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IV = Intravenous, SC = Subcutaneous
Safety Data Sheets:
Healthcare Provider Letters:
Safety Topic: Administration-Related Adverse Events
The information in this section may include content beyond what is in the FDA-approved label. Because the US Food and Drug Administration (FDA) has not approved such content, no conclusions regarding safety or efficacy may be made. Providing this information should not be construed as a recommendation for use of a Genentech product for unapproved uses. For FDA-approved products, please consult the full prescribing information for a complete discussion of risks and benefits of the product(s) for its approved indication(s).
Ocrelizumab Routes of Administration
Ocrelizumab is available in two routes of administration - subcutaneous (SC) and intravenous (IV).
- Adverse events specific to each route of administration are reported below.
Injection Reactions for Subcutaneous Ocrelizumab (OCARINA II)
Injection Reactions in the OCARINA II Study Were Mild to Moderate
In the OCARINA II Study, Week 48, all injection reactions with ocrelizumab SC were nonserious and mild to moderate (Grade 1 or 2) in severity1
Most patients did not need treatment for injection reactions1
Injection Reactions from the OCARINA II Study by Dose and Severity (Week 48)1
OCARINA II: Local and Systemic Injection Reaction Symptoms
The most common symptoms of local injection reactions with ocrelizumab SC were1-3:
The nature of the local injection reaction symptoms did not depend on their time to onset.1-3
Median symptom size decreased on subsequent injections1-3
- Erythema median size: from 2.36 in to 1.97 in
- Swelling median size: from 3.94 to 2.76 in
The most common symptoms of systemic injection reactions were1-3:
The nature of the systemic injection reactions symptoms did not depend on their time to onset1,3
Most systemic injection reactions (81.8%) resolved in <3 days
Infusion Reactions for Intravenous Ocrelizumab (OPERA I and II)
Infusion Reactions with Ocrelizumab IV in Relapsing Multiple Sclerosis: Over 9 Years of Data from OPERA OLE
Infusion reactions were the most common adverse events in the ocrelizumab IV OPERA I/II studies4
35.2% of patients in the OPERA OLE study reported at least 1 IRR over 9 years of follow-up.4
Infusion reactions were typically mild to moderate, were most frequent with the first infusion, and decreased with subsequent doses4
Ocrelizumab IV and Infusion Reactions from the OPERA I and II Studiesᵃ and OLE by Dose and Severity4
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