|Frequency:||At the beginning of treatment, there are two doses separated by 14 days. After that, there is a single infusion every 6 months.|
|TGA approval date:||Jul 2017|
|PBS listed:||Yes for relapsing-remitting MS only|
|Mechanism of action||Ocrevus is a humanised monoclonal antibody, which stops the growth of the CD20-positive B lymphoma cells. These cells play a major role in damaging nerve cells and the myelin around the nerves.|
|Clinical trial results||46% reduction in annualised relapse rate
94% reduction in new active lesions
77%-83% reduction in new/enlarging T2 lesions
15-23% reduction in brain volume loss
40% reduction in disability risk
These numbers are in comparison to a control group treated with interferon beta-1a. Previous clinical trials of earlier medications were compared to a placebo treatment group.
|Safe in Pregnancy||Avoid treatment during pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus. Women of childbearing potential should use effective contraception during treatment and for 6 months after the last infusion.|
|Breastfeeding (information predominatly from LACTMED database)||Women are advised to discontinue breastfeeding during therapy. Research in laboratory models has shown that Ocrevus is excreted in breastmilk.
No information is available on the clinical use of ocrelizumab during breastfeeding. Because ocrelizumab is a large protein molecule, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant’s gastrointestinal tract. Until more data become available, ocrelizumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant.
|Potential side effects (not a comprehensive list)||Infusion-related reactions and upper respiratory tract infections, which were mostly mild to moderate in severity.
Potential serious side effects may include infusion-related reactions, infections and malignancies (e.g. breast cancer) where only routine screening is required based on age and medical history.