Europe — EMA
Nintedanib Stada
GNH USA supplies Nintedanib Stada (Nintedanib), a tyrosine kinase inhibitor for idiopathic pulmonary fibrosis, systemic sclerosis‑associated ILD and NSCLC.
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What is Nintedanib?
Nintedanib, the active ingredient in Nintedanib Stada, 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 with chemotherapy for non‑small cell lung cancer.
GNH USA supplies Nintedanib Stada as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.
What is Nintedanib used for?
Nintedanib acts on multiple fibrotic and oncogenic pathways, providing therapeutic benefit in several lung‑related conditions.
Idiopathic pulmonary fibrosis: slows disease progression and reduces decline in lung function. Systemic sclerosis‑associated interstitial lung disease: helps preserve lung capacity and delay worsening. Non‑small cell lung cancer (in combination with chemotherapy): contributes to tumor growth inhibition when used with standard chemotherapy regimens.
What are the side effects of Nintedanib?
Nintedanib may cause a range of adverse reactions that vary in frequency and severity.
Common Side Effects: - Diarrhoea: frequent, often mild to moderate. - Nausea and vomiting: may occur after dosing. - Abdominal pain: intermittent discomfort. - Decreased appetite: reduced food intake. - Weight loss: gradual reduction in body weight. - Elevated liver enzymes: mild transaminase rise.
Serious or Rare Side Effects: - Hepatotoxicity: significant liver injury requiring monitoring. - Bleeding events: gastrointestinal or other hemorrhage. - Cardiovascular complications: myocardial infarction or arterial thrombosis. - Severe infections: opportunistic or bacterial infections. - Gastrointestinal perforation: rare but potentially life‑threatening. - Interstitial lung disease exacerbation: worsening respiratory status.
What precautions apply to Nintedanib?
Before initiating therapy, clinicians should evaluate patient‑specific risk factors and monitor key parameters.
Monitor liver function: obtain baseline and periodic LFTs during treatment. Assess cardiovascular status: check blood pressure and cardiac history. Avoid in severe hepatic impairment: contraindicated in patients with Child‑Pugh C disease. Use caution with anticoagulants: increased risk of bleeding, monitor coagulation parameters. Store at room temperature: keep in the original container, protect from moisture and light.
What does Nintedanib interact with?
Nintedanib can interact with several drug classes, influencing its safety and efficacy.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase nintedanib exposure. - Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened bleeding risk. - P‑glycoprotein inhibitors (e.g., verapamil): increased plasma levels.
Moderate Interactions (Monitor Closely): - CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy. - Antacids containing magnesium/aluminum: may affect absorption; separate dosing by at least 2 hours. - Diuretics: monitor for dehydration and renal function changes.



