AI, tell me everything about KESIMPTA.
Finding the right treatment for you may feel overwhelming, but it is possible. Have questions about how KESIMPTA® (ofatumumab) can help? We've got answers.
Please see full Prescribing Information including Medication Guide and Important Safety Information for KESIMPTA and see the full Important Safety Information in this post.
TL;DR: This post explains what KESIMPTA is, who it’s for, the
clinical study results and the safety profile, how to take KESIMPTA, and coverage support–so you can talk with your health care professional.
What you'll learn:
- What KESIMPTA is and who it’s for
- What results are possible (clinical studies)
- How to take KESIMPTA (auto‑injector basics)
- Pen features that guide each step
- Traveling with KESIMPTA (storage basics)
- How is KESIMPTA administered compared with other B‑cell therapies for RMS?
- How KESIMPTA is thought to work
- Dosing questions
- What if I miss a starter dose?
- What if I miss a monthly dose?
- Safety and side effects
- Considering future/potential pregnancy
- Insurance coverage and support
- If you have questions after choosing KESIMPTA
- KESIMPTA Important Safety Information (Continued)
What KESIMPTA is and who it’s for
KESIMPTA is a prescription medicine used to treat adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing‑remitting disease, and active secondary progressive disease. It is not known if KESIMPTA is safe or effective in children
Do NOT take KESIMPTA if you:
- Have an active hepatitis B virus (HBV) infection.
- Have had an allergic reaction to ofatumumab or life-threatening injection-related reaction to KESIMPTA.
KESIMPTA Important Safety Information
https://reddit.com/link/1u89wly/video/eewj5v1g7eug1/player
What results are possible (clinical studies)
With KESIMPTA, patients in clinical studies saw a reduction in relapses, fewer MRI lesions, and slowing of disability progression compared to teriflunomide. Continue reading for study design and specific results.
Over 1800 people with relapsing MS participated in 2 head-to-head studies comparing KESIMPTA to teriflunomide. In the 1 to 2 years leading up to the studies, all of them had experienced a relapse or saw activity on an MRI scan.
These 2 clinical studies (1 and 2) show:
- Relapse Reduction: 51% fewer in Study 1 and 58% fewer in Study 2
- Reduction in Active Lesions (Gd+ T1): 98% fewer in Study 1 and 94% fewer in Study 2
- Reduction in New or Enlarging Lesions (T2): 82% fewer in Study 1 and 85% fewer in Study 2
- Reduction in Disability Progression: 34% less likely at 3 months and 32% less likely at 6 months, in Studies 1 and 2 combined
How to take KESIMPTA (auto-injector basics)
KESIMPTA is taken once a month,* and can be taken at home or on the go,† using a prefilled auto-injector pen. Your health care team will show you how to use it and review the Instructions for Use (IFU). The pen will be delivered to your home in a prefilled auto-injector. Watch real patient Zenovia walk you through the process:
https://reddit.com/link/1u89wly/video/gdv07etv7eug1/player
Someone from your health care team will show you how to use KESIMPTA, so you’ll be ready on treatment day. To recap, the steps to inject are‡:
- Remove from fridge for 15-30 minutes to allow it to reach room temperature
- Visually inspect for expiration date and liquid clarity
- Choose and clean your injection site
- Twist off cap only when ready to use. Discard cap. Use within 5 minutes
- Press firmly against skin at 90º. After the second click, the green indicator will stop moving. Remove pen from your skin
- Dispose the pen in an FDA-cleared sharps container
*Once monthly after 3 weekly starter doses.
†KESIMPTA pens must be refrigerated at 2 ºC to 8 ºC (36 ºF to 46 ºF). Keep product in the original carton to protect from light until the time of use. Do not freeze. To avoid foaming, do not shake. If necessary, 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.
‡These are not the full Instructions for Use (IFU). Please see IFU for more information.
Pen features that guide each step
The KESIMPTA auto-injector pen has features that help you use it safely, right from the comfort of home. Once you press against your skin to start, it will guide you.
You can’t see the needle:
- It's thinner than a pediatric needle*
- It goes just under the skin, not into muscle
- Just press pen against skin to start
It guides you with sounds:
- You'll hear 1 click when it starts
- You'll hear a 2nd click when it's almost done
You can see the progress:
- Watch as the window fills with green
- It stops moving when complete
- Ensure the green progress indicator fills the window and stops moving before removing the pen
In a real-world survey,† people described their experience with the auto-injector pen.
- ~90% found the pen easy to use
- ~90% said monthly dosing was convenient
In a separate survey,‡ 9 out of 10 nurses and 8 out of 10 patients preferred the pen’s features.
*KESIMPTA pens come with a staked needle of 29-gauge. Pediatric needles average between 23-gauge and 25-gauge.
†Real-world 30-question survey of 105 US patients (aged ≥18) diagnosed with RMS for 1+ years who took KESIMPTA with the auto-injector pen within previous 12 months. On a scale of 1-5, 89.5% of patients rated it a 4 or 5 (5 being most positive) on overall ease of use and ease of monthly dosing schedule. Questionnaire not validated.
‡Based on a survey of MS nurses (N=50) and patients (N=80) in the US, Germany, France, and Italy. Participants were asked to compare attributes of the KESIMPTA auto-injector pen with those of other disease modifying therapy (DMT) auto-injectors, some of which are not available in the US. The KESIMPTA pen was not injected during the survey, nor were all devices compared against each other by participants. A total of 17 attributes were assessed, with “easy to perform self-injection with the pen,” “ease of preparation and set-up,” and “ease of training patient in use” among those most preferred.
Traveling with KESIMPTA (storage basics)
If you’re traveling on treatment day, the pen can be kept at room temperature for up to seven days. Keep KESIMPTA between 36 ºF and 46 ºF (2-8 ºC) and in the original carton until ready to use; do not freeze and do not shake. Bring a sharps container and alcohol swabs if dosing away from home.
https://reddit.com/link/1u89wly/video/upi3w00b8eug1/player
How is KESIMPTA administered compared with other B-cell therapies for RMS?
KESIMPTA is self-administered and can be taken at home or brought with you. Besides someone from your health care team showing you how to use it the first time, no doctor's office or infusion center visits are required to take your treatment. KESIMPTA does not require premedication* and there is no postdose observation.
*Only limited benefit of premedication was observed in relapsing MS clinical studies
Administration times and methods*
| KESIMPTA(ofatumumab) | <1 minute auto-injection^(†) (3-4 secs avg injection time) | 1x monthly^(‡) at home or on the go |
|---|---|---|
| Ocrevus® (ocrelizumb) | 2-4 hours infusion | 2x yearly at a medical facility |
| Ocrevus Zunovo® (ocrelizumab and hyaluronidase-ocsq) | 10 mins injection | 2x yearly at a medical facility |
| Briumvi® (ublituximab-xiiy) | 1-4 hrs^(§) infusion | 2x yearly at a medical facility |
This is not a complete list of all the available treatments for RMS.*
The comparison pertains only to differences in dosing and administration and should not be considered a comparison of efficacy or safety.
*B-cell treatments for RMS include: KESIMPTA, Ocrevus, Ocrevus Zunovo, and Briumvi. Please see each product’s respective prescribing information for additional information, including indication, dosing, administration, and safety. Trademarks are the property of their respective owners.
^(†)Typical administration time when ready to inject.
‡Once monthly after 3 weekly starter doses.
^(§)The 1st infusion of Briumvi takes 4 hrs. Subsequent infusions take 1 hr.
How KESIMPTA is thought to work
In relapsing multiple sclerosis (RMS), certain immune cells called B-cells are activated in the lymph nodes. These B-cells mistakenly attack the protective covering of your nerves.
While it is not fully understood how KESIMPTA works, it is designed to target the B-cells^(*) in the lymph nodes believed to play a role in RMS.
Here’s an easy-to-understand scientific breakdown:
RMS-related B-cell
- As a subcutaneous injection just under the skin, KESIMPTA is thought to target a precise path to RMS-related B-cells in the lymph nodes.*
B-cell
- The targeted delivery is thought to limit the impact on other B-cells your body needs to maintain immune function.*
*Based on preclinical studies
Dosing questions
How often do I take KESIMPTA?
- After 3 weekly starting doses, KESIMPTA is taken once a month
What if I miss a starter dose?
- If you miss an injection of KESIMPTA at Week 0, 1, or 2, talk to your doctor
What if I miss a monthly injection?
- 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
Considering future/potential pregnancy
Tell your doctor if you're pregnant, think you might be pregnant, or plan to become pregnant before starting 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. Advise females of reproductive potential of the potential risk to a fetus.
- It is not known if KESIMPTA passes into your breast milk. Talk to your health care provider about the best way to feed your baby if you take 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.org/join-study, call 1-877-311-8972 or send an email to MotherToBaby@health.ucsd.edu.
Safety and side effects
Safety was evaluated in 2 head-to-head studies vs teriflunomide. The most common side effects include upper respiratory infections (symptoms can include sore throat, runny nose, and headache) and headache. For other possible side effects, see the Important Safety Information (above and below).
Here are some other things to know:
- Few people stopped treatment due to side effects: comparable to teriflunomide: 5.7% for KESIMPTA, 5.2% for teriflunomide
- 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
- KESIMPTA has a proven safety profile and has been studied for 7 years and counting
Real patient taking KESIMPTA who was compensated for time. Individual results may vary.
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 7 years. No conclusions of clinical outcomes can be drawn. (September 25, 2024 data cut-off date.)
To learn more about other possible side effects, see the Important Safety Information.
Insurance coverage and support
A KESIMPTA prescription comes with Novartis Patient Support™, which may include:
- Getting Started – Help with insurance verification and coordinating medication delivery
- Financial Support – If you are privately insured, you may pay as little as $0 with Co-Pay Plus
- Co-pay assistance - Many prescriptions filled pay as little as $0 when used with the Co-Pay Plus offer*†
- Ongoing support and helpful resources
- Contact 855-KESIMPTA, 8:30 AM-8:00 PM ET, Monday-Friday. Press option 2 for financial and insurance support or press option 3 for ongoing support.
*Limitations apply. Offer not valid under Medicare, Medicaid, or any other federal or state health insurance program. Patients with commercial insurance who are initially denied coverage may receive free KESIMPTA for up to 15 doses while seeking coverage. Patients with commercial insurance who have coverage for KESIMPTA may receive up to $18,000 in annual co-pay benefits. Novartis reserves the right to rescind, revoke, or amend this program without notice. Additional limitations may apply. Learn more about how to enroll and see complete Terms & Conditions at start.kesimpta.com.
†2025 data on file.
If you have questions after choosing KESIMPTA
People who are prescribed KESIMPTA will have a dedicated coordinator–a real person who is personally aligned to you and will be able to help you get started, answer questions, and provide helpful resources. You can ask them about:
- Paying for treatment
- Home delivery of KESIMPTA
- Supplemental auto-injector resources
- Long-term support, like calls, texts, and emails
KESIMPTA Important Safety Information (Continued)
Important Safety Information
Who should not take KESIMPTA?
Do NOT take KESIMPTA if you:
- Have an active hepatitis B virus (HBV) infection.
- Have had an allergic reaction to ofatumumab or life-threatening injection-related reaction to KESIMPTA.
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.
- 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 a history of liver problems.
- 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. There are two kinds of reactions:
- At or near the injection site: redness of the skin, swelling, itching, and pain. Talk to your HCP if you have any of these signs and symptoms.
- That may happen when certain substances are released in your body: 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. Contact your HCP right away if you experience any of these signs and symptoms, especially if they become worse or you have new severe signs of reactions after subsequent injections. It could be a sign of an allergic reaction, which can be serious.
- Low immunoglobulins. KESIMPTA may cause a decrease in some types of antibodies. Your HCP will do blood tests to check your blood immunoglobulin levels.
- Liver damage. KESIMPTA may cause liver damage. Your HCP will do blood tests to check your liver before you start KESIMPTA and while you take KESIMPTA if needed. Tell your HCP right away if you have any symptoms of liver damage such as:
- yellowing of the skin and eyes (jaundice)
- nausea
- vomiting
- unusual darkening of the urine
- feeling tired or weak
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.
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.
Please see full Prescribing Information including Medication Guide.
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Posted Jun 17, 2026, 1:15 PM UTC · locked