Zejula (niraparib)

A test will be performed to ensure Zejula is suitable for you.

Zejula’s safety and efficacy in children is unknown.

What are the side effects of Zejula?

Common side effects of Zejula include:

• irregular heartbeat,
• changes in liver function or blood tests,
• nausea,
• joint, muscle, and back pain,
• constipation,
• headache,
• vomiting,
• dizziness,
• stomach pain,
• changes in taste,
• 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 urine color or amount

Your dose may be adjusted or treatment discontinued if you experience certain side effects.

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

QUESTION

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.

Take the dose of Zejula at approximately the same time each day. Swallow the capsule whole and do not chew, crush, or split it. Zejula may be taken with or without food. Bedtime administration may help manage nausea.

If a dose is missed, take the next dose at the regularly scheduled time. Do not take an additional dose if a dose is missed or vomited.

First-Line Maintenance Treatment Of Advanced Ovarian Cancer

• For patients weighing ≥77 kg (≥170 lbs) AND with a platelet count ≥150,000/mcL, take 300 mg (three 100-mg capsules) orally once daily.

Treatment with Zejula should begin no later than 12 weeks after the most recent platinum-containing regimen for the maintenance treatment of advanced ovarian cancer.

Maintenance Treatment Of Recurrent Ovarian Cancer

Take 300 mg (three 100-mg capsules) of Zejula orally once daily for the maintenance treatment of recurrent ovarian cancer. Treatment should begin no later than 8 weeks after the most recent platinum-containing regimen.

Treatment Of Advanced Ovarian Cancer After 3 Or More Chemotherapies

Take 300 mg (three 100-mg capsules) of Zejula orally once daily for the treatment of advanced ovarian cancer after 3 or more chemotherapies.

Dosage Adjustments For Adverse Reactions

Manage adverse reactions by interrupting treatment, reducing dose, or discontinuing. Refer to Tables 1, 2, and 3 for recommended dose modifications.

Table 1: Recommended Dose Modifications for Adverse Reactions

Table 2: Dose Modifications for Non-Hematologic Adverse Reactions

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

Table 3: Dose Modifications for Hematologic Adverse Reactions

• 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 ≤50,000/mcL, discontinue Zejula if the count has not returned to acceptable levels within 28 days of the dose interruption period or if the patient is already on a reduced dose of 100 mg once daily. a
• 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.
• Consider platelet transfusion for patients with platelet count ≤10,000/mcL. 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.

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 further reduce the dose if needed.

What drugs interact with Zejula?

No Information Provided

Is Zejula safe to use while pregnant or breastfeeding?

• Zejula can cause fetal harm in pregnant women.
• Data regarding the use of Zejula in pregnant women is unavailable.
• Zejula has the potential to cause harm to the fetus due to its genotoxic nature and targeting of actively dividing cells in animals and patients (e.g., bone marrow).
• Due to the potential risk, developmental and reproductive toxicology studies were not conducted with niraparib. Pregnant women should be aware of the potential risk.
• Data on the presence of niraparib or its metabolites in human milk, or its effects on breastfed infants or milk production, is unavailable.
• Lactating women should not breastfeed during treatment with Zejula and for 1 month after the final dose.

Summary

Zejula is a prescription medicine used for the maintenance treatment of adults with ovarian cancer, advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. Common side effects include irregular heartbeat, changes in liver function or blood tests, nausea, joint, muscle, and back pain, constipation, headache, vomiting, dizziness, stomach pain, changes in taste, mouth sores, trouble sleeping, diarrhea, and anxiety.