Product image of Leflunomide Aspire Pharma (Leflunomide) supplied by GNH India

Leflunomide Aspire Pharma

Active Ingredient:
Leflunomide
Origin:
EU

Leflunomide Aspire Pharma (Leflunomide)

Leflunomide, the active ingredient in Leflunomide Aspire Pharma, is an immunomodulatory agent presented as a tablet for oral use. It is indicated for the treatment of rheumatoid arthritis and psoriatic arthritis in adult patients. The medication is formulated to provide consistent systemic exposure, supporting long‑term disease control.

GNH India supplies Leflunomide Aspire Pharma as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, with a focus on quality assurance, regulatory compliance and reliable logistics for global markets.

Manufacturer / TM Owner

Aspire Pharma Limited

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Indications & Clinical Uses

  • Leflunomide is a disease-modifying antirheumatic drug that modulates immune activity in inflammatory arthritis.
  • Rheumatoid arthritis: reduces joint inflammation, pain, and slows structural damage.
  • Psoriatic arthritis: improves skin lesions and joint symptoms, helping to control disease activity.

How It Works

  • Leflunomide inhibits the mitochondrial enzyme dihydroorotate dehydrogenase, a key step in de novo pyrimidine synthesis. By limiting pyrimidine availability, it suppresses proliferation of activated T‑lymphocytes and other immune cells, thereby reducing the autoimmune inflammatory response that drives joint damage in rheumatoid and psoriatic arthritis. The drug’s effect is selective for rapidly dividing cells, sparing resting lymphocytes, and it also exhibits modest inhibition of tyrosine kinases involved in cytokine signaling, contributing to its overall immunomodulatory profile.

Side Effects

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

Common Side Effects

  • Nausea: mild to moderate gastrointestinal upset.
  • Diarrhea: loose stools, often transient.
  • Headache: occasional tension‑type headaches.
  • Hypertension: elevation of blood pressure.

Serious or Rare Side Effects

  • Hepatotoxicity: significant increase in liver enzymes or liver injury.
  • Severe infection: increased susceptibility to bacterial, viral or fungal infections.
  • Aplastic anemia or pancytopenia: rare bone‑marrow suppression.

Precautions & Warnings

When prescribing Leflunomide, clinicians should observe several precautionary measures to minimize risk.

  • Pregnancy: contraindicated (Category X); avoid use in women of childbearing potential.
  • Liver function: obtain baseline tests and monitor periodically for hepatotoxicity.
  • Blood pressure: monitor regularly as hypertension may develop.
  • Infection risk: assess for active infections before initiating therapy.
  • Vaccination: avoid live vaccines during treatment.
  • Store at ambient temperature: keep in the original packaging, protect from moisture.

Avoid Interactions

Leflunomide can interact with other medicines, affecting its safety or efficacy.

Major Interactions (Avoid)

  • Teriflunomide: additive toxicity due to shared metabolic pathways.
  • Methotrexate: increased risk of hepatotoxicity and bone‑marrow suppression.
  • Strong CYP1A2 inhibitors (e.g., fluvoxamine): may raise Leflunomide plasma levels.

Moderate Interactions (Monitor Closely)

  • Warfarin: potential enhancement of anticoagulant effect, requiring INR monitoring.
  • Live vaccines: reduced effectiveness, consider timing of vaccination.
  • Statins: possible increased risk of myopathy, monitor muscle symptoms.

Frequently Asked Questions

Leflunomide Aspire Pharma is a prescription‑only disease‑modifying antirheumatic drug (DMARD) 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 works by inhibiting the mitochondrial enzyme dihydroorotate dehydrogenase, which is essential for de novo pyrimidine synthesis. This inhibition limits the availability of nucleotides required for the proliferation of activated T‑lymphocytes, thereby suppressing the autoimmune inflammatory response that drives joint damage.

The dosing regimen for Leflunomide Aspire Pharma is individualized and set by the prescribing healthcare professional based on the patient’s clinical condition, disease severity, and laboratory parameters. Physicians determine the appropriate starting dose and any subsequent adjustments during treatment.

Leflunomide is classified as pregnancy category X, meaning it is contraindicated in pregnancy because of a high risk of fetal harm. It should not be used by women who are pregnant, planning to become pregnant, or breastfeeding. Effective contraception is required for women of child‑bearing potential during treatment and for a defined period after discontinuation.

To place an order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity of Leflunomide Aspire Pharma. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any temperature‑controlled logistics) and the necessary import documentation.

The most common alternative DMARD for rheumatoid and psoriatic arthritis is methotrexate. While both agents suppress immune activity, methotrexate primarily inhibits dihydrofolate reductase, whereas Leflunomide blocks pyrimidine synthesis. Leflunomide may be preferred in patients who cannot tolerate methotrexate’s hepatic or gastrointestinal side effects, but it carries its own risks such as hepatotoxicity and hypertension.

Leflunomide Aspire Pharma tablets should be stored at ambient temperature, preferably below 25 °C. Keep the product in its original packaging, protect it from moisture and direct sunlight, and ensure the container is tightly closed to maintain stability throughout its shelf life.

The medication is supplied as oral tablets that are taken whole with a glass of water. Patients should follow the dosing schedule prescribed by their healthcare provider and should not crush, split, or chew the tablets unless specifically instructed to do so.

Serious adverse events include hepatotoxicity (significant liver enzyme elevations or liver injury), severe infections due to immunosuppression, and rare hematologic disorders such as aplastic anemia or pancytopenia. Regular monitoring of liver function tests, complete blood counts, and blood pressure is essential to detect these risks early.

Leflunomide is contraindicated in pregnant women, individuals with severe hepatic impairment, patients with uncontrolled hypertension, and those with known hypersensitivity to Leflunomide or any of its excipients. Caution is also advised for patients with active infections, immunodeficiency, or those receiving live vaccines.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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