Europe — EMA
Nintedanib Sandoz
GNH USA supplies Nintedanib Sandoz (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 Sandoz, is a tyrosine kinase inhibitor presented as an oral tablet for oral use. It is indicated for certain fibrotic lung diseases and selected lung cancer patients.
GNH USA supplies Nintedanib Sandoz as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Nintedanib used for?
Nintedanib is used to treat progressive fibrotic lung conditions and a specific type of lung cancer.
- Idiopathic pulmonary fibrosis: slows the rate of decline in lung function. - Systemic sclerosis‑associated interstitial lung disease: reduces disease progression. - Non‑small cell lung cancer: used in combination therapy to inhibit tumor growth.
What are the side effects of Nintedanib?
Nintedanib may cause a range of adverse reactions, from mild to serious.
Common Side Effects: - Diarrhea: frequent loose stools. - Nausea: feeling of sickness. - Vomiting: expulsion of stomach contents. - Abdominal pain: discomfort in the stomach area. - Decreased appetite: reduced desire to eat. - Elevated liver enzymes: increased ALT/AST levels.
Serious or Rare Side Effects: - Hepatotoxicity: severe liver injury. - Hypertension: significant increase in blood pressure. - Bleeding events: gastrointestinal or other bleeding. - Cardiovascular events: myocardial infarction or stroke. - Severe infections: opportunistic infections in immunocompromised patients.
What precautions apply to Nintedanib?
Before initiating therapy, clinicians should assess baseline health and monitor for known risks.
- Liver function monitoring: check ALT/AST before and during treatment. - Bleeding risk assessment: avoid in patients with active bleeding or uncontrolled anticoagulation. - Cardiovascular evaluation: monitor blood pressure and cardiac status regularly. - Pregnancy and lactation: use only if potential benefit justifies potential risk; safety data are lacking. - Drug interaction review: assess concomitant medications that affect P‑gp or CYP3A4. - Store at ambient temperature: keep below 25 °C, in the original container, protected from moisture and light.
What does Nintedanib interact with?
Nintedanib can interact with other medicines, altering its effectiveness or safety.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase nintedanib exposure. - Potent P‑gp inhibitors (e.g., verapamil): can raise plasma concentrations. - Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened bleeding risk.
Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inhibitors (e.g., fluconazole): may modestly raise levels. - P‑gp inducers (e.g., rifampicin): may reduce efficacy. - Antacids containing magnesium or aluminum: may affect absorption if taken simultaneously.



