Rhumakin Tablets 20 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 started with a loading dose to reach steady-state plasma concentrations more quickly. Administer 100mg 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 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. Monitor liver enzyme levels; dosage adjustment may be necessary. (See Warnings—Hepatotoxicity.) Because the half-life of the active metabolite of this drug is prolonged, it may take several weeks for the metabolite concentration to decrease. Therefore, monitor patients carefully after reducing the dose.

This medication has an active metabolite that remains in the body for a long time, so side effects may occur or persist even after discontinuation of the drug. If severe side effects occur, certain drugs may need to be administered to quickly eliminate this medication from the body, and repeated administrations may be necessary. Since it can affect liver function, patients with liver issues must undergo liver function tests before using this medication and should regularly check liver status during treatment. If liver enzyme levels rise significantly, it may be necessary to reduce or discontinue the dosage. Caution should be exercised when using this medication together with other drugs that affect the liver, as this may increase the risk of side effects. Patients with lung problems or a history of lung diseases should use this medication cautiously and consult a doctor immediately if symptoms such as difficulty breathing or coughing appear. It may suppress immune function, which can increase the risk of infections, so immediate treatment is required if infection symptoms occur, and the medication should be discontinued in cases of severe infections. Serious allergic reactions or ulcers may occur on the skin, so if skin abnormal symptoms appear, the use of this medication should be stopped, and consulting a doctor is necessary. This drug should not be administered to pregnant women or women who may become pregnant, as it may pose risks to the fetus, and consultation with a physician is required for those planning to become pregnant. Breastfeeding women are also advised not to take this medication, and it is not recommended for pediatric patients as safety and efficacy have not been established. Elderly patients do not require special dose adjustments, but caution may be needed depending on kidney or liver function status. Overdose may result in diarrhea, abdominal pain, blood abnormalities, liver function abnormalities, etc., and treatment for drug elimination may be necessary in such cases. Regular blood tests, liver function tests, and monitoring of lung health are crucial while taking this medication, and any unusual symptoms should be immediately reported to healthcare providers. Additionally, since there may be interactions with other medications, any other medications being taken must be reported to a doctor or pharmacist.

• Diarrhea
• elevated liver enzymes (ALT, AST)
• hair loss
• rash
• weakness
• flu-like syndrome
• upper respiratory infection
• injury
• pain
• abdominal pain

This medication is sensitive to light and should be stored away from direct sunlight. It should be kept in a sealed container to avoid contact with air, and it is important to maintain a storage temperature below 25 degrees Celsius.

Appearance

Yellow to light yellow triangular film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle