Topatinib 5 mg Tablets (Topacitinib Citrate)

Adult dose

Recommended dosage for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis The recommended dose of this medicine is 5mg twice daily. Patients receiving the following medicines: -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) Discontinue treatment ANC 500-1,000 cells/mm3 Temporarily interrupt treatment. When ANC exceeds 1,000 cells/mm3, resume this medicine at 5 mg twice daily. ANC less than 500 cells/mm3 Discontinue treatment Hemoglobin decrease of more than 2 g/dL or hemoglobin level below 8.0 g/dL Temporarily interrupt treatment until hemoglobin levels return to normal 1 In patients with rheumatoid arthritis, this medicine is administered alone or in combination with methotrexate and other nonbiologic disease-modifying antirheumatic drugs. 2 In patients with psoriatic arthritis, this medicine is administered in combination with nonbiologic disease-modifying antirheumatic drugs (DMARDs). The efficacy of this medicine as monotherapy in patients with psoriatic arthritis has not been studied. 3 Clinical improvement in ankylosing spondylitis was observed within 16 weeks after starting this medicine. Continued treatment should be carefully considered in patients who show no clinical improvement within this period. 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 achieved after administering 10 mg twice daily for 16 weeks. Patients receiving the following medicines: -Strong CYP3A4 inhibitors (e.g., ketoconazole), or -Moderate CYP3A4 inhibitors and strong CYP2C19 inhibitors (e.g., fluconazole) For patients receiving 10 mg twice daily, reduce the dose to 5 mg twice daily. For patients receiving 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 10 mg twice daily, reduce the dose to 5 mg twice daily. For patients receiving 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 10 mg twice daily, reduce the dose to 5 mg twice daily. When ANC exceeds 1,000 cells/mm3, increase the dose back to 10 mg twice daily according to clinical response. For patients previously receiving 5 mg twice daily, temporarily interrupt treatment. When ANC exceeds 1,000 cells/mm3, resume this medicine at 5 mg twice daily. ANC less than 500 cells/mm3 Discontinue treatment Hemoglobin decrease of more than 2 g/dL or hemoglobin level below 8.0 g/dL Temporarily interrupt treatment until hemoglobin levels return to normal A maintenance dose of 10mg is not recommended in patients with risk factors for venous thromboembolism (VTE), major adverse cardiovascular events (MACE), and malignancy, regardless of the availability of other treatment options.

This medication can affect the immune system and reduce resistance to infections. Therefore, the risk of serious infections such as pneumonia, tuberculosis, and shingles may be increased during treatment with this medicine. If infection is suspected or occurs, it is important to consult a healthcare professional immediately, and the use of this medication may be discontinued until the infection is controlled. Before initiating and during treatment, patients should be screened for tuberculosis, and if latent tuberculosis is confirmed, treatment must be received first. Additionally, patients over 50 years old or those with cardiovascular risk factors should be cautious due to an increased risk of cardiovascular adverse effects such as myocardial infarction and stroke, as well as thromboembolism. This medication may also increase the risk of malignant tumors, so patients with a history of cancer or smoking should use it with caution. Routine blood tests are required as results may indicate decreased lymphocyte or neutrophil counts, or decreased hemoglobin levels. Liver function abnormalities may occur, so liver enzyme levels should be checked periodically, and dosage adjustments may be needed in patients with liver dysfunction, or avoidance of the medication altogether. This medication may elevate lipid levels, necessitating cholesterol management. If symptoms of thromboembolism occur, medication should be discontinued immediately, and a healthcare professional should be consulted. Women who are pregnant or may become pregnant should not take this medication. The risk of infection is further increased when combined with other immunosuppressants, so combination therapy should be avoided. Additionally, live vaccinations should be completed prior to administration of this medication, and live vaccinations should be avoided during therapy, along with caution taken when in contact with vaccinated individuals. While using this medication, patients should be closely monitored for symptoms of infection, abnormal blood test results, cardiovascular symptoms, and should undergo regular testing.

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

This medication should be stored in a tightly closed container to protect it from air and moisture and should be kept at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the effectiveness of the medication for a longer duration.

Appearance

White circular film-coated tablets

Package unit

30 tablets/bottle