Arava 10mg Tablet (Leflunomide (Micronized))

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 remains in the body for a long time, which may cause side effects even after stopping the medication. If serious side effects occur or rapid elimination of the drug is needed, specific antidotes should be used to quickly eliminate the drug. Caution is needed for patients with liver disease or impaired liver function, as it may affect liver function; regular liver function tests are required. The risk of liver toxicity may increase when taken with other medications, especially when combined with methotrexate, hence frequent monitoring of liver function should be done. Patients with lung-related diseases or a history of pneumonia should consult a physician thoroughly before taking this medication and receive lung function tests. It may suppress immune function, so patients with serious infections or immunodeficiency should avoid or use this medication with caution. Severe allergic reactions or ulcers may occur on the skin; therefore, if any skin abnormalities appear, immediate discontinuation of the medication and consultation with a physician is necessary. This medication should not be taken by women who are pregnant or may become pregnant as it can pose serious risks to the fetus. If pregnancy is confirmed during use, consult a physician immediately. Additionally, patients with genetic lactose intolerance should not take this medication. There is no need for special dosage adjustment for elderly patients, but safety has not been confirmed for pediatric patients, so it is not recommended for those under 18 years old. In case of overdose, side effects such as diarrhea, abdominal pain, and blood anomalies may occur, in which case the use of specific antidotes for drug elimination is necessary. While taking this medication, regular blood tests and liver function tests should be conducted, and if any abnormal symptoms such as signs of infection, skin rashes, or difficulty breathing occur, immediate consultation with a medical professional is required. This medication may interact with other drugs, so it is essential to inform your physician or pharmacist about any other medications being taken.

• Diarrhea
• elevated liver enzyme levels (ALT, AST)
• hair loss
• rash
• hypersensitivity reactions
• weakness
• flu-like syndrome
• upper respiratory tract infection
• injury accident
• pain

This medication should be stored in a container that blocks light and kept in a tightly sealed container with limited air exposure. It should also be stored at a cool temperature below 25 degrees Celsius.

Appearance

This medication is a round, film-coated tablet that is white to nearly white in color.

Package unit

30 tablets/bottle