Indication and Important Safety Information

 

Indication

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.

It is not known if ZEJULA is safe and effective in children.

Important Safety Information

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:

  • 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 monthly for the first year during your treatment with ZEJULA and as needed afterward. Your doctor may lower the dose of ZEJULA to treat high blood pressure.

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

  • Have heart problems
  • Have high blood pressure
  • 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

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

The most common side effects of ZEJULA include:

  • 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
  • Shortness of breath
  • Cough
  • Rash
  • Changes in liver function blood tests
  • Pain in your joints, muscles, and back
  • Headache
  • Dizziness
  • Change in the way food tastes
  • Trouble sleeping
  • Anxiety
  • Sore throat

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.

These are not all the possible side effects of ZEJULA. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Prescribing Information.