Pronunciation:

mon-oh-METH-il FUE-ma-rate

Brand Names:

• Bafiertam

Dosage Forms:

• Capsule, Delayed Release

Classifications:

Therapeutic—

Immune Modulator

Uses of This Medicine:

Monomethyl fumarate is used to treat the relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. This medicine will not cure MS, but it may slow some of the disabling effects and decrease the number of relapses of the disease.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of monomethyl fumarate in the pediatric population. Safety and efficacy have not been established.

Older adults—

Although appropriate studies on the relationship of age to the effects of monomethyl fumarate have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Infection—May decrease your body's ability to fight infections.

• Liver disease or
• Weak immune system—Use with caution. May increase risk for more serious side effects.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine usually comes with patient information leaflet. Read the instructions carefully and make sure you understand them before taking this medicine. If you have any questions, ask your doctor.

You may take this medicine with or without food.

Swallow the delayed-release capsule whole. Do not crush, chew, open, or mix its contents with food.

You may receive other medicines (eg, aspirin) to help prevent redness or feeling of warmth or burning of the face, neck, arms, or upper chest.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (delayed-release capsules):
  • For relapsing forms of multiple sclerosis:
    • Adults—At first, 95 milligrams (mg) taken 2 times a day for 7 days. Your doctor may adjust your dose as needed and tolerated. The recommended dose after 7 days is 190 mg (two 95 mg) taken 2 times a day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the unopened medicine in the refrigerator. Do not freeze. Keep the opened medicine bottle at room temperature for up to 3 months.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests will be needed 6 months after starting treatment, then every 6 to 12 months after, to check for any unwanted effects. Urine tests may also be needed.

Symptoms of your MS may return and become worse after stopping treatment with this medicine. Do not stop using this medicine without checking first with your doctor.

Do not use this medicine together with dimethyl fumarate (Tecfidera®) or diroximel fumarate (Vumerity®). Using these medicines together may increase your risk for more serious side effects.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema. These can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals after using this medicine.

This medicine may increase your risk of developing a serious and rare brain infection called progressive multifocal leukoencephalopathy (PML). Check with your doctor right away if you have vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, or weak legs.

This medicine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection (including herpes). If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever, chills, cough, hoarseness, lower back or side pain, or painful or difficult urination.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Chills

cough

fever

hoarseness

lower back or side pain

painful or difficult urination

Incidence not known

Chest tightness

dark urine

difficulty swallowing

dizziness

fast heartbeat

hives, itching, skin rash

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

loss of appetite

painful blisters on trunk of body

right upper stomach tenderness

trouble with breathing

unusual tiredness or weakness

weight loss

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Diarrhea

feeling of warmth

nausea

redness of the face, neck, arms, and occasionally, upper chest

stomach pain

vomiting

Less common

Belching

heartburn

indigestion

stomach discomfort or upset

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.