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Tocinib Tablet 5mg(Tofacitinib)
Category
ETC
Indication(s)·Usage
  • In the following patients, this drug should be used only when it does not respond appropriately to existing treatments or is not tolerable.
    - Next. -
    A. Patients over 65 years of age
    B. High-risk cardiovascular patients
    C. Patients at risk of malignant tumors
    1. Rheumatoid arthritis
    Treatment of moderate to severe active rheumatoid arthritis in adults (over 18 years of age) who do not respond adequately to methotrexate or are not tolerant.
    The drug can be administered alone or in combination with methotrexate or other non-biological antirheumatic agents (DMARDs).
    This drug should not be used in combination with biological antirheumatic agents or with potent immunosuppressants such as azathioprine and cyclosporine.
    2. Psoriasis arthritis
    Treatment of active psoriasis arthritis in adults (over 18 years of age) who do not adequately respond to previous antirheumatic drugs (DMARDs).
    This drug is administered in combination with methotrexate or other non-biological antirheumatic drugs (DMARDs). The efficacy of this drug monotherapy in patients with psoriasis arthritis has not been studied.
    This drug should not be used in combination with biological antirheumatic agents or with potent immunosuppressants such as azathioprine and cyclosporine.
    3. Ankylosing spondylitis
    It is used for the treatment of adult patients with active ankylosing spondylitis (AS) who do not adequately respond to existing treatments.
    This drug should not be used in combination with biological antirheumatic agents or with potent immunosuppressants such as azathioprine and cyclosporine.
    4. Ulcerative colitis
    Treatment of moderate-severe active ulcerative colitis in adults (ages 18 and older) who do not respond adequately to conventional treatments or biological agents, including corticosteroids, azathioprine, and 6-mercaptofurin (6-MP).
    This drug should not be used in combination with biological agents or with potent immunosuppressants such as azathioprine and cyclosporine.
Effective components
tofacitinib 5mg

Active ingredient(s) and Contents

  • Effective components

    • tofacitinib 5mg
  • Other

    • Lactose hydrate, sodium crosschamelose, magnesium stearate, microcrystalline cellulose, opadryII white (85F18422)

Dosage and administration

  • 1. The administration of this drug is not initiated in adult patients who 1) absolute lymphocyte count (ALC) less than 500 cells/mm3, absolute neutrophil count (ANC) less than 1,000 cells/mm3, or hemoglobin levels less than 9 g/dL. The administration of this drug is not initiated in pediatric patients who have absolute lymphocyte count (ALC) less than 750 cells/mm3, absolute neutrophil count (ANC) less than 1,200 cells/mm3, or hemoglobin levels less than 10 g/dL. 2) The administration of this drug should be closely monitored for infections including tuberculosis before, during, and after administration of this drug, and patients who develop a serious infection should stop administration of this drug until the infection is controlled. 3) In order to control lymphocyte reduction, neutrophil reduction, and anemia, it may be necessary to temporarily stop administration of this drug. 4) The drug may be administered orally regardless of food intake. 5) The drug should be initiated and monitored by a specialist who has experience in diagnosing and treating the disease. 2. The recommended doses for rheumatoid arthritis, psoriasis arthritis, and ankylosing spondylitis are 5 mg once per adult and twice daily doses. The recommended adult doses for patients on CYP2C19 and/or CYP3A4 inhibitors, patients with moderate and severe renal impairment, patients with moderate liver failure, lymphocyte reduction, neutropenia, and anemia are shown in the table. (Omitted) 3. The recommended dose for ulcerative colitis is once per adult, once 10 mg twice a day, for at least 8 weeks, followed by 5 mg or 10 mg twice a day, depending on the treatment response. (Omitted) The recommended adult doses for patients on CYP2C19 and/or CYP3A4 inhibitors, patients with moderate and severe renal impairment, patients with moderate liver impairment, lymphocyte reduction, neutropenia, and anemia are shown in the table. (Omitted)

Storage and handling

  • Airtight container, keep at room temperature (1~30°C)