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Safety Information

See below for full Indication and Important Safety Information

Serious Side Effects

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 bonemarrow 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 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.

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 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

  • Are pregnant or plan to become pregnant. ZEJULA may 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 may 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

The most common side effects of ZEJULA include1

  • 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

Start by talking with your doctor

Let your doctor know about any side effects that you experience. He or she may have ideas for ways you can address side effects you may experience. For example, if you experience nausea, your doctor may suggest taking ZEJULA before bed or suggest other ideas for you to try.

If you experience severe side effects, your doctor may interrupt your treatment with ZEJULA for up to 28 days and then reduce the number of capsules that you take each day. This dose interruption and adjustment is to allow your blood counts or other severe side effects to improve. Your doctor may ask you to make adjustments in the schedule of your blood tests. Be sure to keep your doctor informed about how you feel. Your doctor will determine when you can resume taking ZEJULA.

  • Call your doctor for medical advice about side effects1
  • If you have certain side effects, then your doctor may change your dose of ZEJULA,1,2 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.2

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References: 1. ZEJULA (niraparib) Prescribing Information. GlaxoSmithKline; 2021. 2. 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 theEuropean Society for Medical Oncology; September 8-12, 2017; Madrid, Spain. Poster 933PD.

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