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 a disease-modifying antirheumatic drug (DMARD) presented as a tablet for oral use. It is indicated for the treatment of rheumatoid arthritis and psoriatic arthritis in adult patients, helping to reduce inflammation and slow joint damage.

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 that acts on autoimmune joint disease pathways.
  • Rheumatoid arthritis: reduces disease activity, pain, and structural joint damage.
  • Psoriatic arthritis: improves skin lesions and joint inflammation.
  • Moderate to severe rheumatoid arthritis in adults: provides disease control when conventional therapy is insufficient.

How It Works

  • Leflunomide inhibits the mitochondrial enzyme dihydroorotate dehydrogenase, which blocks de novo pyrimidine synthesis. This limits the proliferation of activated T and B lymphocytes, thereby reducing the autoimmune inflammatory response that drives joint damage in rheumatoid and psoriatic arthritis.

Side Effects

Leflunomide may cause a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects

  • Diarrhoea or nausea.
  • Elevated liver enzymes.
  • Hypertension.
  • Alopecia or mild rash.

Serious or Rare Side Effects

  • Severe liver injury or hepatitis.
  • Bone‑marrow suppression leading to neutropenia or anemia.
  • Pulmonary toxicity, including interstitial lung disease.
  • Stevens‑Johnson syndrome or toxic epidermal necrolysis.

Precautions & Warnings

  • When prescribing Leflunomide, several safety considerations should be observed.
  • Pregnancy: contraindicated; teratogenic risk requires effective contraception.
  • Liver function: monitor transaminases before and during therapy.
  • Hematology: regular complete blood counts to detect bone‑marrow suppression.
  • Infection: avoid initiating therapy in patients with active severe infections.
  • Store at ambient temperature below 25°C: keep in original packaging, protect from moisture and light.

Avoid Interactions

Leflunomide interacts with several medicines, requiring careful management.

Major Interactions (Avoid)

  • Warfarin: may increase anticoagulant effect and bleeding risk.
  • Methotrexate: combined use can heighten hepatotoxicity and bone‑marrow suppression.

Moderate Interactions (Monitor Closely)

  • Cholestyramine or activated charcoal: can reduce leflunomide plasma levels.
  • CYP1A2 inducers (e.g., rifampicin): may lower drug exposure.
  • Live vaccines: increased risk of infection; avoid during therapy.

Frequently Asked Questions

Leflunomide Sandoz is prescribed for adult patients with rheumatoid arthritis and psoriatic arthritis. In both conditions it helps to reduce inflammation, relieve pain, and slow the progression of joint damage by modulating the immune response.

Leflunomide blocks the enzyme dihydroorotate dehydrogenase, which is essential for pyrimidine synthesis. By limiting pyrimidine production, the drug suppresses the proliferation of activated T‑ and B‑lymphocytes, thereby dampening the autoimmune inflammation that drives rheumatoid and psoriatic arthritis.

The exact dose of Leflunomide Sandoz is set by the prescribing clinician based on the patient’s disease severity, prior treatment response, liver function, and overall health status. The prescriber follows approved labeling and clinical guidelines to select an appropriate regimen.

Leflunomide is classified as pregnancy category X because it is teratogenic. It should not be used by pregnant women, and effective contraception is required for women of child‑bearing potential. Breastfeeding is not recommended while taking leflunomide.

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.

Both leflunomide and methotrexate are conventional DMARDs, but they act on different pathways. Methotrexate inhibits folate metabolism, whereas leflunomide blocks pyrimidine synthesis. Clinical choice depends on patient tolerance, liver function, and prior response; some patients who do not respond adequately to methotrexate may benefit from leflunomide.

Leflunomide tablets should be stored at ambient temperature below 25 °C. Keep them in the original blister pack or container, protect from moisture and direct light, and store out of reach of children.

Leflunomide Sandoz is taken orally as a tablet with a glass of water. The tablet is usually swallowed whole; it should not be crushed or chewed. Patients should follow the dosing schedule prescribed by their healthcare professional.

The most serious risks include severe liver injury, bone‑marrow suppression (which can lead to neutropenia or anemia), pulmonary toxicity such as interstitial lung disease, and teratogenic effects that can cause birth defects. Prompt reporting of symptoms like jaundice, persistent fever, or unexplained bruising is essential.

Leflunomide should not be used by pregnant women, individuals with severe liver disease, patients with active serious infections, or those with known hypersensitivity to leflunomide or its excipients. Caution is also advised for patients with significant renal impairment or a history of bone‑marrow disorders.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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