Jelzani 5 mg Tablet (Tofacitinib Citrate)

Adult dose

Recommended dosage for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis The recommended dosage of this drug is 5 mg per dose, twice daily. Patients receiving the following drugs: -Strong CYP3A4 inhibitors (e.g., ketoconazole), or -Moderate CYP3A4 inhibitors and strong CYP2C19 inhibitors (e.g., fluconazole) Administer 5 mg per dose, once daily Patients with: -Moderate or severe renal impairment -Moderate hepatic impairment* [See section ‘5. General Precautions’] Administer 5 mg per dose, once daily ALC less than 500 cells/mm3 (confirmed by repeat testing) Discontinue treatment ANC 500-1,000 cells/mm3 Temporarily interrupt treatment. When the ANC is greater than 1,000 cells/mm3, resume this drug at 5 mg per dose, twice daily. ANC less than 500 cells/mm3 Discontinue treatment Hemoglobin decrease of more than 2 g/dL or hemoglobin level less than 8.0 g/dL Temporarily interrupt treatment until the hemoglobin level returns to normal Recommended dosage for ulcerative colitis Administer 10 mg per dose, 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. If adequate therapeutic benefit is not observed after administering this drug at 10 mg per dose, twice daily for 16 weeks, discontinue treatment. 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 per dose, twice daily, reduce the dose to 5 mg per dose, twice daily. If receiving this drug at 5 mg per dose, 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’] If receiving this drug at 10 mg per dose, twice daily, reduce the dose to 5 mg per dose, twice daily. If receiving this drug at 5 mg per dose, 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 If receiving this drug at 10 mg per dose, twice daily, reduce the dose to 5 mg per dose, twice daily. When the ANC is greater than 1,000 cells/mm3, increase the dose again to 10 mg per dose, twice daily, according to clinical response. If previously receiving this drug at 5 mg per dose, twice daily, temporarily interrupt treatment. When the ANC is greater than 1,000 cells/mm3, resume this drug at 5 mg per dose, twice daily. ANC less than 500 cells/mm3 Discontinue treatment Hemoglobin decrease of more than 2 g/dL or hemoglobin level less than 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 as maintenance therapy, regardless of the availability of alternative treatments.

This medication may suppress immune function and increase the risk of infections. There is a particular risk of serious infections such as pulmonary tuberculosis or fungal infections, so tuberculosis screening must be performed before and during treatment. If major symptoms of infection occur, medication should be stopped immediately and treatment should be sought. The risk of infection may be higher when this medication is used alongside immunosuppressive agents, so caution is necessary. Patients over 65 years of age or those with cardiovascular disease risk should use this medication carefully, particularly a 10 mg dose which is not given to certain patients. During use, there may be an increased risk of malignancies, including cancers such as malignancies or lymphomas, necessitating regular check-ups. This is particularly important for smokers or patients with a history of cancer. There is also a risk of thrombosis, the formation of clots within blood vessels, so if symptoms such as leg pain, swelling, or sudden breathing difficulties occur, the doctor should be notified immediately. Patients with impaired liver and kidney function may need dose adjustments and should undergo regular enzyme and kidney function tests. Blood tests are also important since a low white blood cell and lymphocyte count increases the risk of infections, necessitating regular monitoring of blood levels. This medication can cause allergic reactions, so if symptoms like hives, swelling, or breathing difficulties occur, it should be stopped immediately and medical consultation should be sought. Live vaccines are not to be administered with this medication, and vaccinations should ideally be completed following the latest guidelines before starting treatment. Patients should be vigilant for symptoms of infection, skin changes, breathing difficulties, or blood abnormalities during treatment, and report any concerns to their healthcare provider immediately. This medication should be taken strictly according to a specialist's instructions, and safe use requires regular check-ups and monitoring.

• Severe 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. It is best stored at room temperature, between 1 to 30 degrees Celsius.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle