Gefitinib is an EGFR tyrosine kinase inhibitor primarily used for the treatment of EGFR mutation positive non-small cell lung cancer. Its contraindications include specific allergic reactions and severe liver function damage. Special populations should pay special attention to risks such as pregnancy and abnormal liver and kidney function when taking medication. The following items will provide specific details.

1. Contraindications

(1) Known to be contraindicated for individuals allergic to gefitinib or any ingredient in the formulation.

(2) Patients with severe liver function impairment (Child Pugh C grade) are contraindicated as significant inhibition of drug metabolism may lead to cumulative toxicity.

(3) Breastfeeding women are prohibited from using the medication, as animal data shows that it can be secreted through breast milk and may pose a risk to infants.

2. Medication for special populations

(1) Pregnancy period

Based on animal teratogenic data, it is contraindicated during pregnancy. Women of childbearing age should confirm their pregnancy status before taking medication, and take effective contraceptive measures at least 2 weeks during treatment and after discontinuing medication.

(2) Lactation period

Medications may enter human breast milk. Breastfeeding should be stopped during the treatment period and within 2 weeks after the last administration to avoid the risk of infant exposure.

(3) Liver dysfunction

Patients with mild to moderate damage should closely monitor their liver function, and severe damage (Child Pugh C grade) is absolutely prohibited. When ALT/AST levels increase by more than 5 times ULN, the medication should be permanently discontinued.

(4) Renal insufficiency

Mild to moderate damage does not require dose adjustment, and there is a lack of data for end-stage renal disease or dialysis patients. It is recommended to use with caution and monitor for adverse reactions.

(5) Elderly patients

Patients over 65 years old do not need to adjust the dosage, but it is necessary to strengthen the monitoring of adverse reactions, as age-related organ dysfunction may increase the risk of toxicity.

(6) Pediatric patients

The safety and efficacy of using it for patients under 18 years old have not been established and is not recommended.