Product image of Leflunomide Orion (Leflunomide) supplied by GNH India

Leflunomide Orion

Active Ingredient:
Leflunomide
Origin:
EU

Leflunomide Orion (Leflunomide)

Leflunomide, the active ingredient in Leflunomide Orion, is a dihydroorotate dehydrogenase inhibitor 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 joint inflammation and slow disease progression.

GNH India supplies Leflunomide Orion as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, ensuring quality and regulatory conformity across EU and global markets. The company provides full batch traceability and adheres to Good Distribution Practice standards for every shipment.

Manufacturer / TM Owner

Orion Corporation

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Indications & Clinical Uses

Leflunomide is a disease-modifying antirheumatic drug (DMARD) that modulates inflammatory pathways in autoimmune arthritis.

  • Rheumatoid arthritis: reduces joint swelling, pain and slows structural damage.
  • Psoriatic arthritis: improves skin lesions and joint symptoms, decreasing disease activity.
  • Inadequate response to methotrexate: offers an alternative therapeutic option to achieve disease control.

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 lymphocytes, particularly T‑cells, which reduces the autoimmune inflammatory response in the joints. The blockade also diminishes cytokine production such as interleukin‑6 and tumor necrosis factor‑α, contributing further to the attenuation of synovial inflammation.

Side Effects

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

Common Side Effects

  • Nausea: mild to moderate stomach upset.
  • Diarrhea: loose stools, often transient.
  • Alopecia: thinning or loss of hair.
  • Elevated liver enzymes: mild increase in ALT/AST.

Serious or Rare Side Effects

  • Severe liver injury: hepatitis or hepatic failure.
  • Bone marrow suppression: anemia, leukopenia, thrombocytopenia.
  • Pulmonary toxicity: interstitial lung disease or pneumonitis.
  • Severe skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis.

Precautions & Warnings

Before initiating Leflunomide therapy, several safety considerations should be reviewed.

  • Liver function monitoring: assess baseline enzymes and repeat regularly.
  • Hematologic monitoring: check complete blood count for cytopenias.
  • Pregnancy avoidance: drug is contraindicated in pregnancy; effective contraception required.
  • Hypertension surveillance: monitor blood pressure during treatment.
  • Drug interactions: review concomitant medications for potential major interactions.
  • Store at ambient temperature: keep tablets in original packaging, protect from moisture and light.

Avoid Interactions

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

Major Interactions (Avoid)

  • Teriflunomide: combined use may increase risk of hepatotoxicity.
  • Azathioprine or cyclophosphamide: additive bone marrow suppression.
  • Strong CYP1A2 inducers (e.g., rifampicin): may reduce leflunomide plasma levels.

Moderate Interactions (Monitor Closely)

  • Warfarin: may enhance anticoagulant effect, requiring INR monitoring.
  • Methotrexate: concurrent use can increase hepatic toxicity risk.

Frequently Asked Questions

Leflunomide Orion is prescribed for adult patients with rheumatoid arthritis or psoriatic arthritis. In these conditions it helps to reduce joint inflammation, relieve pain, and slow the progression of structural damage, thereby improving overall functional ability and quality of life.

Leflunomide blocks the enzyme dihydroorotate dehydrogenase, which is essential for de novo pyrimidine synthesis. This limits the availability of nucleotides needed for rapid lymphocyte proliferation, especially activated T‑cells, and consequently dampens the autoimmune inflammatory response that drives joint damage.

The appropriate dose of Leflunomide Orion is individualized by the prescribing clinician based on the patient’s disease severity, prior therapy, liver function, and overall health status. Dosage decisions follow local prescribing guidelines and are not disclosed in public product literature.

Leflunomide is contraindicated in pregnancy because of known teratogenic risk, and women of child‑bearing potential must use effective contraception before, during, and for a defined period after treatment. Safety during breastfeeding has not been established, so the drug is generally avoided.

To place an order, submit an enquiry on the Leflunomide Orion 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.

Compared with methotrexate, another first‑line DMARD, leflunomide offers a once‑daily oral regimen and may be preferred when methotrexate is poorly tolerated or ineffective. Both drugs share hepatic monitoring requirements, but leflunomide has a longer half‑life and a distinct safety profile that includes a higher risk of pulmonary toxicity.

Leflunomide Orion tablets should be stored at ambient temperature, below 25 °C, in the original container to protect them from moisture and light. Keep the product out of reach of children and avoid storing in areas with high humidity or direct sunlight.

Leflunomide Orion is taken orally as a whole tablet with a glass of water. It is usually swallowed whole and not chewed or crushed. The exact timing and any loading dose are determined by the prescribing physician based on individual therapeutic goals.

The most critical risks include severe liver injury, bone‑marrow suppression leading to anemia or low white‑blood‑cell counts, interstitial lung disease or pneumonitis, and rare but life‑threatening skin reactions such as Stevens‑Johnson syndrome. Prompt reporting of symptoms like jaundice, persistent fever, respiratory difficulty or rash is essential.

Leflunomide Orion should be avoided in patients who are pregnant, planning pregnancy, or not using reliable contraception. It is also contraindicated in individuals with severe hepatic impairment, active infections, uncontrolled hypertension, or known hypersensitivity to leflunomide or related compounds.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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