Sibinko Tablet 50 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 should not be administered to patients with serious infection risks. Risks and benefits should be carefully evaluated in patients with chronic infections or exposure to tuberculosis or those with a history of infections. Symptoms of infection should be carefully monitored during therapy, and treatment should begin immediately if an infection occurs. In patients over 50 years of age with cardiovascular risk, there may be increased mortality and risk of cardiovascular adverse reactions, thus it should only be used when other treatments are ineffective or intolerable. Due to the increased risk of malignant tumors, especially in smokers, patients over 65 years old, or those with a history of malignant tumors, this medication should be used with caution. There is a risk of non-melanoma skin cancer, therefore, patients at high risk of skin cancer should undergo regular skin examinations. The risk of thrombosis, particularly deep vein thrombosis and pulmonary embolism, is present; patients with thrombosis risk factors should use with caution, and if symptoms appear, they should be evaluated immediately, and administration should be stopped. This medication should not be used in patients with certain allergies, active tuberculosis, severe liver impairment, pregnant or breastfeeding women, or patients with lactose intolerance. Side effects such as nausea, headache, acne, vomiting, and dizziness may occur during use, and regular blood tests should monitor platelet count, lymphocyte count, lipid levels, etc. This medication should be used while monitoring liver function and blood levels, and blood tests and lipid tests must be performed, especially 4 weeks after starting treatment. Caution should be taken when driving or operating machinery if dizziness is felt. This medication may interact with other drugs, so patients must inform about any medications they are taking, especially those related to CYP2C19, CYP2C9, and OAT3 enzymes. Pregnant or breastfeeding women should not use this medication, and women of childbearing age should use effective birth control methods during and for 1 month after the treatment. Safety and efficacy have not been confirmed for children under 12 years, and elderly patients over 65 years face a higher risk of side effects; caution should be exercised. In case of overdose, there is no specific antidote, so appropriate treatment should be given according to symptoms, and this medication must be kept out of reach of children and stored in its original container.

• nausea
• headache
• acne
• herpes simplex
• vomiting
• dizziness
• increased blood creatine phosphokinase
• upper abdominal pain
• pneumonia
• thrombocytopenia

This medication should be stored in a sealed container to protect it from air and moisture. It is recommended to maintain storage temperatures between 1 to 30 degrees Celsius to ensure the effectiveness and safety of the medication.

Appearance

Pink oval film-coated tablet imprinted with “ABR50” on one side and “PFE” on the other side

Package unit

30 tablets/bottle