dimethyl fumarate

HOS-155173 · has-adverse-reaction-information · PDF-Seite 7

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 Lymphopenia Very common disorders Leukopenia Very common Eosinophilia Common Leukocytosis Common Acute lymphatic leukaemia* Very rare Irreversible pancytopenia* Very rare Metabolism and nutrition Decreased appetite Common 7  System organ class Adverse reactions Frequency disorders Nervous system disorders Headache Common Paraesthesia Common Dizziness* Uncommon Progressive multifocal leukoencephalopathy Not known Vascular disorders Flushing Very common Gastrointestinal disorders Diarrhoea Very common Abdominal distension Ver

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HOS-155169 · has-contraindication-information · PDF-Seite 4

‒ Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. ‒ Severe gastrointestinal disorders. ‒ Severe hepatic or renal impairment. ‒ Pregnancy and breast-feeding.

HOS-155168 · has-indication-information · PDF-Seite 2

Skilarence is indicated for the treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal therapy.

HOS-155171 · has-interaction-information · PDF-Seite 6

No interaction studies have been performed. Skilarence should be used cautiously in combination with other systemic antipsoriatic therapy (e.g. methotrexate, retinoids, psoralens, ciclosporin, immunosuppressants or cytostatics) (see section 4.4). During treatment, simultaneous use of other fumaric acid derivatives (topical or systemic) should be avoided. Concurrent therapy with nephrotoxic substances (e.g. methotrexate, ciclosporin, aminoglycosides, diuretics, non-steroidal anti-inflammatory drugs (NSAIDs) or lithium) may increase the potential for renal adverse reactions (e.g. proteinuria) in patients taking Skilarence. In cases of severe or prolonged diarrhoea during treatment with Skilarence, absorption of other medicinal products may be affected. Caution should be exercised when prescribing medicinal products with a narrow therapeutic index that require absorption in the intestinal tract. The efficacy of oral contraceptives may be reduced and the use of an alternative barrier contraceptive method is recommended to prevent possible failure of contraception (see the prescribing information of the oral contraceptive). Consumption of large quantities of strong alcoholic drinks (more than 30% alcohol by volume) should be avoided because it may lead to increased dissolution rates of Skilarence and, therefore, may increase the frequency of gastrointestinal adverse reactions. Vaccination during treatment with Skilarence has not been studied. Immunosuppression is a risk factor for the use of live vaccines. The risk of vaccination should be weighed against the benefit. There is no evidence for interaction with cytochrome P450 and the most common efflux and uptake transporters, thus no interactions are expected with medicinal products metabolised or transported by these systems (see section 5.2). 6

HOS-155172 · has-pregnancy-information · PDF-Seite 7

Women of child-bearing potential Skilarence is not recommended in women of child-bearing potential not using appropriate contraception. Additional contraceptive methods in case of stomach and intestinal problems that could reduce the effectiveness of oral contraceptives could be necessary (see section 4.5). Pregnancy There are limited data from the use of dimethyl fumarate in pregnant women. Animal studies have shown reproductive toxicity (see section 5.3). Skilarence is contraindicated during pregnancy (see section 4.3). Breast-feeding It is unknown whether dimethyl fumarate or its metabolites are excreted in human milk. A risk to newborns or infants cannot be excluded. Therefore, Skilarence is contraindicated during breast- feeding (see section 4.3). Fertility There are no human or animal data on the effects of Skilarence on fertility.

HOS-155170 · has-warning-information · PDF-Seite 4

Haematology Skilarence may decrease leukocyte and lymphocyte counts (see section 4.8). 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. Treatment should not be initiated if leukopenia below 3.0x109/L, lymphopenia below 1.0x109/L or other pathological results are identified. During treatment During treatment, a complete blood count with differential should be performed every 3 months. Action is needed in the following circumstances: Leukopenia If a marked decrease in the total number of white blood cells is found, the situation should be monitored carefully and treatment should be discontinued at levels below 3.0x109/L. Lymphopenia If the lymphocyte count falls below 1.0x109/L but is ≥ 0.7 x109/L, blood monitoring should be performed monthly until levels return to 1.0x109/L or higher for two consecutive blood tests at which point monitoring can again be performed every 3 months. If the lymphocyte count falls below 0.7x109/L, the blood test must be repeated and if the levels are confirmed to be below 0.7x109/L, then treatment must be stopped immediately. Patients developing lymphopenia should be monitored after stopping treatment until their lymphocyte count has returned to the normal range (see section 4.8). 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. Opportunistic infections/progressive multifocal leukoencephalopathy (PML) Cases of opportunistic infections, particularly of progressive multifocal leukoencephalopathy (PML) have been reported with other dimethyl fumarate-containing products (see section 4.8). PML is an opportunistic in

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