GNH USA

Europe — EMA

Leflunomide Aurovitas

GNH USA supplies Leflunomide Aurovitas (Leflunomide), a DMARD for rheumatoid arthritis and psoriatic arthritis. Request a quote for global supply today.

Leflunomide

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What is Leflunomide?

Leflunomide, the active ingredient in Leflunomide Aurovitas, is a disease-modifying antirheumatic drug (DMARD) presented as an oral tablet for systemic use. It is indicated for the treatment of inflammatory arthritis in adult patients and reduces joint damage by inhibiting lymphocyte proliferation, often prescribed when conventional therapy is inadequate. The formulation complies with EU pharmaceutical regulations and is manufactured under GMP conditions.

GNH USA supplies Leflunomide Aurovitas as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company follows stringent Good Distribution Practice (GDP) standards, ensuring product integrity during global shipment to hospitals, pharmacies and clinics across Europe, Asia, Africa and the Americas.

What is Leflunomide used for?

Leflunomide Aurovitas is a disease-modifying antirheumatic drug that targets immune-mediated inflammatory pathways in arthritis. - Rheumatoid arthritis: reduces joint inflammation, pain, and slows radiographic progression of structural damage. - Psoriatic arthritis: improves both skin lesions and joint symptoms, helping maintain functional ability and quality of life. - Moderate to severe inflammatory arthritis when other DMARDs are insufficient: offers an oral alternative that can achieve disease control and reduce flare frequency.

What are the side effects of Leflunomide?

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

Common Side Effects: - Diarrhea - Nausea or vomiting - Elevated liver enzymes - Hypertension

Serious or Rare Side Effects: - Severe liver injury or hepatitis - Life‑threatening infections - Pulmonary toxicity or interstitial lung disease - Stevens‑Johnson syndrome or toxic epidermal necrolysis

What precautions apply to Leflunomide?

Before initiating Leflunomide therapy, several precautions and monitoring measures should be observed. - Pregnancy contraindication: avoid use in women of childbearing potential and discontinue immediately if pregnancy occurs. - Liver function monitoring: obtain baseline liver enzymes and repeat regularly during treatment. - Hematologic monitoring: perform complete blood counts to detect neutropenia or anemia. - Infection risk: assess for active infections and avoid initiating therapy in the presence of serious infection. - Hypertension monitoring: measure blood pressure periodically as the drug may raise systolic pressure. - Store at ambient temperature below 25°C: keep in the original pack, protect from moisture.

What does Leflunomide interact with?

Leflunomide can interact with several medicines, requiring dose adjustments or monitoring.

Major Interactions (Avoid): - Warfarin: may increase INR and bleeding risk. - Methotrexate: additive bone‑marrow suppression and hepatotoxicity. - Cholesterol‑binding resins (e.g., cholestyramine): markedly reduce leflunomide exposure.

Moderate Interactions (Monitor Closely): - CYP2C9 substrates (e.g., phenytoin, tolbutamide): may have altered plasma levels. - Statins: increased risk of myopathy when combined.

Frequently asked questions

What is Leflunomide Aurovitas used for?+
Leflunomide Aurovitas is prescribed for adult patients with rheumatoid arthritis or psoriatic arthritis. It helps reduce joint inflammation, pain, and structural damage by modulating the immune response that drives these chronic inflammatory conditions.
How does Leflunomide work?+
After oral administration, Leflunomide is converted to its active metabolite teriflunomide, which blocks the enzyme dihydroorotate dehydrogenase. This inhibition stops de novo pyrimidine synthesis, limiting the proliferation of activated lymphocytes and thereby dampening the autoimmune activity that contributes to joint inflammation.
What is the usual dose of Leflunomide Aurovitas?+
The exact dose of Leflunomide Aurovitas is determined by the prescribing physician based on the severity of disease, patient weight, renal and hepatic function, and tolerance. The prescriber may start with a loading dose followed by a maintenance dose, but the specific regimen should follow the clinician’s judgment and local prescribing guidelines.
Is Leflunomide safe in pregnancy or breastfeeding?+
Leflunomide is classified as Pregnancy Category X, meaning it is contraindicated in women who are pregnant or may become pregnant because it can cause fetal malformations. It is also not recommended during breastfeeding, as it may be excreted in breast milk and affect the infant.
How do I order Leflunomide Aurovitas from GNH USA?+
To place an order, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity of Leflunomide Aurovitas. GNH USA 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.
How does Leflunomide compare with the main alternative drug or class?+
Leflunomide is an oral DMARD that offers a convenient alternative to injectable biologics and to methotrexate, another oral DMARD. Compared with methotrexate, leflunomide has a different safety profile, with less hepatotoxicity but a higher risk of hypertension and teratogenicity. Unlike biologics, it does not require injection and is less costly, but may be less effective in patients who fail multiple DMARDs.
What are the storage and handling requirements for Leflunomide Aurovitas?+
Leflunomide Aurovitas should be stored at ambient temperature below 25 °C. Keep the tablets in the original packaging, protect them from moisture and direct sunlight, and ensure the container is tightly closed to maintain product stability throughout its shelf life.
How is Leflunomide Aurovitas given/ administered?+
The medication is supplied as oral tablets that are swallowed whole with a glass of water. It can be taken with or without food, but patients should follow the prescriber’s instructions regarding timing and any required loading dose to achieve therapeutic levels.
What are the most serious risks to watch for while taking Leflunomide?+
Serious risks include severe liver injury, life‑threatening infections, pulmonary toxicity such as interstitial lung disease, and rare but severe skin reactions like Stevens‑Johnson syndrome. Patients should report any signs of jaundice, persistent fever, respiratory difficulty, or unexplained rash to their healthcare provider immediately.
Who should not use Leflunomide Aurovitas?+
Leflunomide Aurovitas is contraindicated in pregnant women, women of childbearing potential not using reliable contraception, patients with severe liver disease, uncontrolled hypertension, or known hypersensitivity to leflunomide or its excipients. Caution is also advised for individuals with active infections or significant renal impairment.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Leflunomide
Route
Oral Use
Manufacturer
Aurovitas Pharma Polska Sp. Z O.O
Origin
EU

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