Deroximel DR Capsule (Enteric Coated) EC Capsule 231 mg is a Product of the Generic Diroximel Fumarate

What Is Deroximel DR Capsule (Enteric Coated) EC Capsule 231 mg Indications and 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.

Pharmacology (Source, Chemical and Physical Composition) Of Deroximel DR Capsule (Enteric Coated) EC Capsule 231 mg

The mechanism by which Deroximel DR Capsule (Enteric Coated) EC Capsule 231 mg (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.

Dosage And Administration of Deroximel DR Capsule (Enteric Coated) EC Capsule 231 mg

Blood Tests Prior to Initiation of Deroximel DR Capsule (Enteric Coated) EC Capsule 231 mg (Diroximel Fumarate) : 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.

Side Effects of Deroximel DR Capsule (Enteric Coated) EC Capsule 231 mg

The following important adverse reactions are shown: Anaphylaxis and Angioedema Progressive Multifocal Leukoencephalopathy Herpes Zoster and Other Serious Opportunistic Infections Lymphopenia Liver Injury Flushing

Precautions And Warnings for Deroximel DR Capsule (Enteric Coated) EC Capsule 231 mg

Anaphylaxis and Angioedema : Discontinue and do not restart Deroximel DR Capsule (Enteric Coated) EC Capsule 231 mg (Diroximel Fumarate) 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.

Use During Pregnancy and Lactation

There are no adequate data on the developmental risk associated with the use of Diroximel or dimethyl fumarate (which has the same active metabolite as Diroximel) in pregnant women. There are no data on the presence of Deroximel DR Capsule (Enteric Coated) EC Capsule 231 mg (Diroximel Fumarate) or metabolites (MMF, HES) in human milk. The effects on the breastfed infant and on milk production are unknown.

Storage Conditions of It

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children. Thanks for using MedEx! How would you rate your experience so far?