What is Ocrevus (ocrelizumab) for?
Ocrevus (ocrelizumab) is a CD20-directed cytolytic antibody indicated for the treatment of people with relapsing or primary progressive forms of multiple sclerosis (MS)1,4. It is the first approved treatment for the primary progressive form of MS2.
Relapsing MS (RMS) is characterized by episodes of worsening function (relapses) which are initially followed by recovery periods (remissions). In its primary progressive form (PPMS), MS is characterized by steadily worsening function from the onset of symptoms, often without early relapses or remissions2.
How does Ocrevus (ocrelizumab) work?
MS is a chronic, inflammatory, autoimmune disease that affects the central nervous system, and in particular the communication between the brain and other parts of the body2. The patient’s own immune system is supposed to be the cause of the damage to neurons3.
The precise mechanism by which ocrelizumab exerts its therapeutic effects in multiple sclerosis is unknown, but is presumed to bind to a type of antigen, named CD20, found on the surface of some antibodies (pre-B and mature B lymphocytes) and induce their death2. In this way, it is supposed to prevent these antibodies from damaging neurons.
Where has Ocrevus (ocrelizumab) been approved?
Ocrevus (ocrelizumab) was approved for relapsing or primary progressive forms of multiple sclerosis (MS) by:
Food and Drug Administration (FDA), USA, March 28, 20171
European Medical Agency (EMA), European Union, January 11, 20175
Therapeutic Goods Administration (TGA), Australia, July 13, 20174
Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.
How is Ocrevus (ocrelizumab) taken?
The standard dosage is1,4,5:
Starting dose of 300 mg intravenous infusion, followed two weeks later by a second 300 mg intravenous infusion
Subsequent doses of 600 mg intravenous infusion every 6 months.
Patients should be monitored closely during and for at least one hour after infusion as infusion reactions may be possible.
Complete information about Ocrevus (ocrelizumab) dosage and administration can be found in the official prescribing information listed in our resources section1,4,5.
Note: Please consult with your treating doctor for personalised dosing.
Are there any known adverse reactions or side effects of Ocrevus (ocrelizumab)?
Common Adverse Reactions
Relapsing MS
The most common adverse reactions listed in the prescribing information include1,4,5:
upper respiratory tract infections
infusion reactions.
Primary progressive MS
The most common adverse reactions listed in the prescribing information include1,4,5:
upper respiratory tract infections
infusion reactions
skin infections
lower respiratory tract infections.
Serious adverse reactions
The serious adverse reactions listed in the prescribing information include1,4,5:
serious infusion reactions requiring hospitalisation
infections: administration should be delayed in patients with an active infection until the infection is resolved.
an increased risk of malignancy, including breast cancer, may exist.
Use in a specific population
Ocrevus (ocrelizumab) can cause fetal harm, it is advised to avoid pregnancies1 unless the potential benefit to the mother outweighs the potential risk to the foetus4,5. It is unknown whether ocrelizumab/metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. Women should be advised to discontinue breastfeeding during Ocrevus (ocrelizumab) therapy1,4,5.
Patients in a severely immunocompromised state must not be treated until the condition resolves1,4,5.
For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information1,4,5.