Kesimpta: How It’s Used to Treat Relapsing Forms of Multiple Sclerosis

Kesimpta and multiple sclerosis (MS)

Kesimpta is prescribed to treat the following types of MS in adults:

• relapsing-remitting MS (RRMS)
• secondary progressive MS (SPMS) that is actively causing symptoms

Kesimpta is also prescribed to treat clinically isolated syndrome (CIS). With CIS, you have an episode of MS-like symptoms that last 24 hours or longer. CIS is often classified as a type of MS, but it may or may not develop into MS.

Note: Kesimpta is not for use in children. To learn more about MS treatment options for children, talk with your child’s doctor.

What is MS?

MS is a chronic (long-term) condition that affects the brain and spinal cord. MS symptoms occur when your immune system mistakenly attacks myelin, which is a protective layer wrapped around your nerve fibers. This action causes inflammation and lesions in your nervous system, interfering with how well your brain communicates with the rest of your body.

Symptoms of MS can include:

• difficulty walking
• fatigue
• vision problems, such as blurry vision
• problems with speech, such as slurred speech or changes in your speech volume
• pain
• tremors

Kesimpta is a type of drug called a monoclonal antibody. It specifically targets and blocks a certain protein in your immune system, which suppresses your immune system. This can reduce inflammation in your nervous system and relieve MS symptoms. It can also prevent your immune system from attacking myelin, which can slow or prevent MS from worsening.

What are the side effects of Kesimpta?

Kesimpta may cause side effects in some people. These can be mild to serious. The following lists include some of the main side effects that have been reported by people using Kesimpta.

What are Kesimpta’s mild side effects?

Kesimpta may cause mild side effects in some people. These include:

• back pain
• headache
• injection site reactions, such as pain or swelling where you inject Kesimpta
• upper respiratory infection, such as the common cold
• urinary tract infection (UTI)
• whole-body injection reactions, including any of the following, after you inject Kesimpta:
  • fatigue
  • muscle aches and pains
  • chills or fever

In many cases, mild side effects can be temporary, and some may be easy to manage. But if side effects are ongoing, bothersome, or severe, talk with your doctor or pharmacist.

Experiencing side effects? After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. If you develop a side effect while taking this drug and want to tell the FDA about it, visit MedWatch or call 800-FDA-1088.

What are Kesimpta’s serious side effects?

In rare cases, Kesimpta treatment may lead to serious side effects. Examples include:

• liver injury
• increased risk of serious infection, such as progressive multifocal leukoencephalopathy (PML)
• low level of immunoglobulin M (an immune system protein)
• serious reactions after receiving your Kesimpta injection, such as bronchospasm and shortness of breath

Call your doctor right away if you have any serious side effects while using Kesimpta. If the side effects seem life threatening or you think you’re having a medical emergency, call 911 or your local emergency number immediately.

To learn more about Kesimpta’s side effects, talk with your doctor or pharmacist or check out the drug’s prescribing information.

Allergic reaction

For some people, Kesimpta can cause an allergic reaction. While this side effect was not reported in the drug’s studies, it has been reported since Kesimpta became available to prescribe.

In general, symptoms of an allergic reaction can be mild or serious.

What might help

If you have mild symptoms of an allergic reaction, such as a mild rash, call your doctor right away. They may suggest a treatment to manage your symptoms and can determine whether you should continue Kesimpta treatment.

If you have symptoms of a severe allergic reaction, such as swelling or difficulty breathing, call 911 or your local emergency number right away. These symptoms could be life threatening and require immediate medical care.

If your doctor confirms you’ve had a serious allergic reaction to Kesimpta, they may have you switch to a different treatment.

What should I know before starting Kesimpta?

Kesimpta may not be a safe option if you have certain medical conditions or other factors that affect your health.

If any of the following factors apply to you, talk with your doctor before receiving Kesimpta.

• if you’ve ever had hepatitis B (your doctor will not prescribe Kesimpta if you have an active hepatitis B infection)
• if you have an active infection (currently causing symptoms)
• if you have a scheduled vaccination or have recently received a vaccination
• if you have a weakened immune system
• if you’re pregnant or breastfeeding, or planning to become pregnant or breastfeed
• if you consume alcohol
• if you’ve had an allergic reaction to Kesimpta or any of its ingredients

Note: Before you start Kesimpta, your doctor will screen you for hepatitis B. This is because Kesimpta could potentially reactivate the hepatitis B virus (HBV), which can be extremely dangerous. Your doctor will also order liver function tests because Kesimpta can cause drug-induced liver injury. Your doctor may continue monitoring you for these conditions throughout your Kesimpta treatment.

Kesimpta vs. Ocrevus

Like Kesimpta, Ocrevus is a monoclonal antibody prescribed to treat certain types of MS, but these medications do have some differences. Kesimpta and Ocrevus are both prescribed to treat relapsing forms of MS. But unlike Kesimpta, Ocrevus is also approved to treat primary progressive multiple sclerosis (PPMS).

Kesimpta cost

The price of Kesimpta depends on several factors. These can include your treatment plan, your insurance plan, the pharmacy you use, and your location. Kesimpta is a brand-name biologic drug that is not available as a biosimilar. Brand-name biologic drugs usually cost more than biosimilars.

• A program called Alongside Kesimpta is available for this drug. For more information and to find out whether you’re eligible for support, call 855-KESIMPTA (855-537-4678) or visit the program website.
• Some websites provide details about drug assistance programs, ways to make the most of your insurance coverage, and links to savings cards and other services. Two such websites are:
  • Medicine Assistance Tool
  • NeedyMeds

Dosage and administration

Here are some key details on how Kesimpta treatment is administered.

What is Kesimpta’s form?

Kesimpta comes as a liquid solution inside single-dose prefilled injection pens or syringes. The drug is given as an injection under the skin.

What’s the usual dosage for Kesimpta?

The usual dose of Kesimpta is 20 milligrams (mg). You can give yourself injections at home after your doctor or pharmacist shows you how. The drug manufacturer also provides step-by-step instructions on how to inject Kesimpta.

You’ll typically receive this drug once weekly for your first 3 weeks of treatment. After that, you’ll skip injecting Kesimpta for 1 week before you switch to a dosage of 20 mg once per month.

Once you’re receiving Kesimpta on a monthly basis, try to inject your dose on the same day each month. This helps keep a steady level of the drug in your system, which helps it work effectively.

How effective is Kesimpta?

Kesimpta was effective for treating relapsing forms of MS in clinical trials. Your doctor or pharmacist may be able to provide more details, or you can read the drug’s prescribing information to learn more.

The American Academy of Neurology’s guidelines for treating MS do not specifically mention Kesimpta, but they do recommend using a disease-modifying therapy (DMT) to treat relapsing forms of MS. Kesimpta is considered a DMT because it can help slow the worsening of MS symptoms over time.