Medical Information

The contraindications and use of Brigatinib in special populations must strictly follow clinical guidelines, involving risk management for specific disease states, physiological stages, and organ dysfunction. The following sub items detail contraindications and medication guidelines for special populations to ensure treatment safety and effectiveness.

1. Contraindications

(1) It is contraindicated for patients with a history of hypersensitivity reactions to the active ingredients or excipients of brigatinib, as it may cause severe allergic reactions.

(2) Patients with severe liver function impairment (Child Pugh C grade) are contraindicated as drug metabolism may be significantly inhibited, leading to toxic accumulation.

(3) Pregnant women are prohibited from using it. Based on animal studies showing embryonic toxicity and teratogenic risks, the pregnancy status needs to be confirmed before treatment.

2. Medication for special populations

(1) Pregnancy period

Medications can pass through the placental barrier, and animal data shows that they can cause fetal weight loss and skeletal abnormalities. Pregnancy testing is required before treatment, and those who test positive should evaluate the risk return ratio.

(2) Lactation period

It is not yet clear whether brigatinib is secreted into human milk, but drug components have been detected in animal milk. It is recommended to suspend breastfeeding during the treatment period and within one week after the last administration.

(3) People with reproductive potential

Women of childbearing age should take effective contraceptive measures during treatment and within 4 months after discontinuing medication. Male patients need to use barrier contraception such as condoms when having a reproductive partner.

(4) Pediatric patients

The safety and efficacy of using it for patients under 18 years old have not been established and is not recommended. There is a lack of clinical data to support the adjustment of dosage based on body surface area.

(5) Elderly patients

There is no difference in efficacy between patients over 65 years old and young people, but the incidence of adverse reactions such as pneumonia and fatigue may increase, and monitoring needs to be strengthened.

(6) Liver dysfunction

For patients with mild to moderate liver function impairment, the dosage should be reduced to 60mg starting from, and for those with severe impairment, it is contraindicated. Regular monitoring of transaminase and bilirubin levels is required during treatment.

(7) Renal insufficiency

Mild to moderate renal impairment (creatinine clearance rate ≥ 30mL/min) does not require dose adjustment. Due to severe damage or insufficient data from dialysis patients, caution should be exercised when using it.