Niraparib-Abiraterone (AKEEGA)

Prostate cancer, BRCA-mutated metastatic, castration resistant

Prostate cancer, BRCA-mutated metastatic, castration resistant

• Oral: 200/1000 mg daily continuously until disease progression or unacceptable toxicity

Available as 100/500 mg and 50/500 mg tablets. Tablets should NOT be crushed or broken. Store at room temperature. Tablets contain lactose.

PARP (poly (ADP-ribose) polymerase) Inhibitor + Antiandrogen

Take an empty stomach at least 1 hour before or at least 2 hours after a meal

If a dose is missed, patients should be instructed to take it as soon as they can if it is remembered on the same day. Otherwise, patients should skip the missed dose and resume with the next scheduled dose.

Common: Anemia, Constipation, Neutropenia, Thrombocytopenia, Nausea, Fatigue, Hypertension, Hepatotoxicity.

Less Common: Dizziness, Dyspnea, Arthralgia, Decreased appetite, Edema, Insomnia, Potassium imbalances, Urinary tract infection, Arrhythmias, Posterior reversible encephalopathy syndrome, Myelodysplastic syndrome/Acute myeloid leukemia (MDS/AML), Venous thromboembolic events.

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, AST, ALT, bilirubin, alkaline phosphatase, blood pressure, glucose. If clinically indicated: ECG, edema.

CBC: Monitor weekly for first month, then every two weeks for the second and third month, then monthly thereafter. After one year (cycles 12+) monitoring can be decreased to every second month or as clinically indicated.

Every week for the first two months, then monthly: Potassium, blood pressure, edema.

Every week for the first three months, then monthly: AST, ALT, bilirubin.e. If clinically indicated: MUGA scan or echocardiogram, glucose.

• 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-abiraterone. Hypertensive crisis can occur as early as after first dose.
• Hepatotoxicity is a common adverse effect, liver function should be closely monitored.
• Secondary MDS or AML may occur, and fatal cases have been reported.

Lexicomp. Niraparib-abiraterone Monograph. In: Lexi-Drugs. Hudson, Ohio: Lexi-Comp, Inc. Accessed May 9, 2024.

Janssen. Akeega Product Monograph. In: Health Canada, Drug Product Database. Available at: https://pdf.hres.ca/dpd_pm/00071216.PDF Updated June 7, 2023. Accessed May 9, 2024