Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Almirall, S.A., Ronda General Mitre, 151, 08022, Barcelona, Spain
Skilarence is indicated for the treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal therapy.
Skilarence is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of psoriasis.
To improve tolerability, it is recommended to begin treatment with a low initial dose with subsequent gradual increases. In the first week, Skilarence 30 mg is taken once daily (1 tablet in the evening). In the second week, Skilarence 30 mg is taken twice daily (1 tablet in the morning and 1 in the evening). In the third week, Skilarence 30 mg 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 Skilarence 120 mg in the evening. This dose is then increased by 1 Skilarence 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 (3 × 2 tablets of Skilarence 120 mg).
| Week | Number of tablets | Total daily dose (mg) of dimethyl fumarate | ||
|---|---|---|---|---|
| Morning | Midday | Evening | ||
| 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.
Dosage modifications may also be necessary if abnormalities in laboratory parameters are observed (see section 4.4).
Clinical studies of Skilarence did not include sufficient numbers of patients aged 65 years and above to determine whether they respond differently compared to patients under 65 years (see section 5.2). Based on the pharmacology of dimethyl fumarate, a need for dose adjustment in the elderly is not expected.
No dose adjustment is needed in patients with mild to moderate renal impairment (see section 5.2). Skilarence has not been studied in patients with severe renal impairment, and use of Skilarence is contraindicated in these patients (see section 4.3).
No dose adjustment is needed in patients with mild to moderate hepatic impairment (see section 5.2). Skilarence has not been studied in patients with severe hepatic impairment, and use of Skilarence is contraindicated in these patients (see section 4.3).
The safety and efficacy of Skilarence in paediatric patients below the age of 18 years have not been established. There are no data available with Skilarence in paediatric patients.
Skilarence is for oral use.
Skilarence 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 should not be crushed, divided, dissolved or chewed.
Symptomatic treatment is indicated in the case of an overdose. No specific antidote is known.
Shelf life: 3 years.
This medicinal product does not require any special storage conditions.
Skilarence 30 mg: 42, 70 and 210 gastro-resistant tablets in PVC/PVDC-aluminium blister packs.
Skilarence 120 mg: 40, 70, 90, 100, 120, 180, 200, 240, 300, 360 and 400 gastro-resistant tablets in PVC/PVDC-aluminium blister packs.
Not all pack sizes may be marketed.
No special requirements for disposal.
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