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

Leflunomid Pharmathen

Active Ingredient:
Leflunomide
Origin:
EU

Leflunomid Pharmathen (Leflunomide)

Leflunomide, the active ingredient in Leflunomid Pharmathen, is an immunomodulatory agent presented as an oral tablet for oral use. It is employed to treat inflammatory joint diseases such as rheumatoid arthritis and psoriatic arthritis in adult patients. It is indicated for adult patients with moderate to severe disease activity.

GNH India supplies Leflunomid Pharmathen as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides reliable sourcing for regulated markets.

Manufacturer / TM Owner

Pharmathen S.A.

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Indications & Clinical Uses

Leflunomide, a disease-modifying antirheumatic drug (DMARD), modulates immune pathways involved in inflammatory arthritis.

  • Rheumatoid arthritis: reduces joint inflammation, pain, and slows radiographic progression.
  • Psoriatic arthritis: improves skin lesions and joint symptoms, decreasing disease activity.
  • Rheumatoid arthritis refractory to conventional DMARDs: provides an alternative therapeutic option when standard treatments fail.

How It Works

  • Leflunomide is metabolized to its active form, teriflunomide, which selectively inhibits the mitochondrial enzyme dihydroorotate dehydrogenase. This blockade reduces de novo pyrimidine synthesis, limiting proliferation of activated lymphocytes, particularly T‑cells. The resulting decrease in DNA synthesis dampens the immune response, thereby reducing inflammation and joint damage in autoimmune arthritis. By curbing the expansion of autoreactive cells, leflunomide also interferes with cytokine production and reduces B‑cell activity, contributing to its overall disease‑modifying effect.

Side Effects

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

Common Side Effects

  • Diarrhea
  • Nausea
  • Elevated liver enzymes

Serious or Rare Side Effects

  • Severe liver injury or hepatitis
  • Bone marrow suppression leading to anemia or leukopenia
  • Stevens‑Johnson syndrome or toxic epidermal necrolysis

Precautions & Warnings

Before initiating therapy, clinicians should evaluate patient-specific risk factors and monitor relevant parameters throughout treatment.

  • Pregnancy: contraindicated (Category X); avoid use in pregnant women.
  • Liver function: monitor transaminases before and during therapy.
  • Hematology: perform regular complete blood counts to detect cytopenias.
  • Infections: postpone initiation in patients with active serious infections.
  • Drug interactions: avoid concomitant use with teratogenic agents and live vaccines.
  • Store at ambient temperature: keep in original container, protect from moisture and light.

Avoid Interactions

Leflunomide can interact with several medicines, requiring careful assessment of concomitant use.

Major Interactions (Avoid)

  • Methotrexate: increased hepatotoxicity risk.
  • Warfarin: enhanced anticoagulant effect.
  • Live vaccines: risk of severe infection.

Moderate Interactions (Monitor Closely)

  • NSAIDs: increased gastrointestinal adverse effects.
  • Oral contraceptives: possible reduction in contraceptive efficacy.

Frequently Asked Questions

Leflunomid Pharmathen contains leflunomide, which is indicated for the treatment of moderate to severe rheumatoid arthritis and psoriatic arthritis in adult patients. It helps reduce joint inflammation, pain, and slows disease progression.

Leflunomide is converted in the body 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 immune cells, thereby dampening the inflammatory response.

The dosing regimen for leflunomide is individualized and set by the prescribing clinician based on the patient’s condition, response, and tolerability. Typical initiation and maintenance doses are defined in the product’s prescribing information, but exact amounts should be confirmed by a qualified healthcare professional.

Leflunomide is classified as pregnancy category X, meaning it is contraindicated during pregnancy because of a high risk of fetal harm. It is also not recommended for breastfeeding mothers, as the drug can be excreted in breast milk and may affect the infant.

To order Leflunomid Pharmathen, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, and will request verification of trade or institutional credentials before providing pricing, availability, shipping details and any necessary import documentation.

Compared with conventional DMARDs such as methotrexate, leflunomide offers a once‑daily oral regimen and a distinct mechanism targeting pyrimidine synthesis. It may be chosen when patients cannot tolerate methotrexate or when disease activity remains uncontrolled. However, leflunomide carries specific liver‑related safety considerations that differ from other agents.

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

The medication is supplied as oral tablets that are swallowed whole with water. It can be taken with or without food, according to the prescriber’s instructions. Patients should follow the dosing schedule provided by their healthcare professional.

The most serious risks include severe liver injury, bone marrow suppression leading to anemia or leukopenia, and rare but life‑threatening skin reactions such as Stevens‑Johnson syndrome. Additionally, leflunomide is teratogenic and must be avoided in pregnancy.

Leflunomide should not be used by pregnant women, individuals with pre‑existing severe liver disease, patients with active serious infections, or those with known hypersensitivity to the drug. Caution is also advised for patients with significant immunosuppression or uncontrolled hypertension.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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