Dimethyl Fumarate

Almirall AG

(no prior cost approval required)

Differential complete blood count, liver function tests, kidney function tests, creatinine, urinalysis, pregnancy test.

p. o.

Tolerance-dependent*, gradual dose increase. Weeks 1–3: increase by 30 mg per week. From week 4: increase by 120 mg per week up to a maximum of 720 mg per day.
Average long-term maintenance dose: 3 × 120 mg per day.

*If a particular dose increase is not tolerated, the dose may be temporarily reduced to the last tolerated dose.

16 weeks on average for PASI 75. It is recommended to discontinue treatment if there is no improvement within 24 weeks.

Complete blood count, liver enzymes, creatinine, urinalysis.

Monthly for the first 4 months, then every 2–3 months (EMA recommendation: every 3 months).

Pregnancy and breastfeeding, severe gastrointestinal disorders, severe liver or kidney dysfunction, conditions involving chronic abnormalities in white blood cell counts (leucopenia < 3 × 10⁹/L (= 3 G/L), lymphopenia < 1 × 10⁹/L (= 1 G/L)), known severe, active infections.

Potentially nephrotoxic medicines (including NSAIDs) were not investigated. Rare hereditary galactose intolerance (contains lactose). Caution is advised with systemic anticholinergics (potential impairment of gastrointestinal transit).

Mild nausea, diarrhoea (40 per cent; recommendation: take with yoghurt or milk). Flushing symptoms (20 per cent; recommendation: take mainly in the evening, acetylsalicylic acid (ASA) 325–500 mg). Both symptoms usually subside over time.
Mild leucopenia and lymphocytopenia (10 per cent); treatment to be discontinued if the white blood cell count falls below 3 × 10⁹/L (= 3 G/L); monthly monitoring and suspension of dose escalation if the lymphocyte count falls below 1 × 10⁹/L (= 1 G/L); discontinuation of treatment if below 0.7 × 10⁹/L (= 0.7 G/L).

Not restricted.

PLEASE NOTE: It does not yet count as prior biologic therapy in Switzerland (except when used in combination with UV therapy).