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 (DMARD) presented as a 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 B.V.

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Indications & Clinical Uses

Leflunomide is a disease‑modifying antirheumatic drug (DMARD) used in inflammatory arthritis.

  • Rheumatoid arthritis: reduces joint inflammation and slows structural damage.
  • Psoriatic arthritis: improves skin lesions and joint symptoms.

How It Works

  • Leflunomide is converted to its active metabolite teriflunomide, which inhibits dihydroorotate dehydrogenase. This blocks de novo pyrimidine synthesis, limiting proliferation of activated lymphocytes and thereby reducing the autoimmune inflammatory response in the joints.

Side Effects

Leflunomide may cause a range of adverse reactions.

Common Side Effects

  • Diarrhoea: mild to moderate gastrointestinal upset.
  • Nausea: occasional feeling of queasiness.
  • Alopecia: reversible hair thinning.
  • Elevated liver enzymes: mild transaminase rise.

Serious or Rare Side Effects

  • Severe liver injury: hepatitis or hepatic failure.
  • Stevens‑Johnson syndrome or toxic epidermal necrolysis.
  • Bone marrow suppression: neutropenia or anemia.
  • Interstitial lung disease: respiratory symptoms and imaging changes.
  • Teratogenicity: fetal malformations when exposure occurs in pregnancy.
  • Severe infections: opportunistic infections due to immunosuppression.

Precautions & Warnings

Before initiating therapy, several safety considerations are required.

  • Pregnancy: contraindicated (Category X); avoid in women of child‑bearing potential.
  • Liver function: obtain baseline tests and monitor periodically.
  • Blood pressure: monitor for hypertension, especially in patients with pre‑existing disease.
  • Infections: screen for latent tuberculosis and active infections.
  • Hematology: perform regular complete blood counts.
  • Store at below 25°C: keep in the original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Leflunomide can interact with several medicines, requiring careful management.

Major Interactions (Avoid)

  • Teriflunomide (active metabolite) co‑administration: risk of additive toxicity.
  • Strong CYP1A2 inhibitors (e.g., fluvoxamine): increase leflunomide plasma levels.
  • Warfarin: enhanced anticoagulant effect, leading to elevated INR.

Moderate Interactions (Monitor Closely)

  • Statins (e.g., simvastatin): possible increased risk of myopathy.
  • Oral contraceptives: reduced hormonal efficacy, increasing pregnancy risk.
  • NSAIDs: potential additive liver toxicity.

Frequently Asked Questions

Leflunomide Sandoz is a disease‑modifying antirheumatic drug indicated for the treatment of rheumatoid arthritis and psoriatic arthritis in adult patients. It helps reduce joint inflammation, pain, and structural damage associated with these chronic autoimmune conditions.

Leflunomide is metabolised to teriflunomide, which blocks the enzyme dihydroorotate dehydrogenase. By inhibiting de novo pyrimidine synthesis, the drug limits the proliferation of activated lymphocytes, thereby dampening the autoimmune response that drives joint inflammation.

The dosing regimen for Leflunomide Sandoz is determined by the prescribing clinician based on the individual’s disease severity, renal and hepatic function, and other clinical factors. Patients should follow the prescriber’s instructions and not adjust the dose on their own.

Leflunomide Sandoz is classified as Pregnancy Category X, meaning it is contraindicated in pregnancy due to a high risk of fetal malformations. It is also not recommended for breastfeeding mothers because it can be excreted in breast milk and may harm the infant.

To place an order, 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.

The most common alternative to leflunomide is methotrexate, another DMARD. While both reduce disease activity, leflunomide is taken orally once daily and has a different safety profile, notably a higher risk of liver enzyme elevation and teratogenicity, whereas methotrexate carries risks of mucosal ulceration and pulmonary toxicity.

Leflunomide Sandoz tablets should be stored at temperatures below 25 °C, in their original blister pack or bottle, protected from moisture and direct sunlight. Do not store in bathrooms or near heat sources, and keep out of reach of children.

The medication is supplied as oral tablets that are swallowed whole with water. It can be taken with or without food, but patients should follow any specific instructions from their healthcare provider regarding timing relative to meals.

Serious risks include severe liver injury, life‑threatening skin reactions such as Stevens‑Johnson syndrome, bone‑marrow suppression leading to low blood counts, interstitial lung disease, and teratogenic effects if exposure occurs during pregnancy. Prompt medical attention is required if any of these occur.

Leflunomide Sandoz is contraindicated in pregnant women, women of child‑bearing potential not using effective contraception, patients with severe hepatic impairment, uncontrolled infections, and those with known hypersensitivity to leflunomide or its metabolites.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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