Arei Tablet 10 mg (Leflunomide)

Adult dose

1. Loading dose Given the long half-life of this drug and the recommended dosing interval of 24 hours, treatment is generally initiated with a loading dose to reach steady-state plasma concentrations more rapidly. Administer 100mg per dose 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 Administer 20mg once daily as the maintenance dose in patients with rheumatoid arthritis. When administered at 25mg once daily, 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 has poor clinical tolerability, the maintenance dose may be reduced to 10mg once daily. Administer 20mg once daily as the maintenance dose in patients with psoriatic arthritis. Monitor liver enzyme levels; dose adjustment may be necessary. (See Warnings - Hepatotoxicity.) Because the half-life of the active metabolite of this drug is prolonged, several weeks may be required for metabolite levels to decrease. Therefore, carefully monitor patients after reducing the dose.

This medication contains an active metabolite that may remain in the body for a long time, so adverse reactions may occur or persist even after discontinuation. If severe side effects occur or rapid elimination of this medication from the body is required, treatment may be needed to expel the medication using specific drugs. This medication is metabolized in the liver and may burden the liver, so patients with low liver function should be particularly cautious, and it is not administered to patients with a history of liver damage. Regular liver function tests should be conducted before and during treatment to closely monitor liver conditions, and if liver enzyme levels significantly increase, dosage adjustment or discontinuation may be necessary. Furthermore, caution is required when using this medication in conjunction with other immunosuppressants due to the increased risk of hepatotoxicity. Patients with lung problems or a history of lung disease are at risk of developing serious lung diseases such as pneumonia or interstitial pneumonia while taking this medication, and careful judgment and examination by a physician are necessary. This medication may suppress immune function and is not recommended for patients with severe infections or immune deficiencies; if infection symptoms appear, use should be discontinued immediately, and treatment should be sought. Serious allergic reactions or ulcers may occur on the skin, so consultation with a physician should be sought immediately if abnormal symptoms arise; care should also be taken as it may affect wound healing before and after surgery. The risk of malignant tumors cannot be completely ruled out during the use of this medication, so regular check-ups are necessary during long-term use. Women who are pregnant or may become pregnant should not take this medication, and if pregnancy is confirmed during use, immediate consultation with a physician is required. Patients with certain genetic conditions such as lactose intolerance should not take this medication. Safety in pediatric patients has not been established, and it is not recommended for patients under 18 years of age. Elderly patients aged over 65 can take it without special dosage adjustments but should be observed carefully. In cases of overdose, symptoms such as diarrhea, abdominal pain, blood abnormalities, and liver function abnormalities may occur, and in such cases, treatment may be needed to quickly eliminate the medication from the body using specific drugs. During treatment, regular liver and blood tests should be conducted, and if symptoms of infection or respiratory symptoms appear, immediate consultation with a healthcare professional is required. Furthermore, there may be interactions with other medications, so it is essential to inform the physician or pharmacist of any medications being taken.

• Diarrhea
• increased liver enzyme levels (ALT, AST)
• hair loss
• rash
• weakness
• flu-like syndrome
• upper respiratory tract infection
• injury accidents
• pain
• abdominal pain

This medication should be stored in a container that blocks light, and it is important to keep it in a tightly closed container that allows for proper air circulation. In addition, the medicine should be stored at a cool temperature below 25 degrees Celsius to maintain its effectiveness.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle