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

Leflunomid Sandoz

Active Ingredient:
Leflunomide
Origin:
EU

Leflunomid Sandoz (Leflunomide)

Leflunomide, the active ingredient in Leflunomid Sandoz, is an immunomodulatory disease-modifying antirheumatic drug (DMARD) presented as an oral tablet for systemic use. It is indicated for the treatment of rheumatoid arthritis, psoriatic arthritis and juvenile idiopathic arthritis, helping to reduce joint inflammation and slow disease progression in adult and pediatric patients.

GNH India supplies Leflunomid Sandoz as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies, clinics and procurement teams, ensuring regulatory compliance and reliable delivery worldwide through a robust quality management system.

Manufacturer / TM Owner

Sandoz N.V.

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Indications & Clinical Uses

Leflunomide is used to modify immune activity in inflammatory arthritis conditions.

  • Rheumatoid arthritis: reduces joint inflammation and slows structural damage.
  • Psoriatic arthritis: alleviates skin and joint symptoms while limiting disease progression.
  • Juvenile idiopathic arthritis: helps control disease activity and improve functional outcomes in children.

How It Works

  • Leflunomide inhibits the mitochondrial enzyme dihydroorotate dehydrogenase, which is essential for de novo pyrimidine synthesis. By limiting pyrimidine availability, the drug suppresses proliferation of activated lymphocytes, thereby reducing autoimmune inflammation and the pathological processes underlying rheumatoid, psoriatic, and juvenile idiopathic arthritis.

Side Effects

Adverse reactions may occur with leflunomide therapy.

Common Side Effects

  • Diarrhea: mild to moderate gastrointestinal upset.
  • Nausea: occasional feeling of queasiness.
  • Headache: transient cranial discomfort.
  • Hypertension: elevated blood pressure readings.
  • Alopecia: thinning or loss of scalp hair.
  • Rash: mild skin erythema or itching.

Serious or Rare Side Effects

  • Hepatotoxicity: significant elevation of liver enzymes or liver injury.
  • Severe infections: opportunistic or bacterial infections requiring medical attention.
  • Pulmonary toxicity: interstitial lung disease or pneumonitis.
  • Bone marrow suppression: neutropenia, anemia, or thrombocytopenia.
  • Stevens‑Johnson syndrome: severe mucocutaneous reactions.
  • Teratogenicity: fetal malformations when exposure occurs during pregnancy.

Precautions & Warnings

Before initiating leflunomide, several safety considerations are recommended.

  • Pregnancy: contraindicated (Category X) due to high teratogenic risk.
  • Liver function: obtain baseline tests and monitor periodically for hepatotoxicity.
  • Hematology: perform regular complete blood counts to detect cytopenias.
  • Infection risk: assess for active infections and avoid initiating therapy during uncontrolled infection.
  • Vaccination: avoid live vaccines while on treatment.
  • Store at ambient temperature: keep tablets in the original container, protect from moisture and heat.

Avoid Interactions

Leflunomide may interact with several medicines, requiring careful management.

Major Interactions (Avoid)

  • Warfarin: increased anticoagulant effect, leading to higher INR.
  • Methotrexate: additive hepatotoxicity risk.
  • CYP1A2 inhibitors (e.g., fluoroquinolones, ciprofloxacin): elevated leflunomide plasma levels.

Moderate Interactions (Monitor Closely)

  • Live vaccines: reduced efficacy and potential safety concerns.
  • TNF‑α inhibitors: heightened infection susceptibility.
  • Statins: possible increased risk of myopathy.
  • Oral contraceptives: reduced effectiveness, consider alternative contraception.

Frequently Asked Questions

Leflunomid Sandoz, containing leflunomide, is prescribed for rheumatoid arthritis, psoriatic arthritis, and juvenile idiopathic arthritis. In these inflammatory joint diseases, it helps reduce pain, swelling, and structural damage by modulating the immune response.

Leflunomide blocks dihydroorotate dehydrogenase, an enzyme needed for making pyrimidine nucleotides. This limits the proliferation of activated lymphocytes, decreasing the autoimmune activity that drives inflammation in arthritis.

The exact dosage of Leflunomid Sandoz is determined by the prescribing physician based on the patient’s condition, disease severity, and response to therapy. Dosage adjustments may be made after monitoring clinical outcomes and laboratory parameters.

Leflunomid 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 while breastfeeding because it can be excreted in milk and affect 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.

Leflunomide is an oral synthetic DMARD that differs from biologic agents such as TNF inhibitors, which are administered by injection or infusion. Compared with methotrexate, another oral DMARD, leflunomide has a distinct safety profile, especially regarding liver monitoring and teratogenic risk.

Leflunomid Sandoz tablets should be stored at ambient temperature, below 25 °C, in the original packaging. Keep them away from moisture, direct sunlight, and excessive heat to maintain product stability.

The medication is taken orally, usually as a tablet swallowed with water. Patients should follow the prescriber’s instructions regarding timing (e.g., with or without food) and any required loading or maintenance phases.

Serious risks include liver toxicity, severe infections, pulmonary complications, bone‑marrow suppression, and teratogenic effects. Regular monitoring of liver enzymes, blood counts, and pulmonary function is essential to detect these adverse events early.

Leflunomid Sandoz is contraindicated in pregnant women, patients with severe liver impairment, active serious infections, and those with known hypersensitivity to leflunomide or any of its excipients. Caution is also advised for patients with renal dysfunction or uncontrolled hypertension.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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