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

Leflunomide Ratiopharm

Active Ingredient:
Leflunomide
Origin:
EU

Leflunomide Ratiopharm (Leflunomide)

Leflunomide, the active ingredient in Leflunomide Ratiopharm, is a disease-modifying antirheumatic drug presented as an oral tablet for oral use. It is indicated for the treatment of rheumatoid arthritis and psoriatic arthritis in adult patients, helping to reduce inflammation and slow joint damage.

GNH India supplies Leflunomide Ratiopharm as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides reliable logistics for global distribution across multiple continents and regulatory compliance.

Manufacturer / TM Owner

Ratiopharm Gmbh

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Indications & Clinical Uses

  • Leflunomide is a disease-modifying antirheumatic drug that targets inflammatory pathways in rheumatic diseases.
  • Rheumatoid arthritis: reduces joint inflammation, pain and structural damage in adult patients.
  • Psoriatic arthritis: improves joint and skin symptoms, slowing disease progression.
  • Severe rheumatoid arthritis: used as part of combination therapy to enhance therapeutic response.

How It Works

  • Leflunomide inhibits the mitochondrial enzyme dihydroorotate dehydrogenase, which blocks de novo pyrimidine synthesis. This limits the proliferation of activated T and B lymphocytes, thereby reducing the autoimmune inflammatory response that drives joint damage in rheumatoid and psoriatic arthritis.

Side Effects

Leflunomide may cause a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects

  • Diarrhea
  • Nausea
  • Alopecia
  • Rash
  • Elevated liver enzymes
  • Hypertension

Serious or Rare Side Effects

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

Precautions & Warnings

  • Before initiating therapy, several safety considerations should be observed.
  • Pregnancy: contraindicated; teratogenic risk mandates effective contraception.
  • Liver function: baseline and periodic monitoring of hepatic enzymes is required.
  • Blood pressure: monitor regularly as hypertension may develop.
  • Infections: assess for active infections; avoid initiating therapy during uncontrolled infection.
  • Immunosuppression: live vaccines should not be administered during treatment.
  • Store at ambient temperature: keep below 25°C, in the original pack, protected from moisture.

Avoid Interactions

Leflunomide can interact with several medicines, affecting efficacy or safety.

Major Interactions (Avoid)

  • Warfarin: increased anticoagulant effect; monitor INR closely.
  • Methotrexate: additive hepatotoxicity; concurrent use should be avoided.
  • Bile‑acid sequestrants (e.g., cholestyramine): reduce Leflunomide exposure, may require dose adjustment.

Moderate Interactions (Monitor Closely)

  • Azathioprine: enhanced immunosuppression; monitor blood counts.
  • Cyclosporine: potential increase in liver toxicity; regular liver function tests are advised.

Frequently Asked Questions

Leflunomide Ratiopharm is prescribed for adult patients with rheumatoid arthritis or psoriatic arthritis. It helps to reduce joint inflammation, pain, and structural damage, and can slow disease progression when used as part of a disease‑modifying treatment plan.

Leflunomide blocks the enzyme dihydroorotate dehydrogenase, which is essential for de novo pyrimidine synthesis. By limiting pyrimidine production, the drug reduces the proliferation of activated lymphocytes, thereby dampening the autoimmune response that drives joint inflammation.

The dosing regimen for Leflunomide is individualized by the prescribing clinician based on the patient’s condition, response, and tolerability. The prescriber determines the appropriate starting dose, any loading dose, and subsequent maintenance dose.

Leflunomide is classified as pregnancy category X, meaning it is contraindicated during pregnancy because of proven teratogenic risk. It is also not recommended while breastfeeding, as it may be excreted in breast milk and affect the infant.

To place an order, 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 any necessary import documentation.

The most common alternative to Leflunomide is methotrexate, another conventional DMARD. While both reduce disease activity, Leflunomide has a different safety profile, with less hepatic toxicity at low doses but a higher risk of hypertension and teratogenicity. Biologic agents are also alternatives for patients who do not respond adequately to conventional DMARDs.

Leflunomide tablets should be stored at ambient temperature, preferably below 25 °C. Keep the medication in its original container, protect it from moisture and direct sunlight, and ensure the packaging remains tightly closed until use.

Leflunomide is taken orally, usually as a tablet swallowed whole with a glass of water. It can be taken with or without food, but patients should follow the specific instructions provided by their healthcare professional.

Serious risks include severe liver injury, life‑threatening skin reactions such as Stevens‑Johnson syndrome, bone‑marrow suppression leading to anemia or leukopenia, and interstitial lung disease. Patients should report any signs of jaundice, rash, unexplained fever, or respiratory symptoms promptly.

Leflunomide should not be used by pregnant women, women planning pregnancy, or those who are not using reliable contraception. It is also contraindicated in patients with severe liver disease, uncontrolled hypertension, or active serious infections, and caution is advised in those with a history of severe skin reactions.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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