Pricing
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All price changes →Indications & Uses
Diroximel Fumarate is used to treat relapsing forms of multiple sclerosis (MS) in adults. This includes clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.
Pharmacology
Nobody knows how diroximel fumarate works in multiple sclerosis. Its active metabolite, MMF, has been shown to activate the nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway, in vitro and in vivo, in animals and humans. This pathway is involved in the cell's response to oxidative stress. MMF has also been identified as a nicotinic acid receptor agonist in vitro.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Blood tests prior to initiation of Diroximel
Before treatment with Diroximel, get these done: a complete blood cell count (CBC), including the lymphocyte count, and serum aminotransferase, alkaline phosphatase and total bilirubin levels.
Dosing information
The starting dosage of Diroximel is 231 mg twice a day, taken orally. After 7 days, the dosage goes up to the maintenance dosage of 462 mg twice a day, taken orally (that is two 231 mg capsules each time). If a person can't tolerate the maintenance dosage, a temporary reduction to 231 mg twice a day may be considered. Within 4 weeks, the recommended dosage of 462 mg twice a day should be resumed. For patients who still can't tolerate the return to the maintenance dosage, stopping Diroximel should be considered.
Non-enteric coated aspirin, up to a dose of 325 mg, taken 30 minutes before the Diroximel dose may reduce how often flushing happens or how severe it is.
Administration instructions
Swallow Diroximel capsules whole and intact. Don't crush or chew them, and don't sprinkle the contents on food. If you take the capsules with food, avoid a high-fat, high-calorie meal or snack. The meal or snack should contain no more than 700 calories and no more than 30 g fat.
Side Effects
The important side effects listed for Diroximel Fumarate are anaphylaxis and angioedema, progressive multifocal leukoencephalopathy, herpes zoster and other serious opportunistic infections, lymphopenia, liver injury, and flushing.
Cautions & Contraindications
Warnings & Precautions
Stop diroximel fumarate and do not restart it if anaphylaxis or angioedema occurs. If there is any first sign or symptom that suggests progressive multifocal leukoencephalopathy (PML), withhold the medicine straight away. With herpes zoster and other serious opportunistic infections, consider withholding diroximel in cases of serious infection until the infection has resolved. For lymphopenia, get a CBC including lymphocyte count before starting diroximel, again after 6 months, and then every 6 to 12 months. Consider interrupting treatment if lymphocyte counts below 0.5 × 109/L persist for more than six months. For the liver, check serum aminotransferase, alkaline phosphatase and total bilirubin levels before starting diroximel and during treatment, as clinically indicated. If clinically significant liver injury caused by diroximel is suspected, discontinue it.
Contraindications
Diroximel fumarate must not be given to patients who are known to be hypersensitive to diroximel fumarate, to dimethyl fumarate, or to any of the excipients in the medicine. Reactions can include anaphylaxis and angioedema. It also must not be taken together with dimethyl fumarate.
Pregnancy & Breastfeeding
We don't have enough data to say what risk Diroximel fumarate carries for development when it is used in pregnant women. The same is true of dimethyl fumarate, which has the same active metabolite as Diroximel. Nobody has measured whether diroximel fumarate or its metabolites (MMF, HES) pass into human milk. So the effects on a breastfed infant, and on milk production, are not known.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Pediatric Use: Safety and effectiveness of Diroximel Fumarate in children have not been established.
Geriatric Use: Clinical studies of Dimethyl fumarate and Diroximel Fumarate did not include enough patients aged 65 years and over to say whether they respond differently from younger patients.
Renal Impairment: No dose adjustment is needed in patients with mild renal impairment.
Storage
Store Diroximel Fumarate below 30°C, and keep it away from light and moisture. Keep it out of the reach of children.
Common questions about Deroximel DR 231 mg
What is Deroximel DR 231 mg Capsule (Enteric Coated)?
Deroximel DR 231 mg Capsule (Enteric Coated) is a medicine that contains Diroximel Fumarate. It is made by Renata PLC.
What is Deroximel DR used for?
Diroximel Fumarate is used to treat relapsing forms of multiple sclerosis (MS) in adults. This includes clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.
What are the side effects of Deroximel DR?
The important side effects listed for Diroximel Fumarate are anaphylaxis and angioedema, progressive multifocal leukoencephalopathy, herpes zoster and other serious opportunistic infections, lymphopenia, liver injury, and flushing.
Can I take Deroximel DR during pregnancy or while breastfeeding?
We don't have enough data to say what risk Diroximel fumarate carries for development when it is used in pregnant women. The same is true of dimethyl fumarate, which has the same active metabolite as Diroximel. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
How should I store Deroximel DR?
Store Diroximel Fumarate below 30°C, and keep it away from light and moisture. Keep it out of the reach of children.
Is there a cheaper medicine with the same ingredient?
Deroximel DR is already among the lowest-priced brands of Diroximel Fumarate at this strength.
Do I need a prescription for Deroximel DR?
Deroximel DR is a prescription (Rx) medicine. Take it as your doctor advises.