Europe — EMA
Nintedanib Accordpharma
GNH USA supplies Nintedanib Accordpharma (Nintedanib), a tyrosine kinase inhibitor for idiopathic pulmonary fibrosis, systemic sclerosis‑associated
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What is Nintedanib?
Nintedanib, the active ingredient in Nintedanib Accordpharma, is a tyrosine kinase inhibitor presented as an oral formulation for oral use. It is indicated for the treatment of idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and certain forms of non‑small cell lung cancer.
GNH USA supplies Nintedanib Accordpharma as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, and pharmacies worldwide, with a focus on quality assurance and regulatory compliance.
What is Nintedanib used for?
Nintedanib is used in fibrotic lung disorders and selected oncology settings to target pathways involved in tissue scarring and tumor growth. - Idiopathic pulmonary fibrosis: slows disease progression and reduces decline in lung function. - Systemic sclerosis‑associated interstitial lung disease: helps preserve lung capacity and delays worsening. - Non‑small cell lung cancer (in specific settings): contributes to tumor growth inhibition when used as indicated.
What are the side effects of Nintedanib?
Nintedanib may be associated with a range of adverse reactions, which are generally categorized by frequency and severity.
Common Side Effects: - Diarrhea: frequent loose stools, often mild to moderate. - Nausea: feeling of sickness or urge to vomit. - Vomiting: occasional episodes of expulsion of stomach contents. - Elevated liver enzymes: increase in ALT/AST detected in blood tests.
Serious or Rare Side Effects: - Hepatotoxicity: severe liver injury, potentially leading to jaundice. - Cardiovascular events: arterial thromboembolism or myocardial infarction. - Severe bleeding: gastrointestinal hemorrhage or other major bleeding episodes.
What precautions apply to Nintedanib?
Before initiating therapy, clinicians should evaluate several safety considerations. - Liver function monitoring: assess ALT, AST, and bilirubin before and during therapy. - Bleeding risk assessment: evaluate for anticoagulant use or history of hemorrhage. - Cardiovascular evaluation: monitor for signs of ischemic events, especially in patients with risk factors. - Pregnancy and lactation: avoid use unless benefits outweigh potential risks, as safety data are limited. - Drug interactions: review concomitant medications, particularly CYP3A4 substrates and anticoagulants. - Store at ambient temperature: keep below 25 °C, in the original packaging, protected from moisture and light.
What does Nintedanib interact with?
Nintedanib can interact with several drug classes, requiring careful management.
Major Interactions (Avoid): - Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine): may markedly reduce nintedanib exposure. - Anticoagulants (e.g., warfarin, direct oral anticoagulants): increased risk of bleeding. - Concomitant use with other potent VEGF inhibitors: additive toxicity risk.
Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole): may increase nintedanib levels. - P‑glycoprotein inhibitors (e.g., verapamil): potential increase in exposure. - Diuretics: monitor for dehydration which can affect drug tolerability.



