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Skilarence is a brand name for Dimethyl Fumarate. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Skilarence is indicated for the treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal therapy.
Verbatim from this product's EMA label. Tap a section to expand.
Skilarence is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of psoriasis. Posology To improve tolerability of Skilarence, it is recommended to begin treatment with a low initial dose with subsequent gradual increases.
In the first week, a 30 mg dose is taken once daily (1 tablet in the evening). In the second week, a 30 mg dose is taken twice daily (1 tablet in the morning and 1 in the evening). In the third week, a 30 mg dose is taken three times daily (1 tablet in the morning, 1 at midday, and 1 in the evening).
From the fourth week, treatment is switched to only 1 tablet of 3 a 120 mg dose in the evening. This dose is then increased by one 120 mg tablet per week at different times of day for the subsequent 5 weeks, as shown in the table below.
The maximum daily dose allowed is 720 mg (six 120 mg tablets). Week Number of tablets Total daily dose (mg) Morning Midday Evening of dimethyl fumarate Skilarence 30 mg 1 0 0 1 30 2 1 0 1 60 3 1 1 1 90 Skilarence 120 mg 4 0 0 1 120 5 1 0 1 240 6 1 1 1 360 7 1 1 2 480 8 2 1 2 600 9+ 2 2 2 720 If a particular dose increase is not tolerated, it may be temporarily reduced to the last tolerated dose.
If treatment success is observed before the maximum dose is reached, no further increase of dose is necessary. After clinically relevant improvement of the skin lesions has been achieved, consideration should be given to gradual reduction of the daily dose of Skilarence to the maintenance dose required by the individual.
4). 2). Based on the pharmacology of dimethyl fumarate, a need for dose adjustment in the elderly is not expected. 2). 3). 2). 3). Paediatric population The safety and efficacy of Skilarence in children below the age of 18 years have not been established.
There are no data available with Skilarence in paediatric population. Method of administration For oral use. Tablets must be swallowed whole with fluid during or immediately after a meal. The coating of the gastro-resistant tablets is designed to prevent gastric irritation.
Therefore, the tablets 4 should not be crushed, divided, dissolved or chewed.
Summary of the safety profile The most common adverse reactions observed with Skilarence are gastrointestinal events followed by flushing and lymphopenia. Tabulated list of adverse reactions The following is a list of adverse reactions experienced by patients treated with Skilarence during the clinical development, post-marketing experience and with Fumaderm, a related medicinal product containing dimethyl fumarate along with other fumaric acid esters.
The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); and not known (cannot be estimated from available data).
System organ class Adverse reactions Frequency Infections and infestations Herpes zoster Not known** Blood and lymphatic system disorders Lymphopenia Leukopenia Eosinophilia Leukocytosis Acute lymphatic leukaemia* Irreversible pancytopenia* Very common Very common Common Common Very rare Very rare Metabolism and nutrition Decreased appetite Common 8 System organ class Adverse reactions Frequency disorders Nervous system disorders Headache Paraesthesia Dizziness* Progressive multifocal leukoencephalopathy Common Common Uncommon Not known Vascular disorders Flushing Very common Gastrointestinal disorders Diarrhoea Abdominal distension Abdominal pain Nausea Vomiting Dyspepsia Constipation Abdominal discomfort Flatulence Very common Very common Very common Very common Common Common Common Common Common Skin and subcutaneous tissue disorders Erythema Skin burning sensation Pruritus Allergic skin reaction Common Common Common Rare Renal and urinary disorders Proteinuria Renal failure Fanconi syndrome* Uncommon Not known Not known General disorders and administration site conditions Fatigue Feeling hot Asthenia Common Common Common Investigations Hepatic enzymes increased Serum creatinine increased Common Uncommon *Additional adverse reactions reported with Fumaderm, a related medicinal product containing dimethyl fumarate along with other fumaric acid esters.
8). It has not been studied in patients with pre-existing low leukocyte or lymphocyte counts. Before treatment Prior to initiating treatment, a current complete blood count (including differential blood count and platelet count) should be available.
0x109/L or other pathological results are identified. During treatment During treatment, a complete blood count with differential should be performed every 3 months. 0x109/L. 0x109/L or higher for two consecutive blood tests at which point monitoring can again be performed every 3 months.
7x109/L, then treatment must be stopped immediately. 8). Other haematological disorders Therapy should be discontinued and caution is advised if other pathological results occur. In any case, blood counts should be monitored until values have returned to the normal range.
Infections Skilarence is an immunomodulator and may affect the way the immune system responds to infection. For patients with pre-existing infections of clinical relevance, the physician should decide if treatment should only be initiated once the infection has resolved.
If a patient develops an infection during treatment, suspension of treatment should be considered and the benefits and risks should be reassessed prior to re-initiation of therapy. Patients receiving this medicinal product should be instructed to report symptoms of infection to a physician.
8). PML is an opportunistic infection caused by the John-Cunningham virus (JCV) that can be fatal or cause severe disabilities. PML is probably caused by a combination of factors. 5 A previous infection with JCV is considered a prerequisite for the development of PML.
Risk factors can include previous immunosuppressive treatment and the existence of certain concomitant disorders (such as some autoimmune disorders or malignant haematological conditions). A modified or weakened immune system as well as genetic or environmental factors can also constitute risk factors.
1. ‒ Severe gastrointestinal disorders. ‒ Severe hepatic or renal impairment. ‒ Pregnancy and breast-feeding.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Dimethyl Fumarate in European Union.
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**Adverse reactions reported during post marketing experience. Description of selected adverse reactions Gastrointestinal disturbances Data from the Phase III clinical study as well as from the literature show that gastrointestinal disorders with dimethyl fumarate-containing products are most likely to occur during the first 2 to 3 months after starting treatment.
No apparent dose relationship and no risk factors for the occurrence of these adverse reactions could be identified. 9%) among patients taking Skilarence, leading to medicinal product withdrawal in about 10% of patients. 4). The only adverse reactions that led to discontinuation of treatment in >5% of patients were gastrointestinal reactions.
4. Flushing Based on observations in the Phase III clinical study as well as on literature data, flushing is most likely to occur during the early weeks of treatment and tends to lessen with time. 4). Published clinical experience with dimethyl fumarate-containing products shows that individual episodes of flushing usually begin shortly after taking the tablets and resolve within a few hours.
Haematological changes Data from the Phase III clinical study as well as from the literature show that changes in 9 haematological parameters are most likely to occur during the first 3 months after starting treatment with dimethyl fumarate.
0x109/L. The mean and median values of lymphocytes remained within the normal range during the clinical study. At week 16 (end of treatment), there was no further decline in lymphocyte counts. 7x 109/L. Blood sampling for safety clinical laboratory tests at follow-up visits was only performed in case of abnormalities at the preceeding visit.
5%) patient at 6 months and 0/28 (0%) at 12 months after stopping treatment. 1%) of the patients started on Skilarence. 0x109/L. A transient increase in mean values of eosinophils was noted as early as week 3, reached a maximum at week 5 and 8, and had returned to baseline values at week 16.
4. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Persistent moderate or severe lymphopenia during treatment with dimethyl fumarate is also considered a risk factor for PML. Patients who develop lymphopenia should be monitored for signs and symptoms of opportunistic infections, particularly for symptoms indicative of PML.
Typical symptoms associated with PML are diverse, become worse over days to weeks and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision and changes in thinking, memory and orientation leading to confusion and personality changes.
If PML is suspected, treatment should be stopped immediately and further appropriate neurological and radiological examinations performed. Prior and concomitant treatment with immunosuppressive or immunomodulating therapies Limited data are available on the efficacy and safety of Skilarence in patients who have been previously treated with other immunosuppressive or immunomodulating therapies.
When switching patients from such therapies to Skilarence, the half-life and mode of action of the other therapy should be considered in order to avoid additive effects on the immune system. 5). Pre-existing gastrointestinal disease Skilarence has not been studied in patients with pre-existing gastrointestinal disease.
3). 8). Renal function During the Phase III placebo-controlled clinical study, renal function was not seen to deteriorate during therapy across treatment groups. However, Skilarence has not been studied in patients with severe renal impairment, and some cases of renal toxicity have been reported during post-marketing surveillance with fumaric acid esters.
3). g. creatinine, blood urea nitrogen and urinalysis) should be checked prior to initiation of treatment and every 3 months thereafter. In the event of a clinically relevant change in renal function, particularly in the absence of alternative explanations, consideration should be given to dose reduction or treatment discontinuation.
Fanconi syndrome Early diagnosis of Fanconi syndrome and discontinuation of Skilarence treatment are important to prevent the onset of renal impairment and osteomalacia, as the syndrome is usually reversible. 8). Progression might involve symptoms such as polyuria, […]