Frequently Asked Questions
ZEJULA is a prescription medicine used for the:
- maintenance treatment of adults with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, when the cancer comes back. ZEJULA is used after the cancer has responded (complete or partial response) to treatment with platinum-based chemotherapy. Learn more about maintenance with ZEJULA.
- 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
- a positive laboratory test, and whose cancer was in response to treatment with platinum-based chemotherapy, and who have progressed more than 6 months after the last treatment.
- Your healthcare provider will perform a test to make sure that ZEJULA is right for you. Learn more about advanced ovarian cancer treatment with ZEJULA.
ZEJULA is a medication called a PARP inhibitor. A PARP inhibitor can target some cancer cells and prevent them from repairing damage to their DNA, which in turn causes the cancer cells to die. ZEJULA can also affect other cells and tissues in the body.1-3 See how ZEJULA works
ZEJULA is for women who have cancer that has
- Previously been treated with 2 or more courses of platinum-based chemotherapy, and responded (completely or partially) to the most recent treatment
- Have had at least 3 prior chemotherapy regimens, and:
- are BRCA-positive
- tested positive for HRd and had a response to platinum-based chemotherapy and who have progressed more than 6 months after the last treatment
- are BRCA-positive
ZEJULA can be taken by women whether or not they carry a BRCA mutation. It is not known if ZEJULA is safe and effective in children.
The most common side effects of ZEJULA include the following:
- Heart not beating regularly
- Pain in the stomach area
- Mouth sores
- Indigestion or heartburn
- Dry mouth
- Loss of appetite
- Urinary tract infection
- Shortness of breath
- Changes in liver function or other blood tests
- Pain in your joints, muscles, and back
- Change in the way food tastes
- Trouble sleeping
- Sore throat
- Changes in the amount or color of your urine
ZEJULA may cause serious side effects, including:
Bone marrow problems called Myelodysplastic Syndrome (MDS) or a type of blood cancer called Acute Myeloid Leukemia (AML).
Some people who have ovarian cancer and who have received previous treatment with chemotherapy or certain other medicines for their cancer have developed MDS or AML during treatment with ZEJULA. MDS or AML may lead to death.
Symptoms of low blood cell counts (low red blood cells, low white blood cells, and low platelets) are common during treatment with ZEJULA, but they can be a sign of serious bone marrow problems, including MDS or AML. These symptoms may include the following:
- Feeling tired
- Weight loss
- Frequent infections
- Shortness of breath
- Blood in urine or stool
- Bruising or bleeding more easily
Your doctor will do blood tests to check your blood cell counts before treatment with ZEJULA. You will be tested weekly for the first month of treatment with ZEJULA, monthly for the next 11 months of treatment, and from time to time afterward.
High blood pressure is common during treatment with ZEJULA, and it can become serious. Your doctor will check your blood pressure and heart rate at least weekly for the first two months, then monthly for the first year, and as needed thereafter during your treatment with ZEJULA.
These are not all the possible side effects of ZEJULA. For more information, ask your doctor or pharmacist.
- Take ZEJULA exactly as your doctor prescribed
- Take ZEJULA once a day, by mouth, with food or without food, at approximately the same time each day
- Take ZEJULA near bedtime. It may help relieve nausea
- Swallow the capsules whole
- Do not take another dose if you miss a dose or vomit after taking ZEJULA. Take your next dose at its scheduled time on the next day
- If you take too much ZEJULA, call your doctor or go to the nearest hospital emergency room right away
- Do not stop taking ZEJULA without first talking to your doctor
Your doctor will monitor your body’s response to ZEJULA and may make adjustments to your dose if you experience certain side effects. Therefore, it is important to tell your doctor about any side effects that you may experience.1
In the clinical trial, even when the dose had to be adjusted, ZEJULA remained effective.1,4
By working with your doctor to customize your dose of ZEJULA, you may be able to stay on and benefit from treatment longer.1
Store ZEJULA at room temperature, between 68ºF and 77ºF. Keep ZEJULA and all medications out of the reach of children.1
- Call your doctor for medical advice about side effects1
- If you have certain side effects, then your doctor may change your dose of ZEJULA,1,4 temporarily stop your treatment with ZEJULA, or permanently stop treatment with ZEJULA1
Even when the dose had to be adjusted in the clinical trial, ZEJULA remained effective.4,5
TOGETHER with GSK Oncology is a patient resource program dedicated to you and your healthcare provider to assist with access issues related to ZEJULA, so that you can be free to focus on your treatment goals and simply living life.
Specialty pharmacy services are used by many doctors to deliver ZEJULA directly to you. This group of pharmacists and nurses is available 24/7 to help you get started, answer your questions, and provide support. The specialty pharmacy services that provide ZEJULA include:
ZEJULA My Way offers timely, customized support delivered to your inbox and your mailbox, including information about maintenance treatment and ZEJULA, and techniques and tools to help you take care of you during your time in response.
REIMBURSEMENT ASSISTANCE AND ACCESS
If your doctor prescribes ZEJULA, he or she can work with professionals at TOGETHER with GSK Oncology and your specialty pharmacy services to help you with access to ZEJULA and assistance paying for it, if you need it. TOGETHER with GSK Oncology does not guarantee coverage or payer reimbursement for product treatment or administration.
Yes. TOGETHER with GSK Oncology is a free patient resource program for you and your doctor to help with access and financial issues related to ZEJULA. To learn whether you are eligible, visit TOGETHER with GSK Oncology.
LIVING WITH RECURRENT OVARIAN CANCER
The makers of ZEJULA care about women with ovarian cancer. That’s why this site has resources to help women manage their medication and their day-to-day lives in response.
- We have a comprehensive list of support groups and organizations that help advance research and support women with ovarian cancer and their families. Check out the Ovarian Cancer Organizations section to learn more
- You can also register for ZEJULA My Way to get timely support delivered directly to your inbox. ZEJULA My Way will be there when you need it and as your support needs change. Learn more and register today
When cancer is in response, you may still have treatment choices. One choice is to watch and wait. Another choice is maintenance treatment. Learn more about your options and what you can do.
Your role as a care partner is an important one. You are the one who has been there through it all. You’ve taken care of so much. Now it’s time to take care of yourself. Learn how you can do that.
Support During Treatment
Find resources that may help you access and pay for ZEJULAGet Access and Support
Get more detailed definitions of commonly used terms in ovarian cancer treatmentView the Glossary
View a list of organizations that help advance research and support women and their familiesSee the organizations
References: 1. ZEJULA (niraparib) Prescribing Information. GlaxoSmithKline; 2020. 2. NCI Dictionary of Cancer Terms: PARP inhibitor. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/parp-inhibitor. Accessed May 4, 2018. 3. Sandhu SK, Schelman WR, Wilding G, et al. The poly(ADP-ribose) polymerase inhibitor niraparib (MK4827) in BRCA mutation carriers and patients with sporadic cancer: a phase 1 dose-escalation trial. Lancet Oncol. 2013;14(9):882-892. 4. Wang J, Zhang Z-Y, Mansoor R, et al. The exposure-response relationship of niraparib in patients with gBRCA and non-gBRCAmut: results from the ENGOT-OV16/NOVA trial. Poster presented at: Annual Congress of the European Society for Medical Oncology; September 8-12, 2017; Madrid, Spain. Poster 933PD.