About ZEJULA (niraparib)

  • What is ZEJULA?

    ZEJULA tablet 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 a certain type of inherited (germline) abnormal BRCA gene 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. 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.

    Learn more about ZEJULA

  • How does ZEJULA work?

    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.

    See how ZEJULA works

  • Who should consider ZEJULA?

    ZEJULA is a maintenance treatment for women who have:

    • recently been diagnosed with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer and have responded (completely or partially) to treatment with platinum-based chemotherapy
    • had their advanced germline BRCA-mutated ovarian cancer return and have responded (completely or partially) to 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.

    See if ZEJULA may be right for you

  • What do I need to discuss with my doctor prior to taking ZEJULA?

    Before starting to take ZEJULA, tell your doctor about all of your medical conditions, including if you:

    • Have heart problems
    • Have liver problems
    • Have high blood pressure
    • Are pregnant or plan to become pregnant. ZEJULA can harm an unborn baby and may cause loss of pregnancy (miscarriage)
      • If you are able to become pregnant, you should use effective birth control (contraception) during treatment with ZEJULA and for 6 months after taking the last dose of ZEJULA
      • If you are able to become pregnant, your doctor should perform a pregnancy test before you start treatment with ZEJULA
      • You should tell your doctor right away if you become pregnant
    • Are breastfeeding or plan to breastfeed
      • ZEJULA may harm your baby. You should not breastfeed your baby during treatment with ZEJULA and for 1 month after taking the last dose of ZEJULA

    Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

  • What are the possible side effects of ZEJULA?

    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. They can be a sign of serious bone marrow problems, including MDS or AML. These symptoms may include the following:

    • Weakness
    • Feeling tired
    • Weight loss
    • Frequent infections
    • Fever
    • Shortness of breath
    • Blood in urine or stool
    • Bruising or bleeding more easily

    Your healthcare provider will do blood tests to check your blood cell counts:

    • Before starting treatment with ZEJULA
    • Weekly for the first month
    • Monthly for the next 11 months of treatment, and as needed 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.

    Posterior reversible encephalopathy syndrome (PRES) is a condition that affects the brain and may happen during treatment with ZEJULA. If you have headache, vision changes, confusion, or seizure, with or without high blood pressure, please contact your doctor.

    As a reminder, the most common side effects of ZEJULA include the following:

    • Nausea
    • Tiredness
    • Constipation
    • Pain in your muscles and back
    • Pain in the stomach area
    • Vomiting
    • Loss of appetite
    • Trouble sleeping
    • Headache
    • Shortness of breath
    • Rash
    • Diarrhea
    • Cough
    • Dizziness
    • Changes in the amount or color of your urine
    • Urinary tract infection
    • Low levels of magnesium in the blood

    If you have certain side effects, then your doctor may change your dose of ZEJULA, temporarily stop, or permanently stop treatment with ZEJULA. This should not discourage you from discussing any side effect(s) you are experiencing with your doctor.

    These are not all of the possible side effects of ZEJULA. For more information, ask your doctor or pharmacist.

    Call your doctor for medical advice about your side effects. You are encouraged to report side effects of prescription drugs to the US Food and Drug Administration (FDA) at 1-800-FDA-1088.

  • How do I take ZEJULA tablets?

    • Take ZEJULA exactly as your healthcare provider tells you to 
    • Take 1 ZEJULA tablet 1 time each day, at the same time each day
    • ZEJULA may be taken with or without food
    • ZEJULA should be swallowed whole. Do not chew, crush, or split ZEJULA before swallowing
    • Taking ZEJULA at bedtime may help relieve any nausea symptoms you may have
    • Do not stop taking ZEJULA without first talking with your healthcare provider
    • If you miss a dose of ZEJULA, take your next dose at your scheduled time. Do not take an extra dose to make up for a missed dose
    • If you vomit after taking a dose of ZEJULA, do not take an extra dose. Take your next dose at your scheduled time
    • If you take too much ZEJULA, call your healthcare provider or go to the nearest hospital emergency room right away

    See how to take ZEJULA

  • What is a dose adjustment? Why might my dose be adjusted?

    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 and all of your medical conditions.

    In the first-line maintenance setting, your dose is customized to you, which has been shown to help you maintain treatment with ZEJULA.

  • How do I store ZEJULA?

    • Store ZEJULA tablets in the original bottle
    • Store ZEJULA at room temperature, between 68° and 77°F (20° and 25°C)
    • Keep ZEJULA and all medicines out of reach of children
  • What should I do if I experience a side effect?

    • Call your doctor for medical advice about side effects
    • If you have certain side effects, then your doctor may change your dose, temporarily stop your treatment, or permanently stop treatment with ZEJULA
    • You may report side effects to the US Food and Drug Administration (FDA) at 1-800-FDA-1088

    See more about potential side effects

  • What support is available for ZEJULA?

    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. Specialty pharmacies 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 pharmacies 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 after platinum-based chemotherapy.

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Living with Ovarian Cancer