Generic drug: niraparib
Brand name: Zejula
What is Zejula (niraparib), and how does it work?
Zejula is a prescription medicine used for the:
- maintenance treatment of adults with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. Zejula is used after the cancer has responded (complete or partial response) to treatment with platinum-based chemotherapy.
- maintenance treatment of adults with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that comes back. Zejula is used after the cancer has responded (complete or partial response) to treatment with platinum-based chemotherapy.
- treatment of adults with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have been treated with 3 or more prior types of chemotherapy and who have tumors with:
- a certain “BRCA” gene mutation, or
- gene mutation problems and who have progressed more than 6 months after their last treatment with platinum-based chemotherapy.
Your healthcare provider will perform a test to make sure that Zejula is right for you.
It is not known if Zejula is safe and effective in children.
What are the side effects of Zejula?
The most common side effects of Zejula include:
- heart not beating regularly,
- changes in liver function or other blood tests,
- pain in your joints, muscles, and back;
- pain in the stomach area,
- change in the way food tastes,
- mouth sores,
- trouble sleeping,
- indigestion or heartburn,
- sore throat,
- dry mouth,
- shortness of breath,
- loss of appetite,
- urinary tract infection, and
- changes in the amount or color of your urine
Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with Zejula, if you have certain side effects.
These are not all the possible side effects of Zejula. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the dosage for Zejula?
Patient Selection For Treatment Of Advanced Ovarian Cancer After 3 Or More Chemotherapies
Select patients for treatment of advanced ovarian cancer after 3 or more chemotherapy regimens associated with HRD positive status based on either deleterious or suspected deleterious BRCA mutation and/or genomic instability score (GIS).
Information on FDA-approved tests for the detection of either deleterious or suspected deleterious BRCA mutation or genomic instability for this indication is available at https://www.fda.gov/companiondiagnostics.
Continue treatment with Zejula until disease progression or unacceptable toxicity.
Instruct patients to take their dose of Zejula at approximately the same time each day. Advise patients to swallow each capsule whole and not to chew, crush, or split Zejula prior to swallowing. Zejula may be taken with or without food. Bedtime administration may be a potential method for managing nausea.
In the case of a missed dose of Zejula, instruct patients to take their next dose at its regularly scheduled time. If a patient vomits or misses a dose of Zejula, an additional dose should not be taken.
First-Line Maintenance Treatment Of Advanced Ovarian Cancer
- For patients weighing <77 kg (<170 lbs) OR with a platelet count of <150,000/mcL, the recommended dosage is 200 mg (two 100-mg capsules) taken orally once daily.
- For patients weighing ≥77 kg (≥170 lbs) AND who have a platelet count ≥150,000/mcL, the recommended dosage is 300 mg (three 100-mg capsules) taken orally once daily.
For the maintenance treatment of advanced ovarian cancer, patients should start treatment with Zejula no later than 12 weeks after their most recent platinum-containing regimen.
Maintenance Treatment Of Recurrent Ovarian Cancer
The recommended dosage of Zejula is 300 mg (three 100-mg capsules) taken orally once daily.
For the maintenance treatment of recurrent ovarian cancer, patients should start treatment with Zejula no later than 8 weeks after their most recent platinum-containing regimen.
Treatment Of Advanced Ovarian Cancer After 3 Or More Chemotherapies
The recommended dosage of Zejula is 300 mg (three 100-mg capsules) taken orally once daily.
Dosage Adjustments For Adverse Reactions
To manage adverse reactions, consider interruption of treatment, dose reduction, or dose discontinuation. The recommended dose modifications for adverse reactions are listed in Tables 1, 2, and 3.
Table 1: Recommended Dose Modifications for Adverse Reactions
|Starting Dose Level||200 mg||300 mg|
|First dose reduction||100 mg/daya (one 100-mg capsule)||200 mg/day (two 100-mg capsules)|
|Second dose reduction||Discontinue Zejula.||100 mg/daya (one 100-mg capsule)|
|a If further dose reduction below 100 mg/day is required, discontinue Zejula.|
Table 2: Dose Modifications for Non-Hematologic Adverse Reactions
|Non-hematologic CTCAE ≥Grade 3 adverse reaction that persists despite medical management||
|CTCAE ≥Grade 3 treatment-related adverse reaction lasting more than 28 days while patient is administered Zejula 100 mg/day||Discontinue Zejula.|
|CTCAE = Common Terminology Criteria for Adverse Events.|
Table 3: Dose Modifications for Hematologic Adverse Reactions
|Monitor complete blood counts weekly for the first month, monthly for the next 11 months of treatment, and periodically after this time.|
|Platelet count <100,000/mcL||First occurrence:
|Neutrophil <1,000/mcL or hemoglobin <8 g/dL||
|Hematologic adverse reaction requiring transfusion||
|a If myelodysplastic syndrome or acute myeloid leukemia (MDS/AML) is confirmed, discontinue Zejula.|
Dosage Adjustment For Hepatic Impairment
Moderate Hepatic Impairment
For patients with moderate hepatic impairment, reduce the starting dosage of Zejula to 200 mg once daily. Monitor patients for hematologic toxicity and reduce the dose further, if needed.
Is Zejula safe to use while pregnant or breastfeeding?
- Based on its mechanism of action, Zejula can cause fetal harm when administered to pregnant women.
- There are no data regarding the use of Zejula in pregnant women to inform the drug-associated risk.
- Zejula has the potential to cause teratogenicity and/or embryo-fetal death since niraparib is genotoxic and targets actively dividing cells in animals and patients (e.g., bone marrow).
- Due to the potential risk to a fetus based on its mechanism of action, animal developmental and reproductive toxicology studies were not conducted with niraparib. Apprise pregnant women of the potential risk to a fetus.
- No data are available regarding the presence of niraparib or its metabolites in human milk, or on its effects on the breastfed child or milk production.
- Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during treatment with Zejula and for 1 month after receiving the final dose.
Zejula is a prescription medicine used for the maintenance treatment of adults with ovarian cancer and advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. The most common side effects of Zejula include heart not beating regularly, changes in liver function or other blood tests, nausea, pain in your joints, muscles, and back; constipation, headache, vomiting, dizziness, pain in the stomach area, change in the way food tastes, mouth sores, trouble sleeping, diarrhea, and others. anxiety
Multimedia: Slideshows, Images & Quizzes
Understanding Cancer: Metastasis, Stages of Cancer, and More
Learn the basics about cancer including types, causes, how it spreads, symptoms and signs, stages and treatment options. Read...
Ovarian Cancer Symptoms, Signs, Stages
Ovarian cancer symptoms and signs include abdominal pain, bloating, frequent urination, and a feeling of fullness. Ovarian cancer...
Cervical Cancer Symptoms, Stages, and Treatment
Cervical cancer is typically caused by HPV infections. Learn about vaccines to prevent cervical cancer. Get information about...
Signs of Cancer in Women: Symptoms You Can't Ignore
Colon and stomach cancer symptoms can surprise women but can be treated if detected early. Learn about breast cancer signs and...
Cancer-Fighting Foods: Resveratrol, Green Tea, and More
Experts have praised certain foods for their ability to reduce cancer risks. Learn which foods and eating strategies may help...
Bladder Cancer Symptoms, Stages, Treatments
Bladder cancer occurs when cancerous cells, often from the lining of the bladder, begin to multiply. Find more information about...
Top 10 Cancers Quiz
Take this quiz to learn the causes of cancer. Get the facts about the causes, symptoms, and treatments for the world's most...
Cervical Cancer Quiz
How is cervical cancer different from other cancers? Take this quiz to learn the basics of cervical cancer.
Ovarian Cancer Quiz: Test Your Medical IQ
How common is ovarian cancer and who is at risk? Take our Ovarian Cancer Quiz to learn the causes, symptoms, and treatment for...
Picture of Uterine Cancer
A malignant tumor of the uterus (womb), which occurs most often in women between the ages of 55 and 70. Abnormal bleeding after...
Cancer: Does This Cause Cancer?
Everything gives you cancer, right? Not really. WebMD's slide show tells you about the research into cancer and cell phones,...
Cancer: Cancer 'Remedies' That Don't Work
You may have read about an all-natural cure for cancer. While many therapies are helpful, some aren't worth your time or money....
Cancer Guide to Eye Cancers
Find out more from WebMD about the early signs of these types of cancer and how they’re diagnosed and treated.
Related Disease Conditions
Cancer is a disease caused by an abnormal growth of cells, also called malignancy. It is a group of 100 different diseases, and is not contagious. Cancer can be treated through chemotherapy, a treatment of drugs that destroy cancer cells.
There are many types of ovarian cancer, epithelial carcinoma is the most common. Women with a family history of ovarian cancer have an increased risk of developing the disease. Some ovarian cancer symptoms include abdominal pain, nausea, diarrhea, constipation, and abnormal vaginal bleeding, however, they usually do not present until the disease has progressed. Early diagnosis is important for successful treatment.
Cancer Risk Factors and Causes
Though it's difficult to say why some people develop cancer while others don't, research shows that certain risk factors increase a person's odds of developing cancer. These risk factors include growing older, family history of cancer, diet, alcohol and tobacco use, and exposure to sunlight, ionizing radiation, certain chemicals, and some viruses and bacteria.
Cervical Cancer (Cancer of the Cervix)
Cervical cancer is cancer of the entrance to the womb (uterus) caused by the human papillomavirus (HPV). Regular pelvic exams, Pap testing, and screening can detect precancerous changes in the cervix. Cervical cancer can be prevented by a vaccine. The most common signs and symptoms are an increase in vaginal discharge, painful sex, and postmenopausal bleeding. The prognosis and survival rate depend upon the stage at which the cancer was diagnosed.
Which Cancer Is the Most Painful?
Cancer spreading to the bone is the most painful type of cancer. Pain can be caused by a tumor pressing on the nerves around the bone. As the tumor size increases, it can release chemicals that irritate the area around the tumor.
What Are the Symptoms of Stage 1 Ovarian Cancer?
At stage 1 of ovarian cancer, the cancer is present only in the ovaries i.e. it has not spread in any other organs. Signs and symptoms at this stage may include a mass felt in the abdomen, distension or swelling of abdomen, abnormal vaginal bleeding (between menstrual periods or after menopause) and other signs. Stage 1 ovarian cancer has no symptoms in many women, however; often they may not experience symptoms until the cancer has spread significantly.
What Type of Cancer Makes You Very Tired?
Extreme and recurrent tiredness is one of the common symptoms of most types of cancers. Tiredness is usually considered a warning sign of cancer progressing. Tiredness related to cancers usually does not get better with adequate rest or sleep.
Is Uterus Cancer Fatal?
Uterine cancer is not fatal when it is diagnosed and treated in the early stages. Generally, a 5-year survival rate for patients in stage 1 of uterine cancer is 90%. However, the 5-year survival rate can vary depending on the extent to which the cancer has spread.
Which Is the Deadliest Cancer?
Lung cancer is considered to be the most deadly cancer. More people die from lung cancer each year than from breast, colorectal and prostate cancer combined.
Cancer pain is a common experience that may result from the disease, treatment, or diagnostic procedure. Check out the center below for more medical references on cancer, including multimedia (slideshows, images, and quizzes), related disease conditions, treatment and diagnosis, medications, and prevention or wellness.
How Can You Get Cervical Cancer?
Cervical cancer may occur because of numerous reasons but has a strong association with a long-standing infection with human papillomavirus (HPV).
Guide for COVID-19 Vaccine for Cancer Patients
The authorities have jointly agreed that patients on active cancer treatment are at a higher risk of COVID-19 infection and complications. Hence, there is a necessity to prioritize patients with cancer for the COVID-19 vaccine.
What Are the 15 Common Signs of Cancer?
The term cancer is given to a group of diseases characterized by the uncontrolled growth of abnormal cells in the body. Some of the common signs of cancer include unintended weight loss, fatigue, bleeding, presence of a mass, persistent cough, abdominal pain and other signs.
Treatment & Diagnosis
- Ovarian Cancer FAQs
- Cancer FAQs
- Cervical Cancer FAQs
- What Is the Number One Cause of Cancer?
- Ovarian Cancer Symptoms, Early Warning Signs, and Risk Factors
- Ovarian Cancer: Exercise May Help Prevent
- What Are the Early Warning Signs of Ovarian Cancer?
- Could Cervical Cancer Recur After Hysterectomy?
- Can Ovarian Cysts Be the Start of Cancer?
- Can You Get Ovarian Cancer after Tubal Ligation?
- Is Peritoneal Cancer Hereditary?
- Can You Prevent Ovarian Cancer?
- Does Stress Cause Cancer?
- Bladder Cancer Causes, Symptoms, and Signs
Medications & Supplements
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.