GNH USA

Europe — EMA

Nintedanib Zentiva

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?

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.

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

What is Nintedanib used for?

Nintedanib is used to target fibrotic and oncologic pathways in several serious lung conditions. - Idiopathic pulmonary fibrosis: slows disease progression and reduces decline in lung function. - Systemic sclerosis‑associated interstitial lung disease: helps preserve pulmonary capacity and delay worsening. - Non‑small cell lung cancer: used in combination therapy to inhibit tumor growth and angiogenesis.

What are the side effects of Nintedanib?

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

Common Side Effects: - Diarrhea: frequent loose stools, often mild to moderate. - Nausea: feeling of sickness, may accompany meals. - Vomiting: occasional expulsion of stomach contents. - Abdominal pain: discomfort or cramps in the stomach area. - Decreased appetite: reduced desire to eat. - Elevated liver enzymes: mild increases in ALT/AST.

Serious or Rare Side Effects: - Hepatic failure: signs of severe liver injury such as jaundice. - Severe bleeding: gastrointestinal or intracranial hemorrhage. - Cardiovascular events: myocardial infarction or stroke. - Serious infections: opportunistic or severe bacterial infections. - Gastrointestinal perforation: sudden severe abdominal pain. - Severe skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis.

What precautions apply to Nintedanib?

Before initiating therapy, clinicians should evaluate patient‑specific risk factors and monitor key parameters. - Liver function monitoring: check ALT/AST before start and periodically during treatment. - Cardiovascular assessment: evaluate history of ischemic heart disease or stroke. - Avoid in severe hepatic impairment: contraindicated when liver function is markedly compromised. - Pregnancy and lactation: use only if potential benefit outweighs unknown risks. - Drug‑specific counseling: advise patients to report persistent diarrhea or signs of bleeding. - Store at below 25°C: keep in the original packaging, protect from moisture and direct sunlight.

What does Nintedanib interact with?

Nintedanib can interact with several drug classes, requiring careful management.

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

Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inhibitors (e.g., fluconazole): may modestly raise plasma levels. - Antacids or proton‑pump inhibitors: could affect absorption, monitor therapeutic response. - Diuretics: may exacerbate dehydration from diarrhea, watch electrolytes.

Frequently asked questions

What conditions is Nintedanib Zentiva used to treat?+
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 when used as part of a combination regimen. It targets pathways that drive fibrosis and tumor angiogenesis.
How does Nintedanib work in the body?+
The drug blocks multiple receptor tyrosine kinases—VEGFR, PDGFR and FGFR—thereby reducing fibroblast activity, extracellular matrix buildup, and new blood‑vessel formation. This dual antifibrotic and anti‑angiogenic action helps slow disease progression in the lungs and limits tumor growth.
What is the usual dose of Nintedanib Zentiva?+
The specific dose and schedule are determined by the prescribing clinician based on the patient’s indication, weight, liver function and other clinical factors. Healthcare professionals should follow the approved prescribing information for each approved indication.
Is Nintedanib safe to use during pregnancy or breastfeeding?+
Safety data in pregnancy and lactation are limited. The drug should only be used if the potential benefit to the mother outweighs any possible risk to the fetus or infant. Women of child‑bearing potential should use effective contraception during treatment.
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 needs) and required import documentation.
How does Nintedanib compare with other antifibrotic agents?+
Compared with pirfenidone, another antifibrotic approved for idiopathic pulmonary fibrosis, Nintedanib has a broader kinase inhibition profile, affecting VEGFR, PDGFR and FGFR. Clinical trials show similar efficacy in slowing lung‑function decline, but the side‑effect spectra differ, with Nintedanib more commonly causing diarrhea.
What are the recommended storage conditions for Nintedanib Zentiva?+
Store the tablets at temperatures below 25 °C, in the original container, protected from moisture and direct sunlight. Do not refrigerate or freeze the product, and keep it out of reach of children.
How is Nintedanib Zentiva administered?+
Nintedanib Zentiva is taken orally, usually with food to reduce gastrointestinal discomfort. The tablets should be swallowed whole with a glass of water and not crushed or chewed unless otherwise directed by a healthcare professional.
What are the most serious risks associated with Nintedanib?+
Serious risks include liver injury, severe bleeding, cardiovascular events such as myocardial infarction or stroke, and rare but life‑threatening gastrointestinal perforations. Patients should be monitored regularly for signs of these complications and advised to seek immediate medical attention if they occur.
Who should not take Nintedanib Zentiva?+
Patients with severe hepatic impairment, uncontrolled cardiovascular disease, active bleeding disorders, or those taking strong CYP3A4 inducers or inhibitors that cannot be managed should avoid the drug. Additionally, it is contraindicated in individuals with known hypersensitivity to nintedanib or any of its excipients.
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
Zentiva, K.S.
Origin
EU

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