Restarting Ocrevus after a Prolonged Interruption of Therapy
This article responds to your request for information on restarting Ocrevus® (ocrelizumab) after a prolonged interruption of therapy.
Last updated September 21, 2023
Summary
- Roche does not have a recommendation on restarting Ocrevus after a prolonged interruption of therapy.
- No formal studies have been conducted to determine the risk of infusion-related reactions after one or more missed doses of Ocrevus.
Ocrevus dosing recommendations
First and subsequent doses
The recommended dose of Ocrevus is 600 mg every six months: [1]
- The first dose is administered as two separate 300 mg IV infusions two weeks apart.
○ This is to reduce the incidence of infusion-related reactions (IRRs).
- Subsequent doses are administered as a single 600 mg IV infusion every 6 months.
Please refer to the locally approved prescribing information for further information on Ocrevus.
Roche is unable to provide treatment recommendations for individual patients. Any decision on administering Ocrevus after a prolonged interruption of therapy will be a clinical decision, taking into consideration individual risk-benefit. Appropriate clinical caution and monitoring is recommended.
The impact of missed doses of Ocrevus in clinical trials
Patients who miss one or more doses of Ocrevus may have a higher risk of IRRs due to B cell repletion. However, based on limited data from the pivotal studies in multiple sclerosis, there is no evidence that after one or more missed Ocrevus doses: [2,3]
- The administration of Ocrevus as a single 600 mg infusion will increase the risk of an IRR, nor
- The re-initiation of Ocrevus treatment with two separate 300 mg infusions will mitigate the potentially higher risk of an IRR.
References
- Roche Internal Regulatory Report.
- Hauser S, Bar-Or A, Comi G, et al. Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis. N Engl J Med 2017;376:221-234. https://www.ncbi.nlm.nih.gov/pubmed/28002679
- Montalban X, Hauser S, Kappos L, et al. Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis. N Engl J Med 2017;376:209-220. https://www.ncbi.nlm.nih.gov/pubmed/28002688
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