Brand Name
Zejula
Generic Name
Niraparib
View Brand Information FDA approval date: June 27, 2023
Classification: Poly(ADP-Ribose) Polymerase Inhibitor
Form: Tablet
What is Zejula (Niraparib)?
ZEJULA is a poly polymerase inhibitor indicated: for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency -positive status defined by either o a deleterious or suspected deleterious BRCA mutation, and/or o genomic instability.
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Brand Information
ZEJULA (niraparib)
1DOSAGE FORMS AND STRENGTHS
- Tablets: 100-mg gray, oval-shaped, film-coated tablet debossed with “100” on one side and “Zejula” on the other side.
- Tablets: 200-mg blue, oval-shaped, film-coated tablet debossed with “200” on one side and “Zejula” on the other side.
- Tablets: 300-mg green, oval-shaped, film-coated tablet debossed with “300” on one side and “Zejula” on the other side.
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- MDS/AML
- Bone marrow suppression
- Hypertension and cardiovascular effects
- Posterior reversible encephalopathy syndrome
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In a pooled safety population of patients (n = 1,314) with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with ZEJULA monotherapy including PRIMA (n = 484), NOVA (n = 367), and another clinical trial (n = 463), the most common adverse reactions >10% were nausea (65%), thrombocytopenia (60%), anemia (56%), fatigue (55%), constipation (39%), musculoskeletal pain (36%), abdominal pain (35%), vomiting (33%), neutropenia (31%), decreased appetite (24%), leukopenia (24%), insomnia (23%), headache (23%), dyspnea (22%), rash (21%), diarrhea (18%), hypertension (17%), cough (16%), dizziness (14%), acute kidney injury (13%), urinary tract infection (12%), and hypomagnesemia (11%).
First-Line Maintenance Treatment of HRD-Positive Advanced Ovarian Cancer
The safety of ZEJULA for the treatment of patients with advanced ovarian cancer following first-line treatment with platinum-based chemotherapy was studied in the PRIMA trial, a placebo-controlled, double-blind study in which 484 patients received ZEJULA. Among this population, 245 patients were HRD-positive and their median duration of treatment was 13 months (range: 3 days to 29 months).
HRD-Positive Patients Receiving ZEJULA in PRIMA: Serious adverse reactions occurred in 30% of patients receiving ZEJULA. Serious adverse reactions in >2% of patients were thrombocytopenia (11%) and anemia (5%). Fatal adverse reactions occurred in 1.6% of patients, including AML (0.4%), cardiac arrest (0.4%), intestinal perforation (0.4%), and sudden death (0.4%).
Permanent discontinuation due to adverse reactions occurred in 11% of patients who received ZEJULA. Adverse reactions resulting in permanent discontinuation in >1% of patients who received ZEJULA included thrombocytopenia (3.7%), nausea (1.6%), and anemia (1.2%).
Adverse reactions led to dose reduction or interruption in 79% of patients, most frequently (>10%) from thrombocytopenia (53%), anemia (32%), and neutropenia (19%).
Tables 4 and 5 summarize the common adverse reactions and abnormal laboratory findings observed in the PRIMA trial.
HRD-Positive Patients Receiving ZEJULA with Dose Based on Baseline Weight or Platelet Count in PRIMA: Among patients who received ZEJULA with the dose based on weight and platelet count (n = 86), the median duration of treatment was 12 months (range: 4 days to 16 months).
Serious adverse reactions occurred in 24% of patients receiving ZEJULA. Serious adverse reactions in >2% of patients were anemia (9%) and thrombocytopenia (2%).
Permanent discontinuation due to adverse reactions occurred in 11% of patients who received ZEJULA. Adverse reactions resulting in permanent discontinuation in >2% of patients who received ZEJULA included nausea (3.5%).
Adverse reactions led to dose reduction or interruption in 72% of patients, most frequently (>10%) from thrombocytopenia (35%), anemia (22%), and neutropenia (17%).
Maintenance Treatment of Recurrent Germline
The safety of monotherapy with ZEJULA 300 mg once daily has been studied in 136 patients with platinum-sensitive recurrent g
Table 8 and Table 9 summarize the common adverse reactions and abnormal laboratory findings, respectively, observed in patients treated with ZEJULA in the gBRCAmut cohort in NOVA.
The following adverse reactions have been identified in ≥1 to <10% of the 136 patients receiving ZEJULA in the g
3.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of ZEJULA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood and Lymphatic System Disorders
Pancytopenia.
Immune System Disorders
Hypersensitivity (including anaphylaxis).
Nervous System Disorders
Posterior reversible encephalopathy syndrome (PRES).
Psychiatric Disorders
Confusional state/disorientation, hallucination, cognitive impairment (e.g., memory impairment, concentration impairment).
Respiratory, Thoracic, and Mediastinal Disorders
Non-infectious pneumonitis.
Skin and Subcutaneous Tissue Disorders
Photosensitivity.
Vascular Disorders
Hypertensive crisis.
4DESCRIPTION
Niraparib is an orally available poly (ADP-ribose) polymerase (PARP) inhibitor.
The chemical name for niraparib tosylate monohydrate is 2-{4-[(3S)-piperidin-3-yl]phenyl}-
Niraparib tosylate monohydrate is a white to off-white, non-hygroscopic crystalline solid. Niraparib solubility is pH independent below the pKa of 9.95, with an aqueous free base solubility of 0.7 mg/mL to 1.1 mg/mL across the physiological pH range.
Each ZEJULA tablet contains 159.3 mg, 318.7 mg, or 478.0 mg of niraparib tosylate monohydrate equivalent to 100 mg, 200 mg, or 300 mg, respectively, of niraparib free base as the active ingredient. The inactive ingredients in the core tablet are crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and silicon dioxide. The film-coating consists of Opadry II Gray (100 mg), Opadry II Blue (200 mg), or Opadry II Green (300 mg).
5HOW SUPPLIED/STORAGE AND HANDLING
ZEJULA is available as oval-shaped, film-coated tablets containing 100 mg, 200 mg, or 300 mg of niraparib free base.
ZEJULA 100-mg tablets are gray, debossed with “100” on one side and “Zejula” on the other side. Bottle of 30 tablets (NDC 0173-0909-13).
ZEJULA 200-mg tablets are blue, debossed with “200” on one side and “Zejula” on the other side. Bottle of 30 tablets (NDC 0173-0912-13).
ZEJULA 300-mg tablets are green, debossed with “300” on one side and “Zejula” on the other side. Bottle of 30 tablets (NDC 0173-0915-13).
Store and dispense in the original bottle. Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C to 30°C (59°F to 86°F)
6PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Myelodysplastic Syndrome/Acute Myeloid Leukemia
Advise patients to contact their healthcare provider if they experience weakness, feeling tired, fever, weight loss, frequent infections, bruising, bleeding easily, breathlessness, blood in urine or stool, and/or laboratory findings of low blood cell counts or a need for blood transfusions. This may be a sign of hematological toxicity or MDS or AML, which has been reported in patients treated with ZEJULA
Bone Marrow Suppression
Advise patients that periodic monitoring of their blood counts is required. Advise patients to contact their healthcare provider for new onset of bleeding, fever, or symptoms of infection
Hypertension and Cardiovascular Effects
Advise patients to undergo blood pressure and heart rate monitoring at least weekly for the first 2 months, then monthly for the first year of treatment and periodically thereafter. Advise patients to contact their healthcare provider if blood pressure is elevated
Posterior Reversible Encephalopathy Syndrome
Inform patients that they are at risk of developing posterior reversible encephalopathy syndrome (PRES) that can present with signs and symptoms including seizure, headaches, altered mental status, or vision changes. Advise patients to contact their healthcare provider if they develop any of these signs or symptoms
Dosing Instructions
Inform patients on how to take ZEJULA
Embryo-Fetal Toxicity
Advise females to inform their healthcare provider if they are pregnant or become pregnant. Inform female patients of the risk to a fetus and potential loss of the pregnancy
Contraception
Advise females of reproductive potential to use effective contraception during treatment with ZEJULA and for 6 months after receiving the last dose
Lactation
Advise patients not to breastfeed while taking ZEJULA and for 1 month after the last dose
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Manufactured for
GlaxoSmithKline
Durham, NC 27701
©2025 GSK group of companies or its licensor.
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