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 an oral formulation for oral use. It treats idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and is used with docetaxel 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 chemotherapy for certain lung cancers. - 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 combination with docetaxel): enhances chemotherapy efficacy and may improve survival outcomes.
What are the side effects of Nintedanib?
Nintedanib may cause a range of adverse reactions, from mild to serious.
Common Side Effects: - Diarrhea: frequent loose stools, often mild to moderate. - Nausea: feeling of sickness, may be accompanied by loss of appetite. - Vomiting: occasional episodes, usually self‑limiting. - Decreased appetite: reduced desire to eat, can affect weight. - Abdominal pain: discomfort or cramping in the stomach area. - Elevated liver enzymes: mild increases in ALT/AST observed in labs.
Serious or Rare Side Effects: - Hepatic failure: severe liver injury requiring immediate medical attention. - Severe bleeding: gastrointestinal or intracranial hemorrhage. - Arterial thromboembolism: clot formation in arteries leading to organ ischemia. - Gastrointestinal perforation: rare tearing of the intestinal wall. - Serious infection: opportunistic infections in immunocompromised patients. - Lung infection: pneumonia or other lower respiratory tract infections.
What precautions apply to Nintedanib?
Before initiating therapy, clinicians should evaluate several safety aspects. - Renal function: assess baseline creatinine and monitor periodically. - Hepatic function: check liver enzymes before start and during treatment. - Bleeding risk: review history of ulcers or anticoagulant use. - Pregnancy: avoid use unless potential benefit justifies potential fetal risk. - Drug interactions: review concomitant medications for CYP3A4 substrates. - Store at ambient temperature: keep in original container, protect from moisture and direct sunlight.
What does Nintedanib interact with?
Nintedanib interacts with several drug classes that may alter its safety or efficacy.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may increase nintedanib exposure. - Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce therapeutic levels. - Anticoagulants (e.g., warfarin): heightened risk of bleeding.
Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inhibitors (e.g., erythromycin, clarithromycin): may modestly raise concentrations. - Antacids containing aluminum or magnesium: can affect absorption, separate dosing by at least 2 hours. - P‑glycoprotein inhibitors (e.g., verapamil): may increase plasma levels modestly.



