Monomethyl Fumarate Delayed-Release Capsules

What is this medication?

MONOMETHYL FUMARATE (MON oh meth il FUE ma rate) 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.

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

COMMON BRAND NAME(S): BAFIERTAM

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

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

• Infection
• Liver disease
• Low white blood cell levels
• An unusual or allergic reaction to monomethyl fumarate, diroximel fumarate, dimethyl fumarate, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the capsules whole. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

Talk to your care team about 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?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Dimethyl fumarate
• Diroximel fumarate

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.

Ask your care team if taking aspirin before taking this medication may reduce flushing.

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.

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
• Bowel blockage—stomach cramping, unable to have a bowel movement or pass gas, loss of appetite, vomiting
• 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
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Stomach bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds
• Stomach pain that is severe, does not go away, or gets worse

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

• Diarrhea
• Flushing
• Nausea
• Stomach pain
• Vomiting

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.

Unopened bottles: Store in the refrigerator. Do not freeze. Get rid of any unused medication after the expiration date.

Opened bottles: Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original container. Protect from light. Get rid of any unused medication after 3 months or after it expires, whichever is first.

To get rid of medications that are no longer needed or 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, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.