Medication info
Arelay Tablet 20 mg (Leflunomide)

Arelay Tablet 20 mg (Leflunomide)

Prescription medicationTabletOral
Ingredient · strength
Leflunomide›20mg / 1 tablet
Manufacturer / importer
Hanlim Pharmaceuticals Co., Ltd.
Appearance
Pale yellow triangular film-coated tablet
Packaging
[For domestic use] 30 tablets/bottle, 100 tablets/bottle [For export] 30 tablets/bottle, 30 tablets (15 tablets/Alu-Alu×2), 200,000 tablets (Drum/bulk)
Approval status
Active

MFDS item code 200711116 · Notified 2007.10.08 · Insurance code 645302320

Summary

Main use
Treatment of rheumatoid arthritis in adults; relief of symptoms of active psoriatic arthritis
Who takes it
Adults
Adult dose
Administer 100mg once daily for 3 days as the loading dose. Administer 20mg once daily as the maintenance dose for patients with rheumatoid arthritis. When 25mg once daily was administered, some patients experienced adverse reactions such as hair loss, weight loss, and elevated liver enzyme levels. Therefore, the maintenance dose should not exceed 20mg once daily. If the patient’s clinical tolerability is poor, the maintenance dose may be reduced to 10mg once daily. Administer 20mg once daily as the maintenance dose for patients with psoriatic arthritis.

Ingredients

Manufacturer
Hanlim Pharmaceuticals Co., Ltd.

Efficacy & effects

Treatment of rheumatoid arthritis in adults; relief of symptoms of active psoriatic arthritis

  • Signs of rheumatoid arthritis
  • symptoms of rheumatoid arthritis
  • reduction of joint space
  • erosion
  • structural damage
  • physical functional decline due to rheumatoid arthritis
  • signs and symptoms of active psoriatic arthritis.
View approved original text

This medication is used for the treatment of rheumatoid arthritis in adults, alleviating the signs and symptoms of arthritis and inhibiting structural damage to the joints, thereby improving physical function. It is also used to relieve the signs and symptoms of active psoriatic arthritis. It can be combined with aspirin, non-steroidal anti-inflammatory drugs, or low-dose corticosteroids during treatment; however, studies on the combination with other medications are still insufficient. Therefore, it is effectively used to improve symptoms of rheumatoid arthritis and psoriatic arthritis.

How to take

Adult dose

Administer 100mg once daily for 3 days as the loading dose. Administer 20mg once daily as the maintenance dose for patients with rheumatoid arthritis. When 25mg once daily was administered, some patients experienced adverse reactions such as hair loss, weight loss, and elevated liver enzyme levels. Therefore, the maintenance dose should not exceed 20mg once daily. If the patient’s clinical tolerability is poor, the maintenance dose may be reduced to 10mg once daily. Administer 20mg once daily as the maintenance dose for patients with psoriatic arthritis.

Precautions

This medication contains an active metabolite that remains in the body for a long time, which may cause side effects to continue even after stopping the medication. Therefore, if serious side effects occur or if rapid removal of the medication is required, specific antidotes should be administered to eliminate the medication from the body. It may affect liver function, so it should not be used, or used with extreme caution in patients with impaired liver function or a history of liver disease. Liver function tests should be performed frequently before and during the early stages of taking the medication, and if liver enzyme levels significantly increase, the dosage should be reduced or the medication should be discontinued. It may suppress immune function, so it is not recommended for patients with serious infections or immunodeficiency; immediate consultation with a doctor should occur if any symptoms of infection appear. Patients with a history of lung disease or lung-related symptoms should undergo chest examinations before administration and pay attention to respiratory symptoms during treatment. Serious allergic reactions on the skin, ulcers, or delayed wound healing may occur; if these symptoms appear, discontinue the medication and consult a doctor. Women who are pregnant or may become pregnant should not take this medication as it may harm the fetus, and immediate consultation with a doctor is necessary if pregnancy is confirmed during treatment. Patients with specific genetic issues, such as lactose intolerance, should not take this medication. The safety for children has not been confirmed, so it is not recommended for patients under 18 years of age. Elderly patients over 65 years can use it without special dosage adjustments, but their overall health status should be considered. The risk of side effects may increase when this medication is used with other hepatotoxic drugs or immunosuppressants, so follow a doctor's instructions during concomitant use. Regular blood tests and liver function tests should be conducted during medication administration, and if any abnormal symptoms occur, notify the medical staff immediately. While serious side effects are uncommon in overdose, symptoms such as diarrhea, abdominal pain, and blood anomalies may occur, and emergency treatment may be necessary. This medication should be stored away from direct sunlight in a cool place, and the dosage should not be arbitrarily stopped or changed.

Side effects

Diarrhea, elevation of liver enzyme levels (ALT, AST), hair loss, rash, weakness, influenza-like syndrome, upper respiratory infection, injury, pain, abdominal pain, low back pain, hypertension, chest pain, loss of appetite, dyspepsia, gastroenteritis, abnormal liver enzyme levels, nausea, gastric pain, oral ulcers, vomiting, hypokalemia, weight loss, joint pain, muscle cramps, joint disorders, synovitis, tendinitis, dizziness, headache, paresthesia, bronchitis, increased cough, respiratory infections, pharyngitis, pneumonia, rhinitis, sinusitis, hair loss, eczema, pruritus, dry skin, urinary tract infection, cholelithiasis, colitis, constipation, esophagitis, bloating, gastritis, gingivitis, blood in stool, oral candidiasis, salivary gland enlargement, stomatitis, dental diseases, oral mucosal abnormalities, hepatitis, jaundice, cholestasis, liver failure, acute liver necrosis, pancreatitis, elevated blood pressure, angina, migraine, palpitations, tachycardia, vasculitis, vasodilation, varicose veins, pulmonary hypertension, agranulocytosis, anemia, petechial hemorrhage, leukopenia, thrombocytopenia, eosinophilia, pancytopenia, anxiety, depression, insomnia, neuralgia, neuritis, sleep disturbances, sweating, drowsiness, taste disorder, peripheral neuropathy, acne, contact dermatitis, fungal dermatitis, hair discoloration, hematoma, herpes simplex, shingles, nail diseases, skin nodules, subcutaneous nodules, maculopapular rash, skin diseases, skin discoloration, skin ulcers, skin erythema lupus, pustular psoriasis, exacerbation of psoriasis, drug reaction DRESS, urticaria, anaphylaxis, Stevens-Johnson syndrome, exfoliative dermatitis, necrotizing vasculitis, severe infections, sepsis, asthma, dyspnea, epistaxis, pulmonary disease, interstitial lung disease, abscess, cyst, fever, hernia, lethargy, pain, neck pain, pelvic pain, elevation of creatine phosphokinase, peripheral edema, hyperglycemia, diabetes, proteinuria, cystitis, dysuria, hematuria, menstrual disorders, vaginal candidiasis, prostate diseases, frequent urination, reduced sperm concentration, reduced total sperm count, reduced sperm motility, arthrosis, bursitis, myalgia, bone necrosis, bone pain, tendon rupture, blurred vision, cataract, conjunctivitis, eye diseases

Not everyone experiences these, and they can vary from person to person.

Storage

This medication is sensitive to light; therefore, it should be stored in a dark place and kept in a tightly sealed container to avoid contact with air. Additionally, to maintain the effectiveness of the medication, it is recommended to store it at a cool temperature below 25 degrees Celsius.

Appearance and packaging

Appearance

Pale yellow triangular film-coated tablet

Package unit

[For domestic use] 30 tablets/bottle, 100 tablets/bottle [For export] 30 tablets/bottle, 30 tablets (15 tablets/Alu-Alu×2), 200,000 tablets (Drum/bulk)

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.