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Zejula

Generic Name: niraparib (nye RAP a rib)
Brand Names: Zejula

What is Zejula?

Zejula (niraparib) is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Zejula is used as a "maintenance" treatment to keep certain types of cancer from coming back. This includes cancers of the ovary, fallopian tube, or peritoneum (the membrane that lines the inside of your abdomen and covers some of your internal organs).

Zejula is given after you have received chemotherapy (with cisplatin, oxaliplatin, carboplatin, or similar) and your cancer has responded to that medicine.

Important information

You should not use Zejula if you are pregnant. Avoid pregnancy for at least 6 months after you stop using this medicine.

You should not breast-feed while using Zejula and for at least 1 month after your last dose.

Before taking this medicine

You should not use Zejula if you are allergic to niraparib.

To make sure this medicine is safe for you, tell your doctor if you have:

  • heart disease;

  • high blood pressure; or

  • liver or kidney disease.

Do not use Zejula if you are pregnant. It could harm the unborn baby or cause a miscarriage. Use effective birth control to prevent pregnancy while you are using Zejula and for at least 6 months after your last dose.

You may need to have a negative pregnancy test before starting this treatment.

This medicine may affect fertility (the ability to have children) in men. Talk with your doctor about your individual risk.

It is not known whether niraparib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using Zejula and for at least 1 month after your last dose.

How should I take Zejula?

Take Zejula exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

You should start taking Zejula no longer than 8 weeks after your most recent chemotherapy treatment with a platinum medicine (cisplatin, oxaliplatin, carboplatin).

You may take this medicine with or without food. Take the medicine at the same time each day.

Zejula is usually taken once a day until your body no longer responds to the medication.

Zejula may be taken at bedtime it upsets your stomach.

Do not crush, chew, break, or open a capsule. Swallow the capsule whole.

If you vomit shortly after taking a capsule, do not take another one. Wait until your next scheduled dose and take the regular amount of medicine at that time.

Niraparib can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

Your blood pressure and heart rate will also need to be checked often.

Store at room temperature away from moisture and heat.

Zejula dosing information

Usual Adult Dose for Ovarian Cancer:

300 mg orally once a day
Duration of Therapy: Until disease progression or unacceptable toxicity

Comments:
-Initiate treatment with this drug no later than 8 weeks after a patient's most recent platinum-containing regimen.
-Bedtime administration may be a potential method for managing nausea.

Use: Maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Usual Adult Dose for Fallopian Tube Cancer:

300 mg orally once a day
Duration of Therapy: Until disease progression or unacceptable toxicity

Comments:
-Initiate treatment with this drug no later than 8 weeks after a patient's most recent platinum-containing regimen.
-Bedtime administration may be a potential method for managing nausea.

Use: Maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Usual Adult Dose for Peritoneal Cancer:

300 mg orally once a day
Duration of Therapy: Until disease progression or unacceptable toxicity

Comments:
-Initiate treatment with this drug no later than 8 weeks after a patient's most recent platinum-containing regimen.
-Bedtime administration may be a potential method for managing nausea.

Use: Maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

See also: Dosage Information (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Zejula?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Zejula side effects

Get emergency medical help if you have signs of an allergic reaction to Zejula: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • pounding heartbeats or fluttering in your chest;

  • sores or white patches in or around your mouth, trouble swallowing or talking, dry mouth, bad breath, altered sense of taste;

  • pain or burning when you urinate;

  • increased blood pressure - severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed;

  • low blood cell counts - fever, chills, flu-like symptoms, swollen gums, mouth sores, skin sores, rapid heart rate, pale skin, easy bruising, unusual bleeding, feeling light-headed; or

  • signs of a bone marrow disorder - fever, weakness, tiredness, feeling short of breath, weight loss, blood in your urine or stools.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Zejula side effects may include:

  • indigestion, stomach pain, loss of appetite, nausea, vomiting;

  • constipation, diarrhea;

  • irregular heartbeats, feeling short of breath;

  • abnormal liver function tests;

  • dry mouth, mouth sores;

  • altered sense of taste;

  • back pain, muscle or joint pain;

  • feeling tired;

  • headache, dizziness, anxiety;

  • sleep problems (insomnia);

  • sore throat; or

  • rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Zejula?

Other drugs may interact with niraparib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about Zejula.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Zejula only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2017 Cerner Multum, Inc. Version: 1.01.

Date modified: July 13, 2017
Last reviewed: May 23, 2017

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