Product image of Leflunomide Zentiva (Leflunomide) supplied by GNH India

Leflunomide Zentiva

Active Ingredient:
Leflunomide
Origin:
EU

Leflunomide Zentiva (Leflunomide)

Leflunomide, the active ingredient in Leflunomide Zentiva, is a disease-modifying antirheumatic drug (DMARD) presented as a tablet for oral use. It is used to treat rheumatoid arthritis and psoriatic arthritis in adult patients, helping to reduce inflammation and slow disease progression.

GNH India supplies Leflunomide Zentiva as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, adhering to stringent quality standards and providing reliable sourcing for therapeutic needs across multiple continents and regulatory jurisdictions, with dedicated customer support.

Manufacturer / TM Owner

Zentiva, K.S.

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Indications & Clinical Uses

  • Leflunomide is a disease-modifying antirheumatic drug that targets immune‑mediated joint inflammation.
  • Rheumatoid arthritis: reduces joint swelling, pain and slows radiographic progression.
  • Psoriatic arthritis: improves skin lesions and joint symptoms.
  • Moderate to severe rheumatoid arthritis refractory to methotrexate: provides clinical improvement when other DMARDs are insufficient.

How It Works

  • Leflunomide inhibits the mitochondrial enzyme dihydroorotate dehydrogenase, a key step in de novo pyrimidine synthesis. By blocking pyrimidine production, it limits proliferation of activated lymphocytes, particularly T‑cells, thereby reducing the autoimmune response that drives joint inflammation in rheumatoid and psoriatic arthritis. The drug’s active metabolite, teriflunomide, maintains this inhibition, leading to sustained immunomodulation without directly affecting cytokine release and contributes to decreased production of inflammatory mediators such as interleukin‑6 and tumor necrosis factor‑α.

Side Effects

Leflunomide may cause a range of adverse reactions, varying from mild to severe.

Common Side Effects

  • Diarrhea: loose stools often mild to moderate.
  • Nausea: feeling of sickness.
  • Elevated liver enzymes: mild increase in ALT/AST.
  • Hypertension: rise in blood pressure.

Serious or Rare Side Effects

  • Severe liver injury: hepatitis or hepatic failure.
  • Aplastic anemia: bone marrow suppression leading to low blood counts.
  • Stevens‑Johnson syndrome: severe skin reaction with blistering.

Precautions & Warnings

  • Before prescribing Leflunomide, clinicians should consider several safety factors.
  • Pregnancy: contraindicated (Category X) – avoid use in pregnant women.
  • Liver disease: contraindicated; assess liver function before initiation.
  • Renal impairment: use with caution; dose may need adjustment.
  • Infection risk: monitor for signs of infection; avoid in active infections.
  • Blood monitoring: perform regular CBC and liver tests during therapy.
  • Store at ambient temperature: keep below 25°C, protect from moisture and light.

Avoid Interactions

Leflunomide can interact with several medicines, requiring careful management.

Major Interactions (Avoid)

  • Warfarin: increased anticoagulant effect, may require dose adjustment.
  • Methotrexate: additive hepatotoxicity, monitor liver function closely.
  • Cholestyramine or activated charcoal: reduce leflunomide plasma levels, avoid co‑administration.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inducers (e.g., rifampin): decrease leflunomide exposure.
  • TNF‑α inhibitors: may reduce efficacy, monitor disease activity.
  • Azathioprine: increased risk of bone marrow suppression.

Frequently Asked Questions

Leflunomide Zentiva is indicated for the treatment of moderate to severe rheumatoid arthritis and psoriatic arthritis in adult patients. It helps to reduce joint inflammation, pain, and structural damage by modifying the underlying immune response that drives these chronic inflammatory conditions.

Leflunomide works by inhibiting dihydroorotate dehydrogenase, an enzyme essential for de novo pyrimidine synthesis. This blockade limits the proliferation of activated T‑lymphocytes, thereby dampening the autoimmune activity that contributes to joint inflammation and tissue damage in rheumatoid and psoriatic arthritis.

The appropriate dose of Leflunomide Zentiva is determined by the prescribing healthcare professional based on the individual’s disease severity, prior treatment response, liver function, and overall health status. Patients should follow the prescriber’s instructions and not adjust the dose without medical guidance.

Leflunomide is classified as pregnancy category X, meaning it is contraindicated during pregnancy because of a high risk of fetal harm. It is also not recommended for breastfeeding mothers, as the drug can be excreted in breast milk and may affect the infant.

To order Leflunomide Zentiva, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any required import documentation) and delivery timelines.

Compared with methotrexate, another first‑line DMARD, leflunomide offers a similar efficacy in controlling disease activity but has a different safety profile, with less hepatic toxicity but a higher risk of hypertension and rare severe skin reactions. Biologic agents provide greater potency for refractory disease but are administered by injection and are generally more costly.

Leflunomide Zentiva should be stored at ambient temperature, preferably below 25 °C. Keep the tablets in the original packaging, protect them from moisture and direct light, and store them out of reach of children to maintain product stability and potency.

Leflunomide Zentiva is taken orally, usually as a tablet swallowed whole with water. The exact dosing schedule, including any loading dose, is set by the prescriber based on the patient’s clinical condition and laboratory monitoring requirements.

The most serious risks include severe liver injury or hepatitis, aplastic anemia leading to low blood cell counts, and rare but life‑threatening skin reactions such as Stevens‑Johnson syndrome. Patients should be monitored regularly for liver function, complete blood counts, and any signs of severe skin or respiratory symptoms.

Leflunomide Zentiva should not be used by pregnant women, individuals with pre‑existing severe liver disease, patients with uncontrolled hypertension, or those with known hypersensitivity to leflunomide or its metabolites. Caution is also advised for patients with significant renal impairment or active infections.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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