Niraparib (ZEJULA)

Ovarian cancer, advanced

Ovarian cancer, relapsed

Ovarian cancer, advanced

• Dose - Oral:  Patients <77 kg or with a platelet count <150,000/mm3 = 200 mg once daily continuously up to three years
• Dose - Oral:  Patients ≥77 kg and with a platelet count ≥150,000/mm3 = 300 mg once daily continuously up to three years

Ovarian cancer, relapsed

• Dose - Oral:  Patients <58 kg = consider 200 mg once daily continuously until disease progression or unacceptable toxicity
• Dose - Oral:  Patients ≥58 kg = 300 mg once daily continuously until disease progression or unacceptable toxicity

Available as 100 tablets. Tablets should NOT be crushed or broken. Store at room temperature. Tablets contain lactose.

PARP (poly (ADP-ribose) polymerase) Inhibitor

Take with or without food

If a dose is missed, patients should be instructed not to take the missed dose but to resume with the next scheduled dose.

Common: Anemia, Neutropenia, Thrombocytopenia, Diarrhea, Nausea, Fatigue, Hypertension.

Less Common: Rash, Decreased appetite, Myelodysplastic syndrome/acute myeloid leukemia (MDS/AML), Insomnia, Posterior reversible encephalopathy syndrome.

The adverse effects listed above are not exhaustive. Please refer to the relevant product monograph for full details.

Baseline before treatment: CBC & differential, platelets, creatinine, sodium, potassium, ALT, bilirubin, alkaline phosphatase, blood pressure. If clinically indicated: tumour marker, ECG.

Every four weeks for the first year (cycles 1 to 12): CBC & differential, platelets, blood pressure. For the first cycle, check CBC & differential, platelets weekly or on Day 14.  After one year (cycles 12+) blood pressure can be decreased to as clinically indicated.

If clinically indicated: creatinine, ALT, bilirubin, alkaline phosphatase, any initially elevated tumour marker, day 14 check of CBC & differential and platelets.

• This drug can impact or be impacted by metabolic enzymes for absorption and excretion. Many drugs can also affect or be affected by these enzymes, so please consult with pharmacy to assess for interactions.
• Current drug interaction databases should be consulted for more information.

• Avoid in pregnancy and lactation.
• Hypertension - Common, but can be managed with antihypertensives and dose reduction of niraparib. Hypertensive crisis can occur as early as after first dose.
• Secondary MDS or AML may occur, and fatal cases have been reported.
• Bedtime administration may be a potential method for managing nausea.
• Neutropenia is a common toxicity, assess promptly for any signs of fever and or infection.

BC Cancer. BC Cancer Drug Manual. Niraparib. Vancouver, British Columbia: BC Cancer Agency. Available at http://www.bccancer.bc.ca/drug-database-site/Drug%20Index/Niraparib_monograph.pdf: Updated August 1, 2023. Accessed January 22, 2024.

Lexicomp. Niraparib Monograph. In: Lexi-Drugs. Hudson, Ohio: Lexi-Comp, Inc.. Available at: https://online.lexi.com/lco/action/doc/retrieve/docid/patch_f/6451837?cesid=auGNROKTRD5&searchUrl=%2Flco%2Faction%2Fsearch%3Fq%3Dniraparib%26t%3Dname%26acs%3Dtrue%26acq%3Dnirapari. Updated January 24, 2024. Accessed January 25, 2024.

Cancer Care Ontario. Niraparib Monograph. Drug Formulary. Toronto, Ontario: Cancer Care Ontario. Available at: https://www.cancercareontario.ca/en/drugformulary/drugs/monograph/69561. Updated October 2023. Accessed January 22, 2024.

GlaxoSmithKline Inc. ZEJULA® Product Monograph. Mississauga, Ontario: GlaxoSmithKline Inc. Updated August 17, 2023.