Kimara Tablet 10 mg (Leflunomide)

Adult dose

1. Loading dose Considering that this medicine has a long half-life and the recommended dosing interval is 24 hours, treatment is generally initiated with a loading dose to reach steady-state blood concentrations more quickly. Administer 100 mg once daily for 3 days as the loading dose. In patients with rheumatoid arthritis, omitting the loading dose may reduce the risk of adverse reactions (see section ‘5. General precautions, 9)’). 2. Maintenance dose For patients with rheumatoid arthritis, administer 20 mg once daily as the maintenance dose. Some patients who received 25 mg daily experienced adverse reactions such as hair loss, weight loss, and increased liver enzyme levels. Therefore, the maintenance dose should not exceed 20 mg daily. If the patient's clinical tolerability is poor, the maintenance dose may be reduced to 10 mg daily. For patients with psoriatic arthritis, administer 20 mg daily as the maintenance dose. Monitor liver enzyme levels; dose adjustment may be necessary. (See Warnings - Hepatotoxicity.) Because the active metabolite of this medicine has a prolonged half-life, it may take several weeks for metabolite levels to decrease. Therefore, monitor the patient carefully after reducing the dose.

This medication contains ingredients that may remain in the body for a long time, and side effects may occur or persist even after discontinuation. In case of serious side effects or if rapid elimination of the drug is necessary, specific medications must be used to quickly discharge this drug from the body. It may affect liver function, so caution is needed in patients with poor liver function, and it should not be administered to patients with a history of liver damage. Regular liver function tests should be conducted before and at the beginning of treatment, and if liver enzyme levels increase, dosage adjustment or discontinuation may be necessary. The risk of hepatotoxicity may increase when used in combination with other drugs, especially certain antineoplastic agents, thus requiring stricter liver function tests. Patients with lung issues or a history of pneumonia should carefully assess lung status before taking this medication, and if any lung-related symptoms arise, they should consult healthcare professionals immediately. It can suppress the immune system; therefore, it is not recommended for patients with serious infections or immune deficiencies, and discontinuation of the medication is advised in case of infection symptoms. Severe reactions may appear on the skin; therefore, if skin rashes or ulcers develop, treatment should be discontinued immediately and follow the instructions of the physician. This medication may pose risks for pregnant women or those who may become pregnant, so it should not be taken if pregnancy is planned or if the individual is pregnant. Patients with certain genetic diseases, such as lactose intolerance, should not be administered this medication due to its lactose content. The safety of this medication has not been established in children, and it is not recommended for patients under 18 years of age. Overdosage may cause symptoms such as diarrhea, abdominal pain, and anemia, and specific medications may be needed to lower the concentration of the drug in the body. Regular blood tests and liver function tests should be performed to check for anomalies while taking this medication, and care should be taken regarding interactions when used with other drugs. Since this medication has immunosuppressive effects, the risk of infection may be increased, and immediate consultation with healthcare providers is necessary if any infection symptoms arise. Additionally, it is advisable to avoid live vaccine administration while on this medication, and caution is needed for a certain period after discontinuation. This medication may cause various side effects such as hypertension, hair loss, gastrointestinal disorders; thus, it is important to inform healthcare providers of any unusual symptoms. Lastly, this medication should be stored in a cool, dark place below 25 degrees Celsius, and should not be discontinued or altered arbitrarily.

Diarrhea, elevation of liver enzyme levels (ALT, AST), hair loss, rash, hypersensitivity reactions, myasthenia, flu syndrome, upper respiratory tract infection, injury, pain, abdominal pain, low back pain, hypertension, chest pain, loss of appetite, dyspepsia, gastritis, abnormal liver enzyme levels, nausea, gastrointestinal pain, oral ulcers, vomiting, hypokalemia, weight loss, arthralgia, muscle cramps, joint disorders, synovitis, tendinitis, dizziness, headache, paresthesia, bronchitis, increased cough, respiratory infection, pharyngitis, pneumonia, rhinitis, sinusitis, hair loss, eczema, pruritus, dry skin, urinary tract infection, cholelithiasis, colitis, constipation, esophagitis, bloating, gastritis, gingivitis, bloody stools, oral candidiasis, salivary gland enlargement, stomatitis, dental diseases, oral mucosal abnormalities, increased liver parameters, dry mouth, hepatitis, jaundice, cholestasis, liver failure, acute liver necrosis, pancreatitis, elevated blood pressure, angina, migraine, palpitations, tachycardia, vasculitis, vasodilation, varicose veins, pulmonary hypertension, agranulocytosis, anemia, petechiae, leukopenia, thrombocytopenia, eosinophilia, pancytopenia, anxiety, depression, insomnia, neuralgia, neuritis, sleep disorders, sweating, drowsiness, taste disturbance, peripheral neuropathy, acne, contact dermatitis, fungal dermatitis, hair discoloration, hematoma, herpes simplex, shingles, nail disorders, skin nodules, subcutaneous nodules, papular rash, skin diseases, skin discoloration, skin ulcers, skin erythema lupus, pustular psoriasis, exacerbation of psoriasis, drug reaction DRESS, urticaria, anaphylaxis, Stevens-Johnson syndrome, epidermal necrolysis, necrotizing vasculitis, severe infections, sepsis, asthma, breathing difficulties, epistaxis, lung disease, interstitial lung disease, abscess, cyst, fever, hernia, malaise, soreness, neck pain, pelvic pain, increased creatine phosphokinase, peripheral edema, hyperglycemia, diabetes, proteinuria, cystitis, dysuria, hematuria, menstrual disorders, vaginal candidiasis, prostate disease, frequent urination, decreased semen concentration, total sperm count reduction, decreased sperm motility, osteoarthritis, bursitis, myalgia, bone necrosis, bone pain, tendon rupture, hypokalemia, hyperlipidemia, decreased uric acid, hyperthyroidism, blurred vision, cataract, conjunctivitis, eye diseases, myocardial infarction

This medication is sensitive to light, so it should be stored in a dark place and kept in a tightly sealed container to avoid contact with air. Additionally, it is important to maintain storage temperatures below 25 degrees Celsius.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle