Formulary
Diroximel fumarate: Indications, Dosing, Side Effects and Interactions
Diroximel fumarate is converted into active monomethyl fumarate which is thought to work by activating the nuclear factor (erythroid-derived 2)-like 2 (Nrf2)...
MedNext Academy | 3 min read
Diroximel fumarate: Indications, Dosing, Side Effects and Interactions
Diroximel fumarate is converted into active monomethyl fumarate which is thought to work by activating the nuclear factor (erythroid-derived 2)-like 2 (Nrf2)...
Drug action
Diroximel fumarate is converted into active monomethyl fumarate which is thought to work by activating the nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway, resulting in immunomodulatory and anti-inflammatory effects.
Indications and dose
**Multiple sclerosis (initiated under specialist supervision)**
- **Adult** (By Mouth): Initially 231 mg twice daily for 7 days, then maintenance 462 mg twice daily, for dose adjustments due to side effects-consult product literature.
Cautions
Reduced lymphocyte count-consult product literature; risk factors for progressive multifocal leukoencephalopathy; serious infection (do not initiate until infection resolved; consider suspending treatment if infection develops); severe active gastrointestinal disease (no information available) Cautions, further information Progressive Multifocal Leukoencephalopathy There is an increased risk of opportunistic infection and progressive multifocal leukoencephalopathy (PML) caused by JC virus associated with dimethyl fumarate and other fumarates. Prolonged moderate to severe lymphopenia increases the risk of PML, although risk cannot be excluded in patients with mild lymphopenia. Other factors that may increase the risk include treatment duration, profound decreases in CD4+ and CD8+ T cell count, and previous immunosuppressant or immunomodulatory treatment. M
Contraindications
Progressive multifocal leukoencephalopathy (suspected or confirmed); severe lymphopenia (lymphocyte count below 0.5 x 10 9 /litre)-consult product literature
Side effects
Common or very common Alopecia; decreased leucocytes; diarrhoea; feeling hot; gastrointestinal discomfort; gastrointestinal disorders; increased risk of infection; nausea; paraesthesia; skin reactions; urine abnormalities; vasodilation; vomiting Uncommon Thrombocytopenia Frequency not known Angioedema; drug-induced liver injury; dyspnoea; hypotension; hypoxia; progressive multifocal leukoencephalopathy (PML); rhinorrhoea
Interactions
**Other interactions (3):**
- In an in vivo study, co-administration of dimethyl fumarate with a combined oral contraceptive (norgestimate and ethinyl estradiol) did not elicit any relevant change in oral contraceptive exposure.
- In MS clinical studies, the concomitant treatment of relapses with a short course of intravenous corticosteroids was not associated with a clinically relevant increase of infection.
- Concurrent therapy with nephrotoxic medicinal products (such as aminoglycosides, diuretics, non-steroidal anti-inflammatory drugs or lithium) may increase the potential of renal adverse reactions...
Pregnancy
Avoid unless potential benefit outweighs risk-toxicity in animal studies. M
Breast feeding
Specialist sources indicate present in milk but amount probably too small to be harmful. Monitor breastfed infants for flushing, vomiting, diarrhoea, adequate weight gain, and developmental milestones, especially younger, exclusively breastfed infants.
Hepatic impairment
Caution in severe impairment (no information available). M
Renal impairment
Caution in moderate or severe impairment (no information available). M
Medicinal forms
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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