Finished product reference
Nintedanib Esilate
Capsule, Liquid Filled · Oral · 100 mg
- List code
- 51458
- Pharmacologic class
- Antifibrotic and antineoplastic agent; tyrosine kinase inhibitor
What it is and how it works
Nintedanib is an intracellular inhibitor of multiple tyrosine kinases, including VEGF, FGF and PDGF receptors, blocking fibroblast proliferation, migration and transformation and inhibiting tumour angiogenesis.
Indications
Idiopathic pulmonary fibrosis; other chronic fibrosing interstitial lung diseases with a progressive phenotype; systemic sclerosis-associated interstitial lung disease; in combination with docetaxel for locally advanced, metastatic or recurrent adenocarcinoma non-small cell lung cancer after first-line chemotherapy.
Dosage and administration (summary)
Oral with food: 150 mg twice daily about 12 hours apart, reduced to 100 mg twice daily for intolerance.
Contraindications
Pregnancy and hypersensitivity to nintedanib, peanut or soya.
Warnings and precautions
Diarrhoea is very common and should be managed promptly with hydration and antidiarrhoeals, with dose reduction or interruption if needed. Monitor liver function before and during treatment; not recommended in moderate or severe hepatic impairment. Increased risk of bleeding, arterial thromboembolism, gastrointestinal perforation and impaired wound healing.
Pregnancy
Contraindicated; women of child-bearing potential must use effective contraception during and for at least 3 months after treatment.
Storage and supply
Store below 25 °C in the original package to protect from moisture.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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