Product Description:

• 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)

What is multiple sclerosis:

• Multiple sclerosis ( MS ) affects the central nervous system , especially the nerves in the brain and spinal cord.


• When you have MS , the immune system (the body's defense system) malfunctions and attacks a protective layer (called the myelin sheath) around the nerve cells, causing inflammation.


• Breakdown of the myelin sheath prevents the normal functioning of the nerves.


• 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 blurred vision, reduced coordination and bladder problems.

In relapsing forms of MS:

• The patient has repeated attacks (relapses) of symptoms. 


• The symptoms can appear quickly, within a few hours, or slowly over several days. 


• The symptoms disappear or improve between relapses, but damage can build up and lead to permanent functional impairment.

In primary progressive MS:

• The symptoms will generally continue to worsen from the time the disease first appears.

How does Ocrevus work:

• Ocrevus attaches to specific B cells, which are a type of white blood cell that is part of the immune system and plays a role in MS.


• Ocrevus attacks and removes these specific B cells.


• This reduces the inflammation and the attack on the myelin sheath, reduces the chances of relapse and slows down the course of the disease.

In relapsing forms of MS (RMS):

• Ocrevus helps to significantly reduce the number of attacks (relapses) and significantly delay the worsening of the disease. 


• Ocrevus also significantly increases the chances that a patient will not experience any signs of disease activity (changes in the brain, relapse and deterioration of functional capacity).

In primary progressive MS (PPMS):

• Ocrevus helps slow the progression of the disease and limits the deterioration of walking speed.

How To Use:

• A doctor or nurse experienced in this type of treatment will give you Ocrevus. 


• They will watch you closely while you receive this medicine. 


• This is in case you experience any side effects.


• You will always receive Ocrevus as a drip ( intravenous infusion).

Other medicines you receive before you receive Ocrevus:

• Before receiving Ocrevus, you will be given other medicines to prevent or reduce possible side effects, such as infusion-related reactions.


• You will be given a corticosteroid and an antihistamine before each infusion, and you may be given antipyretic medicines.

How much and how often you will be given Ocrevus:

• You will receive a total dose of 600 mg of Ocrevus every 6 months.


• The first 600 mg dose of Ocrevus is given as two separate infusions (of 300 mg each), given 2 weeks apart. Each infusion lasts approximately 2 hours and 30 minutes.


• The next 600 mg doses of Ocrevus are given as a single infusion. 


• Depending on the rate of successive infusions, each infusion will either last approximately 3 hours 30 minutes or 2 hours.

How Ocrevus will be given:

• You will be given Ocrevus by a doctor or nurse. 


• It is given as an infusion into a vein ( intravenous infusion or IV infusion).


• You will be monitored closely while receiving Ocrevus and for at least one hour after receiving the infusion.


• It is done in case you get any side effects, such as infusion-related reactions. 


• The infusion may be slowed, temporarily stopped or permanently stopped if you experience an infusion-related reaction, depending on the severity.

If you miss an Ocrevus infusion:

• If you miss an Ocrevus infusion, talk to your doctor to get it as soon as possible. Do not wait until the next scheduled infusion.


• To get the full benefit of Ocrevus, it is important that you receive each infusion as scheduled.

If you stop treatment with Ocrevus:

• It is important to continue the treatment as long as you and your doctor have assessed that it is helping you.


• Some side effects may be due to low B-cell levels.


• When you stop treatment with Ocrevus, you may still experience side effects until your B cells return to normal. 


• The B cells in your blood will gradually increase to normal levels. 


• This can take anywhere from six months to two and a half years, or in rare cases up to several years.


• Before starting other medicines, you should tell your doctor when you had your last infusion of Ocrevus.


• Ask your doctor if you have any questions about the use of this medicine.

Warnings And Precautions:

You must not receive Ocrevus:

• If you are allergic to ocrelizumab or any of the other ingredients of this medicine.


• If you have an infection .


• If you have been told that you have serious problems with your immune system.


• If you have cancer .


• If you are not sure, talk to your doctor before receiving ocrevus.

Talk to your doctor before being given Ocrevus if any of the following apply to you. 

Your doctor may choose to delay treatment with Ocrevus or decide that you cannot receive Ocrevus if:

• You have an infection.Your doctor will wait until the infection is gone before you can receive Ocrevus.


• You have ever had hepatitis B or are a carrier of the hepatitis B virus. 


• The reason is that other medicines such as Ocrevus can cause the hepatitis B virus to become active again.


• Before you are treated with Ocrevus, your doctor will examine whether there is any risk that you may develop a hepatitis B infection.


• Patients who have had hepatitis B or are carriers of the hepatitis B virus take a blood test and are followed up by a doctor to look for signs of hepatitis B infection .


• You have cancer or have previously had cancer.


• Your doctor may choose to delay treatment with Ocrevus.

Effect on the immune system:

Diseases that affect your immune system: 

• If you have another disease that affects your immune system. You may not be able to get ocrevus.

Medicines that affect the immune system: 

• If you have taken, are taking, or plan to take medicines that affect the immune system - such as chemotherapy, medicines that inhibit the immune system or other medicines for MS.


• Your doctor may choose to delay treatment with Ocrevus or ask you to stop taking such medicines before you are treated with Ocrevus. 

Infusion-related reactions:

• Infusion-related reactions are the most common side effects of treatment with Ocrevus.


• Talk to your doctor or nurse immediately if you get an infusion-related reaction.


• Infusion-related reactions can occur during the infusion or up to 24 hours after the infusion.


• To reduce the risk of an infusion-related reaction, your doctor will give you some other medicines before each Ocrevus infusion.


• You will be monitored closely during the infusion and for at least one hour after the infusion has been given.

Infections:

• Talk to your doctor before receiving Ocrevus if you think you have an infection. 


• Your doctor will wait until the infection is over before giving you Ocrevus.


• With Ocrevus you may find that you get infections more easily.


• The reason for this is that the same immune cells that Ocrevus targets can also fight infections.


• Before you start treatment with Ocrevus and before subsequent infusions, your doctor may take a blood test to check your immune system, as infections may occur more often if you have severe problems with your immune system.


• If you receive Ocrevus for primary progressive MS and have difficulty swallowing, Ocrevus may increase the risk of severe pneumonia.

Talk to your doctor or nurse immediately if you experience any of the following signs of infection during or after treatment with Ocrevus:

• Fever or chills


• Cough that won't go away


• Herpes (such as cold sores, shingles or genital sores)

Talk to a doctor or nurse immediately if you think your MS is getting worse or you notice new symptoms:

• The reason for this is that a very rare and life-threatening brain infection called progressive multifocal leukoencephalopathy (PML) can have symptoms similar to those seen in MS.


• PML can occur in patients who have taken Ocrevus.


• Talk to your partner or next of kin about treatment with Ocrevus. 


• They may detect symptoms of PML that you don't see, but which the doctor needs to investigate further, such as memory loss, difficulty thinking, walking difficulties, vision loss and changes in the way you speak.

Vaccines:

• Talk to your doctor if you have recently received a vaccine or are likely to receive a vaccine in the near future.


• While you are being treated with Ocrevus, you should not receive live or weakened vaccines (for example BCG against tuberculosis or vaccines against yellow fever ).


• It is possible that the doctor will recommend that you get a vaccine against seasonal flu.


• The doctor will check whether you need any vaccines before starting treatment with Ocrevus.


• All vaccines must be given at least 6 weeks before starting treatment with Ocrevus.

Children and youth:

• Ocrevus is not intended for use in children and adolescents under the age of 18. 


• The reason is that no studies have been conducted with this age group.

Driving and using machines:

• It is unknown whether Ocrevus affects the ability to drive, use tools or use machines. 


• The doctor will inform you if your MS disease may affect your ability to safely drive or use tools and machines.

Ingredients:

• The active substance is OCRELIZUMAB. 


• Each 10 ml vial contains 300 mg of ocrelizumab at a concentration of 30 mg/ml.

What Ocrevus looks like and contents of the pack:

• Ocrevus is a clear to slightly opalescent, colorless to slightly brown colored solution.


• It is supplied as a concentrate for infusion solution.

Product Details:

• Product Type: Vials
• Brand: Ocrevus
• Product Form: Vials