Medication info

Lefbivio Tablet 20mg (Leflunomide)

Prescription medicationTablet
Ingredient · strength
Leflunomide›20mg / 1 tablet
Manufacturer / importer
Myungmoon Bio Co., Ltd.
Appearance
Yellow to tawny triangular-shaped film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202502497 · Approved 2025.09.19

Summary

Main use
Treatment of rheumatoid arthritis in adults; relief of symptoms of active psoriatic arthritis
Who uses it
Adults
Adult dosage
Administer a loading dose of 100 mg once daily for 3 days. For patients with rheumatoid arthritis, administer a maintenance dose of 20 mg once daily. When administered at 25 mg once daily, 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 the patient's clinical tolerability is poor, the maintenance dose may be reduced to 10 mg once daily. Administer a maintenance dose of 20 mg once daily to patients with psoriatic arthritis.

Ingredients

Manufacturer
Myungmoon Bio Co., Ltd.

Efficacy & effects

Treatment of rheumatoid arthritis in adults; relief of symptoms of active psoriatic arthritis

  • Signs of rheumatoid arthritis
  • symptoms of rheumatoid arthritis
  • decreased joint space
  • erosion
  • symptoms of active psoriatic arthritis
  • signs of active psoriatic arthritis
View approved original text

This medication is used for the treatment of rheumatoid arthritis in adults. It alleviates the signs and symptoms caused by rheumatoid arthritis and inhibits structural damage such as decreased joint space and erosion observed on X-rays. Additionally, it helps improve physical functions diminished due to rheumatoid arthritis. It is also used to relieve symptoms and signs of active psoriatic arthritis. This medication can be used in combination with aspirin, non-steroidal anti-inflammatory drugs, and low-dose corticosteroids; however, insufficient studies have been conducted regarding its combination with some immunosuppressants or gold preparations. Overall, it is an effective medication for improving symptoms of rheumatoid arthritis and active psoriatic arthritis.

Dosage and Administration

Adult dosage

Administer a loading dose of 100 mg once daily for 3 days. For patients with rheumatoid arthritis, administer a maintenance dose of 20 mg once daily. When administered at 25 mg once daily, 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 the patient's clinical tolerability is poor, the maintenance dose may be reduced to 10 mg once daily. Administer a maintenance dose of 20 mg once daily to patients with psoriatic arthritis.

Precautions

This medication contains active metabolites that can remain in the body for a long time, potentially causing side effects to appear or persist even after discontinuation. If serious side effects occur, or if rapid removal of the drug from the body is necessary, certain medications (cholestyramine or activated charcoal) should be used to expeditiously eliminate this medication. Since this drug is metabolized and excreted by the liver, patients with impaired liver function should use it cautiously, and it should not be administered to patients with a history of liver disease. Frequent liver function tests should be conducted before and during early use of this medication to check for liver damage, and if liver enzymes rise above a certain level, dosage adjustment or discontinuation may be necessary. This medication may suppress the immune system; thus, it is not recommended for patients with severe immune deficiency or infections, and if infection symptoms appear, immediate discontinuation should occur. Patients with lung inflammation or damage may experience serious respiratory side effects while taking this medication; therefore, the decision to administer should be carefully considered based on a physician's diagnosis and examination. Rarely, serious allergic reactions or ulcers may occur on the skin; if skin abnormalities present, medication should be immediately discontinued, and medical consultation should occur. 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 necessary. This medication contains lactose; thus, patients with certain genetic lactose metabolism disorders should avoid it. Safety in children has not been established, so it is recommended that children under 18 do not take it. Elderly patients do not require specific dosage adjustments, but use must be based on overall health condition. This medication may interact with other drugs, so if taking other medications, consultation with a physician or pharmacist is essential, particularly when combining it with hepatotoxic drugs or immunosuppressants. In cases of overdose, symptoms such as diarrhea, abdominal pain, and hematological abnormalities may appear, and treatment to remove the drug from the body may be necessary using cholestyramine or activated charcoal. Store this medication away from direct sunlight at temperatures below 25 degrees Celsius, and maintain transportation between 15 to 30 degrees Celsius.

Side effects

  • Diarrhea
  • elevated liver enzyme levels (ALT, AST)
  • hair loss
  • rash
  • weakness
  • flu-like syndrome
  • upper respiratory infection
  • injury accident
  • pain
  • abdominal pain
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  • low back pain
  • hypertension
  • chest pain
  • loss of appetite
  • indigestion
  • gastroenteritis
  • abnormal liver enzyme levels
  • nausea
  • gastrointestinal pain
  • oral ulcer
  • vomiting
  • hypokalemia
  • weight loss
  • joint pain
  • muscle cramps
  • joint disorders
  • synovitis
  • tendinitis
  • dizziness
  • headache
  • sensory disturbance
  • bronchitis
  • increased cough
  • respiratory infection
  • pharyngitis
  • pneumonia
  • rhinitis
  • sinusitis
  • hair loss
  • eczema
  • pruritus
  • dry skin
  • urinary tract infection
  • cholelithiasis
  • colitis
  • constipation
  • esophagitis
  • abdominal distension
  • gastritis
  • gingivitis
  • blood in stool
  • oral candidiasis
  • salivary gland enlargement
  • stomatitis
  • dental disease
  • oral mucosal abnormalities
  • elevated liver parameters
  • dry mouth
  • hepatitis
  • jaundice
  • cholestasis
  • liver failure
  • acute liver necrosis
  • pancreatitis
  • angina
  • migraine
  • palpitations
  • tachycardia
  • vasculitis
  • vasodilation
  • varicose veins
  • pulmonary hypertension
  • agranulocytosis
  • anemia
  • petechiae
  • leukopenia
  • thrombocytopenia
  • eosinophilia
  • pancytopenia
  • anxiety
  • depression
  • insomnia
  • neuralgia
  • neuritis
  • sleep disorders
  • sweating
  • drowsiness
  • taste disorder
  • peripheral neuropathy
  • acne
  • contact dermatitis
  • fungal dermatitis
  • hair discoloration
  • hematoma
  • herpes simplex
  • shingles
  • nail disorders
  • skin nodules
  • subcutaneous nodules
  • papular rash
  • skin diseases
  • skin discoloration
  • skin ulcers
  • skin erythema lupus
  • pustular psoriasis
  • worsening psoriasis
  • drug reaction DRESS
  • urticaria
  • anaphylactic reaction
  • Stevens-Johnson syndrome
  • epidermal necrolysis
  • necrotizing vasculitis
  • severe infection
  • sepsis
  • asthma
  • shortness of breath
  • nosebleed
  • lung disease
  • interstitial lung disease
  • abscess
  • cyst
  • fever
  • hernia
  • malaise
  • pain
  • neck pain
  • pelvic pain
  • elevated creatine phosphokinase
  • peripheral edema
  • hyperglycemia
  • diabetes
  • proteinuria
  • cystitis
  • dysuria
  • hematuria
  • menstrual disorders
  • vaginal candidiasis
  • prostate disease
  • frequent urination
  • decreased sperm concentration
  • total sperm count decrease
  • reduced sperm motility
  • arthritis
  • bursitis
  • myalgia
  • osteonecrosis
  • bone pain
  • tendon rupture
  • hypokalemia
  • hyperlipidemia
  • decreased uric acid
  • hyperthyroidism
  • blurred vision
  • cataract
  • conjunctivitis
  • eye disease
  • myocardial infarction

Not everyone experiences these, and they can vary from person to person.

Storage

This medication is sensitive to light and should be stored in a container that does not allow light exposure. Additionally, it is important to store it at a cool temperature below 25 degrees to maintain its efficacy.

Appearance and packaging

Appearance

Yellow to tawny triangular-shaped film-coated tablet

Package unit

30 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.