Medical Information

The contraindications for Palbociclib mainly involve specific physiological states and drug allergic reactions. Medication for special populations should be adjusted according to liver and kidney function, pregnancy status, etc. The following sub items provide detailed information on contraindications and medication plans for special populations, with a focus on medication standards for pregnant women, those with liver and kidney dysfunction, and other groups.

1. Contraindications

(1) Patients with a history of severe allergic reactions to Pembrolizumab or any of its components, including hypersensitivity reactions such as anaphylactic shock or Stevens Johnson syndrome, are contraindicated.

(2) Pregnant women are strictly prohibited from using this drug, as animal studies have shown that it can cause fetal malformations and growth restriction. Clinical treatment can only be initiated after confirming the non pregnancy status through pregnancy testing.

2. Medication for special populations

(1) Pregnancy period

Based on animal reproductive toxicity data, pembrolizine may cause embryo fetal damage. Pregnant women of childbearing age need to undergo pregnancy testing before taking medication, and efficient contraceptive measures should be used during treatment and at least 3 weeks after the last dose.

(2) Lactation period

There is currently no data on drug excretion in breast milk, but animal experiments have shown milk secretion. It is recommended to suspend breastfeeding during the treatment period and within 3 weeks after discontinuation of medication to avoid potential risks of infant toxicity.

(3) People with reproductive potential

When the spouse of a male patient is a woman of childbearing age, condoms should be used during the treatment period and for 3 months after the last dose. Female patients need to monitor their pregnancy status monthly until 3 weeks after discontinuing medication.

(4) Pediatric patients

The safety and efficacy of patients under 18 years old have not been established, and existing clinical research data is limited to the adult population and is not recommended for use in children.

(5) Elderly patients

Patients over 65 years old do not need to adjust their dosage, but in clinical studies, this group is more prone to hematological toxicity such as neutropenia, and monitoring needs to be strengthened.

(6) Liver dysfunction

Mild or moderate injury (Child Pugh A/B grade) does not require dose adjustment. There is a lack of data on patients with severe liver dysfunction (Child Pugh C grade), and it is recommended to use with caution or reduce dosage.

(7) Renal insufficiency

Mild to moderate renal insufficiency (eGFR ≥ 30mL/min) does not require dose adjustment. End stage renal disease or dialysis patients lack research data and are not recommended for use.