Multiple sclerosis:
Indications for: BAFIERTAM
Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
Adult Dosage:
Swallow whole. Initially 95mg twice daily for 7 days, then increase to maintenance dose of 190mg twice daily. If maintenance dose not tolerated, temporarily reduce back to initial dose. Within 4 weeks, resume maintenance dose; if not tolerated, consider discontinuing.
Children Dosage:
Not established.
BAFIERTAM Contraindications:
Concomitant dimethyl fumarate or diroximel fumarate.
BAFIERTAM Warnings/Precautions:
Obtain a CBC including lymphocyte count prior to initiation, after 6 months, and then every 6 to 12 months thereafter; consider interruption if lymphocyte counts <0.5×109/L persist for >6 months. Pre-existing low lymphocyte counts: not studied. Serious infections; consider withholding until resolved. Monitor for herpes zoster and other opportunistic infections; evaluate and treat if develop. Monitor serum aminotransferase, alkaline phosphatase, and total bilirubin prior to initiation and during treatment; discontinue if significant liver injury is suspected. Discontinue if anaphylaxis or angioedema occurs. Withhold and evaluate at first sign/symptom suggestive of PML. Administration with non-enteric coated aspirin (up to 325mg) may reduce incidence/severity of flushing. Pregnancy. Nursing mothers.
BAFIERTAM Classification:
Nrf2 pathway activator.
Adverse Reactions:
Flushing, abdominal pain, diarrhea, nausea, vomiting, pruritus, rash, albumin urine present, erythema, dyspepsia; lymphopenia, liver injury.
Drug Elimination:
The plasma half-life of MMF is ~0.5 hour and no circulating MMF is present at 24 hours in the majority of individual following oral administration of Bafiertam 190 mg (two 95 mg monomethyl fumarate delayed-release capsules) under fasting conditions.
Generic Drug Availability:
NO
How Supplied:
Caps—120
