Topax 5 mg (Tofacitinib)

Adult dose

Do not initiate this drug in adult patients with an absolute lymphocyte count (ALC; absolute lymphocyte count) below 500 cells/mm3, an absolute neutrophil count (ANC; absolute neutrophil count) below 1,000 cells/mm3, or a hemoglobin level below 9 g/dL. Rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: The recommended dose of this drug is 5mg twice daily. Adults: 5 mg twice daily Patients receiving a strong CYP3A4 inhibitor (e.g., ketoconazole), or a moderate CYP3A4 inhibitor and a strong CYP2C19 inhibitor (e.g., fluconazole): 5 mg once daily Patients with moderate or severe renal impairment or moderate hepatic impairment: 5 mg once daily ALC below 500 cells/mm3 (confirmed by repeat testing): Discontinue 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: Discontinue treatment A decrease in hemoglobin of more than 2 g/dL or a level below 8.0 g/dL: Temporarily interrupt treatment until the hemoglobin level returns to normal Adults with 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 treatment. Discontinue treatment if adequate therapeutic benefit is not achieved after administering this drug at 10 mg twice daily for 16 weeks. Patients receiving a strong CYP3A4 inhibitor (e.g., ketoconazole), or a moderate CYP3A4 inhibitor and a strong CYP2C19 inhibitor (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. Patients with moderate or severe renal impairment or moderate hepatic impairment: 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): Discontinue 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 back 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: Discontinue treatment A decrease in hemoglobin of more than 2 g/dL or a level below 8.0 g/dL: Temporarily interrupt treatment until the hemoglobin level returns to normal A maintenance dose of 10mg is not recommended for patients with risk factors for venous thromboembolism (VTE), regardless of the availability of alternative treatments. For patients receiving 5 mg tablets or an equivalent weight-based dose twice daily who are also receiving a strong cytochrome P450 (CYP) 3A4 inhibitor (e.g., ketoconazole), and for patients receiving one or more concomitant medications that cause both moderate CYP3A4 inhibition and strong CYP2C19 inhibition (e.g., fluconazole), the total daily dose of this drug should be reduced to one 5 mg film-coated tablet once daily or the equivalent weight-based dose once daily.

Child dose

Do not initiate this drug in pediatric patients with an absolute lymphocyte count (ALC) below 750 cells/mm3, an absolute neutrophil count (ANC) below 1,200 cells/mm3, or a hemoglobin level below 10 g/dL.

This medication suppresses the immune system and therefore poses a heightened risk for serious infections. It is necessary to check for tuberculosis and infection prior to administration, and to discontinue the medication immediately if symptoms of infection appear. Additionally, caution is required for patients over 50 with cardiovascular risk factors, and high doses should not be used. This medication may increase the risk of developing malignancies, so it should be administered with caution in patients with a history of cancer or risk factors. There is also a potential risk of thrombosis, so if symptoms of thrombosis appear, the medication should be stopped immediately and healthcare advice should be sought. In patients with impaired liver and kidney function, dosage adjustments are necessary, and it should not be administered to patients with severe liver impairment. Regular monitoring of lymphocyte, neutrophil, and hemoglobin counts is needed to take appropriate actions if any abnormalities occur. This medication contains lactose and should not be given to patients with certain genetic lactose intolerance, nor should it be used by pregnant women or those who may become pregnant. Additionally, it should not be administered with live vaccines, and vaccinations should be completed before administration. During the course of treatment, keen observation for signs of infection, cardiovascular anomalies, malignancies, thrombosis, and liver dysfunction is essential.

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

This medication is sensitive to air and humidity, so it should be stored in a tightly closed container. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius room temperature. This helps keep the medication effective.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle