What is the best course of action for a patient who missed an Ocrevus (ocrelizumab) infusion?

From the Guidelines

If a patient is 3 months late for an Ocrevus 600mg infusion, they should receive the full 600 mg dose as soon as possible, with subsequent doses given 6 months from this new infusion date. This approach is based on the mechanism of action of Ocrevus, which depletes B cells that contribute to multiple sclerosis disease activity, and the importance of maintaining therapeutic levels to prevent disease reactivation 1. The patient should not attempt to compensate for the missed dose by doubling up, and prior to rescheduling, they may need to undergo screening tests again, including infection screening, as Ocrevus affects the immune system. Key considerations include:

• The time elapsed since the last infusion, which in this case is 3 months, is less than 6 months, allowing for the administration of the full 600 mg dose without needing to restart the initial dosing regimen.
• The importance of maintaining the treatment schedule to prevent disease reactivation and ensure continued therapeutic efficacy.
• The need for the healthcare provider to determine the exact approach based on the patient's specific situation, disease activity, and time elapsed since the last infusion, taking into account the patient's overall health and any potential risks associated with the treatment. Some key points to consider when managing a missed Ocrevus infusion include:
• The patient's disease activity and history of multiple sclerosis
• The potential risks and benefits of resuming treatment, including the risk of infection and the importance of maintaining therapeutic levels of Ocrevus
• The need for regular monitoring and follow-up to ensure the patient's safety and the efficacy of the treatment. In general, the management of a missed Ocrevus infusion should prioritize the patient's safety and the prevention of disease reactivation, while also considering the potential risks and benefits of resuming treatment 1.

From the FDA Drug Label

If a planned injection of OCREVUS ZUNOVO is missed, administer OCREVUS ZUNOVO as soon as possible; do not wait until the next scheduled dose. Reset the dose schedule to administer the next sequential dose 6 months after the missed dose is administered. Doses of OCREVUS ZUNOVO must be separated by at least 5 months [see Dosage and Administration (2.4)].

The patient should receive the missed dose of Ocrevus (600mg infusion is not mentioned in the label, but the standard dose is 920 mg/23,000 units or 600mg for the initial doses given in two 300mg infusions) as soon as possible. The next dose should be administered 6 months after the missed dose is given, ensuring that doses are separated by at least 5 months 2.

From the Research

Missed Ocrevus Infusion

• If a patient misses an Ocrevus (ocrelizumab) infusion, there is no clear guidance on the best course of action, as the provided studies do not directly address this issue 3, 4, 5.
• However, a study on personalized ocrelizumab treatment in Multiple Sclerosis during the SARS-CoV-2 pandemic suggests that a delayed infusion schedule may not compromise the short-term efficacy of ocrelizumab 6.
• In this study, 56 patients experienced a delay in treatment, with a mean infusion delay of 103.1 days, and none of the patients presented relapses or active disease at MRI at the end of the observation period 6.
• Another study reviewed patient information leaflets and summaries of product characteristics, and found that advice on missed doses is generally inadequate, with only 9% of medicines providing specific instructions 7.
• The same study found that pharmaceutical companies and regulatory authorities should produce clear and concise instructions on what patients should do if they miss doses, with supporting evidence where necessary 7.

Infusion-Related Reactions

• Infusion-related reactions (IRRs) are a common adverse event associated with ocrelizumab treatment, with 34.3% of patients experiencing IRRs in the pooled OPERA and ORATORIO populations 4.
• The majority of IRRs are mild to moderate in severity, and can be effectively managed through infusion rate adjustment and symptomatic treatment 4.
• Premedication use, particularly antihistamines, is associated with fewer IRRs 4.

Treatment Guidance

• Patients who miss an Ocrevus infusion should consult their healthcare provider for guidance on the best course of action, as the decision to delay or resume treatment should be made on a case-by-case basis 6.
• Healthcare providers may consider factors such as the patient's disease severity, SARS-CoV-2 infection risk profile, and immunophenotype when making decisions about delayed treatment 6.