Niraparib (Zejula) is a PARP inhibitor indicated for maintenance treatment of certain patients with ovarian cancer.

Indications for Niraparib

1. First-line Maintenance Treatment of Advanced Ovarian Cancer

(1) Indicated for patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.

(2) Treatment should be initiated within 12 weeks after the last dose of platinum-based chemotherapy.

2. Maintenance Treatment of Recurrent gBRCA-mutated Ovarian Cancer

(1) Indicated for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a deleterious or suspected deleterious germline BRCA mutation and are in complete or partial response to platinum-based chemotherapy.

(2) Treatment should be initiated within 8 weeks after the last dose of platinum-based chemotherapy, and BRCA mutation status must be confirmed using an FDA-approved companion diagnostic test.

Contraindications and Prohibited Foods for Niraparib

1. Contraindications

According to the FDA label, niraparib has no absolute contraindications. However, multiple warnings and precautions need to be strictly observed.

2. Food and Drug Interactions Requiring Caution

(1) No specific prohibited foods: A high-fat meal (800-1000 calories, approximately 50% fat) does not affect the absorption of niraparib, so it can be taken with or without food.

(2) Bedtime administration suggestion: To reduce nausea, consider taking it at bedtime.

(3) Drug interaction alert: Niraparib inhibits MATE1 and MATE2 transporters and may increase the plasma concentrations of drugs that are substrates of these transporters (e.g., metformin). Although no clinical drug interaction studies have been conducted, caution is advised when co-administering such drugs.

(4) Allergy note: The capsule contains FD&C Yellow No.5 (tartrazine), which may cause allergic reactions (including bronchial asthma) in patients allergic to aspirin or those sensitive to it.

Niraparib Use in Special Populations

1. Patients with Hepatic Impairment

(1) Mild hepatic impairment (total bilirubin ≤1.5×ULN, any AST level): No dose adjustment required.

(2) Moderate hepatic impairment (total bilirubin 1.5-3.0×ULN, any AST): Reduce starting dose to 200 mg once daily and monitor for hematologic toxicity.

(3) Severe hepatic impairment (total bilirubin >3.0×ULN): Recommended dose has not been established.

2. Patients with Renal Impairment

(1) Mild to moderate renal impairment (CLcr 30-89 mL/min): No dose adjustment required.

(2) Severe renal impairment or end-stage renal disease on dialysis: Safety unknown, no data available.

3. Elderly Patients

In clinical trials, 39% (PRIMA) and 35% (NOVA) of patients were aged ≥65 years. No overall differences in safety were observed between elderly and younger patients, but a greater sensitivity in some older individuals cannot be ruled out.

4. Pediatric Patients

Safety and effectiveness have not been established.

5. Pregnant and Lactating Women

(1) Pregnancy: Based on its mechanism of action, niraparib can cause fetal harm. Females of reproductive potential should use effective contraception during treatment and for 6 months after the last dose.

(2) Lactation: Breastfeeding should be discontinued during treatment and for 1 month after the last dose.

6. Male Fertility

Animal studies suggest that niraparib may impair male fertility (reduction in sperm, spermatocytes, and germ cells).