Drug Action
Dimethyl fumarate has immunomodulatory and anti-inflammatory properties.
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Drug reference
Dimethyl fumarate has immunomodulatory and anti-inflammatory properties.
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SKILARENCE ® Plaque psoriasis [moderate-to-severe] (under expert supervision) ▶BY MOUTH ▶Adult: 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 TECFIDERA ® Multiple sclerosis [relapsing-remitting] (initiated by a specialist) ▶BY MOUTH ▶Adult: 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
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SKILARENCE ® Do not initiate if leucocyte count below 3 x 109/litre. do not initiate if lymphocyte count below 1 x 109/litre. do not initiate if pathological haematological abnormalities identified. severe gastro-intestinal disorders
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Reduced lymphocyte count TECFIDERA ® Serious infection (do not initiate until infection resolved; consider suspending treatment if infection develops). severe active gastro-intestinal disease SKILARENCE ® Significant infection (consider avoiding initiation until infection resolved and suspending treatment if infection develops)
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SKILARENCE ® The manufacturer of Skilarence ® has provided a Healthcare Professional Guideline, which includes important safety information on the risk of serious infections.
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TECFIDERA ® NICE decisions ▶Dimethyl fumarate (Tecfidera ®) for treating relapsing- remitting multiple sclerosis (August 2014) NICE TA320 Dimethyl fumarate (Tecfidera ®) is recommended for the treatment of active relapsing-remitting multiple sclerosis, only if: . the patient does not have highly active or rapidly evolving severe relapsing-remitting multiple sclerosis and . the manufacturer provides dimethyl fumarate with the discount agreed in the patient access scheme Patients currently receiving dimethyl fumarate whose disease does not meet the above criteria should be able to continue treatment until they and their clinician consider it appropriate to stop. www.nice.org.uk/guidance/TA320 Scottish Medicines Consortium (SMC) decisions The Scottish Medicines Consortium has advised (April 2014) that dimethyl fumarate (Tecfidera ®) is accepted for use within NHS Scotland for the treatment of patients with relapsing remitting multiple sclerosis. This advice is contingent upon the continuing availability of the Patient Access Scheme in NHS Scotland or a list price that is equivalent or lower. SKILARENCE ® NICE decisions ▶Dimethyl fumarate for treating moderate-to-severe plaque psoriasis (September 2017) NICE TA475 Dimethyl fumarate is recommended as an option for treating plaque psoriasis in adults, only if the disease: . is severe, as defined by a total Psoriasis Area and Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10, and . has not responded to other systemic therapies, including, ciclosporin, methotrexate and PUVA (psoralen and long-wave ultraviolet A radiation), or these options are contra-indicated or not tolerated. Stop dimethyl fumarate treatment at 16 weeks if the psoriasis has not responded adequately. An adequate response is defined as: . a 75% reduction in the PASI score (PASI 75) from when treatment started, or . a 50% reduction in the PASI score (PASI 50) and a 5- point reduction in DLQI from when treatment started. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta475 Scottish Medicines Consortium (SMC) decisions SMC No. 1313/18 The Scottish Medicines Consortium has advised (April 2018) that dimethyl fumarate (Skilarence ®) is accepted for restricted use within NHS Scotland for the treatment of moderate-to-severe plaque psoriasis in adults in need of systemic medicinal therapy, whom other non-biologic systemic treatments (methotrexate, ciclosporin and acitretin) are not appropriate or have failed and who are considered unsuitable for biologic therapy given their current disease state or personal preference.
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→Appendix 1: dimethyl fumarate
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▶Common or very common Appetite decreased. asthenia. constipation. decreased leucocytes. diarrhoea. eosinophilia. feeling hot. flatulence. gastrointestinal discomfort. headache. leucocytosis. nausea. paraesthesia . skin reactions. vasodilation. vomiting ▶Uncommon Dizziness. proteinuria ▶Rare or very rare Acute lymphocytic leukaemia. pancytopenia ▶Frequency not known Progressive multifocal leukoencephalopathy (PML). renal failure 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.
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TECFIDERA ® Manufacturer advises avoid unless essential and potential benefit outweighs risk—toxicity in animal studies. SKILARENCE ® Manufacturer advises avoid—toxicity in animal studies.
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Manufacturer advises avoid.
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TECFIDERA ® Manufacturer advises caution in severe impairment (no information available). SKILARENCE ® Manufacturer advises avoid in severe impairment (no information available).
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TECFIDERA ® Manufacturer advises caution in severe impairment—no information available. SKILARENCE ® Manufacturer advises avoid in severe impairment—no information available.
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▶Manufacturer advises monitor full blood count before treatment initiation then every 3 months thereafter— consult product information for further information. ▶Manufacturer advises monitor patient closely for features of progressive multifocal leukoencephalopathy (PML) (e.g. signs and symptoms of neurological dysfunction) and other opportunistic infections. ▶Manufacturer advises monitor renal and hepatic function before treatment initiation and during treatment—consult product literature for further information. ▶Manufacturer of Tecfidera ® advises perform a baseline MRI as a reference and repeat as required during treatment.
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There can be variation in the licensing of Immune system and malignant disease different medicines containing the same drug. Gastro-resistant capsule CAUTIONARY AND ADVISORY LABELS 21, 25 ▶Tecfidera (Biogen Idec Ltd) Dimethyl fumarate 120 mg Tecfidera 120mg gastro-resistant capsules | 14 capsule P £343.00 Dimethyl fumarate 240 mg Tecfidera 240mg gastro-resistant capsules | 56 capsule P £1,373.00 Gastro-resistant tablet CAUTIONARY AND ADVISORY LABELS 21, 25 ▶Skilarence (Almirall Ltd) Dimethyl fumarate 30 mg Skilarence 30mg gastro-resistant tablets | 42 tablet P £89.04 DT = £89.04 Dimethyl fumarate 120 mg Skilarence 120mg gastro-resistant tablets | 90 tablet P £190.80 DT = £190.80 | 180 tablet P £381.60 DT = £381.60
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Manufacturer advises patients and their carers should be informed of the possibility of experiencing symptoms of flushing; they should also be advised to report symptoms of infection to their doctor. The MHRA recommends that patients and their carers should be counselled on the risk of progressive multifocal leukoencephalopathy and advised to seek immediate medical attention if symptoms develop.
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Initially 30 mg once daily for 1 week, dose to be
First-line fragment. Read the complete Indications and Dose section above.
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Initially 120 mg twice daily for 7 days, then
First-line fragment. Read the complete Indications and Dose section above.
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