Rhumakin Tablet 10 mg (Leflunomide)

Adult dose

1. Loading dose Considering that this medicine has a long half-life and the recommended dosing interval is 24 hours, treatment is generally initiated with a loading dose to reach steady-state blood concentrations more quickly. Administer 100 mg 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 For patients with rheumatoid arthritis, administer 20 mg once daily as the maintenance dose. Some patients who received 25 mg daily experienced adverse reactions such as hair loss, weight loss, and increased liver enzyme levels. Therefore, the maintenance dose should not exceed 20 mg daily. If the patient's clinical tolerability is poor, the maintenance dose may be reduced to 10 mg daily. For patients with psoriatic arthritis, administer 20 mg daily as the maintenance dose. Monitor liver enzyme levels; dose adjustment may be necessary. (See Warnings - Hepatotoxicity.) Because the active metabolite of this medicine has a prolonged half-life, it may take several weeks for metabolite levels to decrease. Therefore, monitor the patient carefully after reducing the dose.

This medication can remain in the body for a long time, so side effects may continue even after stopping the medication. If severe side effects occur, specific medications may need to be administered to rapidly eliminate this drug from the body. Caution is needed for patients with impaired liver function as this drug may impose stress on the liver, and it should not be administered to those with a history of liver damage. Regular liver function tests should be conducted before and during the first 6 months of treatment, and dosage might need to be reduced or stopped if liver enzyme levels increase. Co-administration with other drugs may increase the risk of hepatotoxicity, so liver function tests are necessary. Patients with a history of lung disease or pneumonia symptoms must consult a doctor before taking this medication. It can suppress the immune system; thus, if a serious infection occurs, the medication should be stopped immediately and treated. Rarely, severe allergic reactions or ulcers may occur on the skin, so any skin abnormalities should be reported to a doctor immediately. Treatment may be temporarily halted based on the doctor’s judgment, as the drug can affect wound healing before and after surgery. There is a potential increase in the risk of malignant tumors during treatment, so regular check-ups are necessary. Women who are pregnant or may become pregnant should not take this medication, and if pregnancy occurs while taking it or a pregnancy is planned, consultation with a doctor is needed. This medication contains lactose, so patients with lactose intolerance should not take it. Safety in children has not been established, and it is advisable not to administer it, while elderly patients may not need dose adjustments. In case of overdose, symptoms such as diarrhea, abdominal pain, and blood abnormalities may appear, and drug removal treatment may be necessary. This medication's side effect risk may increase when used in conjunction with other hepatotoxic drugs or immunosuppressants, so caution is advised. Regular blood pressure monitoring is recommended during use, and any abnormal symptoms such as signs of infection, shortness of breath, or rashes should be reported to healthcare providers immediately. Live vaccinations are not recommended during treatment, and caution is still necessary for a period after discontinuation. Taking the medication with food does not affect absorption. This medication can interact with several other drugs, so if other medications are being taken, it is essential to inform the doctor or pharmacist. It is safer for breastfeeding women not to take this medication.

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

This medication is sensitive to light, so it should be stored in a light-protective container. It should also be stored in a sealed container to avoid contact with air, and the suitable storage temperature is at a cool place below 25 degrees.

Appearance

White to nearly white round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle