Jelz Wonjeong 5 mg (Tofacitinib)

Adult dose

Do not initiate this drug in adult patients with an absolute lymphocyte count (ALC; absolute lymphocyte count) below 500 cells/mm3, an absolute neutrophil count (ANC; absolute neutrophil count) below 1,000 cells/mm3, or a hemoglobin level below 9 g/dL. Recommended dosage for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis The recommended dose of this drug is 5mg twice daily. Adults 5 mg twice daily Patients receiving the following medications: - A strong CYP3A4 inhibitor (e.g., ketoconazole), or - A moderate CYP3A4 inhibitor and a strong CYP2C19 inhibitor (e.g., fluconazole) 5 mg once daily For patients with: - Moderate or severe renal impairment - Moderate hepatic impairment* [See section ‘5. 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 exceeds 1,000 cells/mm3, resume this drug at 5 mg twice daily. ANC below 500 cells/mm3 Discontinue treatment A decrease in hemoglobin of more than 2 g/dL or a level below 8.0 g/dL Temporarily interrupt treatment until the hemoglobin level returns to normal Recommended dosage for ulcerative colitis Adults 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 treatment. Discontinue treatment if adequate therapeutic benefit is not achieved after administering this drug at 10 mg twice daily for 16 weeks. Patients receiving the following medications: - 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. If receiving this drug at 5 mg twice daily, reduce the dose to 5 mg once daily. For patients with: - Moderate or severe renal impairment - Moderate hepatic impairment [See section ‘5. 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 receiving this drug at 10 mg twice daily, reduce the dose to 5 mg twice daily. When the ANC exceeds 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 exceeds 1,000 cells/mm3, resume this drug at 5 mg twice daily. ANC below 500 cells/mm3 Discontinue treatment A decrease in hemoglobin of more than 2 g/dL or a level below 8.0 g/dL Temporarily interrupt treatment until the hemoglobin level returns to normal A maintenance dose of 10mg is not recommended for patients with risk factors for venous thromboembolism (VTE), major adverse cardiovascular events (MACE), and malignancy, regardless of the availability of alternative treatments. For patients receiving 5 mg tablets or an equivalent weight-based dose twice daily who are also receiving a strong cytochrome P450 (CYP) 3A4 inhibitor (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 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 drug suppresses the immune system to treat inflammatory diseases. However, taking this drug may increase the risk of serious infections such as pneumonia, herpes zoster, and urinary tract infections. There is a particularly elevated risk of tuberculosis, so a tuberculosis test must be conducted before and during treatment, and if latent tuberculosis is present, it should be treated first. Additionally, in patients aged 50 years and older with cardiovascular disease risk, there may be an increased risk of sudden cardiovascular death or thrombosis, so caution is needed. This drug may increase the risk of malignant tumors, particularly lymphomas and lung cancer; thus, patients with a history of cancer, smokers, and the elderly should use it cautiously. Patients with low white blood cell, lymphocyte, and neutrophil counts or anemia should not take this drug, and regular blood tests must be conducted to monitor their condition during treatment. Patients with impaired liver function should consult with a doctor before using this drug and may require liver function tests due to the possibility of elevated liver enzyme levels. This drug should not be used with live vaccines, and it is important to complete the latest vaccinations before treatment. Pregnant women or women of childbearing potential should not take this drug. Any signs of allergic reactions, thrombotic symptoms, or severe infection symptoms during treatment should be immediately reported to a doctor, and drug administration should be halted if necessary. This drug may lead to severe side effects such as gastrointestinal perforation, interstitial lung disease, and fractures, so patients at risk should be particularly cautious. Therefore, patients on this drug should follow regular monitoring and the doctor's instructions meticulously and consult immediately if any abnormal symptoms arise.

Serious infections, pneumonia, herpes zoster, urinary tract infections, sinusitis, bronchitis, nasopharyngitis, pharyngitis, tuberculosis, diverticulitis, pyelonephritis, soft tissue infections, herpes simplex, viral gastroenteritis, viral infections, sepsis, central nervous system tuberculosis, cryptococcal meningitis, urinary sepsis, disseminated tuberculosis, necrotizing fasciitis, bacteremia, staphylococcal bacteremia, pneumocystis pneumonia, pneumococcal pneumonia, bacterial pneumonia, encephalitis, atypical mycobacterial infections, Mycobacterium avium complex infections, cytomegalovirus infection, bacterial arthritis, anemia, leukopenia, lymphopenia, neutropenia, drug hypersensitivity reactions, hyperlipidemia, dyslipidemia, dehydration, insomnia, headache, paresthesia, hypertension, venous thromboembolism, cough, dyspnea, sinus congestion, abdominal pain, vomiting, diarrhea, nausea, gastric inflammation, dyspepsia, fatty liver disease, rash, acne, erythema, itching, arthralgia, musculoskeletal pain, joint swelling, tendinitis, fever, peripheral edema, fatigue, increased gamma-glutamyl transferase, increased blood cholesterol, weight gain, increased serum creatine phosphokinase, increased liver enzymes, increased aminotransferases, abnormal liver function tests, increased serum creatinine, increased low-density lipoprotein, ligament sprain, muscle tension, weakness, chest discomfort, generalized edema, facial swelling, acute pyelonephritis, peritonsillar abscess, fungal sinusitis, synovitis, rheumatoid nodules, mononeuritis, dizziness, post-herpetic neuralgia, constipation, oral ulcer formation, tachycardia, prostate cancer, dysuria, interstitial lung disease, productive 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 leiomyoma, pain, aseptic meningitis, fractures, angioedema, urticaria, varicella-zoster virus infection, drug-induced liver injury, liver damage, reactivation of hepatitis B, pulmonary embolism, deep vein thrombosis, arterial thrombosis, lymphoma, solid tumors, lung cancer, breast cancer, stomach cancer, colorectal cancer, renal cell carcinoma, prostate cancer, malignant melanoma, Epstein-Barr virus related lymphoproliferative disorder after organ transplantation

This drug should be stored in a tightly closed container to prevent air and moisture from entering and is best kept at room temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain the drug's efficacy.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle