GNH USA

Europe — EMA

Nintedanib Zentiva (Nintedanib Esylate)

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

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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 is indicated for the treatment of idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and certain forms of non‑small cell lung cancer in adult patients. The product is authorized in the European Union and manufactured under stringent quality standards.

GNH USA supplies Nintedanib Zentiva as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics, ensuring consistent quality and regulatory compliance across regions worldwide.

What is Nintedanib Esylate used for?

Nintedanib is used to target fibrotic lung diseases and certain cancers by inhibiting key growth factor receptors. - 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: used in combination therapy to inhibit tumor growth.

What are the side effects of Nintedanib Esylate?

Nintedanib may be associated with 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 occur with or without vomiting. - Vomiting: occasional episodes, usually self‑limiting. - Elevated liver enzymes: increases in ALT/AST observed in laboratory tests.

Serious or Rare Side Effects: - Hepatotoxicity: severe liver injury, jaundice or hepatic failure. - Cardiovascular events: arterial thromboembolism or myocardial infarction. - Severe gastrointestinal perforation: rare but potentially life‑threatening.

What precautions apply to Nintedanib Esylate?

When prescribing Nintedanib, clinicians should consider several safety and handling precautions. - Liver function monitoring: assess baseline ALT/AST and repeat periodically. - Gastrointestinal assessment: evaluate for pre‑existing conditions that may worsen diarrhea. - Bleeding risk: avoid in patients with uncontrolled bleeding or on strong anticoagulants. - Cardiovascular evaluation: monitor for signs of ischemic events, especially in high‑risk patients. - Pregnancy and lactation: contraindicated or use only if benefit outweighs risk (unknown category). - Store at ambient temperature: keep below 25 °C, retain in original packaging, protect from moisture and light.

What does Nintedanib Esylate interact with?

Nintedanib can interact with other medicines, affecting its efficacy or safety.

Major Interactions (Avoid): - Strong CYP3A4 inhibitors: may increase nintedanib exposure, raising toxicity risk. - Anticoagulants (e.g., warfarin): combined use may enhance bleeding risk. - P‑glycoprotein inhibitors: can raise plasma concentrations.

Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inducers: may reduce effectiveness. - Antacids containing magnesium/aluminum: may affect absorption if taken simultaneously. - Diuretics: monitor for dehydration which can exacerbate renal side effects.

Frequently asked questions

What is Nintedanib Zentiva used for?+
Nintedanib Zentiva 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 where inhibition of multiple growth factor receptors is clinically indicated.
How does Nintedanib work?+
The drug inhibits the tyrosine kinase activity of VEGFR, FGFR and PDGFR receptors. This blocks downstream signaling that drives fibroblast proliferation, angiogenesis and extracellular matrix deposition, thereby slowing fibrotic processes and tumor‑related blood vessel formation.
What is the usual dose of Nintedanib Zentiva?+
The specific dose and dosing schedule are determined by the treating physician based on the patient’s condition, renal and hepatic function, and concomitant therapies. Prescribers follow the approved labeling and adjust as clinically indicated.
Is Nintedanib safe during pregnancy or breastfeeding?+
Nintedanib’s pregnancy category is not established. It should be used only if the potential benefit justifies the potential risk to the fetus. Breastfeeding is not recommended while taking the medication because it is unknown whether the drug is excreted in milk.
How do I order Nintedanib Zentiva from GNH USA?+
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?+
For idiopathic pulmonary fibrosis, the primary alternative is pirfenidone, which has a different safety profile and mechanism. Nintedanib targets multiple tyrosine kinases, offering broader inhibition of fibrotic pathways, whereas pirfenidone acts mainly as an anti‑oxidant and anti‑inflammatory agent. Choice depends on efficacy, tolerability and individual patient factors.
How should Nintedanib Zentiva be stored and handled?+
Store the tablets at ambient temperature, preferably below 25 °C. Keep them in the original blister pack, protect from moisture and direct light, and keep out of reach of children.
How is Nintedanib Zentiva administered?+
Nintedanib Zentiva is taken orally, usually with food to reduce gastrointestinal discomfort. Swallow the tablet whole with a glass of water; do not crush or chew it.
What are the most serious risks to watch for while taking Nintedanib?+
Serious adverse events include hepatotoxicity (elevated liver enzymes leading to liver injury), severe bleeding, arterial thromboembolic events, and rare gastrointestinal perforation. Patients should be monitored regularly for liver function, signs of bleeding, and cardiovascular symptoms.
Who should not use Nintedanib Zentiva?+
Patients with severe hepatic impairment, uncontrolled bleeding disorders, recent major cardiovascular events, or those who are pregnant or breastfeeding should avoid Nintedanib unless a specialist determines that 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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