Olaparib is absolutely or relatively contraindicated for patients with severe liver and kidney dysfunction and pregnant women. Before medication, a comprehensive evaluation of liver function, kidney function, and pregnancy status must be conducted to ensure patient safety.

1、 Severe liver dysfunction patients

1.1 Definition and Judgment

Severe liver dysfunction usually refers to Child Pugh C patients.

Patients with significantly elevated baseline ALT/AST (>3 × ULN) or total bilirubin>1.5 × ULN also need to be rigorously evaluated.

1.2 Prohibition Basis

Olaparib is mainly metabolized through the liver, and severe liver damage can lead to drug accumulation, significantly increasing the risk of toxicity.

The drug instructions clearly state that it is contraindicated for Child Pugh Class C patients.

1.3 Clinical recommendations

Prohibited: Olaparib should not be used in patients diagnosed with severe liver dysfunction.

Caution/Reduction: Patients with moderate liver damage (Child Pugh B) should reduce their dosage under the guidance of a specialist physician.

2、 Severe renal insufficiency patients

2.1 Definition

Severe renal dysfunction usually refers to creatinine clearance rate (CrCl)<30mL/min.

End stage renal disease (ESRD) or dialysis dependent patients are also prohibited.

2.2 Prohibition Basis

When renal function is severely impaired, the clearance of olaparib and its metabolites is significantly slowed down, increasing the risk of bone marrow suppression and nephrotoxicity.

2.3 Clinical recommendations

CrCl<30mL/min: Olaparib is prohibited.

CrCl 30-50mL/min: Reduced use may be considered, but close monitoring of renal function and blood routine is required.

3、 Pregnant women and those preparing for pregnancy

3.1 Risk Statement

Olaparib has mutagenicity, and animal experiments have shown clear embryotoxicity and teratogenicity.

Pregnancy is listed as an absolute contraindication in the drug instructions.

3.2 Contraceptive Requirements

Women of childbearing age: A pregnancy test (negative) is required before treatment, and effective contraceptive measures must be taken during treatment and at least 6 months after discontinuation of medication.

Male patients (with partners of childbearing age) should use condoms during treatment and for at least 3 months after discontinuing medication.

3.3 Management of Unexpected Pregnancy

If pregnancy is diagnosed during treatment, medication should be stopped immediately and referral to obstetrics and genetic counseling specialties should be made.