Europe — EMA
Nintedanib Stada
GNH USA supplies Nintedanib Stada (Nintedanib), a tyrosine kinase inhibitor for idiopathic pulmonary fibrosis and non‑small cell lung cancer.
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What is Nintedanib?
Nintedanib, the active ingredient in Nintedanib Stada, is a tyrosine kinase inhibitor presented as an oral dosage form for oral use. It treats idiopathic pulmonary fibrosis and non‑small cell lung cancer in patients for whom these conditions are indicated.
GNH USA supplies Nintedanib Stada as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics worldwide.
What is Nintedanib used for?
Nintedanib is indicated for diseases driven by fibroblast proliferation and tumor angiogenesis.
Idiopathic pulmonary fibrosis: slows disease progression and preserves lung function. 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, from mild to serious.
Common Side Effects: - Diarrhea - Nausea - Vomiting - Abdominal pain - Decreased appetite - Elevated liver enzymes (ALT/AST)
Serious or Rare Side Effects: - Hepatic failure - Severe bleeding events - Arterial thromboembolism - Gastrointestinal perforation - Severe hypertension - Interstitial lung disease
What precautions apply to Nintedanib?
Before initiating therapy, clinicians should assess several safety aspects.
Monitor liver function: perform baseline and periodic hepatic enzyme tests. Assess cardiovascular risk: evaluate history of thromboembolic disease. Evaluate bleeding risk: caution in patients on anticoagulants. Avoid in severe hepatic impairment: contraindicated when liver function is markedly compromised. Pregnancy and lactation: safety unknown; avoid use unless benefit outweighs risk. Store at below 25°C: keep in the original packaging, protect from moisture and light.
What does Nintedanib interact with?
Nintedanib interacts with several drug classes that may alter its exposure or increase toxicity.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): increase nintedanib plasma levels. - Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine): markedly reduce nintedanib exposure. - Anticoagulants (e.g., warfarin): heightened risk of bleeding.
Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inhibitors (e.g., erythromycin): may modestly raise exposure. - Moderate CYP3A4 inducers (e.g., phenobarbital): may modestly lower exposure.



