Pestopacitinib Tablet 5 mg (Topacitinib Citrate)

Adult dose

1. Precautions for administration 1) Do not initiate treatment with this drug in adult 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) This drug may be administered orally with or without food. 2. Recommended dosage for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis The recommended dose of this drug is 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 In the following patients: - Patients with moderate or severe renal impairment - Patients with moderate hepatic impairment* [See section 5. General precautions] 5 mg once daily ALC below 500 cells/mm3 (confirmed by repeat testing) Interrupt treatment ANC 500-1,000 cells/mm3 Temporarily interrupt treatment. When the ANC exceeds 1,000 cells/mm3, resume this drug at 5 mg twice daily. ANC below 500 cells/mm3 Interrupt treatment Hemoglobin level decreases by more than 2 g/dL or is below 8.0 g/dL Temporarily interrupt treatment until the hemoglobin level returns to normal. 3. Recommended dosage for ulcerative colitis 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 observed after administering 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) 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. In the following patients: - Patients with moderate or severe renal impairment - Patients with 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 below 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 exceeds 1,000 cells/mm3, increase the dose again to 10 mg twice daily according to clinical response. If previously receiving this drug at 5 mg twice daily, temporarily interrupt treatment. When the ANC exceeds 1,000 cells/mm3, resume this drug at 5 mg twice daily. ANC below 500 cells/mm3 Interrupt treatment Hemoglobin level decreases by more than 2 g/dL or is below 8.0 g/dL Temporarily interrupt treatment until the hemoglobin level returns to normal. A maintenance dose of 10 mg is not recommended in patients with risk factors for venous thromboembolism (VTE), major adverse cardiovascular events (MACE), and malignancy, regardless of the availability of alternative therapies.

This medication modulates the immune system and is used to treat several inflammatory diseases. However, it may increase the risk of serious infections during treatment, so notify healthcare professionals immediately if any signs of infection appear. Prior to administration, tuberculosis status should be assessed and latent tuberculosis should be treated beforehand. Elderly patients or those at risk for cardiovascular diseases may have an increased risk of cardiovascular adverse reactions and death, necessitating caution. This medication may increase the likelihood of malignant tumors, therefore, it should be used cautiously in patients with a history of cancer or smoking. Thrombosis, i.e., blood clotting within blood vessels may occur, thus patients with risk factors for thrombosis should avoid use or be closely monitored. As this medication can affect liver function and kidney function, regular blood tests should be conducted to monitor liver and kidney status. Decreased lymphocyte and neutrophil counts can increase the risk of infections, and the dosage may need to be adjusted or discontinued based on blood test results. Pregnant women or women who may become pregnant should not use this medication, and if an allergic reaction occurs, usage should be immediately stopped. Live vaccinations should be avoided while taking this medication, and it is recommended to be up-to-date with vaccinations before administration. Risks such as gastrointestinal perforation, interstitial lung disease, and fractures also exist, and healthcare professionals should be consulted immediately if symptoms occur. It is important to fully consult healthcare professionals before starting this medication to evaluate personal health status and risk factors.

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

Store this medication in a tightly closed container to protect it from air and moisture at room temperature, between 1 degree and 30 degrees Celsius. Proper storage maintains the medication's efficacy and safety.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle