White Tofacitinib Tablet 5 mg (Tofacitinib Citrate)

Adult dose

1. Precautions for Administration 1) Do not initiate treatment with this drug in 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. 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 -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 this drug at 5 mg twice daily. ANC less than 500 cells/mm3 Discontinue treatment Hemoglobin decrease greater than 2 g/dL or hemoglobin level less than 8.0 g/dL Temporarily interrupt treatment until the hemoglobin level returns to normal 1 For patients with rheumatoid arthritis, this drug is administered alone or in combination with methotrexate and other nonbiologic disease-modifying antirheumatic drugs. 2 For 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. For patients who do not show clinical improvement within this period, continuation of treatment should be carefully considered. 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 Administer 10 mg twice daily for at least 8 weeks, then administer 5 mg or 10 mg twice daily according to 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 achieved after administration of this drug at 10 mg twice daily for 16 weeks. Patients receiving the following drugs: -Strong CYP3A4 inhibitors (e.g., ketoconazole), or -Moderate CYP3A4 inhibitors and strong CYP2C19 inhibitors (e.g., fluconazole) For patients receiving this drug at 10 mg twice daily, reduce the dose to 5 mg twice daily. For patients 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’] For patients receiving this drug at 10 mg twice daily, reduce the dose to 5 mg twice daily. For patients 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) Discontinue treatment ANC 500-1,000 cells/mm3 For patients 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 according to clinical response. For patients previously receiving this drug at 5 mg twice daily, temporarily interrupt treatment. When the ANC is greater than 1,000 cells/mm3, resume this drug at 5 mg twice daily. ANC less than 500 cells/mm3 Discontinue treatment Hemoglobin decrease greater than 2 g/dL or hemoglobin level 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), major adverse cardiovascular events (MACE), and malignancy, 10 mg is not recommended for maintenance therapy, regardless of the availability of alternative treatments.

This drug may affect the immune system, potentially increasing the risk of serious infections. Therefore, a tuberculosis test must be conducted before starting treatment, and latent tuberculosis should be treated beforehand. If infection symptoms occur, consult a doctor immediately and discontinue this medication. Additionally, caution is necessary for patients over 50 years old with cardiovascular disease risks, as mortality and cardiovascular adverse reactions such as myocardial infarction may increase. The risk of malignant tumors, especially lymphomas or lung cancer, may increase, so patients with a history of cancer or smoking should use this drug with caution. There is also an increased risk of thrombosis, so if symptoms of thrombosis arise, this medication should be discontinued and attended to in a hospital. This drug is not administered to patients with severely impaired liver function, low blood cell counts, pregnant women, or those who may become pregnant. Elderly patients, those with diabetes, immunocompromised patients, and patients with impaired liver or kidney function should be especially cautious when using this drug. During treatment, regular blood tests, liver function tests, and lipid tests should be conducted, and any abnormal findings should be discussed with a doctor. Moreover, live vaccine administration should be avoided while taking this drug, and vaccinations should preferably be completed beforehand. If allergic reactions occur during treatment, discontinue medication immediately and consult a physician. This drug also poses risks such as gastrointestinal perforation, interstitial lung disease, and fractures; rapid evaluation is necessary if symptoms occur.

• serious infections
• pneumonia
• shingles
• urinary tract infections
• sinusitis
• bronchitis
• nasopharyngitis
• pharyngitis
• tuberculosis
• diverticulitis

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain the storage temperature between 1 and 30 degrees Celsius.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle