Europe — EMA
Nintedanib Lotus
GNH USA supplies Nintedanib Lotus (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 Lotus, is a tyrosine kinase inhibitor presented as an oral tablet for oral use. It is used to treat idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and certain forms of non‑small cell lung cancer in adult patients.
GNH USA supplies Nintedanib Lotus as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.
What is Nintedanib used for?
Nintedanib acts on multiple receptor tyrosine kinases involved in fibrotic and oncogenic pathways, providing therapeutic benefit in several serious lung conditions. - Idiopathic pulmonary fibrosis: slows disease progression and helps preserve lung function. - Systemic sclerosis‑associated interstitial lung disease: reduces decline in forced vital capacity. - Non‑small cell lung cancer (specific molecular subtypes): inhibits tumor growth when used as part of combination therapy.
What are the side effects of Nintedanib?
Nintedanib is associated with a range of adverse reactions that vary in frequency and severity.
Common Side Effects: - Diarrhoea: often mild to moderate, may require antidiarrhoeal therapy. - Nausea: usually transient and manageable with food. - Liver enzyme elevation: monitored through routine blood tests. - Decreased appetite: may lead to weight loss if persistent. - Vomiting: generally resolves with supportive care.
Serious or Rare Side Effects: - Severe hepatic injury: indicated by marked transaminase rise, requires discontinuation. - Cardiovascular events: including myocardial infarction or stroke in high‑risk patients. - Gastrointestinal perforation: rare but potentially life‑threatening. - Severe bleeding: especially in patients on anticoagulants. - Interstitial lung disease exacerbation: requires immediate medical attention.
What precautions apply to Nintedanib?
Before initiating therapy, clinicians should assess baseline organ function and comorbidities. - Liver function monitoring: obtain baseline tests and repeat periodically. - Gastrointestinal health: evaluate for pre‑existing conditions that could worsen with treatment. - Cardiovascular risk: consider patient history of ischemic disease before use. - Drug interactions: review concomitant medications for potential CYP3A4 involvement. - Pregnancy and lactation: avoid use unless benefits clearly outweigh potential risks. - Store at ambient temperature: keep below 25 °C, retain in original packaging, protect from moisture and direct sunlight.
What does Nintedanib interact with?
Nintedanib may interact with drugs that affect its metabolism or increase bleeding risk.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may raise plasma levels and toxicity. - Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened bleeding risk.
Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy. - P‑glycoprotein substrates (e.g., digoxin): potential alteration in drug exposure. - NSAIDs and antiplatelet agents: monitor for signs of gastrointestinal bleeding. - Herbal supplements affecting liver enzymes (e.g., St John's wort): assess for possible interaction.



