Zejula (niraparib): Cancer Treatment Side Effects & Warnings

Generic drug: niraparib

Brand name: Zejula

What is Zejula (niraparib), and how does it work?

Zejula is a prescription medicine used for the:

maintenance treatment of adults with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. Zejula is used after the cancer has responded (complete or partial response) to treatment with platinum-based chemotherapy.
maintenance treatment of adults with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that comes back. Zejula is used after the cancer has responded (complete or partial response) to treatment with platinum-based chemotherapy.
treatment of adults with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have been treated with 3 or more prior types of chemotherapy and who have tumors with:
- a certain “BRCA” gene mutation, or
- gene mutation problems and who have progressed more than 6 months after their last treatment with platinum-based chemotherapy.

Your healthcare provider will perform a test to make sure that Zejula is right for you.

It is not known if Zejula is safe and effective in children.

What are the side effects of Zejula?

The most common side effects of Zejula include:

heart not beating regularly,
changes in liver function or other blood tests,
nausea,
pain in your joints, muscles, and back;
constipation,
headache,
vomiting,
dizziness,
pain in the stomach area,
change in the way food tastes,
mouth sores,
trouble sleeping,
diarrhea,
anxiety,
indigestion or heartburn,
sore throat,
dry mouth,
shortness of breath,
tiredness,
cough,
loss of appetite,
rash,
urinary tract infection, and
changes in the amount or color of your urine

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

These are not all the possible side effects of Zejula. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Where does ovarian cancer occur?
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What is the dosage for Zejula?

Patient Selection For Treatment Of Advanced Ovarian Cancer After 3 Or More Chemotherapies

Select patients for treatment of advanced ovarian cancer after 3 or more
chemotherapy regimens associated with HRD positive status based on either
deleterious or suspected deleterious BRCA mutation and/or genomic instability
score (GIS).

Information on FDA-approved tests for the detection of either deleterious or suspected deleterious BRCA mutation or genomic instability for this indication is available at https://www.fda.gov/companiondiagnostics.

Recommended Dosage

Continue treatment with Zejula until disease progression or unacceptable toxicity.

Instruct patients to take their dose of Zejula at approximately the same time each day. Advise patients to swallow each capsule whole and not to chew, crush, or split
Zejula prior to swallowing. Zejula may be taken with or without food. Bedtime administration may be a potential method for managing nausea.

In the case of a missed dose of Zejula, instruct patients to take their next dose at its regularly scheduled time. If a patient vomits or misses a dose of
Zejula, an additional dose should not be taken.

First-Line Maintenance Treatment Of Advanced Ovarian Cancer

For patients weighing <77 kg (<170 lbs) OR with a platelet count of <150,000/mcL, the recommended dosage is 200 mg (two 100-mg capsules) taken orally once daily.
For patients weighing ≥77 kg (≥170 lbs) AND who have a platelet count ≥150,000/mcL, the recommended dosage is 300 mg (three 100-mg capsules) taken orally once daily.

For the maintenance treatment of advanced ovarian cancer, patients should start treatment with
Zejula no later than 12 weeks after their most recent platinum-containing regimen.

Maintenance Treatment Of Recurrent Ovarian Cancer

The recommended dosage of Zejula is 300 mg (three 100-mg capsules) taken orally once daily.

For the maintenance treatment of recurrent ovarian cancer, patients should start treatment with
Zejula no later than 8 weeks after their most recent platinum-containing regimen.

Treatment Of Advanced Ovarian Cancer After 3 Or More Chemotherapies

The recommended dosage of Zejula is 300 mg (three 100-mg capsules) taken orally once daily.

Dosage Adjustments For Adverse Reactions

To manage adverse reactions, consider interruption of treatment, dose reduction, or dose discontinuation. The recommended dose modifications for adverse reactions are listed in Tables 1, 2, and 3.

Table 1: Recommended Dose Modifications for Adverse Reactions

Starting Dose Level
200 mg
300 mg

First dose reduction
100 mg/day^a (one 100-mg capsule)
200 mg/day (two 100-mg capsules)

Second dose reduction
Discontinue Zejula.
100 mg/day^a (one 100-mg capsule)

^a If further dose reduction below 100 mg/day is required, discontinue
Zejula.

Table 2: Dose Modifications for Non-Hematologic Adverse Reactions

Non-hematologic CTCAE ≥Grade 3 adverse reaction that persists despite medical management

Withhold Zejula for a maximum of 28 days or until resolution of adverse reaction.
Resume Zejula at a reduced dose per Table 1.

CTCAE ≥Grade 3 treatment-related adverse reaction lasting more than 28 days while patient is administered
Zejula 100 mg/day
Discontinue Zejula.

CTCAE = Common Terminology Criteria for Adverse Events.

Table 3: Dose Modifications for Hematologic Adverse Reactions

Monitor complete blood counts weekly for the first
month, monthly for the next 11 months of treatment, and periodically
after this time.

Platelet count <100,000/mcL
First occurrence:

Withhold Zejula for a maximum of 28 days and monitor blood counts weekly until platelet counts return to ≥100,000/mcL.
Resume Zejula at same or reduced dose per Table 1.
If platelet count is <75,000/mcL, resume at a reduced dose. Second occurrence:
Withhold Zejula for a maximum of 28 days and monitor blood counts weekly until platelet counts return to ≥100,000/mcL.
Resume Zejula at a reduced dose per Table 1.
Discontinue Zejula if the platelet count has not returned to acceptable levels within 28 days of the dose interruption period or if the patient has already undergone dose reduction to 100 mg once daily.^a

Neutrophil <1,000/mcL or hemoglobin <8 g/dL

Withhold Zejula for a maximum of 28 days and monitor blood counts weekly until neutrophil counts return to ≥1,500/mcL or hemoglobin returns to ≥9 g/dL.
Resume Zejula at a reduced dose per Table 1.
Discontinue Zejula if neutrophils and/or hemoglobin have not returned to acceptable levels within 28 days of the dose interruption period or if the patient has already undergone dose reduction to 100 mg once daily.^a

Hematologic adverse reaction requiring transfusion

For patients with platelet count ≤10,000/mcL, platelet transfusion should be considered. If there are other risk factors such as coadministration of anticoagulation or antiplatelet drugs, consider interrupting these drugs and/or transfusion at a higher platelet count.
Resume Zejula at a reduced dose.

^a If myelodysplastic
syndrome or acute myeloid leukemia (MDS/AML) is confirmed,
discontinue Zejula.

Dosage Adjustment For Hepatic Impairment

Moderate Hepatic Impairment

For patients with moderate hepatic impairment, reduce the starting dosage of
Zejula to 200 mg once daily. Monitor patients for hematologic toxicity and
reduce the dose further, if needed.

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What drugs interact with Zejula?

No Information Provided

Is Zejula safe to use while pregnant or breastfeeding?

Based on its mechanism of action, Zejula can cause fetal harm when administered to pregnant women.
There are no data regarding the use of Zejula in pregnant women to inform the drug-associated risk.
Zejula has the potential to cause teratogenicity and/or embryo-fetal death since niraparib is genotoxic and targets actively dividing cells in animals and patients (e.g., bone marrow).
Due to the potential risk to a fetus based on its mechanism of action, animal developmental and reproductive toxicology studies were not conducted with niraparib. Apprise pregnant women of the potential risk to a fetus.
No data are available regarding the presence of niraparib or its metabolites in human milk, or on its effects on the breastfed child or milk production.
Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during treatment with Zejula and for 1 month after receiving the final dose.