Class: Biological Therapy

Generic Name: niraparib

Trade Name: Zejula™

For which conditions is this drug approved? Niraparib is approved for the maintenance of patients with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer whose cancer has returned after a complete or partial response to treatment with a platinum-based chemotherapy.

What is the mechanism of action? Niraparib is a PARP inhibitor. PARP (poly ADP ribose polymerase) is an enzyme that many cancers are dependent on in order to grow and spread. When the PARP enzymes are inhibited, cancer cell DNA is severely damaged, resulting in cell death.

How is niraparib typically given? Niraparib is taken orally.

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with niraparib. Typically, blood will be drawn to monitor functions of some organ systems, such as the kidneys or liver. Also, heart rate and blood pressure will be checked monthly for the first year and as needed after that. Patients may also undergo physical examinations, scans, or other measures to assess side effects and response to therapy.

What are the most common side effects of treatment with niraparib?

• Irregular heartbeat
• Nausea
• Constipation
• Vomiting
• Pain in the stomach area
• Mouth sores
• Diarrhea
• Ingestion or heartburn
• Dry mouth
• Tiredness
• Loss of appetite
• Urinary tract infection
• Changes in liver function blood tests
• Pain in joints, muscles and back
• Headache
• Dizziness
• Change in the way food tastes
• Trouble sleeping
• Anxiety
• Sore throat
• Shortness of breath
• Cough
• Rash

What are some of the less common but potentially serious side effects of niraparib?

• Bone marrow problems called Myelodysplastic Syndrome (MDS) or a type of cancer of the blood called Acute Myeloid Leukemia (AML). These diseases are very serious and can lead to death.
• High blood pressure

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What should you tell your healthcare provider before starting treatment with niraparib?

Tell your healthcare provider if you:

• Have heart problems.
• Have high blood pressure.
• Are pregnant or plan to become pregnant. Niraparib can harm your unborn baby or cause miscarriage.
• Are breastfeeding or plan to breastfeed.

Tell your health care provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Niraparib and other medicines may affect each other causing side effects. Know the medicines you take. Keep a list of them to show your health care provider or pharmacist when you get a new medicine.

When should patients notify their physician?

Contact your healthcare professional immediately in case of any of the following:

• You have symptoms of bone marrow problems. These include: weakness, feeling tired, weight loss, frequent infections, fever, shortness of breath, blood in urine or stool, bruising or bleeding more easily.
• You become pregnant.

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Last updated on 05/17.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment kin selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

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