Monomethyl Fumarate delayed-release capsules

What is this medication?

MONOMETHYL FUMARATE (MON oh meth il FUE ma rate) helps to decrease the number of multiple sclerosis relapses in people with relapsing-remitting forms of the disease. It is not a cure.

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:

• immune system problems
• infection
• liver disease
• low blood counts, like white cells
• an unusual or allergic reaction to diroximel fumarate, dimethyl fumarate, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush, or chew this medicine. Swallow the capsules whole. You can take it with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine 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 medicine with the following medications:

• 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 health care professional for regular checks on your progress. Tell your health care professional 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 medicine.

Call your doctor if the flushing from this medicine bothers you or does not go away. Ask your doctor if taking aspirin before taking this medicine may reduce flushing.

This medicine may increase your risk of getting an infection. Call your health care professional for advice if you get a fever, chills, or 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 medicine may cause a serious brain infection that may cause death. If you have any problems seeing, thinking, speaking, walking, or standing, tell your healthcare professional right away. If you cannot reach your healthcare professional, 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 doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• fever, chills, sore throat
• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin
• signs and symptoms of a serious brain infection like changes in vision, confusion, weakness on one side of the body, loss of balance or coordination, loss of memory, or changes in personality

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

• diarrhea
• facial flushing
• nausea
• stomach pain
• upset stomach

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.

Unopened bottles of this medicine should be stored in a refrigerator between 2 and 8 degrees C (35 and 46 degrees F). Throw away any unopened, unused medicine after the expiration date.

Once a bottle is opened, store at room temperature between 20 and 25 degrees C (68 and 77 degrees F) for up to 3 months. Keep this medicine in the original container. Protect from heat and light. Throw away any medicine if the bottle has been opened for more than 3 months.

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.