HLB Tofacitinib Tablets 10 mg (Tofacitinib Citrate)

Adult dose

1. Precautions for administration 1) Do not initiate treatment with this product 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) Monitor closely for infections, including tuberculosis, before, during, and after treatment with this product. In patients who develop a serious infection, interrupt treatment until the infection is controlled. 3) Temporary interruption of treatment with this product may be necessary to manage lymphopenia, neutropenia, and anemia. 4) This product may be taken orally with or without food. 2. 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 1. [Table 1] Recommended dosage of this product for patients with ulcerative colitis Adults Administer 10 mg twice daily for at least 8 weeks, then administer 5 mg or 10 mg twice daily according to treatment response. Use the lowest effective dose for maintenance. If adequate therapeutic benefit is not achieved after administering 10 mg twice daily for 16 weeks, discontinue treatment. Patients receiving the following drugs: • Strong CYP3A4 inhibitors (e.g., ketoconazole), or • Moderate CYP3A4 inhibitors and strong CYP2C19 inhibitors (e.g., fluconazole) If receiving this product at 10 mg twice daily, reduce the dose to 5 mg twice daily. If receiving this product at 5 mg twice daily, reduce the dose to 5 mg once daily. Patients with: • Moderate or severe renal impairment • Moderate hepatic impairment* [See 5. General precautions] If receiving this product at 10 mg twice daily, reduce the dose to 5 mg twice daily. If receiving this product 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 If receiving this product 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 again to 10 mg twice daily according to clinical response. If receiving this product at 5 mg twice daily, temporarily interrupt treatment. When the ANC is greater than 1,000 cells/mm3, resume this product at 5 mg twice daily. ANC less than 500 cells/mm3 Discontinue treatment Hemoglobin decrease of more than 2 g/dL or hemoglobin less than 8.0 g/dL Temporarily interrupt treatment until hemoglobin levels return 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 whether other treatments are available.

This medication modulates the immune system, which increases the risk of serious infections. Particularly, serious infections such as pneumonia, fungal infections, and viral infections may occur, and administration should be immediately stopped if symptoms of infection develop. Prior to using this drug, a latent tuberculosis test must be performed, and if latent tuberculosis is confirmed, treatment should be prioritized. Caution should be exercised in elderly patients or patients at risk of cardiovascular diseases, and administration should be considered only when no other treatments are available for those over 65 years. This drug may increase the risk of major cardiovascular adverse reactions, such as heart attack and stroke, so patients with cardiovascular risk factors should be particularly cautious. There is also a risk of thrombosis, therefore, patients with a history of thrombosis or risk factors should avoid using it, and should consult a physician immediately if symptoms arise. This medication may increase the risk of malignant tumors, especially lymphoma and lung cancer, so patients with a history of cancer or smoking history should use it with caution. While taking this medication, regular blood tests and liver function tests must be conducted, and treatment should not be initiated if lymphocyte, neutrophil, or hemoglobin levels are excessively low. Pregnant women or women who may become pregnant should not take this medication, and effective contraception must be used during treatment. This drug should not be combined with other strong immunosuppressants or biological agents. Before and during administration, careful monitoring for symptoms of infection, cardiovascular issues, signs of thrombosis, skin changes, etc., is essential. Additionally, during treatment, live vaccinations should be avoided, and immunizations should preferably be completed before starting treatment. Dose adjustment is needed in patients with liver or kidney dysfunction. In case of overdose, there is no specific antidote, and appropriate treatment should be sought immediately from a medical institution. Keep this medication out of reach of children, and avoid transferring it to other containers.

• Severe infections
• lung diseases
• active tuberculosis
• yeast infections
• interstitial plasma cell pneumonia
• invasive fungal infections
• bacterial infections
• viral infections
• herpes virus infections
• pneumonia

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

Appearance

Blue round film-coated tablets

Package unit

30 tablets/bottle