Europe — EMA
Nintedanib Eg
GNH USA supplies Nintedanib Eg (Nintedanib), a tyrosine kinase inhibitor for idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung
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What is Nintedanib?
Nintedanib, the active ingredient in Nintedanib Eg, is a tyrosine kinase inhibitor presented as an oral dosage form for oral use. It treats idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and non‑small cell lung cancer in appropriate patients.
GNH USA supplies Nintedanib Eg as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics worldwide.
What is Nintedanib used for?
Nintedanib is used in fibrotic lung diseases and certain cancers, targeting pathways that drive fibroblast proliferation and tumor growth.
- Idiopathic pulmonary fibrosis: slows decline in lung function and reduces disease progression. - Systemic sclerosis‑associated interstitial lung disease: improves lung capacity and delays worsening. - Non‑small cell lung cancer: used in combination therapy to inhibit tumor angiogenesis and growth.
What are the side effects of Nintedanib?
Nintedanib may cause a range of adverse reactions, from mild to serious. Patients should be monitored regularly for any new symptoms.
Common Side Effects: - Diarrhea: frequent loose stools, often mild to moderate. - Nausea: feeling of sickness, may affect appetite. - Vomiting: occasional episodes, usually self‑limiting. - Abdominal pain: discomfort in the stomach area. - Decreased appetite: reduced desire to eat, can lead to weight loss. - Weight loss: unintended loss of body weight.
Serious or Rare Side Effects: - Elevated liver enzymes: may indicate hepatic injury. - Bleeding events: increased risk of gastrointestinal or other bleeding. - Cardiovascular events: such as hypertension or arterial thromboembolism. - Severe infections: opportunistic infections in immunocompromised patients. - Gastrointestinal perforation: rare but potentially life‑threatening. - Allergic reactions: rash, pruritus, or anaphylaxis in extreme cases.
What precautions apply to Nintedanib?
Before initiating therapy, clinicians should assess baseline organ function and consider potential risks.
- Liver function monitoring: check ALT, AST, and bilirubin before and during treatment. - Bleeding risk assessment: evaluate concomitant anticoagulant or antiplatelet use. - Cardiovascular evaluation: review history of hypertension, ischemic disease, or thromboembolism. - Pregnancy and lactation: avoid use unless benefits outweigh unknown risks. - Drug interaction review: assess all concomitant medicines for CYP3A4 or P‑gp relevance. - Store at room temperature: keep in the original container, protect from moisture and direct sunlight.
What does Nintedanib interact with?
Nintedanib can interact 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. - Antiplatelet agents (e.g., aspirin, clopidogrel): additive hemorrhagic potential. - P‑glycoprotein inhibitors (e.g., verapamil): may raise plasma levels. - High‑dose aspirin (>325 mg): increased gastrointestinal toxicity.
Moderate Interactions (Monitor Closely): - CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy. - Diuretics: monitor electrolytes and renal function. - NSAIDs: watch for additive GI irritation. - Statins metabolized by CYP3A4: consider dose adjustment. - Herbal supplements (e.g., St John’s wort): potential induction of metabolism.



