Deroximel DR – Diroximel Fumarate

Home / Deroximel DR – Diroximel Fumarate

Deroximel DR

231 mg Capsule (Enteric Coated)
Diroximel Fumarate · Renata PLC
EN বাং
৳200.00
per unit
AI Summary Generated by AI for informational purposes only

This medicine is used to treat multiple sclerosis, a long-term nerve disease. It helps reduce flare-ups and slows down the worsening of the condition. It is not recommended for use during pregnancy or while breastfeeding.

Indications

Diroximel Fumarate 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

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.

Dosage & Administration

Important:
Do not take any medication without a doctor's prescription. Self-medication can be dangerous.
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

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

Pregnancy & 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 diroximel fumarate or metabolites (MMF, HES) in human milk. The effects on the breastfed infant and on milk production are unknown.

Precautions & Warnings

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.

Use in Special Populations

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: Clinical studies of Dimethyl fumarate and Diroximel did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients.

Renal Impairment: No dosage adjustment is necessary in patients with mild renal impairment.

Storage Conditions

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

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