Iguratimod

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.

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.

• Hypersensitivity to Iguratimod or formulation components.
• Severe hepatic impairment.
• Pregnancy and breastfeeding (teratogenic risk and not enough safety data).

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.