GNH USA

Europe — EMA

Nintedanib Stada

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

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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 treats idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and is used in combination with chemotherapy for non‑small cell lung cancer.

GNH USA supplies Nintedanib Stada as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.

What is Nintedanib used for?

Nintedanib acts on multiple fibrotic and oncogenic pathways, providing therapeutic benefit in several lung‑related conditions.

Idiopathic pulmonary fibrosis: slows disease progression and reduces decline in lung function. Systemic sclerosis‑associated interstitial lung disease: helps preserve lung capacity and delay worsening. Non‑small cell lung cancer (in combination with chemotherapy): contributes to tumor growth inhibition when used with standard chemotherapy regimens.

What are the side effects of Nintedanib?

Nintedanib may cause a range of adverse reactions that vary in frequency and severity.

Common Side Effects: - Diarrhoea: frequent, often mild to moderate. - Nausea and vomiting: may occur after dosing. - Abdominal pain: intermittent discomfort. - Decreased appetite: reduced food intake. - Weight loss: gradual reduction in body weight. - Elevated liver enzymes: mild transaminase rise.

Serious or Rare Side Effects: - Hepatotoxicity: significant liver injury requiring monitoring. - Bleeding events: gastrointestinal or other hemorrhage. - Cardiovascular complications: myocardial infarction or arterial thrombosis. - Severe infections: opportunistic or bacterial infections. - Gastrointestinal perforation: rare but potentially life‑threatening. - Interstitial lung disease exacerbation: worsening respiratory status.

What precautions apply to Nintedanib?

Before initiating therapy, clinicians should evaluate patient‑specific risk factors and monitor key parameters.

Monitor liver function: obtain baseline and periodic LFTs during treatment. Assess cardiovascular status: check blood pressure and cardiac history. Avoid in severe hepatic impairment: contraindicated in patients with Child‑Pugh C disease. Use caution with anticoagulants: increased risk of bleeding, monitor coagulation parameters. Store at room temperature: keep in the original container, protect from moisture and light.

What does Nintedanib interact with?

Nintedanib can interact with several drug classes, influencing its safety and efficacy.

Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase nintedanib exposure. - Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened bleeding risk. - P‑glycoprotein inhibitors (e.g., verapamil): increased plasma levels.

Moderate Interactions (Monitor Closely): - CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy. - Antacids containing magnesium/aluminum: may affect absorption; separate dosing by at least 2 hours. - Diuretics: monitor for dehydration and renal function changes.

Frequently asked questions

What is Nintedanib Stada used for?+
Nintedanib Stada is prescribed to treat idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and, in combination with chemotherapy, non‑small cell lung cancer. It works by targeting pathways that drive fibrosis and tumor‑related angiogenesis, helping to slow disease progression and improve patient outcomes.
How does Nintedanib work?+
Nintedanib blocks multiple receptor tyrosine kinases—VEGFR, PDGFR and FGFR—thereby inhibiting fibroblast proliferation, new blood‑vessel formation, and extracellular matrix deposition. This multi‑targeted inhibition reduces fibrotic tissue remodeling in the lungs and limits tumor‑associated vascular growth when used with chemotherapy.
What is the usual dose of Nintedanib Stada?+
The specific dose and dosing schedule are determined by the prescribing clinician based on the patient’s condition, weight, liver function and concomitant therapies. Healthcare professionals follow approved labeling and clinical guidelines to individualise therapy for each indication.
Is Nintedanib safe during pregnancy or breastfeeding?+
Safety data for Nintedanib in pregnancy and lactation are limited, and the product is classified as contraindicated or not recommended for use in these populations. Women of child‑bearing potential should use effective contraception, and breastfeeding mothers should discuss alternatives with their healthcare provider.
How do I order Nintedanib Stada 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 (including any cold‑chain requirements) and the necessary import documentation.
How does Nintedanib compare with the main alternative drug or class?+
The primary alternative for idiopathic pulmonary fibrosis is pirfenidone, another antifibrotic agent with a different mechanism focused on cytokine modulation. Nintedanib’s multi‑kinase inhibition offers broader activity against angiogenic and fibrotic pathways, which can be advantageous in certain patients, while pirfenidone may have a more favorable gastrointestinal profile for some individuals.
What are the recommended storage and handling conditions for Nintedanib Stada?+
Store Nintedanib Stada at room temperature, below 25 °C, in the original blister pack or container. Protect the tablets from moisture, excessive heat and direct sunlight to maintain potency throughout the shelf life.
How is Nintedanib Stada administered?+
Nintedanib Stada is taken orally, usually as a whole tablet swallowed with a glass of water. It can be taken with or without food, but patients should follow the prescriber’s instructions regarding timing relative to meals to optimise absorption and minimize gastrointestinal discomfort.
What are the most serious risks to watch for while taking Nintedanib?+
Clinicians and patients should be vigilant for signs of liver injury (elevated transaminases, jaundice), severe bleeding events, cardiovascular complications such as myocardial infarction, and rare but serious gastrointestinal perforations. Prompt medical evaluation is essential if any of these symptoms arise.
Who should not use Nintedanib Stada?+
Nintedanib is contraindicated in patients with severe hepatic impairment (Child‑Pugh C), those with known hypersensitivity to the active ingredient or any excipients, and individuals receiving strong CYP3A4 inhibitors that cannot be discontinued. Caution is also advised for patients with uncontrolled cardiovascular disease or active bleeding disorders.
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 Ag
Origin
EU

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