Monomethyl fumarate is used to treat relapsing forms of multiple sclerosis in adults (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease).

Monomethyl fumarate may also be used for purposes not listed in this medication guide.

You should not use monomethyl fumarate if you also use dimethyl fumarate or diroximel fumarate.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using monomethyl fumarate.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take monomethyl fumarate with or without food.

When you begin taking monomethyl fumarate you will use a "starter dose" for 7 days, and then you will use a "maintenance dose" as you continue taking the medicine.

Swallow the capsule whole and do not crush, chew, or open it. Do not mix the medicine from a capsule with food.

monomethyl fumarate can cause flushing (a sensation of warmth or tingling under your skin). Your doctor may recommend you take aspirin 30 minutes before taking monomethyl fumarate to help prevent flushing. Take only the type and amount of aspirin your doctor recommends.

Call your doctor if you have signs of infection, such as fever, chills, flu-like-symptoms, or skin sores. Further doses may be delayed until your infection clears up.

You will need frequent medical tests.

Store an unopened bottle of the capsules in a refrigerator, do not freeze.

After opening, store the bottle at room temperature, away from moisture, heat, and light. Keep the capsules in the original bottle. Throw away any unused capsules 3 months after you first opened the bottle.

Usual Adult Dose for Multiple Sclerosis:

Initial dose: 95 mg orally 2 times daily for 7 days
Maintenance dose: After 7 days, increase the dose to 190 mg orally 2 times daily
-Temporary dose reductions to 95 mg 2 times daily may be considered for patients who do not tolerate the maintenance dose.
-Resume 190 mg 2 times daily within 4 weeks.
-Discontinue this drug in patients unable to tolerate return to the maintenance dose.

Comments:
-Prior to initiating therapy, obtain a complete blood cell count (CBC), including lymphocyte count and serum aminotransferase, alkaline phosphatase, and total bilirubin levels.
-Administration of nonenteric coated aspirin (up to a dose of 325 mg) 30 minutes prior to dosing this drug may reduce the incidence or severity of flushing.

Use: For the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults.

You should not use monomethyl fumarate if you are allergic to it, or if:

• you are also using dimethyl fumarate or diroximel fumarate.

Tell your doctor if you have ever had:

• low white blood cell (WBC) counts;

• an infection; or

• liver disease.

Tell your doctor if you are pregnant or breastfeeding.

Monomethyl fumarate is not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Monomethyl fumarate may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly.

Also call your doctor at once if you have:

• severe warmth, redness, burning, or itching under your skin;

• liver problems--loss of appetite, stomach pain (upper right side), tiredness, dark urine, jaundice (yellowing of the skin or eyes);

• signs of infection --fever, chills, sweating, mouth sores, headache, confusion, neck stiffness, sensitivity to light, vomiting, severe diarrhea; or

• symptoms of herpes virus--flu-like symptoms, cold sores around your mouth, tingly or painful blistering rash, burning pain in your thigh or lower back.

Common side effects of monomethyl fumarate may include:

• flushing (sudden warmth, redness, or tingly feeling);

• stomach pain, indigestion;

• nausea, vomiting; or

• diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect monomethyl fumarate, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Keep all appointments with your doctor and the laboratory. Your doctor may order a blood test before you begin your treatment and may order certain lab tests during your treatment to check your body's response to monomethyl fumarate.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.