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This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

AKEEGA® (niraparib and abiraterone acetate)

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Use of AKEEGA in Patients with Renal Impairment

Last Updated: 07/31/2024

Summary

There is no clinical experience reported in patients with prostate cancer and severe renal impairment receiving AKEEGA. Caution is advised in these patients.¹
No dose adjustment for AKEEGA is recommended in patients with mild to moderate renal impairment.¹ Please refer to local labeling for additional considerations.
In MAGNITUDE, the phase 3 study evaluating the efficacy and safety of AKEEGA with prednisone compared to placebo/abiraterone acetate with prednisone (AAP) as first-line (L1) therapy in metastatic castration-resistant prostate cancer (mCRPC) for patients with certain homologous recombination repair (HRR) mutations, including BRCA1/2²^-⁵:
- Renal and urinary treatment-emergent adverse events (TEAEs) leading to dose reduction were reported in the HRR+ cohort. Chronic kidney disease occurred in 1 patient (0.5%) in the niraparib/AAP group vs 0 patients in the placebo/AAP group at the first interim analysis after a median follow-up of 18.6 months. Renal impairment occurred in 1 patient (0.5%) in the niraparib/AAP group vs 0 patients in the placebo/AAP group.⁶

LITERATURE SEARCH

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) conducted on 17 July 2024 did not identify any relevant citations pertaining to this topic in patients with prostate cancer.

References

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1	Data on File. Niraparib/Abiraterone acetate Fixed-Dose Combination. Investigator’s Brochure. Janssen Research & Development, LLC. EDMS-RIM-39141; 2023.
2	Janssen Research & Development, LLC. A study of niraparib in combination with abiraterone acetate and prednisone versus abiraterone acetate and prednisone for treatment of participants with metastatic prostate cancer (MAGNITUDE). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2024 July 15]. Available from: https://clinicaltrials.gov/show/NCT03748641 NLM Identifier: NCT03748641.
3	Chi KN, Rathkopf D, Smith MR, et al. Niraparib and abiraterone acetate for metastatic castration-resistant prostate cancer. J Clin Oncol. 2023;41(18):3339-3351.
4	Chi K, Sandhu S, Smith M, et al. Niraparib plus abiraterone acetate with prednisone in patients with metastatic castration-resistant prostate cancer and homologous recombination repair gene alterations: second interim analysis of the randomized phase III MAGNITUDE trial. Ann Oncol. 2023;34(9):772-782.
5	Chi K, Castro E, Attard G, et al. Niraparib (NIRA) with abiraterone acetate plus prednisone (AAP) as first-line (1L) therapy in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) and homologous recombination repair (HRR) gene alterations: three-year update and final analysis (FA) of MAGNITUDE. Oral presentation presented at: European Society of Medical Oncology (ESMO) Congress; October 20-24, 2023; Madrid, Spain.
6	Chi KN, Rathkopf D, Smith MR, et al. Supplement for: Niraparib and abiraterone acetate for metastatic castration-resistant prostate cancer. J Clin Oncol. 2023;41(18):3339-3351.