nintedanib esilate: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
nintedanib esilate: clinical details
Prescribing considerations
- Specialist initiation is required for the licensed disease context.
- Assess hepatic and renal function, bleeding and cardiovascular risk, gastrointestinal history, blood pressure, pregnancy potential and planned surgery before treatment.
- Persistent gastrointestinal toxicity may require supportive care and specialist-led interruption, modification or discontinuation.
- For the oncology indication, account for docetaxel-related toxicity and the selected product's treatment-day instructions.
Contraindications and cautions
- Hypersensitivity to nintedanib or an excipient in the selected product.
- Pregnancy when treating idiopathic pulmonary fibrosis, progressive fibrosing ILD or systemic sclerosis-associated ILD.
- Moderate or severe hepatic impairment is not recommended rather than an absolute contraindication.
- Use particular caution with significant bleeding risk, recent arterial thromboembolism, gastrointestinal perforation risk, renal impairment, severe pulmonary hypertension or impaired wound healing.
Monitoring
- Liver transaminases and bilirubin before treatment, closely during the early treatment period and periodically thereafter.
- Renal function and clinical evidence of proteinuria, nephrotic syndrome or thrombotic microangiopathy.
- Blood pressure, bleeding, hydration, weight and gastrointestinal tolerability.
- Complete blood count when used with docetaxel, with vigilance for neutropenia, febrile neutropenia and sepsis.
- Clinical response and pulmonary function in fibrosing lung disease.
Clinical pharmacology
Nintedanib competitively inhibits ATP-binding sites of multiple receptor tyrosine kinases, notably VEGFR, FGFR and PDGFR. It is a P-glycoprotein substrate, undergoes mainly esterase-mediated hydrolysis with limited CYP involvement, is highly protein-bound and is eliminated predominantly through the biliary-faecal route.
Formulation and product differences
- The selected product is an oral soft gelatin capsule containing a liquid suspension and must remain intact.
- Product excipients can differ between manufacturers; allergy assessment should use the leaflet and SmPC for the dispensed product.
nintedanib esilate preparations and strengths
Capsule
Route: Oral
Strengths: 25 mg, 100 mg, 150 mg
nintedanib esilate interactions
Ask a pharmacist or prescriber to check all prescribed, non-prescribed and herbal products. Important examples include:
Potent P-glycoprotein inhibitors, such as ketoconazole, erythromycin or ciclosporin
May increase nintedanib exposure and adverse effects, requiring closer tolerability monitoring.
Potent P-glycoprotein inducers, such as rifampicin, carbamazepine, phenytoin or St John's wort
May reduce nintedanib exposure; an alternative with little or no inducing effect should be considered.
Anticoagulants and other medicines that increase bleeding
Bleeding risk may be higher; clinical bleeding and relevant anticoagulation tests require monitoring.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.