Zejula Dosage & Drug Information

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Core Prescribing Info

Contents

Niraparib

Indications/Uses

Monotherapy for the maintenance treatment of adult patients w/ advanced epithelial (FIGO stages III & IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of 1st-line platinum-based chemotherapy; w/ 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.

Dosage/Direction for Use

1st-line ovarian cancer maintenance treatment Recommended starting dose: 200 mg once daily. Patient weighing ≥77 kg & have baseline platelet count ≥150,000/μL Recommended starting dose: 300 mg once daily. Maintenance treatment of advanced ovarian cancer Start treatment no later than 12 wk after patient's most recent platinum-containing regimen. Recurrent ovarian cancer maintenance treatment 300 mg once daily. Patient weighing <58 kg Consider a starting dose of 200 mg. Maintenance treatment of recurrent ovarian cancer Start treatment no later than 8 wk after the patient's most recent platinum-containing regimen.

Administration

May be taken with or without food: Swallow whole w/ water, do not chew/crush.

Contraindications

Hypersensitivity. Lactation.

MIMS Class

Targeted Cancer Therapy

ATC Classification

L01XK02 - niraparib ; Belongs to the class of poly (ADP-ribose) polymerase (PARP) inhibitors. Used in the treatment of cancer.

Regulatory Classification

POM

Presentation/Packing

Form

Zejula FC tab 100 mg

Packing/Price

1's

Form

Zejula FC tab 200 mg

Packing/Price

1's

Zejula

Manufacturer:

Catalent Greenville Inc