KESIMPTA is thought to work by targeting and reducing specific B‑cells in the lymph nodes that are thought to play a role in relapsing multiple sclerosis (RMS). It is not known exactly how KESIMPTA works.

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.

In relapsing MS, B-cells are activated in the lymph nodes. Then they mistakenly attack the protective covering of your nerves in the brain and spinal cord.

See how KESIMPTA works here.

Based on preclinical studies.

KESIMPTA has been shown* to help people with relapsing MS by reducing relapses, reducing active lesions, and slowing disability progression. In clinical studies, KESIMPTA demonstrated superior results compared to teriflunomide.
Visit the Study Results page for more details.

*Reduced annual rate of relapses by 51% and 58%; reduced average number of Gd+ T1 lesions per MRI by 98% (0.01 vs 0.46) and 94% (0.03 vs 0.52); and reduced disability progression by 34% at 3 months and 32% at 6 months; in 2 studies vs teriflunomide.

You should not take KESIMPTA if you have an active Hepatitis B Virus (HBV) infection or if you have had an allergic reaction to ofatumumab, or a life-threatening injection-related reaction to KESIMPTA.

The most important information to know is that KESIMPTA may increase the risk of serious, including life‑threatening or fatal, infections. These may include Hepatitis B virus (HBV) reactivation and progressive multifocal leukoencephalopathy (PML). There is a risk of other serious side effects including local injection-site reactions, systemic injection-related reactions, low immunoglobulins, and liver damage.
Your doctor will check for HBV and perform blood tests to monitor your immunoglobulin levels and liver health before you start KESIMPTA and as needed.
See the full Important Safety Information for more details.

KESIMPTA 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. While no cases of PML were reported in RMS clinical trials with KESIMPTA, it could happen

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

Other serious side effects are:

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

• Injection-related reactions (systemic): Symptoms include fever, headache, pain in the muscles, chills, tiredness, rash, hives, trouble breathing, swelling of the face, eyelids, lips, mouth, tongue and throat, and feeling faint, or chest tightness

• Low immunoglobulins: KESIMPTA may decrease some types of antibodies

• Liver damage: B-cell therapies, including KESIMPTA, may cause liver damage. Symptoms may include yellowing of the skin and eyes, nausea, vomiting, unusual darkening of the urine, and feeling tired or weak
  
  Your doctor will do blood tests to check your immunoglobulin levels and liver before you start KESIMPTA and while you take it, if needed.

See full Important Safety Information here.

The most common side effects of KESIMPTA include upper respiratory infections (symptoms include sore throat, runny nose, and headache) and headache. Everyone responds to medications differently, so talk with your doctor about any symptoms you experience.

You can review more safety details on the Safety & Side Effects page.

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.

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. To help us better understand the effects of the treatment, 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 [email protected] ↗.

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. To help us better understand the effects of the treatment, 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 [email protected] ↗.

Yes, to help us better understand the effects of KESIMPTA, 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 [email protected] ↗.

You should not receive any live vaccines while taking KESIMPTA and until your doctor confirms your immune system has recovered. Any required live vaccines should be received at least 4 weeks before starting treatment. If possible, any non‑live vaccines should be received at least 2 weeks before beginning treatment.

Yes, you can take KESIMPTA at home or travel with it using a cooler or refrigerator. Keep the pen stored between 2°C and 8°C (36°F to 46°F) in its original carton, away from light. Do not freeze or shake the pen. Do not forget to pack a sharps container, alcohol swabs, and cotton balls.
If needed, KESIMPTA can remain at room temperature for up to 7 days. If stored below 86 °F (30 °C), unused KESIMPTA may be returned to the refrigerator and must be used within the next 7 days or discarded.

Store KESIMPTA auto‑injector pens in a refrigerator or cooler between 2°C and 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze or shake the pens.
If stored below 86 °F (30 °C), unused KESIMPTA may be returned to the refrigerator and must be used within the next 7 days or discarded.

You can become a KESIMPTA Crew Member by calling 1-877-879-0245 or emailing us at [email protected] ↗.

Before starting KESIMPTA, your doctor will order blood tests to check for hepatitis B virus (HBV), immunoglobulin levels, and liver function.
These tests help your healthcare team:

• Check for hepatitis B virus (HBV), which can become active again during or after treatment if you’ve had it before

• Measure immunoglobulin levels, because KESIMPTA may lower some types of antibodies

• Assess liver function, since B‑cell therapies may affect the liver

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.

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.

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 this step-by-step demo video, or download a Quick Tips for Use brochure.

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

The first time you take KESIMPTA, someone from your health care team will give you guidance. After that, you can take KESIMPTA at home or take it with you using 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 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.

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.

Check out how to take KESIMPTA here.

The best way to safely dispose of a KESIMPTA pen is to use an FDA-cleared sharps container.

You shouldn’t throw away your auto-injector 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

• Properly labeled to warn of hazardous waste inside the container

People may experience injection‑related reactions within 24 hours of their first dose. These may include fever, headache, muscle pain, chills, or fatigue, and tend to decrease with subsequent doses. Injection‑site reactions such as skin redness, swelling, itching, or pain may also occur. Each person can react to KESIMPTA differently.
You can learn more about reactions on the Safety & Side Effects page.

Do not stop taking KESIMPTA without talking to your neurologist or another medical professional. Treatment decisions should be made with your healthcare team.

More information about COVID-19 can be found from the Centers for Disease Control and Prevention (CDC) ↗ or the World Health Organization (WHO) ↗

Additional patient resources are available through these patient advocacy groups:

• Multiple Sclerosis Association of America ↗

• National Multiple Sclerosis Society ↗

Yes. Once you’ve been prescribed KESIMPTA (ofatumumab) you or your loved one can sign up for Novartis Patient Support. It's a comprehensive program with a dedicated team in your corner.

You’ll have a team you can count on who will reach out to you from the start and get to know you. When you have questions, you can talk to them directly.*

*Novartis Patient Support does not provide clinical advice and is not a substitute for consulting with your health care provider.

Once enrolled in the patient support program, here's what happens next:

After enrolling, the team will help you get started by determining delivery and savings options, including whether you’re eligible to pay as little as $0* co‑pay once coverage is in place. You’ll receive a welcome package, and a dedicated Coordinator will be available to answer questions throughout your membership.

You can reach the team at 855‑KESIMPTA (855‑537‑4678 ↗), Monday through Friday, 8:30 AM–8:00 PM ET.

*Limitations apply. Valid only for those with private insurance. The Program includes the Co-Pay Plus offer, Plus Card (if applicable), and Rebate, with a combined annual limit up to $18,000. Patient is responsible for any costs once limit is reached in a calendar year. Program not valid (i) under Medicare, Medicaid, TRICARE, VA, DoD, or any other federal or state health care program, (ii) where patient is not using insurance coverage at all, (iii) where the patient’s insurance plan reimburses for the entire cost of the drug, or (iv) where product is not covered by patient’s insurance. The value of this program is exclusively for the benefit of patients and is intended to be credited towards patient out-of-pocket obligations and maximums, including applicable co-payments, coinsurance, and deductibles. Program is not valid where prohibited by law. Patient may not seek reimbursement for the value received from this program from other parties, including any health insurance program or plan, flexible spending account, or health care savings account. Patient is responsible for complying with any applicable limitations and requirements of their health plan related to the use of the Program. Valid only in the United States and Puerto Rico. This Program is not health insurance. Program may not be combined with any third-party rebate, coupon, or offer. Proof of purchase may be required. Novartis reserves the right to rescind, revoke, or amend the Program and discontinue support at any time without notice. See complete Terms & Conditions at start.kesimpta.com.

Yes, there are injection support and training resources available.

You will receive guidance on how to take KESIMPTA for the first time from a member of your health care team.  

If you need support later, you can watch this step-by-step demo video or download a Quick Tips for Use brochure.

These resources are supplemental and don’t replace your provider’s instructions. Reach out to your doctor with any questions.

Your Coordinator will help identify insurance support options. If you’re commercially insured and have coverage for KESIMPTA, they can enroll you in the $0* Co‑Pay Plus offer. 

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.

^*Limitations apply. Valid only for those with private insurance. The Program includes the Co-Pay Plus offer, Plus Card (if applicable), and Rebate, with a combined annual limit up to $18,000. Patient is responsible for any costs once limit is reached in a calendar year. Program not valid (i) under Medicare, Medicaid, TRICARE, VA, DoD, or any other federal or state health care program, (ii) where patient is not using insurance coverage at all, (iii) where the patient’s insurance plan reimburses for the entire cost of the drug, or (iv) where product is not covered by patient’s insurance. The value of this program is exclusively for the benefit of patients and is intended to be credited towards patient out-of-pocket obligations and maximums, including applicable co-payments, coinsurance, and deductibles. Program is not valid where prohibited by law. Patient may not seek reimbursement for the value received from this program from other parties, including any health insurance program or plan, flexible spending account, or health care savings account. Patient is responsible for complying with any applicable limitations and requirements of their health plan related to the use of the Program. Valid only in the United States and Puerto Rico. This Program is not health insurance. Program may not be combined with any third-party rebate, coupon, or offer. Proof of purchase may be required. Novartis reserves the right to rescind, revoke, or amend the Program and discontinue support at any time without notice. See complete Terms & Conditions at start.kesimpta.com.

Call Novartis Patient Support at 855-KESIMPTA (855-537-4678), Monday through Friday, 8:00 AM to 8:00 PM ET, excluding holidays.

• Press Option 2 for financial and insurance support

• Press Option 3 for ongoing support

Relapsing multiple sclerosis (RMS) is a disease affecting the central nervous system. The immune system attacks and damages the protective myelin found around nerves in the brain and spinal cord, leading to a variety of symptoms. A relapse occurs when new symptoms appear or existing symptoms worsen.

Clinically isolated syndrome (CIS) is the first episode of signs and symptoms that may suggest MS. CIS may occur when the immune system mistakenly attacks the brain, spinal cord, or optic nerve. CIS may be an early sign of MS, but additional evidence is needed to confirm an MS diagnosis.

Relapsing-remitting MS (RRMS) involves cycles of relapses followed by periods of remission. It is the most common form of relapsing MS.

Active secondary progressive MS (SPMS) is the early stage of SPMS where fewer relapses may occur, but patients may not recover as well between them and may experience increasing disability. “Active” means there has been at least one relapse in the past two years.

RMS symptoms vary widely and can be unpredictable. Each person may have a different combination and pattern of symptoms that change over time.

There are no specific early signs of RMS because symptoms vary from person to person.

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

There are several treatment options for RMS, which differ in effectiveness, side effects, and how they are taken. These include injections, infusions, and pills. Disease-modifying therapies (DMTs) do not generally treat daily symptoms, but studies show they may help reduce relapses and slow disability progression.

A neurologist typically diagnoses and treats patients with RMS.

There is no single test for RMS. Doctors may use a combination of tests—such as a neurologic exam, MRI, spinal fluid analysis, and blood tests—to rule out other conditions.
You can find additional information on the diagnosis process through the National MS Society ↗.