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 an oral formulation for oral use. It is indicated for the treatment of idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and in combination therapy for non‑small cell lung cancer. GNH USA supplies Nintedanib Stada as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics worldwide across multiple regions, ensuring quality and regulatory compliance.

What is Nintedanib used for?

Nintedanib is used to target fibrotic lung disease pathways and certain oncologic indications. - Idiopathic pulmonary fibrosis: slows disease progression and reduces decline in lung function. - Systemic sclerosis‑associated interstitial lung disease: improves pulmonary function and delays worsening. - Non‑small cell lung cancer (in combination therapy): enhances treatment efficacy when combined with chemotherapy.

What are the side effects of Nintedanib?

Nintedanib may cause a range of adverse reactions, varying from mild to serious. Common Side Effects: - Diarrhea: frequent loose stools, often mild to moderate. - Nausea: feeling of sickness, may be transient. - Decreased appetite: reduced desire to eat. - Liver enzyme elevation: mild increase in ALT/AST. Serious or Rare Side Effects: - Severe liver injury: marked transaminase rise or hepatitis. - Gastrointestinal perforation: rare but serious. - Hemorrhage: increased risk of bleeding.

What precautions apply to Nintedanib?

When prescribing Nintedanib Stada, clinicians should consider several safety measures. - Monitor liver function: perform baseline and periodic ALT/AST tests. - Assess for gastrointestinal disorders: evaluate history of ulcer or perforation. - Evaluate bleeding risk: caution in patients on anticoagulants. - Pregnancy and lactation: avoid use as safety is unknown. - Dose adjustments: consider renal or hepatic impairment per prescriber guidance. - Store at ambient temperature: keep below 25°C, retain original packaging, protect from moisture.

What does Nintedanib interact with?

Nintedanib Stada interacts with several drug classes that may require avoidance or close monitoring. Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may increase nintedanib exposure. - Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened bleeding risk. - P‑glycoprotein inhibitors (e.g., verapamil): can raise plasma levels. Moderate Interactions (Monitor Closely): - CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy. - Antiplatelet agents (e.g., aspirin, clopidogrel): monitor for bleeding. - NSAIDs: increase gastrointestinal adverse events.

Frequently asked questions

What is Nintedanib Stada used for?+
Nintedanib Stada contains the active substance nintedanib, a tyrosine kinase inhibitor indicated for the treatment of idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and as part of combination therapy for non‑small cell lung cancer. It works by targeting pathways that drive fibrosis and tumor angiogenesis, helping to slow disease progression in these conditions.
How does nintedanib work?+
Nintedanib blocks several receptor tyrosine kinases, including VEGFR 1‑3, PDGFR‑α/β and FGFR 1‑3. Inhibiting these receptors reduces fibroblast proliferation, extracellular matrix deposition, and new blood‑vessel formation. The resulting decrease in fibrotic tissue development and tumor vascular support underlies its therapeutic effects in pulmonary fibrosis and certain cancers.
What is the usual dose of Nintedanib Stada?+
The specific dose and dosing schedule of Nintedanib Stada are determined by the prescribing physician based on the patient’s condition, weight, renal and hepatic function, and concomitant therapies. Healthcare professionals follow the approved labeling and clinical guidelines to select an appropriate regimen for each individual.
Is Nintedanib Stada safe during pregnancy or breastfeeding?+
The safety of nintedanib in pregnancy and lactation has not been established. It is classified as contraindicated or not recommended for use in pregnant or nursing women because potential risks to the fetus or infant cannot be ruled out. Women of child‑bearing potential should use effective contraception during treatment and discuss alternatives with their doctor.
How do I order Nintedanib Stada from GNH USA?+
To request Nintedanib Stada, visit the product page on gnh-usa.com and submit an enquiry with 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 needs) and necessary import documentation.
How does Nintedanib compare with its main alternative?+
The primary alternative for antifibrotic therapy in idiopathic pulmonary fibrosis is pirfenidone. Both agents slow disease progression, but nintedanib targets multiple tyrosine kinases, whereas pirfenidone’s mechanism involves modulation of cytokine production and oxidative stress. Choice between them depends on patient tolerance, comorbidities, drug‑interaction profile and physician judgment.
What are the recommended storage conditions for Nintedanib Stada?+
Nintedanib Stada should be stored at ambient temperature, preferably below 25 °C. Keep the product in its original container, protect it from moisture and direct sunlight, and avoid exposure to extreme temperatures. Do not refrigerate or freeze unless specifically instructed by the manufacturer.
How is Nintedanib Stada administered?+
Nintedanib Stada is taken orally, usually with food to lessen gastrointestinal discomfort. The tablets (or capsules, depending on the marketed form) are swallowed whole with a glass of water. Patients should follow the prescriber’s instructions regarding timing, dose adjustments and any required monitoring.
What are the most serious risks associated with Nintedanib Stada?+
The most serious adverse events reported with nintedanib include severe liver injury, gastrointestinal perforation and significant bleeding. Patients should be monitored for signs of hepatic dysfunction, abdominal pain suggestive of perforation, and unusual bruising or hemorrhage. Prompt medical evaluation is essential if any of these symptoms arise.
Who should not use Nintedanib Stada?+
Nintedanib Stada is contraindicated in patients with known hypersensitivity to nintedanib or any excipients, in those with active severe hepatic impairment, and in individuals with a history of gastrointestinal perforation. Caution is also advised for patients on strong anticoagulants or with uncontrolled bleeding disorders. The prescriber must assess each patient’s medical history before initiating therapy.
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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