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

Request sourcing

1
Pack/s

What is Nintedanib Esylate?

Nintedanib, the active ingredient in Nintedanib Zentiva, is a tyrosine kinase inhibitor presented as a capsule for oral use. It is indicated for idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and as part of combination therapy for 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 Esylate used for?

Nintedanib targets fibrotic lung disease and certain cancers by inhibiting multiple growth‑factor receptors.

Idiopathic pulmonary fibrosis: slows disease progression and reduces decline in lung function. Systemic sclerosis‑associated interstitial lung disease: helps preserve lung capacity in affected patients. Non‑small cell lung cancer (in combination therapy): contributes to tumor control when used with chemotherapy.

What are the side effects of Nintedanib Esylate?

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

Common Side Effects: - Diarrhea: often mild to moderate, may require supportive care. - Nausea and vomiting: usually transient. - Abdominal pain or discomfort. - Decreased appetite and weight loss. - Elevated liver enzymes (ALT, AST). - Headache.

Serious or Rare Side Effects: - Severe liver injury or hepatitis. - Gastrointestinal perforation. - Significant bleeding events. - Cardiovascular complications such as myocardial infarction. - Severe infections. - Pulmonary embolism.

What precautions apply to Nintedanib Esylate?

Before initiating therapy, clinicians should assess baseline organ function and consider potential risks. - Liver function monitoring: obtain baseline tests and repeat periodically. - Bleeding risk: evaluate concomitant anticoagulant or antiplatelet use. - Gastrointestinal tolerance: monitor for severe or persistent diarrhea. - Pregnancy and lactation: use only if potential benefit justifies potential risk. - Drug interactions: review all concomitant medications for CYP3A4 or P‑gp effects. - Store at ambient temperature: keep below 25°C, retain original packaging, protect from moisture.

What does Nintedanib Esylate interact with?

Nintedanib interacts with several drug classes that can alter its exposure or increase adverse events.

Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin): may increase nintedanib levels. - Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin): may reduce efficacy. - Potent P‑gp inhibitors (e.g., verapamil): can raise systemic exposure. - Anticoagulants/antiplatelet agents: heightened bleeding risk. - High‑dose aspirin: may exacerbate gastrointestinal toxicity.

Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inhibitors (e.g., fluconazole, erythromycin): may modestly increase exposure. - Antacids or proton‑pump inhibitors: could affect absorption; separate dosing by at least 2 hours. - NSAIDs: monitor for additive gastrointestinal bleeding. - Herbal supplements affecting CYP enzymes (e.g., St John's wort): may lower drug levels. - Diuretics: watch for electrolyte disturbances if severe diarrhea occurs.

Frequently asked questions

What conditions is Nintedanib Zentiva used to treat?+
Nintedanib Zentiva is prescribed for idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and as part of combination therapy for non‑small cell lung cancer in adult patients. It works by targeting pathways that drive fibrosis and tumor growth.
How does Nintedanib work in the body?+
Nintedanib inhibits multiple receptor tyrosine kinases—including VEGFR 1‑3, PDGFR‑α/β, and FGFR 1‑3—thereby reducing fibroblast proliferation, angiogenesis, and extracellular matrix formation. This dual antifibrotic and anti‑angiogenic action helps slow disease progression in the lungs and can limit tumor vascularization.
What is the usual dose of Nintedanib Zentiva?+
The specific dose and dosing schedule of Nintedanib Zentiva are determined by the prescribing clinician based on the patient’s condition, weight, renal and hepatic function, and concomitant therapies. Patients should follow the prescriber’s instructions and not adjust the dose on their own.
Is Nintedanib safe to use during pregnancy or breastfeeding?+
Safety data for Nintedanib in pregnancy and lactation are limited. It 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 and for a period after discontinuation.
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 (including any cold‑chain requirements) and necessary import documentation.
How does Nintedanib compare with other antifibrotic agents?+
Nintedanib differs from other antifibrotics such as pirfenidone by targeting a broader range of tyrosine kinases, offering both antifibrotic and anti‑angiogenic effects. Clinical trials have shown comparable efficacy in slowing lung function decline, but the side‑effect profile—particularly gastrointestinal events—may vary between agents.
What are the recommended storage conditions for Nintedanib Zentiva?+
Nintedanib Zentiva capsules should be stored at ambient temperature, preferably below 25 °C. Keep them in the original blister pack, protect from moisture and direct sunlight, and store out of reach of children.
How is Nintedanib Zentiva administered?+
The medication is taken orally, usually with food to lessen gastrointestinal discomfort. Capsules should be swallowed whole with a full glass of water and not crushed, chewed, or opened. Patients should follow the dosing schedule prescribed by their healthcare provider.
What are the most serious risks associated with Nintedanib?+
Serious risks include severe liver injury, gastrointestinal perforation, significant bleeding, cardiovascular events such as myocardial infarction, and rare but severe infections. Patients should be monitored regularly for liver enzyme elevations, signs of bleeding, and any new or worsening symptoms.
Who should not take Nintedanib Zentiva?+
Nintedanib is contraindicated in patients with known hypersensitivity to the active substance or any excipients, and in those with severe hepatic impairment. Caution is advised for individuals with active bleeding disorders, uncontrolled hypertension, or those taking strong CYP3A4 inhibitors or inducers without appropriate dose adjustments.
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 Portugal, Lda
Origin
EU

Related products