Arava Tablet 20 mg (Leflunomide (Unmodified))

Adult dose

1. Loading dose Given the long half-life of this medicine and the recommended 24-hour dosing interval, treatment is generally initiated with a loading dose to reach steady-state plasma concentrations more rapidly. The loading dose is 100 mg once daily for 3 days. 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. When 25 mg once daily was administered, some patients experienced adverse reactions such as alopecia, weight loss, and elevated liver enzyme levels. Therefore, the maintenance dose should not exceed 20 mg once daily. If a patient has poor clinical tolerability, the maintenance dose may be reduced to 10 mg once daily. The maintenance dose for patients with psoriatic arthritis is 20 mg once daily. Monitor liver enzyme levels; dose adjustment may be required. (See Warnings - Hepatotoxicity.) Because the half-life of the active metabolite of this medicine is prolonged, it may take several weeks for metabolite levels to decrease. Therefore, monitor the patient carefully after reducing the dose.

This medication contains an active metabolite that persists in the body for a long time, and side effects may continue even after stopping the medication. In cases of severe side effects, specific medications may be needed to rapidly remove this medication from the body. This medication is mainly metabolized in the liver, so caution is required for patients with impaired liver function, and it should not be used in cases of severe liver damage. Liver function tests should be frequently conducted before and during the first 6 months of treatment, and if liver enzyme levels rise, dose adjustment or discontinuation may be necessary. This medication can suppress immune function, so it is not recommended for patients with severe infections or immunodeficiency. Patients with lung diseases or those who have had lung-related issues in the past should check their lung condition before use and administer it cautiously. Serious allergic skin reactions or ulcers may occur; if these symptoms appear, the medication should be stopped immediately. Women who are pregnant or may become pregnant should not take this medication, and if pregnancy is confirmed during use, consultation with a doctor should be sought immediately. This medication contains lactose, so patients with lactose intolerance should not take it. Its safety and efficacy have not been established in children, so it is advisable not to administer it to them. There is no need for special dose adjustments in the elderly. This medication may interact with other drugs, so if other medications are being taken, the patient should consult a doctor or pharmacist. In cases of overdose, treatment to remove this medication from the body may be necessary, and side effects such as diarrhea or abdominal pain may occur.

• Diarrhea
• elevation of liver enzymes (ALT, AST)
• hair loss
• rash
• hypersensitivity reactions
• weakness
• flu-like syndrome
• upper respiratory infection
• injury
• pain

This medication is sensitive to light, so it should be kept in a dark place and stored in a tightly sealed container to prevent air exposure. Additionally, it is recommended to store it in a cool place below 25 degrees Celsius.

Appearance

This medication is a yellow to yellowish-brown triangular-shaped film-coated tablet.

Package unit

30 tablets/bottle