Zelpanic Tablets 5 mg (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. The recommended dose for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis is 5 mg twice daily. Patients receiving the following drugs: -strong CYP3A4 inhibitors (e.g., ketoconazole), or -moderate CYP3A4 inhibitors and strong CYP2C19 inhibitors (e.g., fluconazole) 5 mg once daily In the following patients: -patients with moderate or severe renal impairment -patients with moderate hepatic impairment* [See section ‘5. General 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 is above 1,000 cells/mm3, resume this drug at 5 mg twice daily. ANC below 500 cells/mm3 Discontinue treatment 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 In patients with rheumatoid arthritis, this drug is administered alone or in combination with methotrexate and other nonbiologic disease-modifying antirheumatic drugs. In patients with psoriatic arthritis, this drug is administered in combination with nonbiologic disease-modifying antirheumatic drugs (DMARDs). The efficacy of this drug as monotherapy in patients with psoriatic arthritis has not been studied. Clinical improvement in ankylosing spondylitis was observed within 16 weeks after initiation of treatment with this drug. For patients who do not show clinical improvement within this period, continued treatment should be considered carefully. 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 administration of 10 mg twice daily for 16 weeks. 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 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. In the following patients: -patients with moderate or severe renal impairment -patients with moderate hepatic impairment [See section ‘5. General 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 this drug was administered 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 this drug was previously administered 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. ANC below 500 cells/mm3 Discontinue treatment 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 maintenance dose of 10 mg is not recommended in patients with risk factors for venous thromboembolism (VTE), major adverse cardiovascular events (MACE), and malignancy, regardless of the availability of alternative therapies. For patients receiving 5 mg tablets or the weight-based equivalent twice daily who are also receiving strong cytochrome P450 (CYP) 3A4 inhibitors (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 5 mg once daily as a film-coated tablet or the weight-based equivalent 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 drug suppresses the immune system to treat inflammatory diseases. However, the risk of serious infections may increase while taking this medication. If an infection occurs, the drug should be discontinued until the treatment is concluded. A latent tuberculosis test must be performed before initiation; if latent tuberculosis is present, treatment should start afterward. Patients over 65 years of age or those with cardiovascular risk factors should use this drug cautiously. This drug may increase mortality related to cardiovascular diseases and the risk of malignancies, thus caution is necessary. The risk of vascular diseases such as thrombosis, pulmonary embolism, and deep vein thrombosis may also increase, and patients should consult healthcare professionals immediately if symptoms appear. Monitoring is necessary, as liver function abnormalities, blood test changes, and hyperlipidemia can occur. Women who are pregnant or may become pregnant should not take this medication. It should also not be used in cases of allergy or hypersensitivity. Live vaccines should not be administered concurrently, and vaccinations should be completed prior to treatment. Dose adjustments are needed in patients with decreased liver or kidney function, and the drug should not be administered to patients with severe liver dysfunction. While on this medication, patients should carefully observe for symptoms of infection, difficulty breathing, skin changes, or thrombotic symptoms, and consult a doctor immediately if any abnormalities occur.

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

Store this medication in a tightly closed container to protect it from air and moisture. It is recommended to maintain storage temperatures between 1 and 30 degrees Celsius.

Appearance

White round film-coated tablets

Package unit

Bottle - 30 tablets/bottle