Jack Paz Tablet 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. This drug may be taken orally with or without food. Rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: The recommended dose of this drug is 5mg twice daily. Patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: 5 mg twice daily Patients receiving the following medications: - A strong CYP3A4 inhibitor (e.g., ketoconazole), or - A moderate CYP3A4 inhibitor and a strong CYP2C19 inhibitor (e.g., fluconazole) 5 mg once daily For patients with: - Moderate or severe renal impairment - Moderate hepatic impairment* [See section ‘5. Precautions’] 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 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 the following medications: - 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. For patients with: - Moderate or severe renal impairment - Moderate hepatic impairment [See section ‘5. 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) 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), major adverse cardiovascular events (MACE), and malignancy, 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 can weaken immunity to infections, increasing the risk of serious infections. Therefore, prior to using this medication, latent infections such as tuberculosis must be tested, and if latent tuberculosis is present, treatment should be initiated first. During treatment, symptoms of infection should be carefully monitored, and if infection is suspected, medical consultation is required immediately. This medication may increase the risk of mortality and cardiovascular events such as myocardial infarction and stroke in patients over 50 with cardiovascular disease risk factors, thus those patients require special caution. While taking this medication, the risk of developing malignancies, especially lymphomas or lung cancer, may increase, so special consideration is necessary for individuals with a history of malignancy, smokers, and the elderly. The risk of thrombosis, specifically the formation of clots inside blood vessels, may also increase, so patients with a history of thrombosis or risk factors should avoid using this medication. If symptoms of thrombosis occur, medication should be stopped immediately, and a medical assessment should be sought. This medication can impact liver function, thus dose adjustments may be necessary based on liver function tests, and it should not be given to patients with severe hepatic impairment. Pregnant women or those who may become pregnant should not take this medication, and patients with hypersensitivity to this medication should also avoid its use. This medication affects the immune system, so it should not be co-administered with live vaccines, and it is important that the latest vaccinations are completed before administration. Regular blood tests to check lymphocyte, neutrophil, hemoglobin levels, etc., are necessary during treatment, and dose adjustments or discontinuation may be needed if abnormalities arise. Additionally, this medication carries a risk of gastrointestinal perforation, requiring caution in patients with gastrointestinal disease histories, and if new abdominal symptoms develop, immediate evaluation is necessary. Lastly, various adverse reactions have been reported with this medication, so any uncomfortable symptoms during use should be reported to a healthcare professional for advice.

• Severe infections
• pneumonia
• shingles
• 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. Additionally, it is recommended to keep the medication at room temperature between 1 and 30 degrees Celsius, away from excessively hot or cold places.

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle