Topact 10 mg Tablets (Tofacitinib Citrate)

Adult dose

1) Do not initiate treatment with this medicine 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. 3) Temporary interruption of this medicine may be necessary to manage lymphopenia, neutropenia, and anemia. 4) This medicine 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 depending on the treatment response. Use the minimum effective dose for maintenance treatment. Discontinue treatment if adequate therapeutic benefit is not observed after administering this medicine at 10 mg twice daily for 16 weeks. Patients receiving any of the following medicines: • Strong CYP3A4 inhibitors (e.g., ketoconazole), or • Moderate CYP3A4 inhibitors and strong CYP2C19 inhibitors (e.g., fluconazole) If receiving this medicine at 10 mg twice daily, reduce the dose to 5 mg twice daily. If receiving this medicine 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 section 5. General Precautions] If receiving this medicine at 10 mg twice daily, reduce the dose to 5 mg twice daily. If receiving this medicine at 5 mg twice daily, reduce the dose to 5 mg once daily. ALC below 500 cells/mm3 (confirmed by repeat testing) Discontinue treatment ANC 500-1,000 cells/mm3 If receiving this medicine at 10 mg twice daily, reduce the dose to 5 mg twice daily. When ANC exceeds 1,000 cells/mm3, increase the dose again to 10 mg twice daily according to the clinical response. If receiving this medicine at 5 mg twice daily, temporarily interrupt treatment. When ANC exceeds 1,000 cells/mm3, resume this medicine at 5 mg twice daily. ANC below 500 cells/mm3 Discontinue treatment Hemoglobin decrease of more than 2 g/dL or 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, 10 mg is not recommended for maintenance treatment, regardless of the availability of alternative therapies.

This medication modulates the immune system to treat inflammatory diseases. During treatment, there may be an increased risk of serious infections, so if any signs of infection occur, medical personnel should be notified immediately. Before and during treatment, screening for latent tuberculosis is mandatory, and if latent tuberculosis is present, this medication should not be started until after treatment. Patients aged 65 or older or with cardiovascular risk factors should be particularly cautious, and this medication is not recommended at certain doses. As there is an increased risk of developing malignant tumors, patients with a history of cancer or those who have smoked require careful consideration regarding the use of this medication. There may also be risks of cardiovascular adverse reactions such as thrombosis, myocardial infarction, and stroke, thus patients with relevant risk factors should undergo thorough consultation and testing before use. Patients with specific low blood parameters (neutrophils, lymphocytes, hemoglobin, etc.) should not receive this medication, and regular blood tests should be conducted to monitor their condition. Pregnant women or those who may become pregnant should not take this medication, and effective contraception must be used during treatment. Patients with liver or kidney impairment may need dosage adjustments, so consultation with medical personnel is necessary. This medication should not be used in combination with other immunosuppressants or biological agents. Up-to-date vaccinations must be completed before treatment, and it should not be administered with live vaccines. During treatment, adverse reactions such as rash, headache, dyspepsia, infections, changes in blood parameters, etc., may occur, and any symptoms should be reported immediately. In the case of an overdose, as there is no specific antidote, appropriate care should be sought immediately from a hospital. This medication should be stored out of reach of children and care should be taken not to transfer it to other containers.

• serious infections
• lung diseases
• active tuberculosis
• candidiasis
• interstitial plasma cell pneumonia
• bacterial infections
• viral infections
• herpes virus infections
• pneumonia
• influenza

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance

Blue, round film-coated tablets

Package unit

30 tablets per bottle