Monomethyl Fumarate (mon-oh-METH-il FUE-ma-rate)

Treats relapsing forms of multiple sclerosis (MS).

Brand Name(s):

Bafiertam

When This Medicine Should Not Be Used:

How to Use This Medicine:

Delayed Release Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the delayed-release capsule whole. Do not crush, chew, open, or mix its contents with food.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• You may receive other medicines (including aspirin) to help prevent redness or feeling of warmth or burning of the face, neck, arms, or upper chest.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the unopened medicine in the refrigerator. Do not freeze. Keep the opened medicine bottle at room temperature for up to 3 months.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine together with dimethyl fumarate or diroximel fumarate.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, any type of infection, or a weak immune system.
• This medicine may cause the following problems:
  • Increased risk of infections, which may be life-threatening, including progressive multifocal leukoencephalopathy (PML) or herpes zoster (shingles)
  • Liver problems, which may lead to liver failure or liver transplant
  • Serious stomach or bowel problems (including bleeding, blockage, perforation, or ulcers)
• 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.
• This medicine lowers the number of white blood cells. This weakens your immune system, so you may get infections more easily. Wash your hands often. Avoid people who are sick.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Black, tarry stools, constipation, diarrhea, stomach pain or upset, vomiting of blood or material that looks like coffee grounds
• Dark urine or pale stools, nausea, vomiting, loss of appetite, yellow skin or eyes
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Lower back or side pain, painful or difficult urination
• Weakness on one side of the body, changes in vision, problems with thinking, memory, or orientation, confusion

If you notice these less serious side effects, talk with your doctor:

• Warmth, redness, itching, or burning feeling of the skin

If you notice other side effects that you think are caused by this medicine, tell your doctor

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