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:
For:
Oral, 30 milligrams dimethyl fumarate, once daily at evening, over the duration of 1 week. Afterwards, oral, 30 milligrams dimethyl fumarate, 2 times daily, over the duration of 1 week. Afterwards, oral, 30 milligrams dimethyl fumarate, 3 times daily, over the duration of 1 week. Afterwards, oral, 120 milligrams dimethyl fumarate, once daily at evening, over the duration of 1 week. Afterwards, oral, 120 milligrams dimethyl fumarate, 2 times daily, over the duration of 1 week. Afterwards, oral, 120 milligrams dimethyl fumarate, 3 times daily, over the duration of 1 week. Afterwards, oral, 480 milligrams dimethyl fumarate, divided 3 times daily, over the duration of 1 week. Afterwards, oral, 600 milligrams dimethyl fumarate, divided 3 times daily, over the duration of 1 week. Afterwards, oral, 240 milligrams dimethyl fumarate, 3 times daily.
To improve tolerability, 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 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) 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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