Product image of Leflunomida Farmoz (Leflunomide) supplied by GNH India

Leflunomida Farmoz

Active Ingredient:
Leflunomide
Origin:
EU

Leflunomida Farmoz (Leflunomide)

Leflunomide, the active ingredient in Leflunomida Farmoz, is an immunomodulatory agent presented as an oral tablet for oral administration. It is used to manage rheumatoid arthritis and psoriatic arthritis in adult patients, helping to reduce joint inflammation and disease progression.

GNH India supplies Leflunomida Farmoz as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The product conforms to EU quality standards and is manufactured under strict GMP conditions for reliable global distribution through a robust logistics network.

Manufacturer / TM Owner

Farmoz - Sociedade Técnico Medicinal, S.A.

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Indications & Clinical Uses

Leflunomide is a disease-modifying antirheumatic drug that acts on the immune system to control inflammatory arthritis.

  • Rheumatoid arthritis: reduces joint swelling, pain, and slows structural damage.
  • Psoriatic arthritis: improves skin lesions and joint function, decreasing disease activity.
  • Adults with moderate to severe disease refractory to other DMARDs: provides an alternative therapeutic option when conventional treatments are insufficient.

How It Works

  • Leflunomide inhibits the mitochondrial enzyme dihydroorotate dehydrogenase, which is essential for de novo pyrimidine synthesis. By blocking this pathway, the drug limits proliferation of activated T‑lymphocytes and B‑cells, reducing the production of inflammatory cytokines and thereby moderating the autoimmune response characteristic of rheumatoid and psoriatic arthritis. The inhibition is reversible and selective, leading to a gradual decrease in immune cell activity without directly affecting DNA replication in resting cells.

Side Effects

Leflunomida Farmoz may be associated with a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects

  • Diarrhea: loose stools that may be mild to moderate.
  • Nausea: feeling of sickness, sometimes with vomiting.
  • Elevated liver enzymes: increase in ALT/AST indicating hepatic stress.
  • Hypertension: rise in blood pressure requiring monitoring.
  • Alopecia: hair thinning or loss observed in some patients.
  • Rash: skin eruptions that may be itchy or erythematous.

Serious or Rare Side Effects

  • Severe liver injury: jaundice, hepatic failure, may require discontinuation.
  • Bone marrow suppression: decreased blood cell counts, risk of anemia or infection.
  • Stevens‑Johnson syndrome: severe skin reaction with blistering and mucosal involvement.

Precautions & Warnings

When prescribing Leflunomida Farmoz, clinicians should observe several precautionary measures to ensure patient safety.

  • Liver function monitoring: perform baseline and periodic ALT/AST tests.
  • Blood pressure assessment: check and control hypertension before and during therapy.
  • Pregnancy avoidance: drug is contraindicated in pregnancy; effective contraception required.
  • Hematologic surveillance: monitor complete blood count for signs of bone marrow suppression.
  • Drug interactions: review concomitant medications for major interaction risks.
  • Store at below 25°C: keep in original packaging, protect from moisture and direct light.

Avoid Interactions

Leflunomida Farmoz can affect or be affected by other medicines; notable interactions are classified by clinical significance.

Major Interactions (Avoid)

  • Warfarin: increased anticoagulant effect leading to bleeding risk.
  • Live vaccines: heightened risk of infection due to immunosuppression.
  • Carbamazepine: induces metabolism, reducing leflunomide plasma levels.

Moderate Interactions (Monitor Closely)

  • Statins: combined use may increase risk of myopathy.
  • Methotrexate: additive hepatotoxic potential requiring liver function monitoring.

Frequently Asked Questions

Leflunomida Farmoz contains leflunomide, an immunomodulatory disease‑modifying antirheumatic drug (DMARD). It is prescribed to treat adults with rheumatoid arthritis and psoriatic arthritis, helping to reduce joint inflammation, pain, and the long‑term structural damage associated with these chronic autoimmune conditions.

Leflunomide blocks the enzyme dihydroorotate dehydrogenase, a key step in de novo pyrimidine synthesis. By limiting pyrimidine production, the drug curtails the proliferation of activated T‑ and B‑lymphocytes, which reduces the release of inflammatory cytokines and dampens the autoimmune response that drives rheumatoid and psoriatic arthritis.

The appropriate dose of Leflunomida Farmoz is determined by the prescribing physician based on the individual patient's disease severity, response to therapy, renal and hepatic function, and any concomitant medications. Dosage regimens are not standardized in public literature and should follow the clinician’s judgment and local prescribing guidelines.

Leflunomida Farmoz is classified as pregnancy category X, meaning it is contraindicated in pregnancy because of a high risk of fetal malformations and embryotoxicity. Women of child‑bearing potential must use effective contraception, and the drug should not be used while breastfeeding, as it may be excreted in milk.

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

Compared with conventional DMARDs such as methotrexate, leflunomide offers a once‑daily oral regimen and a different mechanism targeting pyrimidine synthesis. It may be chosen when patients cannot tolerate methotrexate or need an alternative before escalating to biologic therapies. However, leflunomide carries a distinct safety profile, including a higher risk of liver enzyme elevation and teratogenicity.

Leflunomida Farmoz should be stored at temperatures below 25 °C (77 °F). Keep the tablets in their original blister pack or container, protect them from moisture, excessive heat and direct sunlight. Do not store in the bathroom or near a kitchen sink where humidity is high.

The medication is supplied as oral tablets intended for swallowing whole with a glass of water. It is taken once daily, preferably at the same time each day, and can be taken with or without food. Patients should follow the dosing instructions provided by their healthcare professional.

The most serious adverse events include severe liver injury (jaundice, hepatic failure), bone marrow suppression leading to anemia or infections, and rare but life‑threatening skin reactions such as Stevens‑Johnson syndrome. Early detection through regular laboratory monitoring and prompt reporting of symptoms like unexplained fatigue, yellowing of the skin or severe rash is essential.

Leflunomida Farmoz is contraindicated in pregnant women, patients with known hypersensitivity to leflunomide, and those with severe hepatic impairment. Caution is also advised for individuals with pre‑existing bone marrow disorders, uncontrolled hypertension, or active infections. The drug should be avoided in patients planning pregnancy due to its teratogenic potential.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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