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Infusion-related reactions 3,14

  • OCREVUS (ocrelizumab) can cause infusion-related reactions that can be serious and require hospitalization
    • 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
  • In clinical studies, all patients received premedications for infusion-related reactions before treatment with OCREVUS. In these studies, the rate of infusion-related reactions was 34%-40%
  • Infusion-related reactions were highest with the first infusion
INFUSION-RELATED REACTIONS OVER TIME IN RMS

See primary progressive multiple sclerosis infusion-related reaction data.

Observed rates of infection 3,15

PATIENTS WHO EXPERIENCED 1 OR MORE INFECTIONS
  • 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, although serious infections have occurred
SERIOUS INFECTION RATES VS REBIF: PHASE III TRIAL AND OLE
Serious Infection Rates: All-exposure population*
  • OCREVUS did not increase the risk of serious infections vs. Rebif or placebo, though serious infections have occurred
  • The most common serious infections were UTIs and pneumonia
    • In the OCREVUS all-exposure population, the rate per 100 PY of serious infections as of July 2018 (2.01 [95% CI : 1.77-2.27]) was similar to the rate observed at the primary analysis cutoff date.
*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, OBOE, and ENSEMBLE.

See primary progressive multiple sclerosis infection rate data.

Reported malignancies: additional important safety information 3,15-17

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

AGE-STANDARDIZED INCIDENCE RATE OF FEMALE BREAST CANCER OVER OCREVUS STUDIED POPULATIONS AND SEER POPULATION (PER 100 PY)

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, OBOE, and ENSEMBLE.

§SEER incidence calculated from 2000-2012 data.

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, as well as differences in sample size, temporal changes, and other potential confounding factors.

The FDA recommends that OCREVUS patients follow standard breast cancer screening guidelines
AMERICAN CANCER SOCIETY RECOMMENDATIONS
  • Women under 40 with risk factors for breast cancer (genetic or environmental) should ask their HCP whether mammograms are advisable and how often to have them
  • The risks of and the potential benefits of mammograms should be considered and discussed with the patient’s HCP
  • Breast MRI also has a role in screening for some patients (decision should be made in consultation with a breast cancer specialist)
  • Screening should continue as long as a woman is in good health and is expected to live 10 more years or longer
  • Other screening guidelines from federally recognized sources (eg, the US Preventive Services Task Force, the Centers for Disease Control and Prevention) may be used based on HCP preference and in consultation with their patient

Common adverse events (AEs) 3,5

For complete safety information, please see the full Prescribing Information.

Safety demonstrated in head-to-head clinical trials vs Rebif in RMS

  • In Phase III trials, the most common adverse events were infusion-related reactions and infections (eg, upper respiratory tract infections)
  • Rates of other common AEs were similar between OCREVUS and Rebif
  • OCREVUS did not increase the risk of serious infections, although serious infections have occurred
COMMON ADVERSE EVENTS (≥5% AND HIGHER THAN REBIF)

OPERA I and II (RMS): Two randomized, double-blind, double-dummy, active comparator–controlled clinical trials of identical design vs Rebif in 1656 patients (OCREVUS; OPERA I [n=410], OPERA II [n=417]; Rebif; OPERA I [n=411], OPERA II [n=418]) with RMS treated for 96 weeks. Both studies included patients who had experienced ≥1 relapse within the prior year, or ≥2 relapses within the prior 2 years, and had an EDSS score between 0 and 5.5.

See primary progressive multiple sclerosis common adverse events data.

Dosing and administration

Visit the OCREVUS dosing schedule for your patients.

Request information

Speak to an OCREVUS Representative to learn more about OCREVUS.

OCR=OCREVUS; OLE=open-label extension; PY=patient years; RMS=relapsing multiple sclerosis; SEER=Surveillance, Epidemiology, and End Results.