Topanuseong 10 mg (Tofacitinib Citrate)

Adult dose

1) Do not initiate this drug in patients with an absolute lymphocyte count (ALC) below 500 cells/mm3, an absolute neutrophil count (ANC) below 1,000 cells/mm3, or a hemoglobin level below 9 g/dL. 2) Patients should be closely monitored for infections, including tuberculosis, before, during, and after treatment with this drug. If a serious infection develops, discontinue treatment until the infection is controlled. 3) Temporary interruption of treatment may be necessary to manage lymphopenia, neutropenia, and anemia. 4) This drug may be taken orally with or without food. 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 therapy. Discontinue treatment if an adequate therapeutic benefit is not achieved after 16 weeks of treatment with 10 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) If taking this drug at 10 mg twice daily, reduce the dose to 5 mg twice daily. If taking this drug at 5 mg twice daily, reduce the dose to 5 mg once daily. In the following patients: • Patients with moderate or severe renal impairment • Patients with moderate hepatic impairment* [See 5. General Precautions] If taking this drug at 10 mg twice daily, reduce the dose to 5 mg twice daily. If taking this drug at 5 mg twice daily, reduce the dose to 5 mg once daily. ALC below 500 cells/mm3 (confirmed by repeat testing) Interrupt treatment ANC 500-1,000 cells/mm3 If the patient was receiving 10 mg twice daily, reduce the dose to 5 mg twice daily. When the ANC is above 1,000 cells/mm3, increase the dose back to 10 mg twice daily according to clinical response. If the patient was receiving 5 mg twice daily, temporarily interrupt treatment. When the ANC is above 1,000 cells/mm3, resume treatment at 5 mg twice daily. ANC below 500 cells/mm3 Interrupt treatment Hemoglobin decrease of more than 2 g/dL or hemoglobin level below 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, a 10 mg maintenance dose is not recommended, regardless of the availability of alternative therapies.

This medication is an immunosuppressant, which can increase susceptibility to infections. There is an elevated risk of severe infections, such as pneumonia, tuberculosis, and fungal infections; therefore, thorough screening for infections should be conducted before and during treatment, and careful monitoring is necessary. Elderly individuals over 65 years or patients at risk of cardiovascular issues should use this medication with caution due to the increased risk of heart-related problems or thrombosis. Additionally, this medication may increase the risk of malignancies, especially lymphomas and lung cancer, so patients with a history of cancer or a smoking history should be monitored more closely. Women who are pregnant or may become pregnant should not take this medication and effective contraception should be practiced during treatment. Patients with impaired liver or kidney function may require dose adjustments and should undergo periodic liver and kidney function tests. This medication should not be taken in combination with other immunosuppressants or biological agents, and interaction with other drugs necessitates consultation with a physician. During treatment, regular blood tests should be performed to monitor lymphocyte, neutrophil, and hemoglobin levels; dosage adjustments or discontinuation may be necessary if abnormalities are detected. Live vaccines should be avoided while taking this medication, and vaccinations should be completed prior to starting treatment. In the event of an overdose, there are no specific antidotes; immediate medical attention is required for appropriate treatment. Store in a safe place away from children, and do not transfer to other containers.

• serious infections
• lung disease
• active tuberculosis
• yeast infection
• interstitial plasma cell pneumonia
• bacterial infections
• viral infections
• herpes virus infections
• pneumonia
• influenza

Store this medication in a tightly sealed container to prevent exposure to air or moisture. It is recommended to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature to preserve the efficacy of the medication for a long time.

Appearance

Blue round film-coated tablet

Package unit

30 tablets/bottle