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 unknown/unknown for oral use. It treats idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and is used in combination therapy for non‑small cell lung cancer in appropriate patients.
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 indicated for fibrotic lung disorders and as part of combination therapy for certain lung cancers.
- Idiopathic pulmonary fibrosis: slows decline in lung function and reduces disease progression. - Systemic sclerosis‑associated interstitial lung disease: improves pulmonary capacity and delays worsening. - Non‑small cell lung cancer (in combination therapy): enhances treatment efficacy when used with chemotherapy agents.
What are the side effects of Nintedanib?
Nintedanib may cause a range of adverse reactions, varying from mild to severe.
Common Side Effects: - Diarrhea: frequent loose stools, often mild to moderate. - Nausea: feeling of sickness, may be transient. - Elevated liver enzymes: mild increases in ALT/AST. - Decreased appetite: reduced desire to eat.
Serious or Rare Side Effects: - Hepatotoxicity: significant liver injury indicated by marked enzyme rise. - Bleeding events: gastrointestinal or other hemorrhage. - Severe infections: opportunistic infections that may require medical attention.
What precautions apply to Nintedanib?
Before initiating therapy, clinicians should evaluate patient‑specific risk factors and monitor relevant parameters. - Renal function: assess baseline and monitor during therapy. - Hepatic function: avoid in patients with severe liver impairment; monitor enzymes regularly. - Bleeding risk: use caution in patients receiving anticoagulants or antiplatelet agents. - Pregnancy and lactation: safety not established; avoid unless benefits outweigh risks. - Drug interactions: review concomitant medications for CYP3A4 substrates and P‑gp inhibitors. - Store at ambient temperature: keep below 25 °C, retain original packaging, protect from moisture.
What does Nintedanib interact with?
Nintedanib can interact with several drug classes; careful review is required.
Major Interactions (Avoid): - Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine): may markedly reduce nintedanib exposure. - Anticoagulants (e.g., warfarin, direct oral anticoagulants): increase risk of bleeding. - Potent P‑glycoprotein inhibitors (e.g., itraconazole): may raise plasma concentrations.
Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole): may modestly increase exposure. - Antiplatelet agents (e.g., aspirin, clopidogrel): monitor for bleeding tendencies. - Diuretics: watch for dehydration that could affect drug absorption.



