Generic
Diroximel Fumarate
1 brands available in the market
At a glance
Diroximel Fumarate is a medication used for the treatment of relapsing forms of multiple sclerosis (MS) in adults.
Description
The mechanism by which diroximel fumarate exerts its therapeutic effect in multiple sclerosis is unknown. MMF, the active metabolite of diroximel fumarate, has been shown to activate the Nrf2 pathway, which is involved in the cellular response to oxidative stress.
Indications
- Relapsing forms of multiple sclerosis (clinically isolated syndrome, relapsing-remitting disease, active secondary progressive disease)
Therapeutic class
Immunomodulators
Pharmacological class
Nrf2 Activator
Pharmacology
The mechanism by which diroximel fumarate exerts its therapeutic effect in multiple sclerosis is unknown. MMF, the active metabolite, has been shown to activate the Nrf2 pathway, which is involved in the cellular response to oxidative stress.
Mechanism of action
Diroximel Fumarate activates the Nrf2 pathway to reduce oxidative stress and help regulate inflammation in multiple sclerosis (exact mechanism unknown).
Dosage
Adult: Starting dosage 231 mg twice daily; after 7 days, increase to maintenance dosage of 462 mg (two 231 mg capsules) twice daily. Temporary reduction to 231 mg twice daily if not tolerated; resume 462 mg twice daily within 4 weeks.
Administration
Swallow capsules whole and intact. Do not crush, chew, or sprinkle contents on food. If taken with food, avoid high-fat, high-calorie meals (≤700 calories, ≤30 g fat).
Missed dose
If you miss a dose of Diroximel Fumarate, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose. Do not double the dose.
Side effects
Serious: Anaphylaxis and angioedema, Progressive Multifocal Leukoencephalopathy (PML), herpes zoster and other serious opportunistic infections, lymphopenia, liver injury, flushing.
Precautions & warnings
Discontinue if anaphylaxis/angioedema occurs; withhold if PML suspected; consider withholding in serious infections; monitor lymphocyte counts (baseline, 6 months, then every 6-12 months); monitor liver function tests.
Contraindications
Hypersensitivity to diroximel fumarate, dimethyl fumarate, or any excipient; taking dimethyl fumarate.
Drug interactions
No adequate information on drug interactions is available.
Food interactions
Can be taken with or without food (avoid high-fat/high-calorie meals).
Use in pregnancy
No adequate data on developmental risk associated with use in pregnant women.
Pregnancy Category: N/A — always consult a doctor before taking during pregnancy.
Use in lactation
No data on the presence of diroximel fumarate or metabolites in human milk.
Pediatric use
Safety and effectiveness in pediatric patients have not been established.
Geriatric use
Clinical studies did not include sufficient numbers of patients aged 65 years and over.
Renal / hepatic impairment
Renal impairment: No dosage adjustment necessary in mild renal impairment.
Hepatic impairment: Discontinue if clinically significant liver injury is suspected.
Overdose effects
No adequate information on overdose is available.
Storage conditions
Keep below 30°C temperature, away from light & moisture.
Chemical structure
Diroximel Fumarate