Nintedanib (Ofev) is a tyrosine kinase inhibitor used for the treatment of idiopathic pulmonary fibrosis (IPF). It exerts its effects by inhibiting targets such as platelet-derived growth factor receptor (PDGFR), fibroblast growth factor receptor (FGFR), and vascular endothelial growth factor receptor (VEGFR).

Precautions for Nintedanib (Ofev) Administration

Contraindication Screening

Patients with moderate to severe liver impairment (Child-Pugh Class B or C): Use is not recommended.

Patients with known bleeding risks: The expected benefits and potential risks must be weighed.

Patients who have undergone recent abdominal surgery: May increase the risk of gastrointestinal perforation.

Patients with severe renal impairment (CrCl < 30 mL/min): The efficacy has not been studied.

Pregnant women: Nintedanib has embryofetal toxicity and may cause fetal malformation or death.

Baseline Assessment Requirements

Liver function tests: Including alanine transaminase (ALT), aspartate transaminase (AST), and bilirubin.

Cardiovascular risk assessment: Special attention should be paid to patients with coronary artery disease.

Pregnancy test: Women of childbearing age must confirm they are not pregnant before taking the medication.

Monitoring During Nintedanib (Ofev) Administration

Liver Function Monitoring

Monitoring frequency: Testing is mandatory before treatment initiation.

Once a month for the first 3 months after starting treatment.

Once every 3 months thereafter.

Testing should be performed at any time when clinically necessary.

Key indicators to monitor: ALT, AST, bilirubin.

Management of abnormalities: Adjust the dose or discontinue treatment based on the degree of elevation.

Adverse Reaction Monitoring

Signs of liver injury: Jaundice, dark-colored urine, right upper abdominal pain, unusual fatigue.

Gastrointestinal reactions: Diarrhea (incidence rate: 62%), nausea (24%), abdominal pain (15%), vomiting (12%).

Cardiovascular events: Chest pain, pain in the upper extremities/back/jaw, dyspnea.

Bleeding tendencies: Abnormal bleeding, bruising, delayed wound healing.

Gastrointestinal perforation: Sudden severe abdominal pain, abdominal distension.

Other Monitoring Items

Weight changes: Monitor regularly; 10% of patients may experience weight loss.

Blood pressure monitoring: 5% of patients may develop hypertension.

Thyroid function: Pay attention to potential hypothyroidism (incidence rate: 1.1%).

Monitoring of drug interactions: Special attention should be given to concurrent use of P-gp/CYP3A4 inhibitors or inducers.