Monomethyl fumarate

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 reasons not mentioned in this medication guide.

Your doctor will do blood tests to ensure you do not have any conditions that would make it unsafe for you to use monomethyl fumarate.

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

You can take monomethyl fumarate with or without food.

When you start taking monomethyl fumarate, you will use a "starter dose" for 7 days, and then you will switch to 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 feeling of warmth or tingling under your skin). Your doctor may suggest taking aspirin 30 minutes before taking monomethyl fumarate to help prevent flushing. Take only the type and amount of aspirin your doctor advises.

Call your doctor if you notice signs of infection, such as fever, chills, flu-like symptoms, or skin sores. Further doses may be postponed until your infection is gone.

You will need regular medical tests.

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

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

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

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.

Get emergency medical help if you notice signs of an allergic reaction: hives; trouble 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 immediately if you experience issues with speech, thought, vision, or muscle movement. These symptoms may start slowly and worsen quickly.

Also contact your doctor right away 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.

Usual Adult Dose for Multiple Sclerosis:

Initial dose: 95 mg orally 2 times daily for 7 daysMaintenance 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.

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

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

Follow your doctor's instructions regarding any restrictions on food, drinks, or activities.

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.