Akeega (Niraparib and Abiraterone Acetate)

Akeega (niraparib and abiraterone acetate) is a fixed-dose combination tablet — a PARP inhibitor (niraparib) together with an androgen biosynthesis (CYP17) inhibitor (abiraterone acetate) — taken with prednisone. It is approved for two BRCA-mutated prostate cancer settings, each confirmed by an FDA-approved companion diagnostic test.

BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC): approved August 11, 2023, based on the MAGNITUDE trial.

BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC): approved December 12, 2025, based on the AMPLITUDE trial.

Both indications require patients to be on concurrent gonadotropin-releasing hormone (GnRH) analog therapy or to have undergone bilateral orchiectomy, and require confirmed BRCA1/2 mutation status via an FDA-approved test. Niraparib blocks PARP-1/PARP-2 DNA-repair enzymes, which is especially damaging to tumor cells that already carry a BRCA1/2 mutation, while abiraterone acetate blocks CYP17 to cut off androgen production that fuels prostate cancer growth.

• Myelosuppression: decreased blood counts are common; in the MAGNITUDE trial, 27% of patients required a blood transfusion. Regular complete blood count monitoring is required.
• A rare but serious risk of myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) is associated with PARP inhibitors.
• Hypertension, fluid retention, and hypokalemia can occur due to abiraterone’s mechanism; blood pressure, potassium, and fluid status should be monitored.
• Liver function tests should be monitored periodically due to hepatotoxicity risk.
• Akeega can cause fetal harm (embryo-fetal toxicity); effective contraception is required, and it is not for use in women.
• Common side effects (≥20% incidence) include hypertension, musculoskeletal pain, constipation, fatigue, nausea, respiratory tract infection, and arrhythmia.

What documents are required to import Akeega to India?

Akeega may be imported in the patient’s name only, by patients or government hospitals. The following documentation is required:

• A valid prescription from a registered oncologist/urologist specifying Akeega (niraparib/abiraterone acetate)
• A BRCA1/2 mutation test report from an accredited lab confirming eligibility
• The patient’s diagnostic/medical history summary
• Patient ID proof (issued by the Government of India)

How is the order confirmed?

The order is confirmed only after receipt and verification of a valid prescription, BRCA test report, and the applicable Form 12A import permit.

Is Akeega available in India?

Akeega is a prescription medicine that legally requires a doctor’s prescription to be dispensed. It is not commercially marketed in India. However, patients in India can legally access Akeega through the Named Patient Program (NPP) — an import provision (Form 12A, Rule 36) that allows a medicine not yet registered in India to be imported for an individual patient’s personal treatment.

Indian Pharma Network (IPN) can source Akeega from reliable, authorized channels across the world and facilitate supply to patients, doctors, and hospitals under applicable legal provisions. All prescriptions are verified and dispensed by registered pharmacists and dispatched to the patient’s address after legal requirements are fulfilled.

For Akeega cost in India and availability, contact IPN at Phone: +91-9310090915 or email info@indianpharmanetwork.in.

Global Approval Status:

• United States: Approved by the FDA — August 11, 2023 for BRCA-mutated mCRPC; December 12, 2025 for BRCA2-mutated mCSPC.
• European Union: Approved by the EMA — April 19, 2023 (EMEA/H/C/005932).

Akeega tablets are stored and shipped at room temperature in original, tamper-evident packaging — no cold-chain handling required. Every shipment includes a batch certificate of analysis and import documentation, with pan-India delivery plus SAARC countries (Nepal, Bangladesh, Sri Lanka, Bhutan) on request.

What is the generic name for the brand drug Akeega?

Niraparib and abiraterone acetate is the generic combination for the brand drug Akeega.

What is Akeega used for?

Akeega is used with prednisone to treat adults with BRCA-mutated metastatic castration-resistant or castration-sensitive prostate cancer.

Who manufactures Akeega?

Akeega is manufactured by Janssen Biotech, Inc., a Johnson & Johnson company.

What type of medicine is Akeega?

Akeega is a fixed-dose combination of niraparib, a PARP inhibitor, and abiraterone acetate, a CYP17 (androgen biosynthesis) inhibitor — the first FDA-approved therapy to combine both mechanisms in a single tablet.

Is Akeega approved by the FDA?

Yes. Akeega was first approved by the US FDA on August 11, 2023 for BRCA-mutated mCRPC, with a second indication for BRCA2-mutated mCSPC approved on December 12, 2025.

How much does Akeega cost in India?

Price depends on sourcing country, exchange rate, quantity, customs duty, and logistics. Share your prescription and BRCA test report with IPN’s patient support team for a transparent, itemized quote.