Zeltos 5 mg Tablet (Tofacitinib)

Adult dose

This medicine may be administered orally regardless of food intake. The recommended dose of this medicine is 5mg twice daily. Adults 5mg twice daily Patients receiving the following drugs: - strong CYP3A4 inhibitors (e.g., ketoconazole), or - moderate CYP3A4 inhibitors and strong CYP2C19 inhibitors (e.g., fluconazole) 5mg once daily Patients with: -moderate or severe renal impairment -moderate hepatic impairment* [See ‘5. General Precautions’] 5mg once daily ALC below 500cells/mm3 (confirmed by repeat testing) Discontinue treatment ANC 500-1,000cells/mm3 Temporarily interrupt treatment. When ANC exceeds 1,000cells/mm3, resume this medicine at 5mg twice daily. ANC below 500cells/mm3 Discontinue treatment Hemoglobin decrease of more than 2g/dL or level below 8.0g/dL Temporarily interrupt treatment until hemoglobin levels return to normal

This medication may affect the immune system and increase the risk of infections. Serious infections such as pneumonia, tuberculosis, and herpes zoster may occur, so you should consult a healthcare professional immediately if any infection symptoms appear. Tuberculosis tests must be performed before and during treatment, and if latent tuberculosis is present, treatment should be initiated first. Elderly patients over 65 years of age or those with cardiovascular risk factors should use this drug cautiously as the risk of heart disease and thrombosis may increase. This medication may also increase the risk of malignancy, so patients with a history of cancer or risk factors such as smokers should exercise special caution. Blood tests should be conducted regularly to check the levels of white blood cells, lymphocytes, and hemoglobin; if the levels are too low, administration should be halted or adjusted. Patients with poor liver and kidney function require dose adjustments when using this drug, and adverse reactions related to elevated liver enzyme levels may occur. This medication should not be used in conjunction with other strong immunosuppressants or biological agents, as concomitant use may further increase the risk of infections. Women who are pregnant or may become pregnant should not use this drug and must ensure effective contraception during and for some time after treatment. Nursing women should also consider stopping breastfeeding or the medication due to the possibility of drug transmission through breast milk. Vaccinations should be completed before administering this drug, and it is safest to avoid live vaccine administration. In case of overdose, there is no specific antidote, so you should seek appropriate treatment at a medical institution immediately. During the course of treatment with this drug, symptoms of infection, blood lab values, and liver and kidney function should be monitored regularly following the instructions of your doctor.

serious infections, pneumonia, herpes zoster, urinary tract infection, soft tissue infection, gastroenteritis, diverticulitis, appendicitis, lung disease, invasive fungal infections, bacterial infections, viral infections, herpes virus infections, tuberculosis, pneumococcal pneumonia, bacterial pneumonia, diverticulitis, pyelonephritis, bacterial arthritis, herpes simplex, viral gastroenteritis, central nervous system tuberculosis, cryptococcal meningitis, urosepticemia, disseminated tuberculosis, necrotizing fasciitis, bacteremia, staphylococcal bacteremia, Pneumocystis pneumonia, encephalitis, atypical mycobacterial infections, Mycobacterium avium complex infections, cytomegalovirus infection, lymphocytopenia, neutropenia, leukopenia, anemia, drug hypersensitivity, dyslipidemia, hyperlipidemia, dehydration, insomnia, headache, paresthesia, hypertension, venous thromboembolism, dyspnea, cough, sinus congestion, abdominal pain, vomiting, diarrhea, nausea, gastritis, dyspepsia, hepatic steatosis, rash, erythema, pruritus, musculoskeletal pain, arthralgia, joint swelling, tendinitis, fever, peripheral edema, fatigue, elevated liver enzymes, increased blood cholesterol, weight gain, elevated blood creatine phosphokinase, increased aminotransferases, abnormal liver function tests, elevated gamma-glutamyl transferase, increased blood creatinine, increased low-density lipoprotein, ligament sprain, muscle tension, acne, increased blood creatine phosphokinase, fever, anemia, nausea, facial edema, asthenia, chest discomfort, generalized edema, facial swelling, acute pyelonephritis, peritonsillar abscess, mononeuritis, dizziness, post-herpetic neuralgia, constipation, oral ulcer formation, tachycardia, prostate cancer, dysuria, interstitial lung disease, productive cough, deep vein thrombosis, alopecia, dermatitis, eczema, skin disorders, weight loss, elevated serum creatinine, increased serum creatinine, liver damage, drug-induced liver injury, elevated serum creatinine, increased serum creatinine, hypoglycemia, thrombosis, pulmonary embolism, deep vein thrombosis, arterial thrombosis, varicella-zoster virus infection, angioedema, urticaria, retinal vein thrombosis, malignant tumors, lymphoma, non-melanoma skin cancer, lung cancer, breast cancer, gastric cancer, rectal cancer, renal cell carcinoma, prostate cancer, malignant melanoma, Epstein-Barr virus-associated post-transplant lymphoproliferative disorder, epileptic lung disease, gastrointestinal perforation, diverticular perforation, peritonitis, abdominal abscess, appendicitis

This medication should be stored in a tightly closed container to protect it from air and moisture. It is recommended to maintain the storage temperature between 1°C and 30°C at room temperature. Proper storage helps to preserve the effectiveness and safety of the medication for a longer period.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle