About ZEJULA (niraparib)

  • What is ZEJULA?

    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

    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 ovarian cancer return and have responded (completely or partially) to treatment with platinum-based chemotherapy

    ZEJULA is a treatment for women who:

    • currently have advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer and have had at least 3 prior chemotherapy regimens, and:
      • are BRCA-positive, 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.

    See if ZEJULA may be right for you

  • 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 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 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.

    Tell your doctor if you are allergic to FD&C Yellow No. 5 (tartrazine) or aspirin. ZEJULA capsules contain tartrazine, which may cause allergic-type reactions (including bronchial asthma) in certain people, especially people who also have an allergy to aspirin.

    The most common side effects of ZEJULA include the following:

    • Heart not beating regularly
    • Nausea
    • Constipation
    • Vomiting
    • Pain in the stomach area
    • Mouth sores
    • Diarrhea
    • Indigestion or heartburn
    • Dry mouth
    • Tiredness
    • Loss of appetite
    • Urinary tract infection
    • Changes in liver function or other blood tests
    • Pain in your muscles and back
    • Headache
    • Dizziness
    • Change in the way food tastes
    • Trouble sleeping
    • Anxiety
    • Sore throat
    • Shortness of breath
    • Cough
    • Rash
    • Changes in the amount or color of your urine

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

  • How do I take ZEJULA?

    • Take ZEJULA exactly as your doctor tells you to
    • Take ZEJULA once a day by mouth, with food or without food, at approximately the same time each day
    • Taking ZEJULA near bedtime may help relieve nausea
    • Swallow the capsules whole. Do not chew, crush, or split ZEJULA capsules before swallowing
    • 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

    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 or have liver problems. Therefore, it is important to tell your doctor about any side effects that you may experience and all of your medical conditions.

    By working with your doctor to customize your dose of ZEJULA, you may be able to stay on and benefit from treatment longer.

  • How do I store ZEJULA?

    Store ZEJULA at room temperature (between 68°F and 77°F). Keep ZEJULA and all medications out of the 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 of ZEJULA, temporarily stop your treatment with ZEJULA, or permanently stop treatment with ZEJULA

    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