Formulary
Dimethyl fumarate: Indications, Dosing, Side Effects and Interactions
Dimethyl fumarate is converted into active monomethyl fumarate which is thought to work by activating the nuclear factor (erythroid-derived 2)-like 2 (Nrf2)...
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Dimethyl fumarate: Indications, Dosing, Side Effects and Interactions
Dimethyl 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
Dimethyl 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
**Plaque psoriasis [moderate-to-severe] (under expert supervision)**
- **Adult** (By Mouth): Initially 30 mg once daily for 1 week, dose to be taken in the evening, then increased in steps of 30 mg every week for 3 weeks, then increased in steps of 120 mg every week for 5 weeks, for further information on the dose titration and administration schedule, advice on establishing a maintenance dose, and for dose adjustments due to side-effects, consult product literature; maximum 720 mg per day.
**Multiple sclerosis [relapsing-remitting] (initiated by a specialist)**
- **Adult** (By Mouth): Initially 120 mg twice daily for 7 days, then increased to 240 mg twice daily, for dose adjustments due to side effects-consult product literature.
Cautions
Reduced lymphocyte count Cautions For Skilarence Significant infection (consider avoiding initiation until infection resolved and suspending treatment if infection develops) Cautions For Tecfidera Serious infection (do not initiate until infection resolved; consider suspending treatment if infection develops); severe active gastro-intestinal disease
Contraindications
For Skilarence Do not initiate if leucocyte count below 3 x 10 9 /litre; do not initiate if lymphocyte count below 1 x 10 9 /litre; do not initiate if pathological haematological abnormalities identified; severe gastro-intestinal disorders Contra-indications For Tecfidera Contra-indications, further information See Important safety information .
Side effects
Common or very common Appetite decreased; asthenia; constipation; decreased leucocytes; diarrhoea; eosinophilia; feeling hot; gastrointestinal discomfort; gastrointestinal disorders; headache; increased risk of infection; leucocytosis; nausea; paraesthesia; skin reactions; urine abnormalities; vasodilation; vomiting Uncommon Dizziness (reported in combination with other fumaric acid esters); thrombocytopenia Rare or very rare Acute lymphocytic leukaemia (reported in combination with other fumaric acid esters); pancytopenia (reported in combination with other fumaric acid esters) Frequency not known Angioedema; drug-induced liver injury; dyspnoea; Fanconi syndrome acquired (reported in combination with other fumaric acid esters); hypotension; hypoxia; JC virus infection; progressive multifocal leukoencephalopathy (PML); renal failure; rhinorrhoea Side-effects, further information Severe prolonged lymphopenia reported, and patients are exposed to a potential risk of PML. Treatment should be stopped immediately if PML is suspected.
Interactions
**Other interactions (4):**
- In multiple sclerosis 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...
- Consumption of moderate amounts of alcohol did not alter exposure to dimethyl fumarate and was not associated with an increase in adverse reactions.
- Consumption of large amounts of strong alcoholic drinks (more than 30% alcohol by volume) should be avoided within an hour of taking dimethyl fumarate, as alcohol may lead to increased frequency of...
Pregnancy
For Skilarence Manufacturer advises avoid-toxicity in animal studies. Pregnancy For Tecfidera Manufacturer advises avoid unless essential and potential benefit outweighs risk-toxicity in animal studies.
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
For Skilarence Manufacturer advises avoid in severe impairment (no information available). Hepatic impairment For Tecfidera Manufacturer advises caution in severe impairment (no information available).
Renal impairment
For Skilarence Manufacturer advises avoid in severe impairment-no information available. Renal impairment For Tecfidera Manufacturer advises caution in severe impairment-no information available.
Medicinal forms
Tablet,Capsule
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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