Skilarence Enteric-Coated Tablets 120mg (Dimethyl Fumarate)

Adult dose

This medicine should be used under the supervision of a physician experienced in the diagnosis and treatment of psoriasis. To improve tolerability, it is recommended to start treatment at a low dose and gradually increase the dose. Adjust the dose according to each patient’s tolerability and treatment response, without exceeding the maximum daily dose. During the first week, take this medicine 30mg once daily. (1 tablet in the evening) During the second week, take this medicine 30mg twice daily. (1 tablet in the morning and 1 tablet in the evening) During the third week, take this medicine 30mg three times daily. (1 tablet in the morning, 1 tablet at lunchtime, and 1 tablet in the evening) During the fourth week, switch to taking 1 tablet of this medicine 120mg in the evening. Starting in the fifth week, increase the dose by 1 tablet of this medicine 120mg each week, at different times of day as shown in the table below, for 5 consecutive weeks. The maximum daily dose is 720mg (3 times daily, 2 tablets of 120mg each). However, if a treatment effect is observed before reaching the maximum dose, no further dose increase is needed. After a clinical reduction in skin lesions is observed, the dose may be gradually reduced to a maintenance dose appropriate for the patient. Take this medicine with water during or immediately after a meal. The tablets are enteric-coated to prevent gastric irritation; do not cut, dissolve, or chew the tablets. Week / Number of tablets / Total daily dose (mg) / Morning / Lunch / Evening 30mg / 1 / - / - / 1 30mg / 2 / 1 / - / 1 60mg / 3 / 1 / 1 / 1 90mg 120mg / 4 / - / - / 1 / 120mg 5 / 1 / - / 1 / 240mg 6 / 1 / 1 / 1 / 360mg 7 / 1 / 1 / 2 / 480mg 8 / 2 / 1 / 2 / 600mg 9~ / 2 / 2 / 2 / 720mg If abnormalities are observed in clinical laboratory tests (see “1. Warnings” under Precautions for Use), dose reduction or discontinuation may be necessary. Patients with renal impairment Dose adjustment is not necessary in patients with mild to moderate renal impairment. The safety and efficacy of this medicine have not been established in patients with severe renal impairment. Patients with hepatic impairment Dose adjustment is not necessary in patients with mild to moderate hepatic impairment. The safety and efficacy of this medicine have not been established in patients with severe hepatic impairment.

Before starting this medication, a blood test must be performed to check the white blood cell and lymphocyte counts. If the white blood cell count is too low or the lymphocyte count is below the standard, therapy should not be initiated. While taking this medication, blood tests should be performed every 3 months to continuously check blood cell counts. This medication can cause leukopenia, so if the white blood cell count falls below a certain level, treatment should be discontinued immediately. Regular blood tests are also necessary if the lymphocyte count decreases, and treatment should be stopped and monitored until recovery if it falls below the standard. Patients with infections should start this medication only after the infection has been completely treated, and if any infection symptoms appear during usage, they should consult a physician immediately. Patients should be educated to recognize infection symptoms and report them to healthcare providers. This drug may increase the risk of a serious brain disease called progressive multifocal leukoencephalopathy (PML), so if neurological symptoms or abnormalities occur, treatment should be stopped immediately and professional examination should be sought. Patients with severe gastrointestinal diseases or significant renal and liver dysfunction should not take this medication, and renal and liver function should be regularly monitored during treatment. Symptoms of Fanconi syndrome, which affects the kidneys and bones, may occur, so consult a physician immediately if symptoms such as proteinuria, diabetes, or hypophosphatemia appear. This medication can cause severe allergic reactions, such as anaphylaxis, so if symptoms like difficulty breathing, hypotension, angioedema, or rash appear, treatment should be stopped immediately and emergency care sought. Pregnant or breastfeeding women should not take this drug, and women of childbearing age must use appropriate contraceptive methods while taking this medication. Safety in children under 18 years of age and in the elderly has not been adequately established, so caution is necessary. This medication should be taken with water during or immediately after meals, and tablets should not be cut or chewed. Dizziness or fatigue may occur while on this medication, so caution should be exercised when driving or operating machinery. Taking this medication with other immunosuppressants or nephrotoxic drugs may increase the risk of side effects, so consult a physician before doing so. There is no specific antidote for overdose, so treatment should be symptomatic according to the symptoms present. This medication should be taken cautiously under a doctor's supervision, and any unusual symptoms should be reported to healthcare providers immediately.

Lymphocytopenia, leukopenia, eosinophilia, leukocytosis, acute lymphoblastic leukemia, pancytopenia, decreased appetite, headache, sensory disturbances, dizziness, progressive multifocal leukoencephalopathy, flushing, diarrhea, abdominal bloating, abdominal pain, nausea, vomiting, dyspepsia, constipation, edema, flatulence, gastrointestinal perforation, ulcer, obstruction, bleeding, erythema, burning sensation, itching, allergic reaction, proteinuria, renal failure, Fanconi syndrome, fatigue, heat sensation, weakness, increased liver enzymes, elevated serum creatinine, shingles, ineffective medication, various gastrointestinal disorders, discomfort in the upper abdomen, exacerbation of psoriasis, skin irritation, peripheral edema, difficulty breathing, hypoxia, hypotension, angioedema, rash, urticaria

This medication should be stored in a tightly sealed container to protect it from air and moisture. It should be stored at room temperature, between 1 to 30 degrees Celsius.

Appearance

Blue, double convex, round enteric-coated tablets

Package unit

90 tablets (15 tablets/blister x 6), 180 tablets (20 tablets/blister x 9)