Over 4 years of safety experience in clinical trials

ADVERSE EVENTS PER 100 PY (95% CI) IN OCREVUS PIVOTAL TRIAL POPULATION 10*
Adverse events per 100 patient years in OCREVUS pivotal trial population

For complete safety information, please see the full Prescribing Information

*Includes patients who received any dose of OCREVUS during the controlled treatment and associated OLE periods of the Phase II and Phase III studies; data from patients who were originally randomized to a comparator (Rebif or placebo) are included after the switch to open-label OCREVUS treatment.
Multiple occurrences of the same adverse event (except for malignancies) in 1 patient are counted multiple times. Rate per 100 PY (95% CI) cutoff September 2017.
Includes non-melanoma skin cancer as per MedDRA. Reported as incidence rate per 100 PY of first malignancy.
§Serious infections are defined using adverse events falling into the MedDRA SOC Infections and Infestations, and using “Is the event non-serious or serious?” from the adverse event case report form.

ORATORIO (PPMS): A randomized, double-blind, placebo-controlled clinical trial in 732 patients (OCREVUS, n=488; placebo, n=244) with PPMS treated for at least 120 weeks. Selection criteria included patients aged 18 to 55 and required a baseline EDSS of 3 to 6.5 and a score of 2 or greater for the EDSS pyramidal FSS; FSS=Functional Systems Scale due to lower extremity findings. Patients also had no history of RMS, SPMS, or PRMS. 3

PY=patient-years; MedDRA=Medical Dictionary for Regulatory Activities.

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 OPERA 1 and 2 clinical trials
  • Upper respiratory tract infections occurred in 40% of OCREVUS-treated patients and 33% of Rebif-treated patients
  • Lower respiratory tract infections occurred in 8% of OCREVUS-treated patients and 5% of Rebif-treated patients
  • Herpes infections occurred in 6% of OCREVUS-treated patients and 4% of Rebif-treated patients
  • 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.

An increased risk of malignancy, including breast cancer, may exist in OCREVUS-treated patients

AGE-STANDARDIZED INCIDENCE RATE PER 100 PY OF FEMALE BREAST CANCER OVER TIME OF THE OCREVUS ALL-EXPOSURE POPULATION AND SEER POPULATION 11

* Includes patients who received any dose of OCREVUS during the controlled treatment and associated OLE periods of the Phase II and Phase III studies.
Includes patients who received any dose of OCREVUS during the controlled treatment and associated OLE periods of the Phase II and Phase III studies, plus VELOCE, CHORDS, CASTING, and OBOE (as of September 2017; clinical cut-off date for OBOE: June 2017).

  • As of September 2017, the age-standardized incidence rate of breast cancer in the OCREVUS all-exposure population was 0.20 (95% CI 0.10-0.40) per 100 PY and included patients from controlled treatment and associated OLE periods of the Phase II and Phase III studies, plus VELOCE, CHORDS, CASTING, and OBOE (as of September 2017; clinical cut-off date for OBOE: June 2017)
  • The Surveillance, Epidemiology, and End Results (SEER) Program of the National Cancer Institute (NCI) is an authoritative source of information reporting data on cancer incidence in ≈28% of the general US (non-MS specific) population
  • No comparisons should be made due to limitations which have not been fully accounted for, such as variations in patient populations (eg, risk factors, diagnostic criteria, geographical differences), as well as differences in sample size, temporal changes, and other potential confounding factors
  • More data is being collected as a postmarketing commitment to further study the malignancy risk of OCREVUS

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.