GNH USA

Europe — EMA

Nintedanib Stada

GNH USA supplies Nintedanib Stada (Nintedanib), a tyrosine kinase inhibitor for idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial

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What is Nintedanib?

Nintedanib, the active ingredient in Nintedanib Stada, is a tyrosine kinase inhibitor presented as an oral tablet for oral use. It is employed to treat idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and certain forms of non‑small cell lung cancer in adult patients.

GNH USA supplies Nintedanib Stada as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide. The company adheres to EU GMP standards and provides reliable logistics for bulk and parcel shipments globally.

What is Nintedanib used for?

Nintedanib is indicated for fibrotic lung diseases and certain oncologic conditions, acting on pathways that drive fibroblast proliferation and tumor angiogenesis.

- Idiopathic pulmonary fibrosis: slows disease progression, reduces decline in forced vital capacity and may improve quality of life in adult patients. - Systemic sclerosis‑associated interstitial lung disease: improves forced vital capacity, delays respiratory deterioration and supports functional status in affected individuals. - Non‑small cell lung cancer: used together with standard chemotherapy to inhibit tumor growth, angiogenesis and may extend progression‑free survival.

What are the side effects of Nintedanib?

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

Common Side Effects: - Diarrhea: frequent loose stools that may be mild to moderate. - Nausea: feeling of sickness often accompanied by loss of appetite. - Vomiting: occasional episodes of stomach emptying. - Decreased appetite: reduced desire to eat leading to weight loss. - Abdominal pain: discomfort or cramping in the stomach area. - Elevated liver enzymes: mild increases in ALT/AST observed in laboratory tests.

Serious or Rare Side Effects: - Hepatic failure: severe liver injury requiring medical attention. - Severe bleeding: gastrointestinal or intracranial hemorrhage. - Arterial thromboembolism: clot formation in arteries causing ischemic events. - Gastrointestinal perforation: hole formation in the stomach or intestines. - Severe hypertension: markedly high blood pressure needing urgent care. - Serious infection: opportunistic infections in immunocompromised patients.

What precautions apply to Nintedanib?

When prescribing Nintedanib, clinicians should consider several safety measures to minimize risk.

- Liver function monitoring: assess baseline ALT/AST and repeat regularly during therapy. - Bleeding risk assessment: evaluate history of hemorrhage and avoid concomitant anticoagulants when possible. - Cardiovascular evaluation: monitor blood pressure and manage hypertension before and during treatment. - Drug interaction review: check for strong CYP3A4 modulators that may alter drug exposure. - Contraindication in severe hepatic impairment: avoid use in patients with Child‑Pugh class C liver disease. - Store at room temperature: keep in original packaging, protect from moisture and direct sunlight.

What does Nintedanib interact with?

Nintedanib interacts with several medicines; understanding the level of interaction guides clinical decisions.

Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may increase nintedanib exposure and toxicity. - Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy by lowering drug levels. - Anticoagulants (e.g., warfarin) and antiplatelet agents (e.g., aspirin): heightened risk of serious bleeding. - P‑glycoprotein inhibitors (e.g., verapamil): can raise plasma concentrations. - High‑dose statins (e.g., simvastatin 80 mg): increased risk of liver enzyme elevation.

Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole): may modestly raise nintedanib levels. - Moderate CYP3A4 inducers (e.g., phenobarbital, phenytoin): may modestly decrease drug exposure. - NSAIDs (e.g., ibuprofen): additive gastrointestinal bleeding risk. - Diuretics (e.g., furosemide): monitor electrolytes and renal function. - Proton pump inhibitors: may affect absorption, observe for reduced efficacy.

Frequently asked questions

What conditions is Nintedanib Stada used to treat?+
Nintedanib Stada is prescribed for adult patients with idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and for certain cases of non‑small cell lung cancer when used in combination with standard chemotherapy.
How does nintedanib work in the body?+
Nintedanib blocks the activity of several receptor tyrosine kinases—VEGFR, PDGFR and FGFR—thereby reducing fibroblast activation, extracellular matrix deposition, and angiogenesis, which slows fibrotic lung remodeling and tumor blood‑vessel formation.
What determines the dose of Nintedanib Stada?+
The dose of Nintedanib Stada is individualized by the prescribing clinician based on the specific indication, patient weight, liver function, concomitant medications and tolerability; no fixed regimen is provided here.
Is Nintedanib Stada safe during pregnancy or breastfeeding?+
Safety data for Nintedanib Stada in pregnancy and lactation are limited; it is generally advised to avoid use unless the potential benefit justifies the potential risk to the fetus or infant, and to discuss alternatives with a healthcare professional.
How do I order Nintedanib Stada from GNH USA?+
To 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 required import documentation.
How does Nintedanib compare with other antifibrotic agents?+
Nintedanib differs from other antifibrotics such as pirfenidone by targeting multiple tyrosine‑kinase pathways rather than a single fibrotic mediator, offering a broader mechanism of action that may be advantageous in certain patients, though safety profiles and tolerability vary between agents.
What are the recommended storage conditions for Nintedanib Stada?+
Nintedanib Stada should be stored at room temperature, below 25 °C, in its original packaging, protected from moisture and direct sunlight to maintain stability throughout its shelf life.
How is Nintedanib Stada administered to patients?+
The medication is taken orally, usually with food to lessen gastrointestinal upset. The exact timing and frequency are determined by the prescriber and should be followed exactly as instructed on the prescription label.
What are the most serious risks associated with Nintedanib Stada?+
Serious risks include hepatic failure, severe bleeding events, arterial thromboembolism, gastrointestinal perforation, and marked hypertension. Patients should be monitored regularly for signs of liver injury, bleeding, and cardiovascular changes.
Who should not use Nintedanib Stada?+
Nintedanib Stada is contraindicated in patients with severe hepatic impairment (Child‑Pugh class C), active uncontrolled bleeding, recent major surgery, or known hypersensitivity to the drug or its excipients.
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
Nintedanib
Route
Oral Use
Manufacturer
Stada Arzneimittel Gmbh
Origin
EU

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