Ofatumumab Injection (Multiple Sclerosis)

What is this medication?

OFATUMUMAB (OH fa TUE mue mab) treats multiple sclerosis (MS). It works by slowing down an overactive immune system, which prevents or delays worsening symptoms. It also decreases the number of flare-ups. It is a monoclonal antibody.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Kesimpta

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Infection, especially a viral infection such as hepatitis B, chickenpox, cold sores, or herpes
• Immune system problems
• Recent or upcoming vaccine
• An unusual or allergic reaction to ofatumumab, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is injected under the skin. You will be taught how to prepare and give it. Take it as directed on the prescription label. Keep taking it unless your care team tells you to stop.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or care team to get one.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team regarding the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss any doses. Talk to your care team about what to do if you miss a dose.

What may interact with this medication?

• Live virus vaccines
• Steroid medications, such as prednisone or cortisone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

You may need blood work done while you are taking this medication.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

In some patients, this medication may cause a serious brain infection that may cause death. If you have any problems seeing, thinking, speaking, walking, or standing, tell your care team right away. If you cannot reach your care team, urgently seek other source of medical care.

Talk to your care team if you or your partner wish to become pregnant or think either of you might be pregnant. This medication can cause serious birth defects if taken during pregnancy or for 6 months after stopping therapy.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions or angioedema—skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing
• Dizziness, loss of balance or coordination, confusion or trouble speaking
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Headache
• Pain, redness, or irritation at injection site
• Runny or stuffy nose
• Sore throat

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store in a refrigerator or at room temperature between 15 and 30 degrees C (59 and 86 degrees F).

Refrigeration (preferred): Store it in the refrigerator. Keep it in the original carton until you are ready to take it. Remove the dose from the carton about 15 to 30 minutes before it is time for you to take it. Do not freeze. Protect from light. Do not shake. Throw away any unused medication after the expiration date.

Room Temperature: This medication may be stored at room temperature for up to 7 days. Keep it in the original carton until you are ready to take it. Protect from light. Do not shake. If it is stored at room temperature, throw away any unused medication after 7 days or after it expires, whichever is first.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.