OCREVUS Indication and Important Safety Information

OCREVUS Indication and Important Safety Information


What is OCREVUS? OCREVUS is a prescription medicine used to
treat: Relapsing forms of multiple sclerosis
(MS), to include clinically isolated syndrome, relapsing-remitting disease,
and active secondary progressive disease, in adults
Primary progressive MS, in adults. It is not known if OCREVUS is safe or effective
in children.
Who should not receive OCREVUS? Do not receive OCREVUS if you have an active
hepatitis B virus (HBV) infection. Do not receive OCREVUS if you have had a life
threatening allergic reaction to OCREVUS. Tell
your healthcare provider if you have had an allergic reaction to OCREVUS or any of its
ingredients in the past. What is the most important information I
should know about OCREVUS? OCREVUS can cause serious side effects,
including: Infusion reactions: OCREVUS can cause
infusion reactions that can be serious and require
you to be hospitalized. You will be monitored during your infusion and for at least 1 hour
after each infusion of OCREVUS for signs and
symptoms of an infusion reaction. Tell your healthcare provider or nurse if
you get any of these symptoms:
itchy skin rash hives
tiredness coughing or wheezing
trouble breathing throat irritation or pain
feeling faint fever
redness on your face (flushing) nausea
headache swelling of the throat
dizziness shortness of breath
fatigue fast heart beat
These infusion reactions can happen for up to
24 hours after your infusion. It is important that
you call your healthcare provider right away if you
get any of the signs or symptoms listed above after each infusion.
If you get infusion reactions, your healthcare provider may need to stop or slow down the
rate of your infusion.
Infection: OCREVUS increases your risk of getting
upper respiratory tract infections, lower respiratory tract infections, skin infections,
and herpes infections. Tell your healthcare provider if you have an
infection or have any of the following signs of infection including fever, chills,
a cough that does not go away, or signs of
herpes (such as cold sores, shingles, or genital sores). These signs can happen
during treatment or after you have received your last dose of OCREVUS. If
you have an active infection, your healthcare provider should delay your
treatment with OCREVUS until your infection is gone.
Progressive Multifocal Leukoencephalopathy (PML): Although
no cases have been seen with OCREVUS treatment in clinical trials, PML may
happen with OCREVUS. PML is a rare brain infection that usually leads to death
or severe disability. Tell your healthcare provider right away if you have any new
or worsening neurologic signs or symptoms. These may include problems
with thinking, balance, eyesight, weakness on 1 side of your body,
strength, or using your arms or legs. Hepatitis B virus (HBV)
reactivation: Before starting treatment with OCREVUS, your healthcare provider
will do blood tests to check for hepatitis B
viral infection. If you have ever had hepatitis B virus infection, the hepatitis
B virus may become active again during or
after treatment with OCREVUS. Hepatitis B virus becoming active again (called
reactivation) may cause serious liver problems including liver failure or death.
Your healthcare provider will monitor you if you are at risk for hepatitis B virus
reactivation during treatment and after you stop receiving OCREVUS.
Weakened immune system: OCREVUS taken before or after other medicines that weaken
the immune system could increase your risk of
getting infections.
Before receiving OCREVUS, tell your healthcare provider about all of your medical
conditions, including if you: have ever taken, take, or plan to take
medicines that affect your immune system, or other treatments for MS.
have ever had hepatitis B or are a carrier of the hepatitis B virus.
have had a recent vaccination or are scheduled to receive any vaccinations.
You should receive any required ‘live’ or ‘liveattenuated’
vaccines at least 4 weeks before you start
treatment with OCREVUS. You should not receive ‘live’ or ‘live
attenuated’ vaccines while you are being treated with OCREVUS
and until your healthcare provider tells you that your immune
system is no longer weakened. When possible, you should
receive any ‘non-live’ vaccines at least 2 weeks before you
start treatment with OCREVUS If you would like to receive any
non-live (inactivated) vaccines, including the seasonal flu
vaccine, while you are being treated with OCREVUS, talk to
your healthcare provider. If you are pregnant or planning to
become pregnant talk to your doctor about vaccinations for your
baby, as some precautions may be needed.
are pregnant, think that you might be pregnant, or plan to become pregnant. It
is not known if OCREVUS will harm your unborn baby. You should use birth control
(contraception) during treatment with OCREVUS and for 6 months after your
last infusion of OCREVUS. are breastfeeding or plan to breastfeed.
It is not known if OCREVUS passes into
your breast milk. Talk to your healthcare provider about the best way to feed your
baby if you take OCREVUS. Tell your healthcare provider about all the
medicines you take, including prescription and
over-the-counter medicines, vitamins, and herbal
supplements. What are the possible side effects of
OCREVUS? OCREVUS may cause serious side effects,
including: Risk of cancers (malignancies) including
breast cancer. Follow your healthcare provider’s instructions about standard
screening guidelines for breast cancer. Most common side effects include infusion
reactions and infections. These are not all the possible side effects
of OCREVUS.
Call your doctor for medical advice about side
effects. You may report side effects to FDA at 1-
800-FDA-1088. For more information, go to www.OCREVUS.com
or call 1-844-627-3887. For additional safety information, please see the
full Prescribing Information and Medication Guide.

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