GNH USA

Europe — EMA

Leflunomid Sandoz

GNH USA supplies Leflunomid Sandoz (Leflunomide), a disease-modifying antirheumatic drug for rheumatoid arthritis and psoriatic arthritis.

Leflunomide

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What is Leflunomide?

Leflunomide, the active ingredient in Leflunomid Sandoz, is an immunomodulatory agent presented as an oral formulation for oral use. It is indicated for the treatment of rheumatoid arthritis and psoriatic arthritis in adult patients, helping to reduce inflammation and slow disease progression.

GNH USA supplies Leflunomid Sandoz as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

What is Leflunomide used for?

Leflunomide is used to modify disease activity in autoimmune joint disorders.

Rheumatoid arthritis: reduces joint inflammation, pain, and structural damage. Psoriatic arthritis: improves skin lesions and joint symptoms. Active disease in adults: helps control symptoms and slows progression of autoimmune arthritis.

What are the side effects of Leflunomide?

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

Common Side Effects: - Diarrhoea: loose stools, often mild to moderate. - Nausea: feeling of sickness, may accompany meals. - Alopecia: thinning or loss of hair. - Rash: skin redness or itching. - Elevated liver enzymes: increased ALT/AST on blood tests. - Hypertension: rise in blood pressure readings.

Serious or Rare Side Effects: - Severe liver injury: jaundice, hepatic failure. - Stevens‑Johnson syndrome or toxic epidermal necrolysis: severe skin reactions. - Bone marrow suppression: anemia, leukopenia, thrombocytopenia. - Interstitial lung disease: cough, shortness of breath. - Opportunistic infections: due to immune suppression. - Teratogenicity: birth defects if exposure occurs during pregnancy.

What precautions apply to Leflunomide?

Before initiating therapy, several safety considerations should be reviewed.

Pregnancy contraindication: avoid use in pregnancy and discontinue well before conception. Liver function monitoring: obtain baseline tests and repeat periodically. Blood pressure assessment: monitor regularly, especially in hypertensive patients. Hematologic surveillance: check complete blood count for signs of suppression. Severe hepatic impairment: contraindicated in patients with existing liver disease. Store at below 25°C: keep in the original container, protect from moisture and direct sunlight.

What does Leflunomide interact with?

Leflunomide can affect the pharmacokinetics or safety profile of several concomitant medicines.

Major Interactions (Avoid): - Warfarin: increased anticoagulant effect, risk of bleeding. - Methotrexate: additive hepatotoxicity and bone‑marrow suppression. - Cholesterol‑binding resins (e.g., cholestyramine): reduce leflunomide exposure. - CYP3A4 inducers (e.g., rifampicin): markedly lower plasma levels. - Teriflunomide (active metabolite): combined exposure increases toxicity.

Moderate Interactions (Monitor Closely): - Statins: heightened risk of myopathy. - Azathioprine: potential for enhanced myelosuppression. - TNF‑α inhibitors: increased infection risk when used together. - Oral contraceptives: reduced efficacy, consider alternative contraception. - Vitamin K antagonists: may require dose adjustment.

Frequently asked questions

What conditions is Leflunomid Sandoz used to treat?+
Leflunomid Sandoz contains leflunomide, which is approved for the management of rheumatoid arthritis and psoriatic arthritis in adult patients. It helps reduce joint inflammation, pain, and structural damage associated with these autoimmune conditions.
How does leflunomide work in the body?+
Leflunomide is converted to its active metabolite teriflunomide, which blocks the enzyme dihydroorotate dehydrogenase. This inhibition reduces the synthesis of pyrimidines, limiting the proliferation of activated T‑cells and other immune cells that drive joint inflammation.
What is the usual dose of Leflunomid Sandoz?+
The specific dosage regimen for Leflunomid Sandoz is determined by the prescribing clinician based on the individual’s medical condition, response to therapy, and safety considerations. Patients should follow the prescriber’s instructions and not adjust the dose on their own.
Is Leflunomid Sandoz safe to use during pregnancy or breastfeeding?+
Leflunomid Sandoz is classified as pregnancy category X, meaning it is contraindicated in pregnancy due to a high risk of fetal harm. It is also not recommended while breastfeeding because it may pass into breast milk and affect the infant.
How do I order Leflunomid Sandoz from GNH USA?+
To place an order, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA 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.
How does leflunomide compare with other disease‑modifying antirheumatic drugs?+
Leflunomide offers a once‑daily oral option that targets pyrimidine synthesis, whereas other DMARDs such as methotrexate inhibit folate pathways. Leflunomide may be preferred when patients cannot tolerate methotrexate or need an alternative mechanism, but safety profiles differ, especially regarding liver and hematologic effects.
What are the recommended storage conditions for Leflunomid Sandoz?+
Leflunomid Sandoz should be stored at temperatures below 25 °C, in its original packaging, protected from moisture and direct sunlight. Maintaining these conditions helps preserve the tablet’s stability and potency throughout its shelf life.
How is Leflunomid Sandoz administered?+
Leflunomid Sandoz is taken orally, usually as a tablet, with or without food as directed by the prescriber. The medication should be swallowed whole with a glass of water and not crushed or chewed unless specifically instructed.
What are the most serious risks associated with leflunomide therapy?+
The most serious risks include severe liver injury, life‑threatening skin reactions such as Stevens‑Johnson syndrome, bone‑marrow suppression leading to anemia or infection, and teratogenic effects that can cause birth defects. Patients should be monitored regularly for these complications.
Who should not use Leflunomid Sandoz?+
Leflunomid Sandoz is contraindicated in pregnant women, individuals with severe hepatic impairment, and patients with known hypersensitivity to leflunomide or its metabolites. Caution is also advised for those with uncontrolled hypertension or active infections.
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
Sandoz Hungária Kft
Origin
EU

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