Sivinco Tablet 100 mg (Abrocitinib)

Adult dose

Treatment should be initiated and supervised by a healthcare professional experienced in the diagnosis and treatment of atopic dermatitis. 1. Recommended dosage The recommended starting dosage of this drug is 100 mg or 200 mg once daily, depending on individual patient characteristics. • A starting dosage of 100 mg once daily is recommended for patients with risk factors for adverse reactions to this drug or poor tolerability, including patients at increased risk of venous thromboembolism (VTE), major adverse cardiovascular events (MACE), or malignancy (see sections '1. Warnings,' '3. Adverse Reactions,' and '4. General Precautions'). If the patient does not respond adequately to 100 mg once daily, the dose may be increased to 200 mg once daily. • For most patients, the recommended starting dosage is 200 mg once daily; if the disease is controlled, the dose should be reduced to 100 mg once daily. If disease control is not maintained after dose reduction, restarting at 200 mg once daily may be considered. Some patients may experience a disease flare after dose reduction. Increased risk of disease flare after dose reduction is associated with a history of systemic treatment for atopic dermatitis and extensive disease affecting more than 50% of body surface area (BSA). The lowest effective maintenance dose of this drug should be considered. Discontinuation should be considered in patients who show no effect after 24 weeks. This drug may be used with or without topical corticosteroids. Topical calcineurin inhibitors may be used on sensitive areas, such as the face, neck, intertriginous areas, and genital area. 1) Initiation of treatment Treatment with this drug should not be initiated in patients with a platelet count below 150 × 103/mm3, an absolute lymphocyte count (ALC) below 0.5 × 103/mm3, an absolute neutrophil count (ANC) below 1 × 103/mm3, or a hemoglobin level below 8 g/dL. 2) Missed dose If a dose is missed and 12 hours or more remain until the next dose, take it as soon as possible. If less than 12 hours remain, skip the missed dose. Resume dosing at the scheduled time thereafter. 3) Interruption of treatment If a patient develops a serious infection, sepsis, or an opportunistic infection, consider interrupting treatment with this drug until the infection is controlled. Treatment interruption may be required to manage laboratory abnormalities, as shown in Table 2. 4) Drug interactions For patients receiving strong cytochrome P450 (CYP) 2C19 inhibitors (e.g., fluvoxamine, fluconazole, fluoxetine, ticlopidine), reduce the recommended starting dose of this drug by half to 100 mg or 50 mg once daily. Concomitant use of this drug with moderate or strong CYP2C19/CYP2C9 enzyme inducers (e.g., rifampicin, apalutamide, efavirenz, enzalutamide, phenytoin) is not recommended. 2. Method of administration 1) This drug is administered orally once daily at approximately the same time each day, with or without food. 2) For patients who experience nausea, taking the drug with food may improve nausea. 3) Tablets should be swallowed whole with water and should not be split, crushed, or chewed. Administration by these methods has not been studied in clinical trials. 3. Special populations 1) Renal impairment No dose adjustment is required in patients with mild renal impairment (e.g., estimated glomerular filtration rate [eGFR] 60 mL/min or higher and below 90 mL/min). For patients with moderate renal impairment (eGFR 30 mL/min or higher and below 60 mL/min), reduce the recommended dose of this drug by half to 100 mg or 50 mg once daily. For patients with severe renal impairment (eGFR below 30mL/min), the recommended starting dose of this drug is 50 mg once daily, and the maximum daily dose is 100 mg. This drug has not been studied in patients with end-stage renal disease (ESRD) receiving renal replacement therapy. 2) Hepatic impairment No dose adjustment is required in patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment. This drug should not be used in patients with severe (Child-Pugh C) hepatic impairment.

This medication may cause serious infections; therefore, it should not be administered to patients with active systemic infections. Patients with chronic infections or those exposed to tuberculosis, or those at high risk for infections should carefully consider the risks and benefits before taking this medication. During treatment, signs of infection should be closely monitored, and if new infections occur, diagnosis and treatment should start immediately. Patients older than 65 should only use this medication if they do not respond to or are intolerant of existing treatments. This medication may increase the risk of death associated with cardiovascular adverse reactions; therefore, patients over 50 years with cardiovascular risk factors should exercise caution. There is also a risk of malignancy, so patients with risk factors such as smokers or the elderly should be administered cautiously. Regular skin examinations are necessary due to the risk of skin cancer. Due to the risk of thrombosis, particularly pulmonary embolism and deep vein thrombosis, it should be used with caution in patients with thrombotic risk factors. Regular blood tests are necessary as treatment may be interrupted or paused based on blood test results. Women who are pregnant or breastfeeding should not use this medication, and women of childbearing potential should implement effective contraception during and for one month after treatment. Children under 12 years of age should not be used as safety and efficacy have not been established. This medication should not be administered to patients with severely impaired liver function, nor to patients with lactose intolerance. While taking this medication, symptoms such as nausea, headache, acne, dizziness may occur, hence symptoms should be monitored. There may be interactions with other drugs, so it is essential to inform about any medications being taken. If dizziness occurs after taking this medication, avoid driving or operating machinery. This medication should be stored safely and kept out of reach of children.

• region
• headache
• acne
• herpes simplex
• vomiting
• dizziness
• increase in serum creatine phosphokinase
• upper abdominal pain
• pneumonia
• thrombocytopenia

This medication should be kept in a tightly closed container to protect it from air and moisture. The storage temperature should be maintained between 1 degree and 30 degrees Celsius.

Appearance

Pink, round, film-coated tablet imprinted with “ABR100” on one side and “PFE” on the other side

Package unit

30 tablets/bottle