GNH USA

Europe — EMA

Nintedanib Stada

GNH USA supplies Nintedanib Stada (Nintedanib), a tyrosine kinase inhibitor for idiopathic pulmonary fibrosis and 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 a tablet for oral use. It is indicated for the treatment of idiopathic pulmonary fibrosis and systemic sclerosis‑associated interstitial lung disease in adult patients. GNH USA supplies Nintedanib Stada as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

What is Nintedanib used for?

Nintedanib is an antifibrotic agent that targets progressive fibrotic lung disorders.

Idiopathic pulmonary fibrosis: slows the decline in forced vital capacity and improves survival. Systemic sclerosis‑associated interstitial lung disease: reduces the rate of lung function deterioration. Progressive fibrosing interstitial lung disease (non‑IPF): attenuates disease progression in patients with a fibrotic phenotype.

What are the side effects of Nintedanib?

Nintedanib is associated with a range of adverse reactions that vary in frequency and severity.

Common Side Effects: - Diarrhea: frequent, often mild to moderate. - Nausea: may occur after dosing. - Vomiting: occasional, usually self‑limiting. - Abdominal pain: mild discomfort reported. - Decreased appetite: reduced food intake. - Weight loss: modest, related to gastrointestinal effects.

Serious or Rare Side Effects: - Elevated liver enzymes (ALT/AST): may indicate hepatic injury. - Bleeding events: increased risk of gastrointestinal or other hemorrhage. - Cardiovascular events: such as myocardial infarction or stroke. - Severe infections: opportunistic infections reported. - Gastrointestinal perforation: rare but serious complication. - Worsening of interstitial lung disease: rare progression despite therapy.

What precautions apply to Nintedanib?

When prescribing Nintedanib, clinicians should consider several safety measures.

Monitor liver function: check ALT/AST before initiation and periodically thereafter. Assess bleeding risk: avoid in patients with active ulcers or on strong anticoagulants. Evaluate cardiovascular status: caution in patients with recent myocardial infarction or stroke. Counsel on gastrointestinal symptoms: advise patients to report persistent diarrhea or abdominal pain. Avoid use in severe hepatic impairment: contraindicated in patients with Child‑Pugh C. Store at below 25°C: keep in the original pack, protect from moisture.

What does Nintedanib interact with?

Nintedanib may interact with other medicines that affect its metabolism or increase bleeding risk.

Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may raise plasma levels. - Potent P‑glycoprotein inhibitors (e.g., itraconazole): can increase exposure. - Anticoagulants (e.g., warfarin) at high doses: heightened bleeding risk.

Moderate Interactions (Monitor Closely):\n- Moderate CYP3A4 inhibitors (e.g., fluconazole): may modestly increase concentrations. - CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy. - Non‑steroidal anti‑inflammatory drugs (NSAIDs): monitor for gastrointestinal bleeding.

Frequently asked questions

What conditions is Nintedanib Stada used to treat?+
Nintedanib Stada is prescribed for adults with idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and other progressive fibrosing interstitial lung diseases where it helps slow the decline in lung function.
How does Nintedanib work in the body?+
Nintedanib blocks several receptor tyrosine kinases—VEGFR, PDGFR, and FGFR—thereby inhibiting fibroblast activity, reducing collagen deposition, and limiting the development of fibrotic tissue in the lungs.
What is the usual dose of Nintedanib Stada?+
The exact dosage and schedule are determined by the prescribing physician based on the patient’s condition, renal and hepatic function, and tolerance. Patients should follow the prescriber’s instructions precisely.
Is Nintedanib Stada safe to use during pregnancy or breastfeeding?+
Safety data in pregnancy and lactation are limited, and the product is not recommended for use in pregnant or nursing women unless the potential benefit justifies the potential risk. Consultation with a healthcare professional is essential.
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, and any necessary import documentation.
How does Nintedanib compare with other antifibrotic agents?+
Nintedanib differs from pirfenidone, another antifibrotic, by targeting a broader range of tyrosine kinases. Clinical trials show comparable efficacy in slowing lung function decline, but the side‑effect profiles vary, with Nintedanib more frequently causing gastrointestinal symptoms.
What are the storage requirements for Nintedanib Stada?+
Nintedanib Stada should be stored at temperatures below 25 °C, in its original packaging, and protected from moisture and direct sunlight to maintain stability.
How is Nintedanib Stada administered?+
The medication is taken orally, usually as a tablet, with or without food as directed by the prescriber. Swallow the tablet whole with water and do not crush or chew it.
What are the most serious risks associated with Nintedanib Stada?+
Serious risks include liver enzyme elevations, severe bleeding, cardiovascular events such as myocardial infarction or stroke, gastrointestinal perforation, and rare worsening of interstitial lung disease. Patients should be monitored regularly for these events.
Who should not use Nintedanib Stada?+
Patients with severe hepatic impairment, active bleeding disorders, recent major cardiovascular events, or known hypersensitivity to nintedanib or any excipients should avoid using this medication. The prescriber will assess suitability on an individual basis.
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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