Bafiertam

Bafiertam (monomethyl fumarate) is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

It is not known if Bafiertam is safe and effective in children.

Bafiertam may cause serious side effects including:

• allergic reaction (such as welts, hives, swelling of the face, lips, mouth or tongue, or difficulty breathing). Stop taking Bafiertam and get emergency medical help right away if you get any of these symptoms.
• PML (progressive multifocal leukoencephalopathy) a rare brain infection that usually leads to death or severe disability over a period of weeks or months. Tell your doctor right away if you get any of these symptoms of PML:
  • weakness on one side of the body that gets worse
  • clumsiness in your arms or legs
  • vision problems
  • changes in thinking and memory
  • confusion
  • personality changes
• herpes zoster infections (shingles), including central nervous system infections
• other serious infections
• decreases in your white blood cell count. Your doctor should do a blood test to check your white blood cell count before you start treatment with Bafiertam and while you are on therapy. You should have blood tests after 6 months of treatment and every 6 to 12 months after that.
• liver problems. Bafiertam may cause serious liver problems that may lead to liver failure, a liver transplant, or death. Your doctor should do blood tests to check your liver function before you start taking Bafiertam and during treatment if needed. Tell your doctor right away if you get any of these symptoms of a liver problem during treatment:
  • severe tiredness
  • loss of appetite
  • pain on the right side of your stomach
  • have dark or brown (tea color) urine
  • yellowing of your skin or the white part of your eyes

The most common side effects of Bafiertam include:

• flushing, redness, itching, or rash
• nausea, vomiting, diarrhea, stomach pain, or indigestion
• Flushing and stomach problems are the most common reactions, especially at the start of treatment, and may decrease over time. Call your doctor if you have any of these symptoms and they bother you or do not go away. Ask your doctor if taking aspirin before taking Bafiertam may reduce flushing.

These are not all the possible side effects of Bafiertam. Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088.

Blood Tests Prior to Initiation of Bafiertam

Obtain the following prior to treatment with Bafiertam:

• A complete blood cell count (CBC), including lymphocyte count.
• Serum aminotransferase, alkaline phosphatase, and total bilirubin levels.

Dosing Information

• The starting dosage for Bafiertam is 95 mg twice a day orally for 7 days.
• After 7 days, the dosage should be increased to the maintenance dosage of 190 mg (administered as two 95 mg capsules) twice a day orally.
• Temporary dosage reductions to 95 mg twice a day may be considered for individuals who do not tolerate the maintenance dosage.
• Within 4 weeks, the recommended dosage of 190 mg twice a day should be resumed.
• Discontinuation of Bafiertam should be considered for patients unable to tolerate return to the maintenance dosage.
• Administration of non-enteric coated aspirin (up to a dose of 325 mg) 30 minutes prior to Bafiertam dosing may reduce the incidence or severity of flushing.

Administration Instructions

• Swallow Bafiertam capsules whole and intact.
• Do not crush, chew, or mix the contents with food.
• Bafiertam can be taken with or without food.

Blood Tests to Assess Safety After Initiation of Bafiertam

• Obtain a complete blood cell count (CBC), including lymphocyte count, 6 months after initiation of Bafiertam and then every 6 to 12 months thereafter, as clinically indicated.
• Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels during treatment with Bafiertam, as clinically indicated.

Concomitant Dimethyl Fumarate or Diroximel Fumarate

• Both dimethyl fumarate and diroximel fumarate are metabolized to monomethyl fumarate.
• Therefore, Bafiertam is contraindicated in patients currently taking dimethyl fumarate or diroximel fumarate.
• Bafiertam may be initiated the day following discontinuation of either of these drugs.

• There are no adequate data on the developmental risk associated with the use of Bafiertam or dimethyl fumarate (the prodrug of Bafiertam) in pregnant women.
• There are no data on the presence of DMF or MMF in human milk.
• The effects on the breastfed infant and on milk production are unknown.
• The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Bafiertam and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.