Zejula (niraparib)

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.

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

Table 2: Dose Modifications for Non-Hematologic Adverse Reactions

Table 3: Dose Modifications for Hematologic Adverse Reactions

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.

• 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.