Monomethyl fumarate

Generic name: Monomethyl Fumarate
Brand names: Bafiertam
Dosage form: oral delayed release capsule (95 mg)
Drug class: Selective immunosuppressants

Usage of 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 purposes not listed in this medication guide.

Monomethyl fumarate side effects

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.

    Before taking Monomethyl 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.

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    How to use Monomethyl fumarate

    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.

    Warnings

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

    What other drugs will affect Monomethyl fumarate

    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.

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