• Maintenance treatment of deleterious or suspected deleterious germline BRCA-mutated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients who are in a complete or partial response to platinum-based chemotherapy.
• Maintenance treatment of advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients who are in a complete or partial response to first-line platinum-based chemotherapy.

Contraindicated in:

• OB: Pregnancy
• Lactation: Lactation.

Use Cautiously in:

• Ischemic heart disease, arrhythmias, or hypertension
• Severe renal impairment (CCr <30 mL/min)
• Previous use of platinum chemotherapy agents or radiation (↑ risk of secondary myelodysplastic syndrome or acute myeloid leukemia)
• Moderate or severe hepatic impairment (↓ dose in moderate hepatic impairment)
• Aspirin hypersensitivity (contains tartrazine)
• Rep: Women of reproductive potential
• Pedi: Safety and effectiveness not established in children.

CV: palpitations, hypertension.

Derm: rash.

GI: ↑ liver enzymes, abdominal pain/distention, constipation, diarrhea, dry mouth, dyspepsia, nausea, stomatitis, vomiting.

GU: urinary tract infection, ↓ fertility (males).

Hemat: anemia, leukopenia, neutropenia, thrombocytopenia, MYELODYSPLASTIC SYNDROME (MDS)/ACUTE MYELOID LEUKEMIA (AML), pancytopenia.

Metab: ↓ appetite.

MS: arthralgia, myalgia.

Neuro: anxiety, dizziness, dysgeusia, fatigue, headache, insomnia, POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME (PRES).

Resp: cough, dyspnea.

Drug-Drug:

• None reported.

• Capsules (contain tartrazine): 100 mg;
• Tablets: 100 mg; 200 mg; 300 mg;

Maintenance Treatment of Recurrent Germline BRCA-Mutated Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

• PO (Adults): 300 mg once daily until disease progression or unacceptable toxicity. Treatment should be started within 8 wk after most-recent platinum-containing regimen.

Maintenance Treatment of Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

• PO (Adults ≥77 kg AND platelet count ≥150,000/mm³): 300 mg once daily until disease progression or unacceptable toxicity. Treatment should be started within 12 wk after most-recent platinum-containing regimen.
• PO (Adults <77 kg OR platelet count <150,000/mm³): 200 mg once daily until disease progression or unacceptable toxicity. Treatment should be started within 12 wk after most-recent platinum-containing regimen.

Zejula

• Acts as a poly (ADP-ribose) polymerase (PARP-1 and PARP-2) inhibitor; results in DNA damage, apoptosis, and cell death.

• Decreased progression of ovarian, fallopian tube, or primary peritoneal cancer and improved survival.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: enzyme inhibitors

Absorption: 73% absorbed following oral administration.

Distribution: Extensively distributed to tissues.

Metabolism/Excretion: Primarily metabolized by carboxylesterases to an inactive metabolite; 48% excreted in urine (11% as unchanged drug), 39% in feces (19% as unchanged drug).

Half-life: 36 hr.

(plasma concentrations)

• Instruct patient to take niraparib as directed at the same time each day. Do not stop therapy without consulting health care professional. If dose missed or patient vomits after dose, omit and take next dose at scheduled time; do not double doses. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes.
• Advise patient to notify health care professional if symptoms of MDS or AML (weakness, fever, feeling tired, weight loss, shortness of breath, blood in urine or stool, frequent infections, unusual bruising or bleeding) occur.
• Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
• Rep: May cause fetal harm. Advise females of reproductive potential to use effective contraception during and for 6 mo after last dose and to avoid breast feeding during and for 1 mo after last dose of therapy. Inform male patients niraparib may impair fertility.

nye-RAP-a-rib

NDC Code^*

• 69656- TESARO, Inc.
  • 69656-103- ZEJULA
    • 69656-103-30- 30 CAPSULE in 1 BOTTLE (69656-103-30)

• 69656- TESARO, Inc.
  • 69656-103- ZEJULA
    • 69656-103-90- 90 CAPSULE in 1 BOTTLE (69656-103-90)