Deroximel DR EC Capsule
Diroximel Fumarate
231mg
Renata PLC.
| Pack size | 30's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 200.00 AED |
Indications
Deroximel DR EC Capsule is used for:
Multiple Sclerosis
Adult Dose
Oral
Multiple Sclerosis
Indicated for treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease
Initial: 231 mg PO BID
Maintenance: After 7 days, increase to 462 mg (two 231-mg capsules) PO BID
Unable to tolerate maintenance dose
Consider temporarily reducing dose to 231 mg PO BID if the maintenance dose is not tolerated
Within 4 weeks, resume dose at 462 mg PO BID
Consider discontinuing treatment for patients unable to tolerate return to the maintenance dosage
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
Hepatic impairment
No studies have been conducted in subjects with hepatic impairment
Not expected to affect exposure to monomethyl fumarate (MMF) and therefore no dosage adjustment is necessary
Child Dose
Renal Dose
Renal impairment
Mild: No dosage adjustment necessary
Moderate-severe: Not recommended
Administration
If taken with food, avoid a high-fat, high-calorie meal/snack; meal/snack should contain <700 calories and <30 g fat
Avoid coadministration with alcohol
Contra Indications
Hypersensitivity to diroximel fumarate, dimethyl fumarate, or to any of the excipients.
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.
Pregnancy-Lactation
Pregnancy
No adequate data on the developmental risk associated with the use or dimethyl fumarate (which has the same active metabolite as diroximel fumarate) in pregnant women
Animal studies
In animal studies, administration of diroximel fumarate during pregnancy or throughout pregnancy and lactation resulted in adverse effects on embryofetal and offspring development (increased incidences of skeletal abnormalities, increased mortality, decreased body weights, neurobehavioral impairment) at clinically relevant drug exposure
Lactation
There are no data on the presence of diroximel fumarate or metabolites (MMF, 2-hydroxyethyl succinimide [HES]) in human milk
Effects on the breastfed infant and on milk production are unknown
Interactions
Concomitant use of dimethyl fumarate and diroximel fumarate is contraindicated, as both are metabolized to monomethyl fumarate; initiate diroximel fumarate the day following the discontinuation of dimethyl fumarate
Adverse Effects
Side effects of Diroximel Fumarate :
>10%
Flushing (40%)
Abdominal pain (18%)
Diarrhea (14%)
Nausea (12%)
1-10%
Vomiting (9%)
Pruritus (8%)
Rash (8%)
Albumin urine present (6%)
Erythema (5%)
Dyspepsia (5%)
AST increased (4%)
Lymphopenia (2%)
Frequency Not Defined
Transient increase in mean eosinophil counts
Mechanism of Action
Mechanism of action by which diroximel fumarate elicits 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
Note
Deroximel DR 231mg EC Capsule manufactured by Renata PLC.. Its generic name is Diroximel Fumarate. Deroximel DR is availble in Bangladesh.
Farmaco BD drug index information on Deroximel DR EC Capsule is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.