Safety demonstrated in ORATORIO

For complete safety information, please see the full Prescribing Information

Common adverse events (≥5% and higher than placebo)
Common adverse events (greater than or equal to 5% and higher than placebo) in ORATORIO with OCREVUS vs placebo.
Warnings and precautions for OCREVUS
  • Infusion reactions: Management recommendations for infusion reactions depend on the type and severity of the reaction. Permanently discontinue OCREVUS if a life-threatening or disabling infusion reaction occurs
  • Infections: Delay OCREVUS administration in patients with an active infection until the infection is resolved
  • Malignancies: An increased risk of malignancy, including breast cancer, may exist with OCREVUS. Further safety assessments are ongoing

Important safety considerations

A higher proportion of patients treated with OCREVUS experienced infections.

Patients who experienced 1 or more infections
Patients who experienced one or more infections during ORATORIO clinical trial, OCREVUS 70% vs placebo 68%.
  • Upper respiratory tract infections occurred in 49% of OCREVUS-treated patients and 43% of patients on placebo
  • Lower respiratory tract infections occurred in 10% of OCREVUS-treated patients and 9% of patients on placebo
  • Herpes infections occurred in 5% of OCREVUS-treated patients and 4% of patients on placebo
  • These infections were mainly mild to moderate

OCREVUS did not increase the risk of serious infections, though serious infections have occurred. Delay OCREVUS treatment in patients with active infection.

Reported malignancies

An increased risk of malignancy, including breast cancer, may exist with OCREVUS. Patients should follow standard breast cancer screening guidelines. Further safety assessments are ongoing.

Infusion-related reactions (IRRs) associated with OCREVUS

RATES OF IRRs DURING THE OPERA TRIALS 4

IRR rates in ORATORIO were comparable to those in the OPERA I and II clinical trials. 

6-month dosing schedule

The first dose of OCREVUS is administered as two 300 mg IV infusions 2 weeks apart. Subsequent doses are administered as a single 600 mg infusion every 6 months.

Comprehensive safety information

See the complete safety information, including clinical trial experience in RMS and PPMS, in the OCREVUS full Prescribing Information.