7 mins read

Uses

What is Kesimpta used for?

Kesimpta (ofatumumab) is commonly used for the treatment of relapsing forms of multiple sclerosis (MS).

Learn more about Managing Multiple Sclerosis With Kesimpta.

Kesimpta may also be used for other conditions as determined by your healthcare provider.

How does Kesimpta work (mechanism of action)?

Kesimpta is a monoclonal antibody.  The exact way that it works is not known, but it is thought to involve binding to parts of B-cells in the body, which decreases the activity of your immune system. 

How is Kesimpta supplied (dosage forms)?

Kesimpta is available in the following dosage forms that are injected under the skin.

  • 20 mg/0.4 mL solution for injection, prefilled pens 
  • 20 mg/0.4 mL solution for injection, prefilled syringes

How should I store Kesimpta?

Kesimpta should be stored in the original packaging to protect it from light in the refrigerator between 36 F to 46 F (2 C to 8 C). If needed, you can store the medicine up to 86 F (30 C) for up to 7 days. If you put it back in the refrigerator, it should be used within 7 days. If Kesimpta is not used within those 7 days, it should be thrown away. Do not shake or freeze.

Side Effects

What are the most common side effects of Kesimpta?

The most common side effects of Kesimpta are listed below. Tell your healthcare provider if you have any of these side effects that bother you.

  • Infection, including an infection in the nose or throat, sore throat, or common cold symptoms (see below)
  • Headache
  • Injection-related reactions (see below)

There may be other side effects of Kesimpta that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Kesimpta?

While less common, the most serious side effects of Kesimpta are described below, along with what to do if they happen.

Severe Allergic Reactions. Kesimpta may cause allergic reactions, which can be serious. Stop using Kesimpta and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Infection. Kesimpta can increase the risk of infections, including serious infections. Call your healthcare provider if you have an infection or any of the following symptoms.

  • Burning or stinging when you pee 
  • Cough or coughing up blood
  • Fever, sweats, chills, or muscle aches
  • Shortness of breath
  • Diarrhea or stomach pain
  • Weight loss

Hepatitis B Virus Reactivation. If you have hepatitis B virus in your body or have had hepatitis B in the past, Kesimpta could make the virus active again. Your healthcare provider may do blood tests before starting Kesimpta and may monitor you for infection during treatment. Call your healthcare provider right away if you have any of the following symptoms of hepatitis.

  • Unusual tiredness
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
  • Nausea, vomiting, or loss of appetite
  • Dark-colored pee
  • Fever or chills
  • Pain in your side
  • Stool (poop) that is clay-colored    

Progressive Multifocal Leukoencephalopathy (PML). People using Kesimpta may develop a rare brain disease called PML. It is caused by a virus called the JC virus. PML is very serious and can lead to death. Stop using Kesimpta and call your healthcare provider right away if you have any of the following symptoms of PML.

  • Clumsiness or loss of coordination
  • Difficulty walking or speaking
  • Facial drooping
  • Vision problems
  • Thinking, memory, or personality changes
  • Weakness on one side of your body that gets worse
  • Seizures

Injection-Related Reactions. Sometimes, people can have a reaction to the injection. Injection-related reactions are more likely to occur with the first dose but can happen after any dose. Skin redness, swelling, pain, and itching commonly occur. Call your healthcare provider right away if you get any of the following symptoms, especially if you get new or more severe symptoms with any injection.

  • Fever or chills
  • Headache
  • Muscle pain
  • Tiredness
  • Rash or hives
  • Trouble breathing
  • Swelling of the face, eyelids, lips, mouth, tongue, or throat
  • Feeling faint
  • Chest tightness

Low Antibodies. Kesimpta may cause you to have low levels of certain types of antibodies, called immunoglobulins. Low immunoglobulin levels could increase your risk for infection. Keep all appointments to check your blood work before starting Kesimpta and during and after treatment.

Warnings & Precautions

Who should not use Kesimpta?

Allergies to Ingredients. People who are allergic to any of the following should not use Kesimpta.

  • Kesimpta
  • Ofatumumab
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Kesimpta.

Hepatitis B Infection. People who have a current or active hepatitis B infection should not take Kesimpta.

What should I know about Kesimpta before using it?

Do not take Kesimpta unless it has been prescribed to you by a healthcare provider. Use it as prescribed.

Do not share Kesimpta with other people, even if they have the same condition as you. It may harm them.

Keep Kesimpta out of the reach of children. Since this medicine should be kept in a refrigerator, take special precautions to keep it away from children who also use the refrigerator.

If you develop serious infections while taking Kesimpta, your healthcare provider may delay your treatment until your infection is gone. 

Kesimpta is an injection that is given under the skin (subcutaneous) in either your thigh or stomach. You can give this medication to yourself, or a caregiver can give it to you. 

Make sure that you or a caregiver understands how to properly prepare and use Kesimpta. Read the Instructions for Use that you get with your medicine. If you have any questions, talk to your healthcare provider. You should not inject it into areas of the skin that are tender, bruised, red, scaly, or hard. You should also avoid areas of the skin with moles, scars, or stretch marks.

You will give yourself the first 3 doses of Kesimpta on a weekly schedule (weeks 0, 1, and 2). You will not give yourself the dose on week 3. On week 4, you will give yourself the dose and start the monthly schedule, where you will give yourself the dose one time every month.

What should I tell my healthcare provider before using Kesimpta?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Kesimpta is right for you.

In particular, make sure that you discuss any of the following.

Infection. Tell your healthcare provider if you have an infection, including Hepatitis B Virus (HBV) or progressive multifocal leukoencephalopathy (PML).  

Vaccines. Talk with your healthcare provider about any vaccines that you may need. You should not receive certain vaccines right before or while using Kesimpta. You should wait 4 weeks after a live vaccine and 2 weeks after other vaccines before starting Kesimpta. Tell your healthcare provider about any vaccines you have recently received or have scheduled.

Other Medicines and Supplements. Kesimpta may interact with other medicines and supplements. Before using Kesimpta, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. Kesimpta may cause harm to an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. If you become pregnant, contact your healthcare provider. People who can get pregnant should use effective birth control while receiving Kesimpta and for 6 months after the last dose. Women who need to take Kesimpta while pregnant can enroll in a registry that is keeping track of pregnancy outcomes. To enroll in the MotherToBaby Pregnancy Study in Multiple Sclerosis, you can call 877-311-8972 or email [email protected] or go to mothertobaby.org/join-study. Also, talk with your healthcare provider about vaccines for your baby if you used Kesimpta during your pregnancy.

Breastfeeding. It is not known if Kesimpta passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should use Kesimpta while breastfeeding.

How can I get more information about Kesimpta?

For more information about Kesimpta, you can visit the manufacturer’s website at kesimpta.com or call them at 888-669-6682.

Interactions

Does Kesimpta interact with foods or drinks?

There are no known interactions between Kesimpta and foods or drinks.

It is unknown if drinking alcohol will affect Kesimpta.

Does Kesimpta interact with other medicines (drug interactions)?

Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are taking any corticosteroid, which is a medicine for certain inflammatory conditions, or other medicines that weaken the immune system. 

This may not be a complete list of medicines that can interact with Kesimpta. Always check with your healthcare provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Kesimpta?

If you or someone else has used too much Kesimpta, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Kesimpta?

If you miss a dose of Kesimpta during week 0, 1, or 2, call your healthcare provider for instructions. If you miss one of your monthly doses, use it as soon as possible and use the next dose one month later. 

Look up another drug