What’s on this page:
- OCREVUS (ocrelizumab) can
cause infusion-related reactions that can be serious and require
- 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 reaction rates in ORATORIO (PPMS) were similar to
those in the OPERA I and II (RMS) clinical trials
See relapsing multiple sclerosis infusion-related
PATIENTS WHO EXPERIENCED 1 OR MORE INFECTIONS
- 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, although serious infections have
SERIOUS INFECTION RATES VS PLACEBO: 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 relapsing multiple sclerosis infection
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.
§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 associated LTE), 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.
Breast cancer screening recommendation 41
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
- The risks of and the potential benefits of
mammograms should be considered and discussed with the patient’s
- Breast MRI also has a role in screening for some
patients (decision should be made in consultation with a breast
- Screening should continue as long
as a woman is in good health and is expected to live 10 more years
- 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
For complete safety information, please see the full Prescribing Information.
COMMON ADVERSE EVENTS (≥5% AND HIGHER THAN PLACEBO)
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 due to lower extremity findings. Patients also had no history of RMS, SPMS, or PRMS.
See relapsing multiple sclerosis common adverse events data.
EDSS=Expanded Disability Status Scale; FSS=Functional Systems Score; IRR=infusion-related reaction; OCR=OCREVUS; OLE=open-label extension; PPMS=primary progressive multiple sclerosis; PRMS=progressive relapsing multiple sclerosis; PY=patient years; RMS=relapsing multiple sclerosis; SEER=Surveillance, Epidemiology, and End Results; SPMS=secondary progressive multiple sclerosis; UTI=urinary tract infection.