GNH USA

Europe — EMA

Nintedanib Zentiva (Nintedanib Esylate)

GNH USA supplies Nintedanib Zentiva (Nintedanib), a tyrosine kinase inhibitor for pulmonary fibrosis, sclerosis‑ILD and NSCLC. Request a quote for supply.

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What is Nintedanib Esylate?

Nintedanib, the active ingredient in Nintedanib Zentiva, 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 therapy for non‑small cell lung cancer in appropriate patients.

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

What is Nintedanib Esylate used for?

Nintedanib is indicated for fibrotic lung diseases and certain oncology regimens, targeting pathways that drive fibroblast activity and tumor angiogenesis. - 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 used with standard chemotherapy.

What are the side effects of Nintedanib Esylate?

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

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: - Hepatotoxicity: significant liver injury requiring monitoring. - Bleeding events: increased risk of gastrointestinal or other bleeding. - Cardiovascular events: rare cases of myocardial infarction or stroke.

What precautions apply to Nintedanib Esylate?

When prescribing Nintedanib, clinicians should consider several safety measures. - Dose adjustment: required in patients with moderate hepatic impairment. - Monitoring: regular liver function tests are recommended. - Drug interactions: avoid concomitant use with strong CYP3A4 inhibitors. - Pregnancy: safety not established; avoid use during pregnancy. - Bleeding risk: assess patient history of bleeding disorders. - Store at ambient temperature: keep in original packaging, protect from moisture and heat.

What does Nintedanib Esylate interact with?

Nintedanib interacts with several drug classes; awareness helps prevent adverse events.

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

Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inhibitors (e.g., fluconazole): may modestly raise plasma levels. - P‑glycoprotein substrates (e.g., digoxin): potential altered concentrations. - Antacids containing magnesium/aluminum: may reduce absorption if taken simultaneously.

Frequently asked questions

What is Nintedanib Zentiva used for?+
Nintedanib Zentiva is prescribed to treat idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and to be used in combination with chemotherapy for non‑small cell lung cancer. It targets fibrotic processes and tumor‑related angiogenesis.
How does Nintedanib work?+
Nintedanib blocks several receptor tyrosine kinases—VEGFR, PDGFR and FGFR—thereby inhibiting fibroblast proliferation, migration and extracellular matrix formation, while also reducing angiogenesis. This dual action underlies its antifibrotic and anticancer effects.
What is the usual dose of Nintedanib Zentiva?+
The specific dose and dosing schedule are determined by the prescribing clinician based on the patient’s condition, weight, renal and hepatic function, and other individual factors. No standardized regimen is provided here.
Is Nintedanib safe in pregnancy or breastfeeding?+
Safety data for Nintedanib during pregnancy and lactation are limited, and the product is classified as having an unknown pregnancy category. It is generally avoided in pregnant or nursing women unless the potential benefit outweighs the risk.
How do I order Nintedanib Zentiva 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 the main alternative drug?+
The primary alternative for fibrotic lung disease is pirfenidone, which has a different mechanism—modulating cytokine production and oxidative stress. Nintedanib’s broader kinase inhibition offers anti‑angiogenic activity and is also approved for certain lung cancers, whereas pirfenidone is limited to idiopathic pulmonary fibrosis.
What are the storage and handling requirements for Nintedanib Zentiva?+
Nintedanib Zentiva should be stored at ambient temperature, below 25 °C, in its original packaging to protect it from moisture and excessive heat. Keep the container tightly closed and out of direct sunlight.
How is Nintedanib administered?+
The medication is taken orally, usually as whole tablets swallowed with a glass of water. It is generally recommended to be taken with food to lessen gastrointestinal discomfort, but patients should follow the specific instructions given by their healthcare provider.
What are the most serious risks to watch for while taking Nintedanib?+
Serious adverse events include hepatotoxicity (significant liver enzyme elevations or liver injury), bleeding complications (especially when combined with anticoagulants), and cardiovascular events such as myocardial infarction or stroke. Prompt medical evaluation is advised if any of these occur.
Who should not use Nintedanib Zentiva?+
Patients with severe hepatic impairment, uncontrolled bleeding disorders, or those taking strong CYP3A4 inhibitors should avoid Nintedanib. Additionally, individuals who are pregnant, planning pregnancy, or breastfeeding should not use it unless a clinician determines the benefits outweigh the risks.
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 Esylate
Route
Oral Use
Manufacturer
Zentiva, K.S.
Origin
EU

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