INDICATION
What is KESIMPTA
(ofatumumab) injection?
KESIMPTA is a
prescription medicine used to treat adults with relapsing forms of
multiple sclerosis (MS) including clinically isolated syndrome
(CIS), relapsing-remitting disease, and active secondary
progressive disease.
It is not known if KESIMPTA
is safe or effective in children.
IMPORTANT SAFETY
INFORMATION
Who should not take KESIMPTA?
Do NOT take KESIMPTA if
you have active hepatitis B virus (HBV) infection.
What is the most important
information I should know about KESIMPTA?
KESIMPTA can cause
serious side effects such as:
-
Infections. Serious
infections, which can be life-threatening or cause death,
can happen during treatment with KESIMPTA. If you have
an active infection, your health care provider (HCP) should delay
your treatment with KESIMPTA until your infection is gone.
KESIMPTA taken before or after other medicines that weaken the
immune system may increase your risk of getting infections. Tell
your HCP right away if you have any infections or get any
symptoms including painful and frequent urination, nasal
congestion, runny nose, sore throat, fever, chills, cough, or
body aches.
INDICATION
What is KESIMPTA
(ofatumumab) injection?
KESIMPTA is a
prescription medicine used to treat adults with relapsing forms of
multiple sclerosis (MS) including clinically isolated syndrome
(CIS), relapsing-remitting disease, and active secondary
progressive disease.
It is not known if KESIMPTA
is safe or effective in children.
-
HBV reactivation. If
you have ever had HBV infection, it may become active again
during or after treatment with KESIMPTA (reactivation). If this
happens, it may cause serious liver problems including liver
failure or death. Before starting KESIMPTA, your HCP will do a
blood test to check for HBV. They will also continue to monitor
you during and after treatment with KESIMPTA for HBV. Tell your
HCP right away if you get worsening tiredness or yellowing of
your skin or the white part of your eyes.
-
Progressive Multifocal
Leukoencephalopathy (PML). PML may happen with KESIMPTA. PML is
a rare, serious brain infection caused by a virus that may get
worse over days or weeks. PML can result in death or severe
disability. Tell your HCP right away if you have any new or
worsening neurologic signs or symptoms. These may include
weakness on one side of your body, loss of coordination in arms
and legs, vision problems, changes in thinking and memory, which
may lead to confusion and personality changes.
-
Weakened immune system.
KESIMPTA taken before or after other medicines that weaken the
immune system could increase your risk of getting infections.
Before you take
KESIMPTA, tell your HCP about all your medical conditions,
including if you:
-
Have or think you have an
infection including HBV or PML.
-
Have ever taken, currently
take, or plan to take medicines that affect your immune system.
These medicines could increase your risk of getting an infection.
-
Have had a recent
vaccination or are scheduled to receive any vaccinations.
-
You should receive any
required 'live' or 'live-attenuated' vaccines at least 4 weeks
before you start treatment with KESIMPTA. You should not
receive 'live' or 'live-attenuated' vaccines while you are
being treated with KESIMPTA and until your HCP tells you that
your immune system is no longer weakened.
-
Whenever possible, you
should receive any 'non-live' vaccines at least 2 weeks before
you start treatment with KESIMPTA.
-
Talk to your HCP about
vaccinations for your baby if you used KESIMPTA during your
pregnancy.
-
Are pregnant, think that
you might be pregnant, or plan to become pregnant. It is not
known if KESIMPTA will harm your unborn baby. Females who can
become pregnant should use birth control (contraception) during
treatment with KESIMPTA and for 6 months after your last
treatment. Talk with your HCP about what birth control method is
right for you during this time.
-
Are breastfeeding or plan
to breastfeed. It is not known if KESIMPTA passes into your
breast milk. Talk to your HCP about the best way to feed your
baby if you take KESIMPTA.
Tell your HCP about all the
medicines you take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements.
How should I use KESIMPTA?
See the detailed
Instructions for Use that comes with KESIMPTA for information about
how to prepare and inject a dose of KESIMPTA and how to properly
throw away (dispose of) used KESIMPTA Sensoready pens or prefilled
syringes.
-
Use KESIMPTA exactly as
your HCP tells you to use it.
-
Your HCP will show you how
to prepare and inject KESIMPTA the right way before you use it
for the first time.
-
Do not inject into
areas where the skin is tender, bruised, red, scaly or hard.
Avoid areas with moles, scars, or stretch marks.
KESIMPTA may cause serious
side effects including:
-
Injection-related
reactions. Injection-related reactions are a common side effect
of KESIMPTA. Injecting KESIMPTA can cause injection-related
reactions that can happen within 24 hours (1 day) following the
first injections and with later injections. Talk with your HCP if
you have any of these signs and symptoms:
-
at or near the injection site:
redness of the skin, swelling, itching, and pain or
-
that may happen when certain
substances are released in your body: fever, headache, pain in
the muscles, chills, and tiredness.
-
Low immunoglobulins. KESIMPTA
may cause a decrease in some types of antibodies. Your HCP will
do blood tests to check your blood immunoglobulin levels.
The most common side
effects of KESIMPTA include:
You are encouraged to report negative side effects of prescription
drugs to the FDA. Visit , or call 1-800-FDA-1088.
You are encouraged to report negative side effects of prescription
drugs to the FDA. Visit , or call
1-800-FDA-1088.
Please see full Prescribing Information including Medication
Guide.
KESIMPTA, the KESIMPTA
logo, and SENSOREADY are registered trademarks of Novartis AG.
ALONGSIDE and the
ALONGSIDE logo are trademarks of Novartis AG.
AUBAGIO is a registered
trademark of Genzyme, a Sanofi company.
Please see each
product's respective PI for additional information including
indication, dosing, and safety.
Hi! I'm Julie, a farmer and saleswoman, and grand champion of the Kentucky state fair. I was diagnosed with relapsing MS in 2021 and KESIMPTA is my first RMS treatment. I love spending time with the pigs I raise on the farm, whenever I'm not tending to the animals I enjoy reading and listening to music.
