Active Ingredient: Dimethyl fumarate
Dimethyl fumarate is indicated for the treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal therapy.
For this indication, competent medicine agencies globally authorize below treatments:
Oral
30 - 720 mg
From 10 To 240 mg 3 time(s) per day every day
30 mg
To improve tolerability, it is recommended to begin treatment with a low initial dose with subsequent gradual increases. In the first week, dimethyl fumarate 30 mg is taken once daily (1 tablet in the evening). In the second week, dimethyl fumarate 30 mg is taken twice daily (1 tablet in the morning and 1 in the evening). In the third week, dimethyl fumarate 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 dimethyl fumarate 120 mg in the evening. This dose is then increased by 1 dimethyl fumarate 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 dimethyl fumarate 120 mg).
| Week | Number of tablets | Total daily dose (mg) of dimethyl fumarate | ||
|---|---|---|---|---|
| Morning | Midday | Evening | ||
| Dimethyl fumarate 30 mg | ||||
| 1 | 0 | 0 | 1 | 30 |
| 2 | 1 | 0 | 1 | 60 |
| 3 | 1 | 1 | 1 | 90 |
| Dimethyl fumarate 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 dimethyl fumarate to the maintenance dose required by the individual.
Dosage modifications may also be necessary if abnormalities in laboratory parameters are observed.
It must be swallowed whole with fluid during or immediately after a meal.
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