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Treatment Name: Niraparib (Zejula®)

Niraparib (Zejula®) is a Chemotherapy Regimen for Ovarian Cancer

How does niraparib (Zejula®) work?
Niraparib inhibits a family of enzymes called PARP (PARP stands for: poly ADP ribose polymerase). When the PARP enzymes are inhibited, cancer cell DNA is severely damaged. As a result, the cancer cell is unable to fix the damage which causes the ovarian cancers cell to either die or prevents them from growing.

Note: Niraparib may also be taken for certain types of fallopian tube cancers or primary peritoneal cancers.

Goals of therapy:
Niraparib is taken as maintenance therapy after platinum-based chemotherapy is given. Niraparib is not commonly given with the goal of cure, but is given to keep ovarian cancer from coming back if you are in remission; to stop it from growing or spreading.

Schedule

  • Usual niraparib starting dose: 300 mg (three 100 mg capsules) by mouth once every day. It is preferred to take at night to lessen the risk of experiencing any possible nausea
  • Niraparib is usually started within 8 weeks of receiving chemotherapy

Niraparib is taken at home. Treatment is continued until the drug no longer works or unacceptable side effects are experienced.

Note: Individual doses may vary based upon your Doctor's recommendation, or drug availability.

Side Effects

In clinical studies, the most commonly reported side effects of niraparib (Zejula®) are shown here:

  • Nausea (74%; moderate to severe: 3%)
  • Increased bleeding risk [low platelets; thrombocytopenia] (61%)
  • Fatigue (59%)
  • Anemia [low red blood cells] (50%)
  • Constipation (40%)
  • Vomiting (34%)
  • Low white blood cells [neutropenia] (30%)
  • Headache (26%)
  • Decreased appetite (25%)
  • Trouble sleeping (24%)
  • Abdominal pain (23%)
  • Shortness of breath (19%)
  • High blood pressure (19%)
  • Diarrhea (19%)
  • Dizziness (17%)
  • Cough (15%)
  • Back pain (13%)
  • Joint pain (12%)
  • Heartburn (11%)
  • Sore throat (11%)
  • Urinary tract infection (10%)
  • Heart palpitations (10%)
  • Altered taste (10%)
  • Muscle pain (8%)
  • Swelling of the abdomen (8%)

On average, 14% of patients discontinue niraparib (Zejula®) treatment due to unacceptable side effects.

Side effect videos Side Effect Videos
Nausea and VomitingNausea and VomitingBleedingBleedingFatigue Fatigue AnemiaAnemiaConstipationConstipationPainPainDiarrheaDiarrhea

Monitoring

How often is monitoring needed?
Labs (blood tests) may be checked before treatment, weekly for the first month, then once every month for 11 months, then periodically thereafter. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), plus any others your doctor may order. CA-125 (a tumor marker for ovarian cancer) may also periodically be checked.

BRCA mutation testing, pronounced “Bracka,” is recommended before beginning treatment with niraparib as it may help to predict the response to niraparib.

How often is imaging needed?
Imaging may be checked before treatment, every two months through cycle 14, then every 12 weeks until the end of niraparib treatment, or during treatment at the discretion of your doctor. Imaging may include: X-rays, magnetic resonance imaging (MRI), computerized tomography (CT) scans, or positron emission tomography (PET) scans.

How might blood test results/imaging affect treatment?
Depending upon the results, your doctor may advise to continue niraparib as planned, reduce the dose of future treatments, delay the next dose until the side effect goes away, or switch to an alternative therapy. Niraparib dose reductions for low platelet counts (thrombocytopenia) are common and may be required in one-third or more patients.

Dose reductions for a low neutrophil count (commonly one out of four patients) or hemoglobin (commonly one out of five patients) may be required as well. Discontinuation of niraparib due to a low platelet count, white blood cell count, or hemoglobin is rare and occurs in about 3% or fewer patients.

ChemoExperts Tips

  • If you have a history of high blood pressure or other heart problems, your blood pressure and heart rate will be monitored closely (at least once per month during the first year of treatment) as niraparib can cause an increase in blood pressure and heart rate. If your blood pressure does increase, it can usually be controlled with medications which allows therapy with niraparib to be continued
  • A high number of patients experience nausea while taking niraparib, although the severity is usually mild. Typically, anti-nausea medications do not need to be taken prior to each niraparib dose but patients should have a prescription for an anti-nausea medication to use if needed. It may be helpful to take it at night to avoid experiencing nausea while awake
  • Niraparib can commonly cause low red and white blood cells, low platelets, and in very rare cases is associated with the development of bone marrow disorders such as myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). If you are experiencing unusual bruising or bleeding, severe fatigue, shortness of breath, or frequent infections and fevers, it may be a sign of low blood counts from niraparib or rarely, a more serious bone marrow disorder
  • A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
  • Clinical trials may exist for ovarian cancer. Ask your doctor if any studies are currently enrolling in your area. If not, go to clinicaltrials.gov to search for other centers offering study medications

Patient Assistance & Co-payment Coverage

Patients under the age of 65 years, or those with private insurance plans:
If you have insurance and are looking for patient assistance or copay assistance for Niraparib (Zejula®), we have provided links that may help.

Visit our Patient Assistance page and click the links to various patient assistance programs for help paying for Niraparib (Zejula®). Depending upon your income, they may be able to help cover the cost of:

  • Niraparib

For Branded medications (may be available for generic medications too), check with the manufacturer to determine if a co-pay card is offered and if it could reduce your monthly copay.

  • If you are uninsured, check with the manufacturer to determine if you are eligible to receive medication at no cost.

Medicare and Medicaid patients (Patients 65 years or older):
The clinic providing treatment will likely pre-authorize medications and immune therapies such as Niraparib (Zejula®) and are the best source to help you understand drug cost.

  • Ask to speak with a patient assistance technician or financial counselor at the clinic or hospital administering this therapy.

Emotional Wellness

What is Emotional Wellness?
Emotional wellness is having a positive outlook balanced with a realistic understanding of current life events. This requires both an awareness and acceptance of your emotions. It is with this knowledge that you can develop a plan to take the necessary actions to positively impact your life.

Emotional wellness uses an ongoing process to continually reflect on the stressors of life in a constructive manner to move forward and create happiness.

Because emotional wellness is deeply connected with physical, social, and spiritual wellness, pursuing it often becomes particularly difficult in times of major illness. Despite this difficulty, working toward emotional wellness has been connected to improved treatment outcomes and a higher likelihood of achieving goals of therapy.

Learn more about pursuing emotional wellness while receiving treatment with Niraparib (Zejula®)

Individual Drug Label Information

Niraparib (Zejula®)

  • Niraparib is an oral capsule available as 100 mg capsules
  • Niraparib can be taken with or without food. Swallow capsules whole and do not open, break, or chew
  • If you miss a dose, skip that dose and take the next dose at the regular scheduled time. DO NOT take two doses at once to make up for the missed dose
  • Should be stored at room temperature (68° to 77°F)
  • Dosage adjustments may be required if certain side effects are experienced
  • May cause fetal harm. Do not take while pregnant and use effective contraception during therapy and for at least 6 months after the last dose. Do not to breastfeed during treatment and for 1 month after the last dose
  • Development of blood disorders such as myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) while receiving niraparib have been reported rarely (roughly 1% or less)
  • Low red blood cells, white blood cells, and platelets are common. Therapy may need to be held and the dose of niraparib may need to be lowered but therapy is rarely stopped for low blood counts
  • May increase blood pressure and heart rate. These will be monitored closely after starting treatment. Tell your doctor if you have a history of high blood pressure or other heart problems
General side effects from niraparib (Zejula®)
  • Mild nausea is common
  • Gastrointestinal symptoms such as diarrhea, constipation, abdominal pain, or heartburn
  • Muscle pain, joint pain, and back pain have been reported
  • May alter taste or cause a decrease in appetite
  • Dizziness
  • Headache
  • Cough
  • Trouble sleeping
  • Click on the niraparib (Zejula®) package insert below for reported side effects, possible drug interactions, and other niraparib prescribing information

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaFatigue Fatigue ConstipationConstipationPainPainAnemiaAnemia

See DailyMed package insert.

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References

Mirza MR, Monk BJ, Herrstedt J, et al. Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer. N Engl J Med. 2016;375:2154-2164.

Created: March 30, 2017 Updated: October 17, 2018

What is Ovarian Cancer?

What is Ovarian Cancer?
A disease of the cells found in the ovaries in women. Ovarian cancer is not common, but is the fifth leading cause of cancer related death in women. The exact cause is not known, however risk factors include: older age, obesity, first period at an early age, late menopause, hormone replacement therapy (HRT) after menopause, family history, and genetic causes such as the BRCA (pronounced "bracka") mutation. The use of oral contraceptives or having one or more full-term pregnancies can decrease the risk of ovarian cancer.

The stage of ovarian cancer can vary at diagnosis and throughout treatment. Ovarian cancer is staged using the Tumor, Node, Metastasis (TNM) staging system, as well as Stage Grouping I, II, III, or IV. Staging systems describe the extent of cancer throughout the body and help doctors determine which treatments to offer. The effectiveness of the treatment may depend upon the stage at diagnosis.

NOTE: Treatment Options listed below are not all-inclusive. Other treatments may be available. ChemoExperts provides drug information and does not recommend any one treatment over another. Only your Doctor can choose which therapy is appropriate for you.

What is "Maintenance therapy"?

Maintenance therapy is the phase of treatment that follows the successful completion of a prior chemotherapy regimen. The purpose of maintenance therapy is to target any remaining cancer cells that may be present, but that cannot usually be seen with imaging or blood tests. Maintenance chemotherapy agents are typically well tolerated and can be given over an extended period of time.

What does "Cure" mean?

The word “cure” means there are no cancer cells left in the body and cancer will never come back. Depending on the cancer type and stage, this may be the true goal of therapy. However, it is very difficult to prove all cancer cells are gone. Even though images, like X-rays and MRI’s, and blood tests may not show any signs of cancer, there can be a small amount of cancer cells still left in the body. Because of this, doctors use the word “remission” is used more often. This means there are no signs or symptoms of cancer. Patients in remission are followed closely for any signs of cancer returning. Sometimes, more chemotherapy may be given while in remission to prevent the cancer from coming back.

Doctors usually do not consider a patient “cured” until the chance of cancer returning is extremely low. If cancer does return, it usually happens within 5 years of having a remission. Because of this, doctors do not consider a patient cured unless the cancer has not come back within 5 years of remission. The five-year cutoff does not apply to all cancers.

What is a CBC?

A Complete Blood Count (CBC) is a frequently ordered blood test that tells clinicians the status of your: 1) White blood cell count, 2) Hemoglobin, and 3) Platelet count at the time the test was taken.

Common uses:
1) White blood cell count (WBC): is used to determine infection risk, or response to chemotherapy. Certain chemotherapy agents may harm our good infection-fighting cells. Sometimes chemotherapy may need to be delayed to allow these cells to recover.

2) Hemoglobin: is used to determine if someone is anemic. Anytime the hemoglobin is below 12 g/dL, the person is said to be anemic. Red blood cell transfusions, and sometimes iron can be given to restore the hemoglobin level, but anemia treatment should always aim at treating the underlying cause or condition.

3) Platelet count: is used to determine if the risk of bleeding is increased or if a platelet transfusion is required to prevent bleeding. Certain medications that increase bleeding risk, such as: aspirin, certain chemotherapy agents, and blood thinners, may need to be stopped temporarily until the platelet count is within a safe range.

What is a CMP?

A Comprehensive Metabolic Panel (CMP) is a frequently ordered blood test that tells clinicians the status of your: 1) Electrolytes & Acid/Base status2) Kidney function, 3) Liver function, 4) Blood sugar, and 5) Calcium at the time the test was taken. It is commonly used to monitor liver and kidney function when beginning new medications such as chemotherapy. A total of 14 tests are run simultaneously and are shown below.

Electrolytes & Acid/Base status:
1) Sodium, 2) Potassium, 3) Carbon dioxide, 4) Chloride

Kidney Function:
5) BUN (blood urea nitrogen), 6) Serum creatinine (Scr)

Liver Function:
7) AST, 8) ALT, 9) Total bilirubin, 10) Alk Phos, 11) Albumin, 12) Total protein

Blood sugar:
13) Serum glucose

Calcium:
14) Serum calcium