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Zejula

niraparib
PARP Inhibitor FDA Approved 2017 GSK
Route
Oral
Half-Life
36 hrs
FDA Approved
2017
Manufacturer
GSK
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1. Indications and Usage

Ovarian cancer: Maintenance after platinum-based chemotherapy. Also HRD+ after ≥3 prior regimens.

2. Dosage and Administration

200 mg or 300 mg daily based on weight/platelets.

3. Dosage Forms and Strengths

Capsules: 100 mg

4. Contraindications

None listed.

5. Warnings and Precautions
  • MDS/AML: Fatal cases. Monitor CBCs.
  • Bone Marrow Suppression: Thrombocytopenia 61%, anemia 50%.
  • Hypertension: 20%.
  • Embryo-Fetal Toxicity: Can cause fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Nausea (74%), Thrombocytopenia (61%), Fatigue (59%), Anemia (50%), Constipation (40%), Neutropenia (30%), Insomnia (27%), Headache (26%)

Nausea
74%
Thrombocytopenia
61%
Fatigue
59%
Anemia
50%
Constipation
40%
Neutropenia
30%
Insomnia
27%
Headache
26%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

Metabolized by carboxylesterases, not CYP enzymes.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

PARP-1/2 inhibitor causing DNA damage accumulation in HRD tumors leading to cell death.

Pharmacokinetics

Tmax: 3h. Bioavailability: 73%. t½: 36h. Urine 47%.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
📋 All Zejula Trials on ClinicalTrials.gov ↗ 📚 PubMed: Zejula Clinical Trials ↗
FDA-Approved Tumor Types

Zejula has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

Ovarian Cancer
External Resources
📋 DailyMed Label ↗ 🏛️ FDA Drugs@FDA ↗ 🔬 ClinicalTrials.gov ↗ 📚 PubMed Pivotal Trials ↗
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Zejula. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Zejula (niraparib) approved for?

Zejula (niraparib) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Zejula (niraparib) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Zejula (niraparib) work?

PARP-1/2 inhibitor causing DNA damage accumulation in HRD tumors leading to cell death.

What are the most common side effects?

Nausea (74%), Thrombocytopenia (61%), Fatigue (59%), Anemia (50%), Constipation (40%), Neutropenia (30%), Insomnia (27%), Headache (26%) Nausea 74% Thrombocytopenia 61% Fatigue 59% Anemia 50% Constipation 40% Neutropenia 30% Insomnia 27% Headache 26%

← All Therapies Full Prescribing Information ↗