Home Drug Guide Nintedanib Esylate

Drug Guide

Generic Name

Nintedanib Esylate

Brand Names Ofev

Classification

Therapeutic: Antifibrotic agent

Pharmacological: Tyrosine kinase inhibitor

FDA Approved Indications

Idiopathic Pulmonary Fibrosis (IPF)
Progressive Fibrosing Interstitial Lung Disease (PF-ILD)

Mechanism of Action

Nintedanib is a tyrosine kinase inhibitor that targets multiple pathways involved in fibrosis, including inhibition of vascular endothelial growth factor receptors (VEGFRs), fibroblast growth factor receptors (FGFRs), and platelet-derived growth factor receptors (PDGFRs), thereby reducing fibroblast proliferation and fibrotic progression.

Dosage and Administration

Adult: 150 mg twice daily with food. Dose adjustment may be necessary based on tolerability.

Pediatric: Not approved for pediatric use.

Geriatric: Use with caution; no specific dosage adjustment, but monitor for adverse effects.

Renal Impairment: No initial dose adjustment recommended; use caution.

Hepatic Impairment: Avoid use in severe hepatic impairment; dose adjustment recommended in mild to moderate impairment.

Pharmacokinetics

Absorption: Well-absorbed with food, bioavailability approximately 4%.

Distribution: Widely distributed; protein binding approximately 97%.

Metabolism: Primarily metabolized by ester hydrolysis and CYP3A4-mediated oxidation.

Excretion: Excreted mainly via feces (~93%) and urine (~7%).

Half Life: Approximately 10-15 hours.

Contraindications

Hypersensitivity to nintedanib or any component.
Severe hepatic impairment.

Precautions

Use cautiously in patients with bleeding risk, gastrointestinal disorders, or during surgery.
Monitor liver function during therapy.
Patients should be advised about bleeding risks and gastrointestinal symptoms.

Adverse Reactions - Common

Diarrhea (Common)
Nausea (Common)
Elevated liver enzymes (Common)
Abdominal pain (Less common)

Adverse Reactions - Serious

Bleeding complications (Less common)
Liver toxicity (Less common)
Acute lung injury or pneumonitis (Rare)

Drug-Drug Interactions

CYP3A4 inhibitors (e.g., ketoconazole) may increase nintedanib levels.
CYP3A4 inducers (e.g., rifampin) may decrease effectiveness.

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Monitor for signs of bleeding, liver function tests, gastrointestinal symptoms.

Diagnoses:

Risk for bleeding related to anticoagulant or antiplatelet therapy.
Impaired skin integrity related to gastrointestinal side effects.

Implementation: Administer with food to reduce gastrointestinal upset. Educate patients on bleeding precautions.

Evaluation: Assess lung function, monitor adverse effects, and adjust dose as needed.

Patient/Family Teaching

Take medication exactly as prescribed with food.
Report any unusual bleeding, severe diarrhea, or signs of liver problems.
Avoid alcohol and medications that can increase bleeding risk without consulting healthcare provider.

Special Considerations

Black Box Warnings:

Increased risk of bleeding.
Gastrointestinal perforation.

Genetic Factors: No specific genetic considerations identified.

Lab Test Interference: Potential elevation of liver enzymes, bilirubin, and coagulation parameters.

Overdose Management

Signs/Symptoms: Severe diarrhea, bleeding, elevated liver enzymes.

Treatment: Discontinue medication, supportive care, symptomatic treatment, and monitor closely.

Storage and Handling

Storage: Store at room temperature, 20°C to 25°C (68°F to 77°F).

Stability: Stable under recommended storage conditions until expiration date.