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Beacon Pharmaceuticals PLC · Tablet
/ Piece
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Iguratimod tablet is indicated for the treatment of rheumatoid arthritis (RA), a common autoimmune disease. It is a synthetic disease-modifying antirheumatic drug (csDMARD) that has also shown promise in treating other rheumatic and autoimmune conditions, including Sjögren's syndrome, ankylosing spondylitis, and systemic lupus erythematosus (SLE).
Immunomodulatory Effects: Iguratimod works by acting on both T and B lymphocytes to suppress the immune response. Anti-inflammatory Action: It inhibits the production of pro-inflammatory cytokines, such as TNF-α, IL-1β, IL-6, and IL-17, which contribute to inflammation. Osteoprotective Activity: Iguratimod promotes bone formation while inhibiting the differentiation and activity of bone-resorbing osteoclasts.
Usual Adult Dose (Rheumatoid Arthritis):
25 mg orally twice daily (morning and evening) after meals.
In some cases, physicians may start with 25 mg once daily for 1-2 weeks to improve tolerance, then increase to 25 mg twice daily.
Notes:
Dose adjustments are usually not required in mild renal/hepatic impairment, but the drug should be used with caution.
It is not typically recommended for children (safety and efficacy not established).
Regular monitoring of liver function, renal function, and blood counts is required.
Often used alone or in combination with methotrexate or other DMARDs.
Common side effects
Gastrointestinal: nausea, stomach pain, diarrhea, indigestion
General: headache, dizziness, tiredness
Laboratory findings: mild increase in liver enzymes (ALT, AST), sometimes mild decrease in blood counts
Liver toxicity
May cause elevated liver enzymes (ALT, AST).
Requires regular liver function tests (LFTs) (baseline, then periodically).
Stop if significant hepatotoxicity occurs.
Bone marrow suppression
Can cause leukopenia, neutropenia, anemia, or thrombocytopenia.
Monitor CBC regularly.
Renal impairment
Use with caution; monitor renal function.
Infections
Being an immunomodulator, it can increase risk of infections (respiratory, urinary, etc.).
Avoid use in patients with active infections (e.g., TB, hepatitis).
Gastrointestinal effects
Nausea, dyspepsia, diarrhea may occur.
Take after meals to reduce GI upset.
Pregnancy & breastfeeding
Contraindicated; may cause fetal harm.
Effective contraception is required during treatment and for some time after discontinuation.
Drug interactions
Use caution with other immunosuppressants, DMARDs, hepatotoxic drugs, or anticoagulants.
Combination with methotrexate is common but needs close monitoring.
Disease-modifying antirheumatic drugs (DMARDs)
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.