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

Leflunomide Sandoz

Active Ingredient:
Leflunomide
Origin:
EU

Leflunomide Sandoz (Leflunomide)

Leflunomide, the active ingredient in Leflunomide Sandoz, is an immunomodulatory agent presented as an oral tablet for oral use. It treats rheumatoid arthritis and psoriatic arthritis in adult patients.
GNH India supplies Leflunomide Sandoz as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Sandoz Pharmaceuticals D.D.

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Indications & Clinical Uses

  • Leflunomide is a disease-modifying antirheumatic drug (DMARD) that targets inflammatory pathways in autoimmune arthritis.
  • Rheumatoid arthritis: reduces disease activity, slows joint damage, and improves functional ability.
  • Psoriatic arthritis: alleviates joint inflammation, skin lesions, and prevents structural progression.

How It Works

  • Leflunomide inhibits the mitochondrial enzyme dihydroorotate dehydrogenase, which is essential for de novo pyrimidine synthesis. This blockade limits the proliferation of activated lymphocytes, particularly T cells, thereby dampening the immune response that drives chronic joint inflammation in rheumatoid and psoriatic arthritis.

Side Effects

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

Common Side Effects

  • Diarrhea or abdominal discomfort
  • Nausea and loss of appetite
  • Elevated liver enzymes
  • Hypertension
  • Alopecia or thinning hair
  • Rash or mild skin irritation

Serious or Rare Side Effects

  • Severe liver injury or hepatitis
  • Stevens‑Johnson syndrome or toxic epidermal necrolysis
  • Bone marrow suppression leading to anemia or leukopenia
  • Interstitial lung disease or pulmonary fibrosis

Precautions & Warnings

  • Before initiating therapy, clinicians should assess baseline organ function and counsel patients on risk mitigation.
  • Monitor liver function: obtain baseline and periodic liver enzyme tests.
  • Monitor blood pressure: watch for hypertension and treat as needed.
  • Avoid in pregnancy: teratogenic risk requires effective contraception for women of child‑bearing potential.
  • Assess infection risk: screen for active infections and avoid use in severe infections.
  • Store at below 25°C: keep in the original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Leflunomide can alter the pharmacokinetics or pharmacodynamics of several co‑administered medicines.

Major Interactions (Avoid)

  • Methotrexate: increased toxicity, especially hepatic and hematologic.
  • Warfarin: enhanced anticoagulant effect, risk of bleeding.
  • Cholesterol‑binding resins (e.g., cholestyramine): reduced leflunomide absorption.

Moderate Interactions (Monitor Closely)

  • Statins: heightened risk of myopathy or rhabdomyolysis.
  • Antihypertensives: additive blood‑pressure lowering effect.
  • Live vaccines: diminished immunogenic response, consider postponement.

Frequently Asked Questions

Leflunomide Sandoz is prescribed for adults with rheumatoid arthritis and psoriatic arthritis. In both conditions it helps reduce joint inflammation, slows structural damage, and improves overall functional capacity.

The drug blocks the enzyme dihydroorotate dehydrogenase, which is needed for pyrimidine synthesis. This limits the proliferation of activated lymphocytes, especially T cells, thereby decreasing the autoimmune response that drives arthritis.

The exact dosage regimen is determined by the prescribing clinician based on the patient’s medical condition, renal and hepatic function, and response to therapy. Patients should follow the prescriber’s instructions and not adjust the dose on their own.

Leflunomide is classified as pregnancy category X because it can cause fetal malformations. It is contraindicated in pregnancy, and women of child‑bearing potential must use reliable contraception. Breastfeeding is not recommended while taking the drug.

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.

Leflunomide offers oral administration and a distinct mechanism—pyrimidine synthesis inhibition—compared with biologic DMARDs that target cytokines. It is often used when patients prefer an oral option or when biologics are contraindicated, but safety monitoring differs.

Store the tablets at temperatures below 25 °C in their original container, protected from moisture and direct sunlight. Do not refrigerate or freeze the product.

Leflunomide Sandoz is taken orally, usually once daily, with or without food, as directed by the prescriber. Swallow the tablet whole with a glass of water; do not crush or chew.

The most serious risks include severe liver injury, life‑threatening skin reactions such as Stevens‑Johnson syndrome, bone‑marrow suppression, and interstitial lung disease. Prompt medical attention is required if any signs of these conditions appear.

Patients with active liver disease, severe renal impairment, uncontrolled hypertension, known hypersensitivity to leflunomide, or who are pregnant or planning pregnancy should not use the medication. It is also contraindicated in individuals with certain infections.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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