FAQs

Frequently Asked Questions

About KESIMPTA®

How does KESIMPTA work?

Here's what goes on with relapsing MS:

The immune system uses certain cells, like B cells, to help fight infections. These cells can become activated in the lymph nodes—the communication hub for the immune system.

But there's a miscommunication that happens in relapsing MS. Instead of protecting the immune system, these cells mistakenly attack the body's myelin—the fatty, protective covering of the nerves in the brain and spinal cord.

Here's what KESIMPTA does:

Although it's not known exactly how KESIMPTA works in relapsing MS, it's thought to travel specifically to the lymph nodes based on the way it's taken. From there, it's believed to reduce the number of B cells that are thought to play a role in relapsing MS.

This targeted approach to the lymph nodes is thought to limit the impact on other B cells your body needs to maintain immune function.

How can KESIMPTA help with relapsing MS?

KESIMPTA is a flexible, at-home, once-monthly* treatment with proven results for reducing relapses and active lesions and slowing disability progression. It has a similar overall safety profile to AUBAGIO® (teriflunomide).

See the results here.

Talk to your doctor to find out if KESIMPTA may be right for you.

*After 3 weekly starter doses.
AUBAGIO is a registered trademark of Genzyme, a Sanofi company.

Who should not take KESIMPTA?

You shouldn't take KESIMPTA if you have an active hepatitis B virus (HBV) infection. Your doctor will give you a blood test before starting KESIMPTA to be sure.

What is the most important information I should know about KESIMPTA?

KESIMPTA works by impacting your immune system, so it could increase the risk of getting serious infections, including:

  • 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

  • Weakened immune system: Taking KESIMPTA before or after other medicines that weaken your immune system could increase your risk of getting infections.

What are the most common side effects?

Injection-related reactions are mostly mild to moderate. The likelihood is highest with the first starter dose and decreases with the second and third doses. Please talk to your doctor if you experience any reactions.

  • Local injection-site reactions (redness, pain, itching, and swelling)

  • Injection-related reactions (fever, headache, muscle pain, chills, and fatigue)

Other possible side effects include:

  • Upper respiratory infections (sore throat, runny nose, and headache)

  • Headache

See more details here.

Everyone reacts to medications differently. Talk with your doctor about any possible side effects and if KESIMPTA is right for you.

Can I take KESIMPTA while breastfeeding?

It is not known if KESIMPTA passes into breast milk. Talk to your doctor about the best way to feed your baby if you take KESIMPTA.

Can I take KESIMPTA while pregnant?

It is not known if KESIMPTA will harm your unborn baby. Tell your doctor if you're pregnant, think you might be pregnant, or plan to become pregnant before starting KESIMPTA.

Can I try to get pregnant while taking KESIMPTA?

It is not known if KESIMPTA will harm your unborn baby. Females who can become pregnant should use birth control during treatment with KESIMPTA and for 6 months after your last treatment. Talk to your doctor about what birth control method is right for you during this time.

Can I receive vaccines while on KESIMPTA?

You shouldn't receive any live vaccines while taking KESIMPTA and until your doctor tells you that your immune system is no longer weakened. Any required live vaccines should be received at least 4 weeks before you start KESIMPTA. If possible, any "non-live" vaccines should be received at least 2 weeks before you start treatment with KESIMPTA.

How can I become a KESIMPTA Connector?

You can become a KESIMPTA Connector by calling 1-877-879-0245 or emailing us at info@voices-of-inspiration.com.

Is KESIMPTA on social media?

Yes! You can find us on Facebook, Instagram, YouTube, and Twitter.

Can I travel with KESIMPTA?

Yes! You can take KESIMPTA at home or wherever you go with a cooler or refrigeration. It's important to keep the KESIMPTA Sensoready® Pen between 36 F and 46 F and in its original carton until you are ready to use it. Do not freeze. To avoid foaming, do not shake. Also, don't forget to pack your sharps container, alcohol swabs, and cotton balls.

How do I store KESIMPTA?

You can store KESIMPTA in a cooler or refrigerator. It's important to keep the KESIMPTA Sensoready® Pen between 36 F and 46 F until you are ready to use it. Do not freeze. To avoid foaming, do not shake.

Taking KESIMPTA

What tests will my doctor need to do before I start on KESIMPTA?

Before starting KESIMPTA, you'll get a blood test for hepatitis B virus (HBV). If you've ever had HBV infection, it may become active again during or after treatment with KESIMPTA. Your doctor will also have you get blood tests to check your immunoglobulin levels because KESIMPTA may decrease some types of antibodies.

Why do I need to be tested for hepatitis B virus (HBV) before starting KESIMPTA?

You'll be screened for HBV before starting KESIMPTA because if you've had HBV in the past, there's a chance KESIMPTA can reactivate it. You'll get a simple blood test to be sure.

How often do I take KESIMPTA?

You'll give yourself 1 dose per week for the first 3 weeks, and then you'll skip a week. After that, you can move on to 1 dose per month.

How do I take KESIMPTA?

Someone from your health care team will give you guidance on how to take KESIMPTA for the first time.

If you need a refresher on how to take KESIMPTA, you can watch an additional demo video or download some quick tips here.

You can also ask your Alongside KESIMPTA Coordinator to set up an additional demo—at home or online.

Call 1-855-KESIMPTA (1-855-537-4678), 8:30 AM–8:00 PM ET, Monday–Friday.

Call 1-855-KESIMPTA (1-855-537-4678), 8:30 AM–8:00 PM ET, Monday–Friday.

Do I need to take KESIMPTA at a hospital or doctor's office?

Someone from your health care team will give you guidance on how to take KESIMPTA for the first time. After that, you can take KESIMPTA at home or wherever you go with a cooler or refrigeration. If you are taking KESIMPTA away from home, you'll need to bring your sharps container, alcohol swabs, and cotton balls. It's important to keep the KESIMPTA Sensoready® Pen between 36 F and 46 F and in its original carton until you are ready to use it. Do not freeze. To avoid foaming, do not shake.

What happens if I miss a dose?

If you miss an injection of KESIMPTA at Week 0, 1, or 2, talk to your doctor. If you miss a monthly injection, take it as soon as possible without waiting until the next scheduled dose. After that, take your KESIMPTA injections a month apart.

How do I safely dispose of my KESIMPTA Sensoready® Pen?

The best way is to use an FDA-cleared sharps container.

Ask your Coordinator how to get one for free. You'll get a pre-paid return label to send your full sharps container back, and you'll be sent a new container.

You shouldn't throw away your Sensoready® Pen in your household trash. If you don't have an FDA-cleared sharps container, you can use a household container that is:

  • made of a heavy-duty plastic,

  • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,

  • upright and stable during use,

  • leak-resistant, and

  • properly labeled to warn of hazardous waste inside the container

Is there any latex in the KESIMPTA Sensoready® Pen?

No, the Sensoready® Pen does not contain any latex.

Does KESIMPTA have a patient assistance or support program?

Yes! It's called Alongside KESIMPTA, and every KESIMPTA prescription comes with a membership. Members receive personalized support from a dedicated Coordinator who can determine if you're eligible to save on KESIMPTA, and help you learn how to take it.

See how Alongside KESIMPTA has your back here and become a member if you have a prescription but aren't enrolled yet.

How will I feel after the first dose?

Everyone reacts to KESIMPTA a little differently, but it's not uncommon to feel injection-related reactions within 24 hours after your first dose. These reactions may include fever, headache, muscle pain, chills, and fatigue, but generally decrease with each KESIMPTA dose. Reactions at or near the injection site include redness of the skin, swelling, itching, and pain. For more information on KESIMPTA reactions, please visit our safety page here.

Savings & Support

What is Alongside KESIMPTA?

Alongside KESIMPTA is a membership that comes with every KESIMPTA prescription. Members receive personalized support from a dedicated Coordinator who can determine if you're eligible to save on KESIMPTA, and help you learn how to take it.

See how Alongside KESIMPTA has your back here and become a member if you have a prescription but aren't enrolled yet.

What happens after I'm enrolled in Alongside KESIMPTA?

Here's what happens next:

  • We'll help get you started by figuring out coverage, savings eligibility (including the $0* Access Card), and delivery

  • We'll mail you a welcome package with some important details inside

  • You'll get a dedicated Coordinator who will answer any questions throughout your membership

Get in touch at 1-855-KESIMPTA (1-855-537-4678), 8:30 AM–8:00 PM ET, Monday–Friday.

*Access Card Program: Limitations apply. People with commercial insurance may receive up to an $18,000 annual limit and/or up to 12 months of free product while coverage is pursued. Offer not valid under Medicare, Medicaid, or any other federal or state health insurance program.
See complete Terms & Conditions at start.kesimpta.com.

Does Alongside KESIMPTA offer injection support?

Yes—injection demonstrations are available. Choose from in-person demos at home, virtual demos, or this demo video.

Keep in mind these demos do not replace any instructions provided by your doctor. If you have any questions, please get in touch with your doctor.

To schedule a demo or to get a Sensoready® Training Pen, call 1-855-KESIMPTA (1-855-537-4678), 8:30 AM–8:00 PM ET, Monday–Friday.

How do I get insurance coverage support for KESIMPTA?

Your Alongside KESIMPTA Coordinator will identify the correct coverage assistance options to meet your needs. If you're commercially insured and have coverage for KESIMPTA, they can enroll you in a $0 Copay Program.*

If you are not covered for KESIMPTA, Coordinators will provide support to your doctor as your doctor pursues an appeal with your health care plan.

*Access Card Program: Limitations apply. People with commercial insurance may receive up to an $18,000 annual limit and/or up to 12 months of free product while coverage is pursued. Offer not valid under Medicare, Medicaid, or any other federal or state health insurance program.
See complete Terms & Conditions at start.kesimpta.com.

How do I reach the Alongside KESIMPTA Support Team?

You can reach the Alongside KESIMPTA Support Team by calling 1-855-KESIMPTA (1-855-537-4678), 8:30 AM–8:00 PM ET, Monday–Friday.

About Relapsing Forms of
Multiple Sclerosis

What is relapsing multiple sclerosis (RMS)?

Relapsing multiple sclerosis is a disease that affects the central nervous system (CNS), which is composed of the brain and spinal cord. The myelin, which protects the nerves in the CNS, gets damaged, and results in a variety of symptoms. A relapse is when new symptoms occur or when existing symptoms worsen.

What is clinically isolated syndrome (CIS)?

CIS is the first occurrence of neurological symptoms that lasts a minimum of 24 hours. It is caused by inflammation or loss of myelin, which protects the nerves in the central nervous system (CNS).

What is relapsing-remitting multiple sclerosis (RRMS)?

RRMS describes the condition of experiencing cycles of relapses followed by periods of remission. RRMS is the most common form of relapsing MS.

What is active secondary progressive multiple sclerosis (SPMS)?

Active SPMS is the early stage of SPMS, in which people experience fewer relapses but don't bounce back as well between relapses, and have increased disability. Active SPMS means a person may have had at least 1 relapse in the last 2 years.

What are the symptoms of RMS? What does RMS look like? What does it feel like?

The symptoms associated with RMS are variable and unpredictable. Every individual with RMS may experience a different variety and pattern of symptoms over time.

What are the early signs of RMS?

As the symptoms of RMS vary from person to person, there are no specific early signs of RMS.

What causes RMS? Is RMS hereditary?

The cause of RMS is unknown, and multiple factors are still being studied.

How is RMS treated?

Although there is no cure for RMS, there are a variety of treatment options on the market that differ in efficacy, side effects, and dosing and administration. The treatments are administered through different methods such as injections, infusions, or pills. Medications, called disease-modifying therapies, or DMTs, don't generally treat daily symptoms. Studies show that DMTs may help reduce relapses and slow disability progression.

What kind of doctor diagnoses RMS?

A neurologist typically diagnoses and treats patients with RMS.

How is RMS diagnosed?

There is no single way to diagnose RMS. Your doctor can perform a variety of tests to rule out other conditions including a neurologic exam, an MRI, spinal fluid analysis, and blood tests. For more information on diagnosis, click here.

MS=multiple sclerosis.

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Prescribed KESIMPTA?
Call Alongside™ KESIMPTA for support.

1-855-KESIMPTA
(1-855-537-4678).

8:30 AM–8:00 PM ET, Mon–Fri.

1-855-KESIMPTA (1-855-537-4678).
8:30 AM–8:00 PM ET, Mon–Fri.

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challenges of RMS?

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RMS=relapsing multiple sclerosis.

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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.

Scroll to Complete Important safety information and 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 can happen during treatment with KESIMPTA. If you have an active infection, your healthcare 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.

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.