niraparib

High Alert

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.

Contraind./Precautions ⬆ ⬇

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);
Rep: Women of reproductive potential;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

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

Interactions ⬆ ⬇

Drug-drug:

None reported.

Availability ⬆ ⬇

Tablets: 100 mg; 200 mg; 300 mg
In combination with:
abiraterone (Akeega). See Combination Drugs.

Route/Dosage ⬆ ⬇

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.

Hepatic Impairment

PO (Adults ): Moderate hepatic impairment: 200 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.

Hepatic Impairment

PO (Adults ): Moderate hepatic impairment: 200 mg once daily until disease progression or unacceptable toxicity. Treatment should be started within 12 wk after most recent platinum-containing regimen.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

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

Therapeutic effects:

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

Classifications ⬆ ⬇

Therapeutic Classification: antineoplastics

Pharmacologic Classification: enzyme inhibitors

Pharmacokinetics ⬆ ⬇

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.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	3 hr	24 hr

Patient/Family Teaching ⬆ ⬇

Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes. Instruct patient to take niraparib as directed at the same time each day. Do not stop therapy without consulting health care professional. If a dose is missed or patient vomits after dose, omit and take next dose at scheduled time; do not double doses.
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.
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.
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 breastfeeding during and for 1 mo after last dose of therapy. Inform male patients niraparib may impair fertility.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

0173- GlaxoSmithKline LLC
- 0173-0909- ZEJULA
  - 0173-0909-13- 30 TABLET, FILM COATED in 1 BOTTLE (0173-0909-13)

0173- GlaxoSmithKline LLC
- 0173-0912- ZEJULA
  - 0173-0912-13- 30 TABLET, FILM COATED in 1 BOTTLE (0173-0912-13)

0173- GlaxoSmithKline LLC
- 0173-0912- ZEJULA
  - 0173-0912-61- 30 TABLET, FILM COATED in 1 BOTTLE (0173-0912-61)

0173- GlaxoSmithKline LLC
- 0173-0915- ZEJULA
  - 0173-0915-13- 30 TABLET, FILM COATED in 1 BOTTLE (0173-0915-13)

0173- GlaxoSmithKline LLC
- 0173-0915- ZEJULA
  - 0173-0915-61- 30 TABLET, FILM COATED in 1 BOTTLE (0173-0915-61)

11014- Catalent Pharma Solutions, LLC
- 11014-0565-
  - 11014-0565-1- 1 BAG in 1 PAIL (11014-0565-1) / 46000 CAPSULE in 1 BAG

11014- Catalent Pharma Solutions, LLC
- 11014-0571-
  - 11014-0571-1- 1 BAG in 1 PAIL (11014-0571-1) / 42237 TABLET, FILM COATED in 1 BAG

11014- Catalent Pharma Solutions, LLC
- 11014-0572-
  - 11014-0572-1- 1 BAG in 1 PAIL (11014-0572-1) / 21115 TABLET, FILM COATED in 1 BAG

11014- Catalent Pharma Solutions, LLC
- 11014-0573-
  11014-0573-1- 1 BAG in 1 PAIL (11014-0573-1) / 14078 TABLET, FILM COATED in 1 BAG

61876- DISHMAN CARBOGEN AMCIS LIMITED
- 61876-0723-
  61876-0723-1- 25 kg in 1 DRUM (61876-0723-1)

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Indications ⬇