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

Leflunomide Mylan

Active Ingredient:
Leflunomide
Origin:
EU

Leflunomide Mylan (Leflunomide)

Leflunomide, the active ingredient in Leflunomide Mylan, is an immunomodulatory agent presented as an oral tablet for oral use. It is indicated for the treatment of inflammatory arthritis conditions in adult patients.\n\nGNH India supplies Leflunomide Mylan as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Generics [uk] Limited

1
Pack/s
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Indications & Clinical Uses

  • Leflunomide is a disease‑modifying antirheumatic drug that targets autoimmune inflammation in rheumatic disorders.\n\n- Rheumatoid arthritis: reduces joint inflammation, pain and slows structural damage.\n- Psoriatic arthritis: improves joint symptoms and may benefit associated skin lesions.\n- Refractory disease: provides an alternative option for patients whose disease remains active despite other DMARD therapy.

How It Works

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

Side Effects

  • Leflunomide may cause a range of adverse reactions that vary in frequency and severity.\n\nCommon Side Effects:\n- Diarrhea: mild to moderate gastrointestinal upset.\n- Nausea: occasional feeling of sickness.\n- Elevated liver enzymes: mild increases in ALT/AST.\n- Hypertension: rise in blood pressure during therapy.\n\nSerious or Rare Side Effects:\n- Severe liver injury: risk of hepatitis or hepatic failure.\n- Stevens‑Johnson syndrome: rare severe skin reaction.\n- Bone marrow suppression: possible anemia, leukopenia or thrombocytopenia.

Precautions & Warnings

  • Before initiating therapy, several safety considerations should be addressed.\n\n- Pregnancy: contraindicated; teratogenic risk (Category X).\n- Liver function: obtain baseline tests and monitor regularly.\n- Blood counts: perform periodic CBC to detect bone‑marrow effects.\n- Hypertension: monitor blood pressure throughout treatment.\n- Infections: assess for active infections before starting.\n- Store at ambient temperature: keep below 25°C in the original pack, protect from moisture.

Avoid Interactions

  • Leflunomide can interact with several medicines, requiring careful management.\n\nMajor Interactions (Avoid):\n- Warfarin: may increase anticoagulant effect and bleeding risk.\n- Methotrexate: additive hepatotoxicity when combined.\n- Live vaccines: heightened risk of infection due to immunosuppression.\n\nModerate Interactions (Monitor Closely):\n- Azathioprine: enhanced immunosuppressive effect.\n- TNF‑α inhibitors: combined immunosuppression may increase infection risk.\n- CYP1A2 inhibitors (e.g., fluvoxamine): can raise leflunomide plasma concentrations.

Frequently Asked Questions

Leflunomide Mylan is prescribed to manage moderate to severe rheumatoid arthritis and psoriatic arthritis in adult patients. It belongs to the disease‑modifying antirheumatic drug (DMARD) class and works to reduce joint inflammation, pain, and long‑term structural damage associated with these autoimmune conditions.

Leflunomide blocks the enzyme dihydroorotate dehydrogenase, which is essential for de novo synthesis of pyrimidine nucleotides. By limiting pyrimidine production, the drug suppresses the proliferation of activated T‑lymphocytes, thereby dampening the immune response that drives inflammation in rheumatoid and psoriatic arthritis.

The dosing regimen for Leflunomide Mylan is determined by the prescribing clinician based on the individual’s disease severity, prior therapy, and laboratory monitoring. Physicians typically start with a loading dose followed by a maintenance dose, but the exact schedule should be confirmed with the treating healthcare professional.

Leflunomide is classified as Pregnancy Category X because it is teratogenic and can cause fetal harm. It is contraindicated during pregnancy and women of child‑bearing potential must use effective contraception. The drug is also not recommended 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 Leflunomide Mylan. 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 necessary import documentation.

Leflunomide is often compared with methotrexate, another first‑line 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 such as TNF‑α inhibitors may be used when patients do not respond adequately to either leflunomide or methotrexate.

Leflunomide Mylan 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 as a tablet, usually with or without food according to the prescribing physician’s instructions. Swallow the tablet whole with a glass of water; do not crush or chew it unless directed otherwise.

The most serious adverse events include severe liver injury, which may present as jaundice or elevated liver enzymes, and rare but life‑threatening skin reactions such as Stevens‑Johnson syndrome. Bone‑marrow suppression leading to anemia, leukopenia or thrombocytopenia, and teratogenic effects in pregnancy are also critical safety concerns that require regular monitoring.

Leflunomide is contraindicated in pregnant women, individuals with severe hepatic impairment, and patients with known hypersensitivity to the drug. Caution is also advised for those with uncontrolled hypertension, active infections, or significant bone‑marrow disorders. The prescriber should evaluate each patient’s medical history before initiating therapy.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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