Product image of Leflunomid (Leflunomide) supplied by GNH India

Leflunomid

Active Ingredient:
Leflunomide
Origin:
EU

Leflunomid (Leflunomide)

Leflunomide, the active ingredient in Leflunomid, is an immunomodulatory agent presented as an oral formulation for oral use. It is used to manage inflammatory joint diseases such as rheumatoid arthritis and psoriatic arthritis in adult patients.
GNH India supplies Leflunomid as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Pharmathen S.A.

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Indications & Clinical Uses

Leflunomid is a disease‑modifying antirheumatic drug that targets immune‑mediated joint inflammation.

  • Rheumatoid arthritis: reduces joint swelling, pain and structural damage.
  • Psoriatic arthritis: improves skin lesions and joint symptoms.

How It Works

  • Leflunomide inhibits the mitochondrial enzyme dihydroorotate dehydrogenase, which blocks de novo pyrimidine synthesis. This limits the proliferation of activated lymphocytes, thereby reducing the immune response that drives chronic inflammation in rheumatic diseases.

Side Effects

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

Common Side Effects

  • Diarrhoea: loose stools occurring during early treatment.
  • Nausea: feeling of sickness or upset stomach.
  • Elevated liver enzymes: mild increases in ALT/AST levels.
  • Hypertension: rise in blood pressure requiring monitoring.

Serious or Rare Side Effects

  • Severe liver injury: jaundice, abdominal pain, or marked enzyme elevation.
  • Bone marrow suppression: low blood counts leading to infection or anemia.
  • Pulmonary toxicity: cough, shortness of breath, or interstitial lung disease.

Precautions & Warnings

Leflunomid requires careful monitoring and specific safety measures.

  • Pregnancy: contraindicated; teratogenic risk mandates effective contraception.
  • Liver function: baseline and periodic testing recommended to detect hepatotoxicity.
  • Hematology: regular blood counts to identify bone‑marrow suppression.
  • Live vaccines: avoid during therapy due to impaired immune response.
  • Renal impairment: use with caution in severe renal dysfunction.
  • Store at below 25°C: keep in the original pack, protect from moisture.

Avoid Interactions

Leflunomid can alter the activity of several co‑administered medicines.

Major Interactions (Avoid)

  • Warfarin: increased anticoagulant effect, risk of bleeding.
  • Cholesterol‑binding resins (e.g., cholestyramine): markedly reduce leflunomide exposure.
  • Strong CYP1A2 inhibitors (e.g., fluvoxamine): raise leflunomide plasma levels.

Moderate Interactions (Monitor Closely)

  • Methotrexate: additive hepatotoxicity, monitor liver enzymes.
  • TNF‑α inhibitors: heightened infection risk, observe clinical signs.
  • Statins: possible increase in muscle toxicity, check CK levels.

Frequently Asked Questions

Leflunomid, containing leflunomide, is prescribed for adult patients with rheumatoid arthritis and psoriatic arthritis. In both conditions it helps reduce joint inflammation, pain, and long‑term structural damage by modulating the immune response.

Leflunomide blocks the enzyme dihydroorotate dehydrogenase, which is essential for de novo pyrimidine synthesis. By limiting pyrimidine production, the drug suppresses the proliferation of activated T‑lymphocytes, thereby decreasing the inflammatory activity that drives rheumatic disease.

The dosage of Leflunomid is individualized by the prescribing clinician based on the patient’s clinical status, laboratory results, and tolerance. Physicians determine the appropriate loading and maintenance doses according to current treatment guidelines.

Leflunomid is classified as pregnancy category X because it is teratogenic. It should not be used by pregnant women or women who may become pregnant. Breastfeeding is also contraindicated, as the drug can be excreted in milk and affect the infant.

To request Leflunomid, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Compared with conventional DMARDs such as methotrexate, leflunomide offers a once‑daily oral regimen and a distinct mechanism targeting pyrimidine synthesis. It may be used as monotherapy or in combination, but clinicians consider liver safety, blood‑count effects and patient comorbidities when selecting therapy.

Leflunomid should be stored at temperatures below 25 °C, in its original packaging, and protected from moisture and direct sunlight. Maintaining these conditions helps preserve the drug’s stability and potency throughout its shelf life.

Leflunomid is taken orally, usually as a tablet, with or without food. The exact timing and any required loading dose are determined by the prescribing physician, who will also advise on any necessary laboratory monitoring.

The most serious risks include severe liver injury, bone‑marrow suppression leading to low blood counts, and teratogenic effects that can cause fetal malformations. Patients should be monitored regularly for liver enzymes, complete blood counts, and must use effective contraception.

Leflunomid is contraindicated in pregnant women, women of child‑bearing potential not using reliable contraception, patients with severe liver disease, and those with known hypersensitivity to leflunomide or its excipients. Caution is also advised for individuals with significant renal impairment.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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