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Generic Name: niraparib
Dosage Form: Capsules
Date of Approval: March 27, 2017
Company: Tesaro Inc.

Treatment for: Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer

FDA Approves Zejula

The U.S. Food and Drug Administration (FDA) has approved Zejula (niraparib), an oral, once-daily poly(ADP-ribose) polymerase (PARP) inhibitor for the maintenance treatment of women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response (CR or PR) to platinum-based chemotherapy.

Patient Information

Read this Patient Information before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

Important information

Zejula may cause serious side effects including:

  • Bone marrow problems called Myelodysplastic Syndrome (MDS) or a type of cancer of the blood 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. If you develop MDS or AML, your healthcare provider will stop your treatment.
    Symptoms of low blood cell counts (low red blood cells, low white blood cells, and low platelets) are common during treatment, but can be a sign of serious bone marrow problems, including MDS or AML. Symptoms may include:
    • 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 you start treatment
    • weekly for the first month of treatment
    • every month for the next 11 months, then as needed during treatment
  • High blood pressure. High blood pressure is common during treatment, and can become serious. Your healthcare provider will check your blood pressure and heart rate monthly for the first year and as needed thereafter during your treatment.

See Zejula side effects for more information about side effects.

What is Zejula?

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. It 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.

Before taking Zejula

Before taking Zejula, tell your healthcare provider about all of your medical conditions, including if you:

  • have heart problems.
  • have high blood pressure.
  • are pregnant or plan to become pregnant. Zejula can harm your unborn baby and may cause loss of pregnancy (miscarriage).
    • If you are able to become pregnant, your healthcare provider may perform a pregnancy test before you start treatment.
    • Females who are able to become pregnant should use effective birth control (contraception) during treatment, and for six months after the last dose. Talk to your healthcare provider about birth control methods that may be right for you.
    • Tell your healthcare provider right away if you become pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if Zejula passes into your breast milk. Do not breastfeed during treatment, and for two weeks after the last dose of Zejula. Talk to your healthcare provider about the best way to feed your baby during this time.

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

How should I take Zejula?

  • Take Zejula exactly as your healthcare provider tells you to.
  • Take the capsules one time each day, at the same time each day.
  • Take the capsules with or without food.
  • The capsules should be swallowed whole.
  • Taking the dose at bedtime may help relieve any nausea symptoms you may have.
  • Do not stop treatment without first talking with your healthcare provider.
  • If you miss a dose, 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, do not take an extra dose. Take your next dose at your scheduled time.
  • If you take too much or overdose, call your healthcare provider or go to the nearest hospital emergency room right away.

Zejula side effects

Zejula can cause serious side effects, including:

  • See Important information.

The most common side effects 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
  • 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
  • shortness of breath
  • cough
  • rash

Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment if you have certain side effects.

These are not all the possible side effects. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Zejula?

Store the capsules at room temperature between 68° to 77°F (20° to 25°C).

Keep all medicines out of the reach of children and pets.

General information about the safe and effective use of Zejula.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information that is written for health professionals.

What are the ingredients in Zejula?

Active ingredient: niraparib

Inactive ingredients:

  • Capsule fill: magnesium stearate and lactose monohydrate
  • Capsule shell: titanium dioxide and gelatin in the white capsule body and FD&C Blue #1, FD&C Red #3, FD&C Yellow #5 and gelatin in the purple capsule cap.
  • The black printing ink: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, purified water, strong ammonia solution, potassium hydroxide and black iron oxide. The white pritnting ink: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, sodium hydroxide, povidone and titanium oxide.