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 a 150 mg oral capsule for adult use. It is indicated for idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and certain forms of non‑small cell lung cancer. The drug works by blocking multiple growth factor receptors that drive fibroblast activity and tumor angiogenesis, helping to slow disease progression.
GNH USA supplies Nintedanib Sandoz as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.
What is Nintedanib used for?
Nintedanib is used in fibrotic lung disorders and selected oncologic settings, targeting disease pathways that involve fibroblast proliferation and angiogenesis.
Idiopathic pulmonary fibrosis: slows decline in lung function and reduces disease progression. Systemic sclerosis‑associated interstitial lung disease: improves forced vital capacity and stabilizes respiratory symptoms. 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, which are categorized by frequency and severity.
Common Side Effects: - Diarrhea: frequent loose stools, often mild to moderate. - Nausea: feeling of sickness, may be transient. - Vomiting: occasional episodes. - Abdominal pain: discomfort in the stomach area. - Elevated liver enzymes: increase in ALT/AST levels.
Serious or Rare Side Effects: - Hepatic failure: severe liver injury requiring monitoring. - Bleeding events: gastrointestinal or other hemorrhage. - Cardiovascular events: arterial thromboembolism or myocardial infarction. - Severe infections: opportunistic or serious bacterial infections. - Perforations of the gastrointestinal tract: rare but potentially life‑threatening.
What precautions apply to Nintedanib?
Before initiating therapy, clinicians should assess baseline health status and monitor for specific risks. - Liver function monitoring: perform baseline and periodic ALT/AST tests. - Bleeding risk assessment: evaluate for anticoagulant use and history of hemorrhage. - Cardiovascular evaluation: monitor for signs of arterial thrombotic events. - Pregnancy and lactation: avoid use unless benefits outweigh risks; discuss with healthcare provider. - Drug interactions: review concomitant medications, especially CYP3A4 inhibitors or inducers. - Store at ambient temperature: keep below 25 °C, in original container, protected from moisture and light.
What does Nintedanib interact with?
Nintedanib interacts with several drug classes; some combinations should be avoided while others require close monitoring.
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., itraconazole): can raise plasma levels.
Moderate Interactions (Monitor Closely): - CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy. - Antacids containing aluminum or magnesium: may affect absorption; separate dosing. - Herbal supplements (e.g., St John’s wort): potential induction of metabolism.



