Medical Editor: John P. Cunha, DO, FACOEP
What Is Zejula?
Zejula (niraparib) capsules 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.
What Are Side Effects for Zejula?
Common side effects of Zejula include:
- irregular heartbeat,
- low blood platelet count (thrombocytopenia),
- anemia,
- low white blood cell count (neutropenia, leukopenia),
- palpitations,
- nausea,
- constipation,
- vomiting,
- abdominal pain,
- bloating,
- mucositis,
- swelling and sores inside the mouth,
- diarrhea,
- indigestion,
- heartburn,
- dry mouth,
- fatigue,
- weakness,
- decreased appetite,
- urinary tract infection,
- AST/ALT elevation,
- muscle pain,
- back pain,
- joint pain,
- headache,
- dizziness,
- changes in taste,
- insomnia,
- anxiety,
- runny or stuffy nose,
- shortness of breath,
- cough,
- rash,
- high blood pressure (hypertension),
- trouble sleeping,
- sore throat,
- tiredness,
- loss of appetite, and
- urinary tract infection.
Dosage for Zejula
The recommended dose of Zejula is 300 mg taken once daily with or without food.
What Drugs, Substances, or Supplements Interact with Zejula?
Zejula may interact with other drugs. Tell your doctor all medications and supplements you use.
Zejula During Pregnancy and Breastfeeding
Zejula is not recommended for use during pregnancy; it may harm a fetus. A pregnancy test is recommended for females of reproductive potential prior to initiating Zejula treatment. Consult your doctor before breastfeeding. Women are advised not to breastfeed during treatment with Zejula and for one month after receiving the final dose.
Additional Information
Our Zejula (niraparib) Capsules Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
SLIDESHOW
Skin Cancer Symptoms, Types, Images See SlideshowGet emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop taking this medicine and call your doctor at once if you have signs of a bone marrow disorder: fever, frequent infections, weakness, tiredness, feeling short of breath, weight loss, blood in your urine or stools, easy bruising or bleeding.
Call your doctor at once if you have:
- pounding heartbeats or fluttering in your chest;
- sores or white patches in or around your mouth, trouble swallowing or talking, dry mouth, bad breath, altered sense of taste;
- pain or burning when you urinate; or
- severe headache, blurred vision, pounding in your neck or ears.
Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.
Common side effects may include:
- indigestion, stomach pain, loss of appetite, nausea, vomiting;
- constipation, diarrhea;
- irregular heartbeats, feeling short of breath;
- abnormal liver function or other blood tests;
- little or no urination, changes in the color of your urine, painful urination;
- dry mouth, mouth sores;
- altered sense of taste;
- back pain, muscle or joint pain;
- headache, dizziness, anxiety;
- sleep problems (insomnia);
- tiredness;
- cough, sore throat; or
- rash.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Zejula (Niraparib Capsules)
SIDE EFFECTS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Myelodysplastic Syndrome/Acute Myeloid Leukemia [see WARNINGS AND PRECAUTIONS]
- Bone Marrow Suppression [see WARNINGS AND PRECAUTIONS]
- Cardiovascular Effects [see WARNINGS AND PRECAUTIONS]
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 to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of ZEJULA monotherapy 300 mg once daily has been studied in 367 patients with platinum-sensitive recurrent ovarian, fallopian tube, and primary peritoneal cancer in Trial 1 (NOVA). Adverse reactions in Trial 1 led to dose reduction or interruption in 69% of patients, most frequently from thrombocytopenia (41%) and anemia (20%). The permanent discontinuation rate due to adverse reactions in Trial 1 was 15%. The median exposure to ZEJULA in these patients was 250 days.
Table 4 and Table 5 summarize the common adverse reactions and abnormal laboratory findings, respectively, observed in patients treated with ZEJULA.
Table 4: Adverse Reactions Reported in ≥10% of Patients Receiving ZEJULA
| Grades 1-4* | Grades 3-4* | |||
| ZEJULA N=367 % | Placebo N=179 % | ZEJULA N=367 % | Placebo N=179 % | |
| Blood and Lymphatic System Disorders | ||||
| Thrombocytopenia | 61 | 5 | 29 | 0.6 |
| Anemia | 50 | 7 | 25 | 0 |
| Neutropenia† | 30 | 6 | 20 | 2 |
| Leukopenia | 17 | 8 | 5 | 0 |
| Cardiac Disorders | ||||
| Palpitations | 10 | 2 | 0 | 0 |
| Gastrointestinal Disorders | ||||
| Nausea | 74 | 35 | 3 | 1 |
| Constipation | 40 | 20 | 0.8 | 2 |
| Vomiting | 34 | 16 | 2 | 0.6 |
| Abdominal pain/distention | 33 | 39 | 2 | 2 |
| Mucositis/stomatitis | 20 | 6 | 0.5 | 0 |
| Diarrhea | 20 | 21 | 0.3 | 1 |
| Dyspepsia | 18 | 12 | 0 | 0 |
| Dry mouth | 10 | 4 | 0.3 | 0 |
| General Disorders and Administration Site Conditions | ||||
| Fatigue/Asthenia | 57 | 41 | 8 | 0.6 |
| Metabolism and Nutrition Disorders | ||||
| Decreased appetite | 25 | 15 | 0.3 | 0.6 |
| Infections and Infestations | ||||
| Urinary tract infection | 13 | 8 | 0.8 | 1 |
| Investigations | ||||
| AST/ ALT elevation | 10 | 5 | 4 | 2 |
| Musculoskeletal and Connective Tissue Disorders | ||||
| Myalgia | 19 | 20 | 0.8 | 0.6 |
| Back pain | 18 | 12 | 0.8 | 0 |
| Arthralgia | 13 | 15 | 0.3 | 0.6 |
| Nervous System Disorders | ||||
| Headache | 26 | 11 | 0.3 | 0 |
| Dizziness | 18 | 8 | 0 | 0 |
| Dysgeusia | 10 | 4 | 0 | 0 |
| Psychiatric Disorders | ||||
| Insomnia | 27 | 8 | 0.3 | 0 |
| Anxiety | 11 | 7 | 0.3 | 0.6 |
| Respiratory, Thoracic, and Mediastinal Disorders | ||||
| Nasopharyngitis | 23 | 14 | 0 | 0 |
| Dyspnea | 20 | 8 | 1 | 1 |
| Cough | 16 | 5 | 0 | 0 |
| Skin and Subcutaneous Tissue Disorders | ||||
| Rash | 21 | 9 | 0.5 | 0 |
| Vascular Disorders | ||||
| Hypertension | 20 | 5 | 9 | 2 |
| *CTCAE=Common Terminology Criteria for Adverse Events version 4.02 †Neutropenia includes preferred terms of neutropenic infection and neutropenic sepsis | ||||
Table 5: Abnormal Laboratory Findings in ≥25% of Patients Receiving ZEJULA
| Grades 1-4 | Grades 3-4 | |||
| ZEJULA N=367 (%) | Placebo N= 179 (%) | ZEJULA N= 367 (%) | Placebo N= 179 (%) | |
| Decrease in hemoglobin | 85 | 56 | 25 | 0.5 |
| Decrease in platelet count | 72 | 21 | 35 | 0.5 |
| Decrease in WBC count | 66 | 37 | 7 | 0.7 |
| Decrease in absolute neutrophil count | 53 | 25 | 21 | 2 |
| Increase in AST | 36 | 23 | 1 | 0 |
| Increase in ALT | 28 | 15 | 1 | 2 |
| N=number of patients; WBC=white blood cells; ALT=Alanine aminotransferase; AST=Aspartate aminotransferase | ||||
The following adverse reactions and laboratory abnormalities have been identified in ≥1 to <10% of the 367 patients receiving ZEJULA in the NOVA trial and not included in the table: tachycardia, peripheral edema, hypokalemia, bronchitis, conjunctivitis, gamma-glutamyl transferase increased, blood creatinine increased, blood alkaline phosphatase increased, weight decreased, depression, epistaxis.
Read the entire FDA prescribing information for Zejula (Niraparib Capsules)
© Zejula Patient Information is supplied by Cerner Multum, Inc. and Zejula Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.