in 10 people)

  ‑ sore throat and runny nose (upper respiratory tract

  infection)

  ‑ COVID‑19

  ‑ flu

  ‑ Common (may affect up to 1 in 10 people)

  ‑ sinus infection

  ‑ bronchitis (bronchial tube inflammation) ‑ herpes infection (cold sore or shingles)

  ‑ infection of the stomach and bowel (gastroenteritis) ‑ respiratory tract infection

  ‑ infection of the lungs (pneumonia) caused by

  COVID‑19 virus

  ‑ viral infection

  ‑ skin infection (cellulitis)

Some of them might be serious.

• Tell your doctor or nurse straight away if you notice any of these signs of infection:

  ‑ fever or chills

  ‑ cough which does not go away

  ‑ herpes (such as cold sore, shingles and genital sores)

  Other side effects:

  Very common (may affect more than 1 in 10 people) ● decrease in specific proteins in the blood (immunoglobulins)

  which help protect against infection

  Common (may affect up to 1 in 10 people)

  • discharge from the eye with itching, redness and swelling

    (conjunctivitis)

  • cough
  • a build‑up of thick mucus in the nose, throat or chest ● low levels of a type of white blood cell (neutropenia) Not known (it is not known how often these side effects happen)
  • a reduction in white blood cells which can be delayed

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ocrevus

Ocrevus will be stored by the healthcare professionals at the hospital or clinic under the following conditions: ● This medicine is to be kept out of the sight and reach of

children.

• This medicine is not to be used after the expiry date which

  is stated on the outer carton and the vial label after ‘EXP’. The expiry date refers to the last day of that month. ● This medicine is to be stored in a refrigerator (2 °C ‑ 8 °C). It

  is not to be frozen. The vials are to be kept in the outer carton to protect them from light.

Ocrevus must be diluted before it is given to you. Dilution will be done by a healthcare professional. It is recommended that the product is used immediately after dilution. If not used immediately, in‑use storage times and conditions prior to use are the responsibility of the healthcare professional and would normally not be longer than 24 hours at 2 °C ‑ 8 °C and subsequently 8 hours at room temperature.

Do not throw away any medicines via wastewater. These measures will help to protect the environment.

6. Contents of the pack and other information

What Ocrevus contains

• The active substance is ocrelizumab. Each vial contains

  300 mg of ocrelizumab in 10 mL at a concentration of 30 mg/mL.

• The other ingredients are sodium acetate trihydrate (see

  section 2 ‘Ocrevus contains sodium’), glacial acetic acid, trehalose dihydrate, polysorbate 20 and water for injections.

What Ocrevus looks like and contents of the pack

• Ocrevus is a clear to slightly opalescent, and colourless to

  pale brown solution.

• It is supplied as a concentrate for solution for infusion. ● This medicine is available in packs containing 1 or 2 vials

  (vials of 10 mL concentrate). Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Roche Products Limited

6 Falcon Way, Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

This leaflet was last revised in September 2026

The following information is intended for healthcare professionals only:

Read the SmPC for additional information.

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

Posology

• Initial dose

In adults, the initial 600 mg dose is administered as two separate intravenous infusions; first as a 300 mg infusion, followed 2 weeks later by a second 300 mg infusion (see Table 3).

In paediatric patients (aged 10 years and older), the initial dose is administered according to the patient’s body weight (see Table 4):

• Paediatric patients with body weight less than 35 kg: The

  initial 300 mg dose is administered as two separate intravenous infusions: first as a 150 mg infusion, followed 2 weeks later by a second 150 mg infusion.

• Paediatric patients with body weight 35 kg or more: The

  initial 600 mg dose is administered as two separate intravenous infusions: first as a 300 mg infusion, followed 2 weeks later by a second 300 mg infusion.

• Subsequent doses

In adults, subsequent doses of ocrelizumab thereafter are administered as a single 600 mg intravenous infusion every 6 months (see Table 3).

In paediatric patients (aged 10 years and older), subsequent doses of ocrelizumab thereafter are administered as a single intravenous infusion every 6 months according to the patient’s body weight (see Table 4):

• Paediatric patients with body weight less than 35 kg: 300 mg. ● Paediatric patients with body weight 35 kg or more: 600 mg.

Paediatric patients who start on a 300 mg dose and subsequently reach a stable body weight of 35 kg or more should be switched to the 600 mg dose. The first 600 mg dose will be given as 2 separate infusions (300 mg each), given 2 weeks apart. The next 600 mg doses will be given as a single infusion.

A minimum interval of 5 months should be maintained between each dose of ocrelizumab.

Figure 1 Dose and schedule of Ocrevus for adult patients and paediatric patients with body weight 35 kg or more

DOSE 1 SUBSEQUENT DOSES

DAY 1 DAY 15 EVERY 6 MONTHS

Figure 2 Dose and schedule of Ocrevus for paediatric patients with body weight less than 35 kg

DOSE 1 SUBSEQUENT DOSES

DAY 1 DAY 15 EVERY 6 MONTHS

150mg 150mg 300mg

Management of IRRs before the infusion

• Treatment should be initiated and supervised by an experienced healthcare professional with access to appropriate medical support to manage severe reactions such as serious infusion‑related reactions (IRRs), hypersensitivity reactions and/or anaphylactic reactions.

• Premedication for IRRs

  The two following premedications must be administered prior to each ocrelizumab infusion to reduce the frequency and severity of IRRs (Table 1):

  ‑ intravenous methylprednisolone (or an equivalent); ‑ antihistamine;

In addition, premedication with an antipyretic (e.g., paracetamol) may also be considered prior to each infusion.

• Hypotension, as a symptom of IRR, may occur during infusions. Therefore, withholding of antihypertensive treatments should be considered for 12 hours prior to and throughout each Ocrevus infusion. Patients with a history of congestive heart failure (New York Heart Association III & IV) were not studied.

Table 1 Premedication prior to Ocrevus IV Infusion

Instructions for dilution professional using aseptic technique. Do not shake the vial. A sterile needle and syringe should be used to prepare the diluted infusion solution.

• The product is intended for single use only.
• Concentrate may contain fine translucent and/or reflective particles associated with enhanced opalescence. Do not use the concentrate if discoloured or if the concentrate contains foreign particulate matter.
• Medicinal product must be diluted before administration.
• The diluted infusion solution must be administered using an infusion set with a 0.2 or 0.22 micron in‑line filter. ● Prior to the start of the intravenous infusion, the content of the infusion bag should be at room temperature to avoid an infusion reaction due to the administration of the solution at low temperatures.

Table 2 Dilution of Ocrevus

Method of administration

• After dilution, treatment is administered as an intravenous infusion through a dedicated line.

• Infusions should not be administered as an intravenous push or bolus.

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Table 3 Dose and schedule for adult patients

Table 4 Dose and schedule for paediatric patients

(aged 10 years and older)

Management of IRRs during and after the infusion

Patients should be monitored during the infusion and for at least one hour after the completion of the infusion.

During the infusion

• Infusion adjustments in case of IRRs

In case of IRRs during any infusion, see the following adjustments.

Life-threatening IRRs

If there are signs of a life threatening or disabling IRR during an infusion, such as acute hypersensitivity or acute respiratory distress syndrome the infusion must be stopped immediately and the patient should receive appropriate treatment. The infusion must be permanently discontinued in these patients.

Severe IRRs

If a patient experiences a severe IRR (such as dyspnoea) or a complex of flushing, fever, and throat pain symptoms, the infusion should be interrupted immediately and the patient should receive symptomatic treatment. The infusion should be restarted only after all symptoms have resolved. The initial infusion rate at restart should be half of the infusion rate at the time of onset of the reaction. No infusion adjustment is necessary for subsequent new infusions, unless the patient experiences an IRR.

Mild to moderate IRRs

If a patient experiences a mild to moderate IRR (e.g., headache), the infusion rate should be reduced to half the rate at the onset of the event. This reduced rate should be maintained for at least 30 minutes. If tolerated, the infusion rate may then be increased according to the patient’s initial infusion rate. No infusion adjustment is necessary for subsequent new infusions, unless the patient experiences an IRR.

• Patients who experience severe pulmonary symptoms, such as bronchospasm or asthma exacerbation, must have their infusion interrupted immediately and permanently. After administering symptomatic treatment, monitor the patient until the pulmonary symptoms have resolved because initial improvement of clinical symptoms could be followed by deterioration.

• Hypersensitivity may be clinically indistinguishable from an

  IRR in terms of symptoms. If a hypersensitivity reaction is suspected during infusion, the infusion must be stopped immediately and permanently.

After the infusion

• Patients should be observed for at least one hour after the completion of the infusion for any symptom of an IRR. ● Physicians should alert patients that an IRR can occur within

  24 hours of infusion.

Shelf life

Unopened vial

2 years

Diluted solution for intravenous infusion

• Chemical and physical in‑use stability has been

  demonstrated for 24 hours at 2‑8 °C and subsequently 8 hours at room temperature.

• From a microbiological point of view, the prepared infusion should be used immediately. If not used immediately, in‑use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2‑8 °C and subsequently 8 hours at room temperature, unless dilution undertaken in controlled and validated aseptic conditions.

• In the event an intravenous infusion cannot be completed the same day, the remaining solution should be discarded.

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