Niraparib
Niraparib is a PARP inhibitor medication used primarily for treating certain ovarian, fallopian tube, and primary peritoneal cancers. It works by blocking PARP enzymes involved in DNA repair, causing DNA damage accumulation and cancer cell death, particularly in tumors with BRCA mutations. It is typically given as maintenance therapy after initial chemotherapy response.
A PARP inhibitor cancer medication used for ovarian and related cancers that exploits DNA repair vulnerabilities in cancer cells.
Key facts at a glance
- ATC
- L01XK02
- RxNorm
- 1918231
- Generic
- Niraparib
- Class
- atc-l01
- Brands
- Zejula, Akeega
- Availability
- rx
- Lactation
- unknown
- Routes
- oral
- Forms
- tablet, capsule
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 300mg once daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- Not FDA approved for pediatric use
- Maximum
- consult physician
- Frequency
- N/A
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 200mg once daily (starting dose)
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
13 groupspregnancy
first trimesteravoid use
avoid use during pregnancy due to potential for embryofetal toxicity and fetal harm; discontinue therapy if pregnancy occurs
regular fetal monitoring and pregnancy testing
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
second trimesteravoid use
continue to avoid use; potential for ongoing fetal harm
regular fetal monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
third trimesteravoid use
avoid use; discuss delivery planning with oncology and obstetrics teams
regular fetal monitoring and growth assessment
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingavoid breastfeeding
do not breastfeed during treatment and for at least 1 month after last dose due to potential for serious adverse reactions in nursing infants
monitor infant for signs of toxicity
Use of this medication in this population requires careful consideration of risks and benefits.
pediatric_age
adolescents 12 17not established
safety and efficacy not established in pediatric patients; use only in clinical trials
no specific monitoring guidelines established
geriatric
elderly 65 plusno initial dose adjustment required
use with caution; monitor for adverse reactions including myelosuppression and hypertension; no dose adjustment for age alone
monitor blood counts more frequently; monitor blood pressure regularly
Use with caution and monitor for adverse effects.
geriatric
very elderly 75 plusconsider dose reduction based on tolerability
use with increased caution; consider starting at reduced dose in frail patients; individualize therapy based on comorbidities and tolerability
frequent monitoring of blood counts and vital signs; assess renal function
Use with caution and monitor for adverse effects.
renal_impairment
mild creatinine clearance 60 90no dose adjustment required
no dosage adjustment needed for mild renal impairment
routine monitoring of renal function
renal_impairment
moderate creatinine clearance 30 59no specific dose adjustment required per label
use with caution; monitor patients closely for adverse reactions; may require more frequent blood count monitoring
more frequent complete blood count monitoring recommended
Use with caution and monitor for adverse effects.
renal_impairment
severe creatinine clearance less 30use with caution; limited data available
use only if benefits outweigh risks; no specific dosing recommendations; consider reduced starting dose
frequent blood count monitoring and renal function assessment
Use with caution and monitor for adverse effects.
hepatic_impairment
mild bilirubin 1 1 5x ulnno dose adjustment required
no dosage adjustment needed for mild hepatic impairment
routine liver function monitoring
hepatic_impairment
moderate bilirubin 1 5 3x ulnno specific dose adjustment required per label
use with caution; no formal dosing recommendations; monitor for increased adverse effects
monitor liver function tests and for signs of hepatic toxicity
Use with caution and monitor for adverse effects.
hepatic_impairment
severe bilirubin greater 3x ulnuse with caution; limited data
use only if benefits outweigh risks; limited clinical data; consider reduced dose
frequent liver function monitoring
Use with caution and monitor for adverse effects.
Statistics and clinical data
FDA Approval Year
Initial FDA approval for Niraparib (Zejula)
Drug class
Mechanism-based classification as poly ADP-ribose polymerase inhibitor
Primary indication
Approved indication for epithelial ovarian, fallopian tube, or primary peritoneal cancer
Combination therapy
Combination product for metastatic castration-resistant prostate cancer
Treatment of adult patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer who have responded to platinum-based chemotherapy. Used as maintenance therapy regardless of BRCA mutation status, and as monotherapy for BRCA-mutated ovarian cancer after prior chemotherapy.
Inhibits PARP-1 and PARP-2 enzymes involved in base excision repair of DNA damage. This leads to accumulation of single-strand breaks that convert to double-strand breaks during replication, causing cytotoxicity particularly in cancer cells with homologous recombination deficiency (e.g., BRCA mutations) due to synthetic lethality.
Requires specialist oncology supervision. Complete blood count monitoring needed due to myelosuppression risk. Contraindicated in pregnancy (teratogenic). Common adverse effects include fatigue, nausea, anemia, and thrombocytopenia. Dose adjustments may be needed based on toxicity and baseline weight.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy