Understanding-safety-Hero-image

UNDERSTANDING SAFETY

quotes I felt ready to start KESIMPTA® after
talking with my doctor
about the potential
side effects. quotes

– KRISTIN C.

Kristin C. has taken KESIMPTA and has been compensated for her time.

Let's Talk KESIMPTA Safety

Before you start any treatment, it's important to understand the safety profile and potential side effects.

PROVEN SAFETY PROFILE

KESIMPTA was studied in 2 head-to-head studies vs AUBAGIO® (teriflunomide).

  • Few people stopped treatment due to side effects

    comparable to AUBAGIO: 5.7% for KESIMPTA, 5.2% for AUBAGIO

  • Mild to moderate injection-related reactions

    99.8% of injection-related reactions were mild to moderate. They were most common in the first injection and decreased to less than 3% after the 3rd dose

Image of clipboard.

KESIMPTA has a proven safety profile and has been studied for 5 years and counting.

Because safety is so important, KESIMPTA continues to be studied in an ongoing, open-label* extension study.†

*A type of study where participants are aware of the type of treatment they're being given. Interpreting results from open-label studies can be uncertain. They are not considered representative results, since participants chose whether to stay in the trial.

†After the original KESIMPTA studies, over 1700 people continued to participate for further evaluation, where they all took KESIMPTA. The goal of this extended study was to learn about the safety and tolerability of KESIMPTA in the long term, with a focus on injection-related reactions, malignancies, and serious infections for up to 5 years. No conclusions of clinical outcomes can be drawn. (September 25, 2022 data cut-off date.)

POTENTIAL SIDE EFFECTS

KESIMPTA works by impacting your immune system, so it could increase the risk of serious, including life-threatening or fatal, infections:

  • Hepatitis B virus (HBV) reactivation: Before starting KESIMPTA, you'll get a blood test for HBV. If you've ever had HBV infection, it may become active again during or after treatment with KESIMPTA

  • 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, and can result in death or severe disability

Another serious side effect is:

  • Low immunoglobulins: KESIMPTA may decrease some types of antibodies. Your doctor will do blood tests to check your immunoglobulin levels

HERE'S WHAT'S MOST COMMON

injection

Local injection-site reactions:
Symptoms include redness, pain,
itching, and swelling.

thermometer

Injection-related reactions (systemic): Symptoms include fever, headache, muscle pain, chills, and fatigue.

  • Injection-related reactions were mostly mild to moderate (99.8%) in the clinical trials

  • The incidence of systemic injection-related reactions with KESIMPTA was highest with the first injection (14.4%), decreasing with subsequent injections (4.4% with second, less than 3% with third)

Other possible side
effects include:

tissuebox

Upper respiratory infections:
Symptoms include sore throat, runny nose, and headache.

headache

Headache

THINGS TO TELL YOUR DOCTOR

Before you take KESIMPTA, it's important to tell your doctor if you have any infections, or if you:

  • Have or think you have HBV or PML

  • Have taken or plan to take medication that affects your immune system

  • Had a recent vaccination or have one scheduled

  • Are pregnant, think you may be, or are planning to be. There is a registry for women who become pregnant during treatment with KESIMPTA. For more information or to register, visit MotherToBaby, call 1-877-311-8972 or send an email to MotherToBaby@health.ucsd.edu

  • Are breastfeeding or plan to

Sarah

quotes My doctor and I discussed the possible side effects of KESIMPTA, and decided its potential benefits outweighed the potential risks for me. quotes

– SARAH Q.

Sarah Q. has taken KESIMPTA and has been compensated for her time.

Sarah Image

quotes quotes My doctor and I discussed the possible side effects of KESIMPTA, and decided its potential benefits outweighed the potential risks for me. quotes

– SARAH Q.

Sarah Q. has taken KESIMPTA and has been compensated for her time.

Learn about
KESIMPTA and COVID-19.

GET SOME ANSWERS
ABOUT COVID-19

Check out the results from the
KESIMPTA clinical trials.

SEE THE RESULTS
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Pay as little as $0 copay‡ & enroll in the
Alongside™ KESIMPTA Support Program.

Learn More

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Pay as little as $0 copay‡ &
enroll in the Alongside™
KESIMPTA Support Program.

Learn More

RMS, relapsing multiple sclerosis.

‡Limitations apply. Offer not valid under Medicare, Medicaid, or any other federal or state health insurance program. Patients with commercial insurance coverage for KESIMPTA may receive up to $18,000 in annual copay benefits. Patients with commercial insurance and an initial denial of coverage may receive up to 12 months of free product while coverage is pursued. Novartis reserves the right to rescind, revoke, or amend this program without notice. See complete Terms & Conditions at start.kesimpta.com.

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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?

INDICATION

What is KESIMPTA (ofatumumab) injection?

KESIMPTA is a prescription medicine used to treat adults with relapsing forms of multiple sclerosis (MS) including

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.

IMPORTANT SAFETY INFORMATION & INDICATION

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:

  • Upper respiratory tract infection, with symptoms such as sore throat and runny nose, and headache.

  • Headache.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, 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.