Elanz 5 mg Tablets (Tofacitinib)

Adult dose

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. This drug may be administered orally with or without food. Rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: The recommended dose of this drug is 5 mg twice daily. Patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis who are 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 rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis who have moderate or severe renal impairment or moderate hepatic impairment: 5 mg once daily Patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis with an ALC below 500 cells/mm3 (confirmed by repeat testing): Discontinue treatment Patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis with an ANC of 500-1,000 cells/mm3: Temporarily interrupt treatment. When the ANC is above 1,000 cells/mm3, resume this drug at 5 mg twice daily. Patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis with an ANC below 500 cells/mm3: Discontinue treatment Patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis whose 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 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 ‘12. Information for Healthcare Professionals’] Use the lowest effective dose for maintenance therapy. Discontinue treatment if adequate therapeutic benefit is not achieved after administration of this drug at 10 mg twice daily for 16 weeks. Patients with ulcerative colitis who are 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. Patients with ulcerative colitis who are 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 5 mg twice daily, reduce the dose to 5 mg once daily. Patients with ulcerative colitis who have 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. Patients with ulcerative colitis who have moderate or severe renal impairment or moderate hepatic impairment: If receiving this drug at 5 mg twice daily, reduce the dose to 5 mg once daily. Patients with ulcerative colitis with an ALC below 500 cells/mm3 (confirmed by repeat testing): Discontinue treatment Patients with ulcerative colitis with an ANC of 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 is above 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 is above 1,000 cells/mm3, resume this drug at 5 mg twice daily. Patients with ulcerative colitis with an ANC below 500 cells/mm3: Discontinue treatment Patients with ulcerative colitis whose 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 10 mg dose is not recommended for maintenance therapy in patients with risk factors for venous thromboembolism (VTE), major adverse cardiovascular events (MACE), and malignancy, regardless of the availability of alternative therapies. In patients receiving 5 mg tablets or the equivalent weight-based dose twice daily who are also receiving a strong cytochrome P450 (CYP) 3A4 inhibitor (e.g., ketoconazole), and in 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 may increase the risk of serious infections, thus it is crucial to confirm the patient's infection status before administration. Particularly, in cases of latent tuberculosis, treatment for tuberculosis should be completed before using this medication, and symptoms of infection should be monitored closely during treatment. This drug can affect the immune system, leading to various infections such as pneumonia, shingles, and urinary tract infections. Additionally, in patients over 50 years of age or those with cardiovascular risk factors, the risks of cardiovascular adverse events such as heart attack or stroke, as well as thrombosis, may increase, thus it should be used with caution. There may be an increased risk of malignant tumors, particularly lymphoma and lung cancer, so patients with a history of cancer or a smoking history should consult a physician before using this medication. Patients with very low neutrophils, lymphocytes, or hemoglobin levels should not be administered this medication, and regular blood tests should be conducted during treatment. This medication should not be used in patients with severely impaired liver function, as liver enzyme levels may increase; regular liver function tests are recommended. Since this medication contains lactose, it should not be administered to patients with certain genetic metabolic disorders. Women who are pregnant or may become pregnant should not use this medication, and live vaccinations should be avoided during treatment. Patients taking this medication should report any new symptoms of infection or adverse reactions to healthcare professionals immediately, and treatment may be stopped if necessary. Furthermore, this medication poses risks of gastrointestinal perforation, interstitial lung disease, fractures, etc., so patients with such histories should be cautious. Finally, sufficient vaccination should be performed before and during treatment with this medication, and infection prevention should be prioritized.

• Serious infections
• lung diseases
• active tuberculosis
• candidiasis
• interstitial plasmacytic pneumonia
• invasive fungal infections
• bacterial infections
• viral infections
• herpesvirus infections
• pneumonia

This medication should be stored in a tightly closed container to prevent air or moisture from entering, and it is best to store it at room temperature between 1 and 30 degrees Celsius. Storing it this way can well maintain the effectiveness of the drug.

Appearance

White round film-coated tablet

Package unit

30 tablets per bottle