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 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.

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 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.

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.

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 are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see accompanying full Prescribing Information for capsules as well as tablets.