Deroximel DR
Generic: Diroximel Fumarate
Daily Dose:
Duration:
Cheaper & Alternative Brands (231 mg)
Same active generic (Diroximel Fumarate), same form (Capsule (Enteric Coated)), exact same strength (231 mg)No other brands currently registered with this exact active generic and dosage form.
Clinical Prescribing Information
Medical monograph and safety information for healthcare professionals & patients.Indications & Clinical Uses
Deroximel DR is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Dosage & Administration
Blood Tests Prior to Initiation of Diroximel
: Obtain the following prior to treatment with Diroximel:
A complete blood cell count (CBC), including lymphocyte count
Serum aminotransferase, alkaline phosphatase, and total bilirubin levels
Dosing Information
: The starting dosage for Diroximel is 231 mg twice a day orally. After 7 days, the dosage should be increased to the maintenance dosage of 462 mg (administered as two 231 mg capsules) twice a day orally. Temporary dosage reductions to 231 mg twice a day may be considered for individuals who do not tolerate the maintenance dosage. Within 4 weeks, the recommended dosage of 462 mg twice a day should be resumed. Discontinuation of Diroximel 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 Diroximel dosing may reduce the incidence or severity of flushing.
Administration Instructions
: Swallow Diroximel capsules whole and intact. Do not crush or chew, or sprinkle the capsule contents on food. If taken with food, avoid a high-fat, high-calorie meal/snack; the meal/snack should contain no more than 700 calories and no more than 30 g fat.
Contraindications
Diroximel is contraindicated in patients
With known hypersensitivity to diroximel fumarate, dimethyl fumarate, or to any of the excipients of Diroximel. Reactions may include anaphylaxis and angioedema.
Taking dimethyl fumarate.
Side Effects & Adverse Reactions
The following important adverse reactions are shown:
Anaphylaxis and Angioedema
Progressive Multifocal Leukoencephalopathy
Herpes Zoster and Other Serious Opportunistic Infections
Lymphopenia
Liver Injury
Flushing
Warnings & Precautions
Anaphylaxis and Angioedema
: Discontinue and do not restart diroximel if these occur.
Progressive Multifocal Leukoencephalopathy (PML)
: Withhold diroximel at the first sign or symptom suggestive of PML.
Herpes zoster and other serious opportunistic infections
: Consider withholding diroximel in cases of serious infection until the infection has resolved.
Lymphopenia
: Obtain a CBC including lymphocyte count before initiating diroximel, after 6 months, and every 6 to 12 months thereafter. Consider interruption of diroximel if lymphocyte counts <0.5 × 109/L persist for more than six months.
Liver Injury
: Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels before initiating diroximel and during treatment, as clinically indicated. Discontinue diroximel if clinically significant liver injury induced by diroximel is suspected.
Pharmacology & Mechanism of Action
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 nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway in vitro and in vivo in animals and humans. The Nrf2 pathway is involved in the cellular response to oxidative stress. MMF has been identified as a nicotinic acid receptor agonist in vitro.