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

Leflunomid Stada

Active Ingredient:
Leflunomide
Origin:
EU

Leflunomid Stada (Leflunomide)

Leflunomide, the active ingredient in Leflunomid Stada, is an immunomodulatory agent presented as an oral formulation for oral administration. It modulates the immune response and is indicated for the treatment of rheumatoid arthritis and psoriatic arthritis in adult patients, helping to reduce inflammation and slow disease progression.

GNH India supplies Leflunomid Stada as a licensed, GDP‑compliant international pharmaceutical supplier, providing the product to hospitals, pharmacies and clinics across global markets while adhering to stringent quality and regulatory standards, and ensuring reliable delivery timelines.

Manufacturer / TM Owner

Stada Arzneimittel Gmbh

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Indications & Clinical Uses

Leflunomide is employed to manage autoimmune inflammatory disorders that affect the joints and skin.

  • Rheumatoid arthritis: reduces disease activity, slows joint damage, and improves functional ability.
  • Psoriatic arthritis: alleviates joint inflammation and skin lesions, enhancing overall disease control.
  • Active disease in adult patients: provides disease‑modifying benefits to control progression.

How It Works

  • Leflunomide is converted in vivo to its active metabolite teriflunomide, which selectively inhibits the mitochondrial enzyme dihydroorotate dehydrogenase. This blockade reduces de novo pyrimidine synthesis, limiting the proliferation of activated lymphocytes, particularly T‑cells, and thereby dampening the autoimmune inflammatory response that drives joint and skin pathology. The inhibition is reversible and leads to cell‑cycle arrest in the S phase, contributing to the immunomodulatory effect without broadly suppressing innate immunity.

Side Effects

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

Common Side Effects

  • Diarrhea: loose stools or increased frequency.
  • Nausea: feeling of sickness or urge to vomit.
  • Alopecia: thinning or loss of hair.
  • Elevated liver enzymes: increased ALT/AST levels.

Serious or Rare Side Effects

  • Severe liver injury: hepatitis or hepatic failure.
  • Bone marrow suppression: anemia, leukopenia, or thrombocytopenia.
  • Stevens‑Johnson syndrome: severe skin and mucosal reaction.
  • Teratogenic effects: fetal malformations if exposure occurs during pregnancy.

Precautions & Warnings

Before initiating therapy, several safety considerations should be observed.

  • Pregnancy contraindication: avoid use in pregnancy due to high teratogenic risk.
  • Liver monitoring: perform baseline and periodic liver function tests.
  • Infection risk: screen for active infections before initiating therapy.
  • Live vaccines: do not administer live vaccines during treatment.
  • Concomitant nephrotoxic drugs: use caution with agents that may impair renal function.
  • Store at ambient temperature: keep in original packaging, protect from moisture and heat.

Avoid Interactions

Leflunomide can interact with other medicines, requiring careful management.

Major Interactions (Avoid)

  • Warfarin: increased anticoagulant effect and bleeding risk.
  • Carbamazepine: induces metabolism, reducing leflunomide efficacy.
  • Live vaccines: heightened risk of infection.

Moderate Interactions (Monitor Closely)

  • Statins: increased risk of myopathy.
  • Methotrexate: combined hepatotoxic potential.
  • NSAIDs: additive gastrointestinal irritation.

Frequently Asked Questions

Leflunomid Stada contains leflunomide, which is prescribed for adult patients with rheumatoid arthritis and psoriatic arthritis. It helps to reduce joint inflammation, limit disease progression, and improve functional outcomes in these autoimmune conditions.

Leflunomide is metabolized to teriflunomide, an inhibitor of dihydroorotate dehydrogenase. By blocking this enzyme, the drug reduces pyrimidine synthesis, limiting the proliferation of activated T‑cells and other lymphocytes, thereby dampening the autoimmune response that drives joint and skin inflammation.

The dosing regimen for Leflunomid Stada is individualized by the prescribing clinician based on the patient’s disease severity, response, and laboratory monitoring. No fixed dose can be stated here; the prescriber sets the appropriate dose and titration schedule.

Leflunomid Stada is contraindicated in pregnancy (Category X) because of a high risk of fetal malformations. It is also not recommended for breastfeeding mothers, as the drug can be excreted in milk and may affect the infant.

To request Leflunomid Stada, 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 required import documentation.

The primary alternative to leflunomide is methotrexate, another disease‑modifying antirheumatic drug. 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 a risk of pulmonary toxicity and requires folic acid supplementation.

Leflunomid Stada should be stored at ambient temperature, preferably below 25 °C, in its original container to protect it from moisture and light. Keep the product out of reach of children and avoid exposing it to excessive heat or humidity.

Leflunomid Stada is administered orally, typically as a tablet taken with or without food. The exact dosing schedule is determined by the prescribing physician, and patients should follow the instructions on the prescription label.

Serious risks include severe liver injury, bone‑marrow suppression leading to anemia or low white‑cell counts, teratogenic effects if pregnancy occurs, and opportunistic infections. Patients should report signs of jaundice, unusual bruising, persistent fever, or any pregnancy‑related concerns to their healthcare provider promptly.

Leflunomid Stada should not be used by pregnant women, individuals with severe liver disease, those with active infections, or patients who are unable to use effective contraception. Caution is also advised for patients with significant renal impairment or a history of hypersensitivity to leflunomide.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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