Monomethyl Fumarate

Monomethyl Fumarate is a prescription medication used for the treatment of relapsing forms of multiple sclerosis.

• Monomethyl Fumarate is available under the following different brand names: Bafiertam

Common side effects of Monomethyl Fumarate include:

• flushing,
• abdominal pain,
• diarrhea,
• nausea,
• vomiting,
• itching,
• rash,
• albumin in urine,
• redness, and
• indigestion/heartburn

Serious side effects of Monomethyl Fumarate include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• severe warmth, redness, burning, or itching under the 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.

Rare side effects of Monomethyl Fumarate include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Capsule, delayed-release

• 95 mg
• 190 mg of monomethyl Fumarate is bioequivalent to 240 mg of the prodrug dimethyl Fumarate

Multiple sclerosis

Adult dosage

• Starting dose: 95 mg orally twice daily for 7 days
• Maintenance dose after 7 days: 190 mg orally twice daily
• Unable to tolerate the maintenance dose
  • Consider temporarily reducing the dosage to 95 mg orally twice daily; within 4 weeks, resume at 190 mg orally twice daily
  • Unable to tolerate a return to the maintenance dose: Consider discontinuing treatment
  • Administration of non-enteric-coated aspirin (up to a 325-mg dose) 30 min before administration may reduce the incidence or severity of flushing

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Monomethyl Fumarate has severe interactions with no other drugs.
• Monomethyl Fumarate has serious interactions with the following drugs:
  • axicabtagene ciloleucel
  • brexucabtagene autoleucel
  • ciltacabtagene autoleucel
  • idecabtagene vicleucel
  • lisocabtagene maraleucel
  • tisagenlecleucel
• Monomethyl Fumarate has moderate interactions with the following drugs:
  • isavuconazonium sulfate
  • ozanimod
  • ublituximab
• Monomethyl Fumarate has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to MMF, DMF, diroximel Fumarate, or any of its excipients
• Taking DMF or diroximel Fumarate

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Monomethyl Fumarate?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Monomethyl Fumarate?”

Cautions

• Clinically significant cases of liver injury reported; onset ranges from a few days to several months after initiating; discontinue if clinically significant drug-induced liver injury is suspected
• May cause flushing (e.g., warmth, redness, itching, and/or burning sensation)
• Anaphylaxis and angioedema
  • Anaphylaxis and angioedema after the initial dose or at any time during treatment may occur
  • Signs and symptoms have included difficulty breathing, urticaria, and swelling of the throat and tongue
• Progressive multifocal leukoencephalopathy
  • Progressive multifocal leukoencephalopathy (PML) has occurred with DMF
  • Withhold the dose at first sign or symptom suggestive of PML and perform a diagnostic evaluation
  • Typical symptoms (e.g., progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, changes in thinking, memory changes, orientation leading to confusion, and personality changes) may progress over days to weeks
  • Monitor with MRI for signs consistent with PML and investigate any suspicious findings to allow for an early diagnosis of PML, if present
• Herpes zoster and other serious opportunistic infections
  • Serious cases of herpes zoster reported; these events may occur at any time during treatment
  • Monitor for signs and symptoms of herpes zoster
  • If herpes zoster occurs, administer appropriate treatment
  • Other serious opportunistic infections reported, including serious viral (herpes simplex virus, West Nile virus, cytomegalovirus), fungal (Candida and Aspergillus), and bacterial (Nocardia, Listeria monocytogenes, Mycobacterium tuberculosis) infections
  • Consider withholding treatment in patients with herpes zoster or other serious infections until the infection has resolved
  • Lymphopenia
• May decrease lymphocyte counts
  • Consider interrupting dose in patients with lymphocyte counts less than 0.5 x 109/L persisting for more than 6 months
  • Continue to monitor CBC count until their recovery if therapy is discontinued or interrupted because of lymphopenia
  • Consider withholding treatment from patients with serious infections until the resolution
  • Decide whether or not to restart treatment based on clinical circumstances
• Drug interaction overview
  • DMF or diroximel Fumarate
  • Both DMF and diroximel Fumarate are metabolized to MMF
  • Therefore, coadministration of MMF with DMF or diroximel Fumarate is contraindicated
  • MMF may initiate the day following the discontinuation of either of these drugs

Pregnancy and Lactation

• No adequate data is available on the use of MMF or its prodrug in pregnant females
• Lactation
  • No data available on the presence of DMF or MMF in human milk
  • Effects on breastfed infants and milk production are unknown
  • Consider the mother’s clinical need and any potential adverse effects on the breastfed infants from the drug or the underlying maternal condition.