Niraparib/abiraterone acetate
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Niraparib | Antineoplastic agent |
Abiraterone acetate | Hormone antagonist |
Clinical data | |
Trade names | Akeega |
Routes of administration | By mouth |
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KEGG |
Niraparib/abiraterone acetate, sold under the brand name Akeega, is a combination anti-cancer medication used for the treatment of prostate cancer.[2] It contains niraparib, a poly (ADP-ribose) polymerase (PARP) inhibitor (antineoplastic agent), and abiraterone acetate, a CYP17 inhibitor (hormone antagonist).[2]
The most common side effects include anemia (low levels of red blood cells), high blood pressure, constipation, tiredness, nausea, thrombocytopenia (low levels of blood platelets), difficulty breathing, back pain, reduced appetite, neutropenia (low levels of neutrophils, a type of white blood cell), joint pain, vomiting, low levels of potassium, dizziness, difficulty sleeping, high blood glucose levels, and urinary tract infection.[1]
Niraparib/abiraterone acetate was approved for medical use in the European Union in April 2023.[1]
Medical uses
Niraparib/abiraterone is indicated for the treatment of adults with prostate cancer.[1] It is for people who have genetic mutations known as BRCA 1/2 mutations and who cannot have chemotherapy.[1] It is used in combination with prednisolone or another medicine prednisone, which is converted into prednisolone.[1]
Society and culture
Legal status
On 23 February 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Akeega, intended for the treatment of adults with metastatic castration-resistant prostate cancer with BRCA 1/BRCA 2 mutations.[2] The applicant for this medicinal product is Janssen-Cilag International N.V.[2][3] Niraparib/abiraterone acetate was approved for medical use in the European Union in April 2023.[1]
References
- 1 2 3 4 5 6 7 "Akeega EPAR". European Medicines Agency. 2 June 2023. Archived from the original on 3 June 2023. Retrieved 2 June 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- 1 2 3 4 "Akeega: Pending EC decision". European Medicines Agency (EMA). 24 February 2023. Archived from the original on 25 February 2023. Retrieved 24 February 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ↑ "Janssen Receives Positive CHMP Opinion for Akeega (Niraparib and Abiraterone Acetate Dual Action Tablet) Plus Prednisone or Prednisolone for the Treatment of Adult Patients with BRCA1/2 Gene-Mutated Metastatic Castration Resistant Prostate Cancer" (Press release). Janssen Pharmaceutica NV. 24 February 2023. Archived from the original on 25 February 2023. Retrieved 24 February 2023 – via GlobeNewswire.
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