Topacel Tablet 10 mg (Tofacitinib Citrate)

Adult dose

This medicine may be administered orally with or without food. Administer 10 mg twice daily for at least 8 weeks, then administer 5 mg or 10 mg twice daily according to the treatment response. Use the lowest effective dose for maintenance therapy. Discontinue treatment if an adequate therapeutic benefit is not observed after administering 10 mg twice daily for 16 weeks. Patients receiving the following medicines: • Strong CYP3A4 inhibitors (e.g., ketoconazole), or • Moderate CYP3A4 inhibitors and strong CYP2C19 inhibitors (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. In the following patients: • Patients with moderate or severe renal impairment • Patients with moderate hepatic impairment* [See 5. General Precautions] 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 less than 500 cells/mm3 (confirmed by repeat testing) Discontinue treatment ANC 500-1,000 cells/mm3 If receiving this medicine at 10 mg twice daily, reduce the dose to 5 mg twice daily. When ANC is greater than 1,000 cells/mm3, increase the dose again to 10 mg twice daily according to clinical response. If receiving this medicine at 5 mg twice daily, temporarily interrupt treatment. When ANC is greater than 1,000 cells/mm3, resume this medicine at 5 mg twice daily. ANC less than 500 cells/mm3 Discontinue treatment Decrease in hemoglobin level 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, a maintenance dose of 10mg is not recommended regardless of whether alternative treatments are available.

This medication carries a high risk of serious infections; therefore, it should be discontinued immediately if symptoms of infection appear. Before and during treatment, tests for tuberculosis should be conducted, and if latent tuberculosis is present, treatment must be initiated first. Patients over 65 years or those at risk of cardiovascular issues should use this medication with particular caution, and specific dosages should not be used. This medication may increase the risk of malignant tumors, so it should be administered cautiously to patients with a history of cancer. There is a possibility of thrombosis, and treatment should be sought immediately if symptoms of thrombosis occur; patients with risk factors should use this with caution. Patients with allergies to this medication or any of its ingredients, active infections, severe liver dysfunction, or pregnant women should not use it. Patients suspected of infection, those with weakened immune systems, the elderly, and patients with diabetes should be administered this medication cautiously. During treatment, various adverse reactions, including infections, blood anomalies, liver function abnormalities, and changes in lipid levels, should be monitored closely. This medication should not be combined with other strong immunosuppressants or biological agents, and regular blood tests and liver function tests are necessary before and during administration. Pregnant women or those who may become pregnant should not take this medication, and effective contraception must be used during treatment. Breastfeeding women should consult their physician regarding whether to discontinue breastfeeding as this medication can be transferred to breast milk. Safety in pediatric patients has not been established, and caution is necessary for the elderly due to a higher infection risk. In case of overdose, there is no specific antidote, so appropriate treatment should be administered based on symptoms, and it should be stored out of reach of children.

Active tuberculosis with serious infections, lung diseases, and diseases outside the lungs, yeast infection, 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, urinary sepsis, disseminated tuberculosis, necrotizing fasciitis, bacteremia, staphylococcemia, pneumocystis pneumonia, pneumococcal pneumonia, bacterial pneumonia, encephalitis, atypical mycobacterial infections, Mycobacterium avium complex infections, cytomegalovirus infections, bacterial arthritis, anemia, leukopenia, lymphocytopenia, neutropenia, drug hypersensitivity, hyperlipidemia, dyslipidemia, dehydration, insomnia, headache, sensory abnormalities, hypertension, venous thromboembolism, cough, dyspnea, sinus congestion, abdominal pain, vomiting, diarrhea, nausea, gastritis, dyspepsia, hepatic steatosis, rash, acne, erythema, pruritus, arthralgia, musculoskeletal pain, joint swelling, tendinitis, fever, peripheral edema, fatigue, gamma-glutamyl transferase elevation, increased serum cholesterol, weight gain, increased serum creatine phosphokinase, elevated liver enzymes, increased aminotransferases, abnormal liver function tests, increased serum creatinine, increased low-density lipoprotein, ligament sprain, muscle tension, exacerbation of ulcerative colitis, gastroesophageal reflux disease, amenorrhea, atrophic vaginitis, cervical polyps, cervical inflammation, irregular menstruation, onycholysis, skin hyperpigmentation, increased appetite, essential thrombocythemia, uterine leiomyoma, pain, pulmonary embolism, deep vein thrombosis, arterial thrombosis, lymphoma, solid tumors, lung cancer, non-melanoma skin cancer, retinal vein thrombosis, hypoglycemia, fractures, angioedema, urticaria, varicella-zoster virus infection

This medication should be kept in a tightly closed container to prevent air or moisture from entering and should be stored at a temperature between 1 and 30 degrees Celsius at room temperature. By storing it this way, the medication’s effectiveness can be well maintained.

Appearance

Blue round film-coated tablet

Package unit

30 tablets/bottle