Topanux Tablet 5 mg (Tofacitinib Citrate)

Adult dose

Recommended dose for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis The recommended dose of this medicine is 5mg twice daily. The recommended adult doses for patients receiving CYP2C19 and/or CYP3A4 inhibitors, patients with moderate or severe renal impairment, patients with moderate hepatic impairment, and patients with lymphopenia, neutropenia, or anemia are shown in Table 1. 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 ANC is above 1,000 cells/mm3, resume this medicine at 5 mg twice daily. ANC below 500 cells/mm3: Discontinue treatment Decrease in hemoglobin level of more than 2 g/dL or hemoglobin level below 8.0 g/dL: Temporarily interrupt treatment until the hemoglobin level returns to normal Recommended dose for ulcerative colitis The recommended adult doses for patients receiving CYP2C19 and/or CYP3A4 inhibitors, patients with moderate or severe renal impairment, patients with moderate hepatic impairment, and patients with lymphopenia, neutropenia, or anemia are shown in Table 2. Adults: 10 mg twice daily for at least 8 weeks, followed by 5 mg or 10 mg twice daily depending on treatment response. Use the lowest effective dose for maintenance treatment. If adequate therapeutic benefit is not achieved after administration of this medicine at 10 mg twice daily for 16 weeks, discontinue treatment. 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 medicine at 10 mg twice daily, reduce the dose to 5 mg twice daily. If receiving this medicine 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 medicine at 10 mg twice daily, reduce the dose to 5 mg twice daily. If receiving this medicine 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 medicine was being administered at 10 mg twice daily, reduce the dose to 5 mg twice daily. When ANC is above 1,000 cells/mm3, increase the dose back to 10 mg twice daily according to clinical response. If this medicine was previously being administered at 5 mg twice daily, temporarily interrupt treatment. When ANC is above 1,000 cells/mm3, resume this medicine at 5 mg twice daily. ANC below 500 cells/mm3: Discontinue treatment Decrease in hemoglobin level of more than 2 g/dL or hemoglobin level below 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, 10mg is not recommended for maintenance treatment, regardless of the availability of alternative therapies.

This drug may increase the risk of serious infections; therefore, signs of infection should be carefully monitored before and during treatment. Especially, latent tuberculosis testing must be performed, and if latent tuberculosis is confirmed, it should be treated beforehand. This drug has immunosuppressive effects, so various infections such as pneumonia, urinary tract infections, and shingles may occur; if infection is suspected, the healthcare provider should be notified immediately. This drug may increase cardiovascular mortality and thrombotic risk in patients over 50 with cardiovascular risk factors; therefore, such patients should carefully weigh the risks and benefits before using this drug. Especially, the 10 mg dose is not used in rheumatoid arthritis or psoriatic arthritis patients. This drug may raise the risk of malignant tumors, so patients with a history of cancer or smoking should consult a specialist before administration. Patients with very low neutrophil, lymphocyte, or hemoglobin counts, severe liver or kidney impairment, pregnant women, or women of childbearing potential should not use this drug. Regular monitoring of liver function tests, blood tests, lipid tests, etc., should be performed during treatment to detect and manage any abnormalities early. Live vaccine administration should be avoided during therapy, and vaccinations should be completed prior to treatment for safety. If symptoms of thrombosis appear during this drug regimen, such as sudden shortness of breath, chest pain, or leg swelling, immediate medical attention is required. This drug carries a risk of gastrointestinal perforation, so patients with a history of gastrointestinal disorders or currently taking NSAIDs should use it cautiously and seek prompt medical advice if abdominal pain or other symptoms arise. If an allergic reaction occurs, administration should be stopped immediately and medical consultation should be sought. This drug affects immune function, so it should be administered with caution in patients at high risk of infection, elderly patients, or diabetic patients, requiring regular check-ups and monitoring.

Serious infections, lung diseases, active tuberculosis, yeast infections, interstitial plasma cell pneumonia, bacterial infections, viral infections, herpes virus infections, pneumonia, influenza, shingles, urinary tract infections, sinusitis, bronchitis, nasopharyngitis, pharyngitis, tuberculosis, diverticulitis, pyelonephritis, soft tissue infections, herpes simplex, viral gastroenteritis, sepsis, central nervous system tuberculosis, cryptococcal meningitis, urosepticemia, disseminated tuberculosis, necrotizing fasciitis, bacteremia, staphylococcal bacteremia, pneumocystis pneumonia, pneumococcal pneumonia, bacterial pneumonia, encephalitis, atypical mycobacterial infections, Mycobacterium avium complex infections, cytomegalovirus infections, bacterial arthritis, anemia, leukopenia, lymphopenia, neutropenia, drug hypersensitivity reactions, hyperlipidemia, dyslipidemia, dehydration, insomnia, headache, sensory disturbances, hypertension, venous thromboembolism, cough, dyspnea, sinus congestion, abdominal pain, vomiting, diarrhea, nausea, gastritis, dyspepsia, fatty liver disease, rash, acne, erythema, itching, arthralgia, musculoskeletal pain, joint swelling, tendinitis, peripheral edema, fever, fatigue, increased gamma-glutamyl transferase, increased blood cholesterol, weight gain, increased blood creatine phosphokinase, increased liver enzymes, increased aminotransferases, abnormal liver function tests, increased blood creatinine, increased low-density lipoprotein cholesterol, ligament sprains, muscle tension, weakness, chest discomfort, generalized edema, facial swelling, synovitis, rheumatic nodules, mononeuritis, dizziness, postherpetic neuralgia, constipation, oral ulcer formation, tachycardia, prostate cancer, dysuria, interstitial lung disease, wet cough, deep vein thrombosis, hair loss, dermatitis, eczema, skin disorders, weight loss, exacerbation of ulcerative colitis, gastroesophageal reflux disease, amenorrhea, atrophic vaginitis, cervical polyps, cervical inflammation, irregular menstruation, onycholysis, skin hyperpigmentation, increased appetite, essential thrombocythemia, uterine leiomyomas, pain, aseptic meningitis, fractures, angioedema, urticaria, anaphylaxis, varicella-zoster virus infections, drug-induced liver injury, decreased lymphocyte count, neutropenia, decreased hemoglobin levels, increased serum creatinine, increased LDL cholesterol, increased HDL cholesterol

This drug should be stored in a tightly sealed container to protect it from air and moisture. Additionally, it is recommended to store the drug at room temperature between 1 to 30 degrees Celsius. Avoid storing it in locations that are excessively hot or cold.

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle