Tofacitinib Tablet 5 mg (Tofacitinib)

Adult dose

1) Do not initiate treatment with this drug in adult patients with an absolute lymphocyte count (ALC) less than 500 cells/mm3, an absolute neutrophil count (ANC) less than 1,000 cells/mm3, or a hemoglobin level less than 9 g/dL. 2) Patients should be closely monitored for infections, including tuberculosis, before, during, and after treatment with this drug. In patients who develop a serious infection, treatment with this drug should be interrupted until the infection is controlled. 3) Temporary interruption of treatment with this drug may be necessary to manage lymphopenia, neutropenia, and anemia. 4) This drug may be administered orally with or without food. 5) Treatment with this drug should be initiated and monitored by a specialist experienced in the diagnosis and treatment of the disease. 2. Recommended dosage for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis The recommended dosage of this drug is 5 mg twice daily. The recommended adult dosage for patients receiving CYP2C19 and/or CYP3A4 inhibitors, patients with moderate or severe renal impairment, patients with moderate hepatic impairment, and patients with lymphopenia, neutropenia, or anemia is shown in Table 1. [Table 1] Recommended dosage of this drug for patients with rheumatoid arthritis1, psoriatic arthritis2, and ankylosing spondylitis3 This drug Adults 5 mg twice daily Patients receiving the following drugs: -Strong CYP3A4 inhibitors (e.g., ketoconazole), or -Both moderate CYP3A4 inhibitors and strong CYP2C19 inhibitors (e.g., fluconazole) 5 mg once daily Patients with: -Moderate or severe renal impairment -Moderate hepatic impairment* [See section ‘5. General Precautions’] 5 mg once daily ALC less than 500 cells/mm3 (confirmed by repeat testing) Interrupt treatment ANC 500-1,000 cells/mm3 Temporarily interrupt treatment. When the ANC is greater than 1,000 cells/mm3, resume treatment with this drug at 5 mg twice daily. ANC less than 500 cells/mm3 Interrupt treatment Hemoglobin level decreased by more than 2 g/dL or less than 8.0 g/dL Temporarily interrupt treatment until the hemoglobin level returns to normal 1 In patients with rheumatoid arthritis, this drug is administered alone or in combination with methotrexate and other nonbiologic disease-modifying antirheumatic drugs. 2 In patients with psoriatic arthritis, this drug is administered in combination with nonbiologic disease-modifying antirheumatic drugs (DMARDs). The efficacy of this drug as monotherapy in patients with psoriatic arthritis has not been studied. 3 Clinical improvement in ankylosing spondylitis was observed within 16 weeks after initiation of treatment with this drug. In patients who do not show clinical improvement within this period, continued treatment should be considered carefully. 3. Recommended dosage for ulcerative colitis The recommended adult dosage for patients receiving CYP2C19 and/or CYP3A4 inhibitors, patients with moderate or severe renal impairment, patients with moderate hepatic impairment, and patients with lymphopenia, neutropenia, or anemia is shown in Table 2. [Table 2] Recommended dosage of this drug for patients with ulcerative colitis Ulcerative colitis This drug Adults 10 mg twice daily for at least 8 weeks, followed by 5 mg or 10 mg twice daily depending on treatment response. [See section ‘12. Information for Healthcare Professionals’] Use the lowest effective dose for maintenance therapy. Discontinue treatment if adequate therapeutic benefit is not observed after 16 weeks of this drug at 10 mg twice daily. Patients receiving the following drugs: -Strong CYP3A4 inhibitors (e.g., ketoconazole), or -Both moderate CYP3A4 inhibitors and strong CYP2C19 inhibitors (e.g., fluconazole) If receiving this drug at 10 mg twice daily, reduce the dose to 5 mg twice daily. If receiving this drug at 5 mg twice daily, reduce the dose to 5 mg once daily. Patients with: -Moderate or severe renal impairment -Moderate hepatic impairment [See section ‘5. General Precautions’] If receiving this drug at 10 mg twice daily, reduce the dose to 5 mg twice daily. If receiving this drug at 5 mg twice daily, reduce the dose to 5 mg once daily. ALC less than 500 cells/mm3 (confirmed by repeat testing) Interrupt treatment ANC 500-1,000 cells/mm3 If receiving this drug at 10 mg twice daily, reduce the dose to 5 mg twice daily. When the ANC is greater than 1,000 cells/mm3, increase the dose back to 10 mg twice daily depending on clinical response. If previously receiving this drug at 5 mg twice daily, temporarily interrupt treatment. When the ANC is greater than 1,000 cells/mm3, resume treatment with this drug at 5 mg twice daily. ANC less than 500 cells/mm3 Interrupt treatment Hemoglobin level decreased by more than 2 g/dL or less than 8.0 g/dL Temporarily interrupt treatment until the hemoglobin level returns to normal For patients with risk factors for venous thromboembolism (VTE), 10 mg is not recommended for maintenance therapy, regardless of the availability of alternative treatments. [Interactions] In patients receiving 5 mg tablets or an equivalent weight-based dose twice daily who are also receiving strong cytochrome P450 (CYP) 3A4 inhibitors (e.g., ketoconazole), and in patients receiving one or more concomitant medications that cause both moderate CYP3A4 inhibition and strong CYP2C19 inhibition (e.g., fluconazole), the total daily dose of this drug should be reduced to 5 mg once daily as a film-coated tablet or an equivalent weight-based dose once daily.

Child dose

Do not initiate treatment with this drug in pediatric patients with an absolute lymphocyte count (ALC) below 750 cells/mm3, an absolute neutrophil count (ANC) below 1,200 cells/mm3, or a hemoglobin level below 10 g/dL.

This medication modulates the immune system, which can reduce resistance to infections. Therefore, the risk of developing serious infections such as pneumonia, tuberculosis, and herpes zoster may increase during its use. Before starting this medication, a tuberculosis screening test must be performed, and if latent tuberculosis is confirmed, treatment should be initiated before starting this medicine. Patients should notify their doctor immediately if symptoms of infection appear, and if the infection is severe, the use of this medicine should be discontinued. This medication may increase the risk of cardiovascular issues such as heart attack or stroke in patients aged 50 and older with cardiovascular risk factors, thus these patients require special caution. Furthermore, this medication may increase the risk of tumor development, and special consideration should be given to smokers, the elderly, and patients with a history of cancer before use. It may decrease the number of lymphocytes and neutrophils in the blood, so regular blood tests are necessary, and if the counts become too low, the medication should be discontinued or the dosage adjusted. It may affect liver function, and regular liver function tests should be performed; if liver enzyme levels are elevated, a consultation with a doctor is necessary. Due to the risk of thrombosis, immediate medical attention is required if symptoms such as leg pain or swelling occur; it is advisable to avoid using this medication in patients at high risk. Women who are pregnant or may become pregnant should not take this medication, and if any allergic reactions occur, discontinuation of the medication should be immediate. Lastly, this medication can cause various side effects, including gastrointestinal perforation, fractures, and interstitial lung disease, so if any abnormal symptoms appear, consultation with a doctor should be immediate.

• serious infections
• pneumonia
• herpes zoster
• urinary tract infections
• soft tissue infections
• gastroenteritis
• diverticulitis
• sepsis
• pulmonary embolism
• deep vein thrombosis

This medication should be stored in a tightly closed container to protect it from air and moisture. Additionally, it is best stored at a cool room temperature, between 1 to 30 degrees Celsius, to maintain its effectiveness.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle - 30 tablets/bottle