HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ZEJULA safely and effectively. See full prescribing information for ZEJULA.
ZEJULA™ (niraparib)capsules, for oral use
Initial U.S. Approval: 2017
INDICATIONS AND USAGE
ZEJULA is a poly(ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. (1)
DOSAGE AND ADMINISTRATION
Recommended dose is 300 mg taken once daily with or without food. (2.1)
Continue treatment until disease progression or unacceptable adverse reaction. (2.1, 2.2)
For adverse reactions, consider interruption of treatment, dose reduction, or dose discontinuation. (2.2)
DOSAGE FORMS AND STRENGTHS
Capsules: 100 mg (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): MDS/AML occurred in patients exposed to ZEJULA, and some cases were fatal. Monitor patients for hematological toxicity and discontinue if MDS/AML is confirmed (5.1)
Bone Marrow Suppression: Test complete blood counts weekly for the first month, monthly for the next 11 months and periodically thereafter for clinically significant changes. (5.2)
Cardiovascular Effects: Monitor blood pressure and heart rate monthly for the first year and periodically thereafter during treatment with ZEJULA. Manage with antihypertensive medications as well as adjustment of the ZEJULA dose, if necessary. (5.3)
Embryo-Fetal Toxicity: ZEJULA can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. (5.4, 8.1, 8.3)
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥10%) are thrombocytopenia, anemia, neutropenia, leukopenia, palpitations, nausea, constipation, vomiting, abdominal pain/distention, mucositis/stomatitis, diarrhea, dyspepsia, dry mouth, fatigue/asthenia, decreased appetite, urinary tract infection, AST/ALT elevation, myalgia, back pain, arthralgia, headache, dizziness, dysgeusia, insomnia, anxiety, nasopharyngitis, dyspnea, cough, rash, and hypertension. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact TESARO at 1-844-4-TESARO or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Lactation: Advise women not to breastfeed during treatment and for 1 month after receiving the final dose. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 3/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
2.2 Dose Adjustments for Adverse Reactions
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Myelodysplastic Syndrome/Acute Myeloid Leukemia
5.2 Bone Marrow Suppression
5.3 Cardiovascular Effects
5.4 Embryo-Fetal Toxicity
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1