ZEJULA

What it is

ZEJULA contains niraparib tosilate monohydrate equivalent to 100 mg niraparib per unit. Niraparib is a highly selective PARP inhibitor. ZEJULA is available as a capsule formulation (first listed on the ARTG on 28 June 2019) and as a film-coated tablet formulation (first listed on the ARTG on 2 August 2023).

Approved indications

— Maintenance treatment of adult patients with advanced high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. — Monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.

Dosing overview

Patients should be encouraged to take their dose at approximately the same time each day, with bedtime administration being a potential method for managing nausea. Treatment should be continued until disease progression or unacceptable toxicity. For adverse reactions, treatment interruption, dose reduction, or dose discontinuation may be considered.

Key safety warnings

ZEJULA contains lactose monohydrate and the capsule shell contains the colouring agent tartrazine. Treatment with ZEJULA should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.

Regulatory history

ZEJULA niraparib 100 mg capsule was first listed on the ARTG on 28 June 2019. The TGA approved ZEJULA on 28 June 2019 for monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. The film-coated tablet formulation was first listed on the ARTG on 2 August 2023. In July 2023, PBAC recommended ZEJULA for epithelial ovarian, fallopian tube, or primary peritoneal cancer.