ZEJULA 100 mg/1
niraparib · TABLET, FILM COATED · GlaxoSmithKline LLC
Niraparib (Zejula) is an oral tablet used to treat certain types of ovarian, fallopian tube, and peritoneal cancers, particularly in patients with specific genetic mutations or those who have responded to prior chemotherapy. It works by blocking proteins that help cancer cells repair their DNA, which can slow or stop cancer growth.
Key Facts
- Brand Name
- ZEJULA
- Generic Name
- niraparib
- NDC Code (Product)
0173-0909- Manufacturer
- GlaxoSmithKline LLC
- Strength
- 100 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA214876
- Marketing Start
- 06/27/2023
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE ZEJULA is a poly (ADP-ribose) polymerase (PARP) 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 (HRD)-positive status defined by either: o a deleterious or suspected deleterious BRCA mutation, and/or o genomic instability. Select patients for therapy based on an FDA‑authorized companion diagnostic for ZEJULA. ( 1.1 , 2.1 ) • for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA‑authorized companion diagnostic for ZEJULA. ( 1.2 , 2.1 ) 1.1 First-Line Maintenance Treatment of HRD-Positive Advanced Ovarian Cancer ZEJULA is indicated for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • First‑Line Maintenance Treatment of HRD‑Positive Advanced Ovarian Cancer: o For patients weighing <77 kg (<170 lbs) OR with a platelet count <150,000/mcL, the recommended dosage is 200 mg taken orally once daily. ( 2.2 ) o For patients weighing ≥77 kg (≥170 lbs) AND a platelet count ≥150,000/mcL, the recommended dosage is 300 mg taken orally once daily. ( 2.2 ) • Maintenance Treatment of Recurrent Germline BRCA‑Mutated Ovarian Cancer: The recommended dosage is 300 mg taken orally once daily. ( 2.2 ) • Continue treatment until disease progression or unacceptable toxicity. ( 2.2 ) • ZEJULA may be taken with or without food. ( 2.2 ) • For adverse reactions, consider interruption of treatment, dose reduction, or dose discontinuation. ( 2.3 ) • For patients with moderate hepatic impairment, recommended dosage is 200 mg taken orally once daily. ( 2.4 ) 2.1 Patient Selection First-Line Maintenance Treatment of HRD-Positive Advanced Ovarian Cancer Select patients for first-line maintenance treatment of advanced ovarian cancer with ZEJULA based on the presence of HRD defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instabil…
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • MDS/AML [see Warnings and Precautions ( 5.1 )] • Bone marrow suppression [see Warnings and Precautions ( 5.2 )] • Hypertension and cardiovascular effects [see Warnings and Precautions ( 5.3 )] • Posterior reversible encephalopathy syndrome [see Warnings and Precautions ( 5.4 )] Most common adverse reactions (incidence ≥10%) in patients who received ZEJULA were nausea, thrombocytopenia, anemia, fatigue, constipation, musculoskeletal pain, abdominal pain, vomiting, neutropenia, decreased appetite, leukopenia, insomnia, headache, dyspnea, rash, diarrhea, hypertension, cough, dizziness, acute kidney injury, urinary tract infection, and hypomagnesemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical 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…
Frequently Asked Questions
What is ZEJULA used for?
Niraparib (Zejula) is an oral tablet used to treat certain types of ovarian, fallopian tube, and peritoneal cancers, particularly in patients with specific genetic mutations or those who have responded to prior chemotherapy. It works by blocking proteins that help cancer cells repair their DNA, which can slow or stop cancer growth.
Is ZEJULA a controlled substance?
ZEJULA is not classified as a controlled substance by the DEA.
What is the generic name for ZEJULA?
The generic name for ZEJULA is niraparib. There are 2 other brand versions of niraparib.
What is the NDC code for ZEJULA 100 mg/1?
The NDC (National Drug Code) for ZEJULA 100 mg/1 is 0173-0909, listed by GlaxoSmithKline LLC.