Targeted Therapy / Oncology — Prostate Cancer

Akeega (niraparib and abiraterone acetate)

Janssen Oncology (Johnson & Johnson) · PARP Inhibitor + CYP17 Inhibitor Combination

FDA Approved 2023 Oral tablet Specialty Medication
Akeega niraparib abiraterone acetate 50mg/500mg tablets, Janssen, prostate cancer targeted therapy

What is Akeega? Akeega (niraparib and abiraterone acetate) is the first FDA-approved combination of a PARP inhibitor and an androgen biosynthesis inhibitor in a single tablet, approved for BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC) with methylprednisolone.

About Akeega

Brand NameAkeega
Generic / INNniraparib and abiraterone acetate
Drug ClassPARP Inhibitor + CYP17 Inhibitor Combination
ManufacturerJanssen Oncology (Johnson & Johnson)
AdministrationOral tablet
FDA Approval2023
📦 Tablets: niraparib 50 mg / abiraterone acetate 500 mg. Daily dose is 2 tablets (niraparib 100 mg / abiraterone 1000 mg). Must be taken with methylprednisolone 4 mg BID — NOT prednisone.

FDA-Approved Uses for Akeega

Indications are based on FDA approval. Your healthcare provider determines appropriate use based on your specific diagnosis, stage, biomarker status, and overall clinical picture.

  • BRCA-mutated (germline and/or somatic) metastatic castration-resistant prostate cancer (mCRPC) — in combination with methylprednisolone and androgen deprivation therapy
Biomarker Note: BRCA1 or BRCA2 mutation (germline and/or somatic) must be confirmed using an FDA-approved companion diagnostic before starting Akeega.

How Does Akeega Work?

Niraparib inhibits PARP1 and PARP2 enzymes — exploiting the synthetic lethality of BRCA1/2-deficient tumor cells (DNA repair impairment). Abiraterone acetate inhibits CYP17 to block androgen biosynthesis. The combination targets both androgen signaling and DNA repair, providing synergistic activity in BRCA-mutated mCRPC.

Dosage & Administration

Two tablets daily (niraparib 100 mg / abiraterone acetate 500 mg = two 50/250 mg tablets orally once daily) on an empty stomach (no food 2 hours before or 1 hour after). Taken with methylprednisolone 4 mg twice daily (not prednisone — methylprednisolone is required with Akeega).

⚠️ Important

Dosing is individualized by the prescribing clinician. Never adjust your dose without consulting your healthcare provider. This information is educational only and does not replace the official prescribing information.

Warnings, Precautions & Side Effects

General Warning

Myelosuppression (niraparib component) — CBC monitoring required. MDS/AML risk (niraparib). Adrenocortical insufficiency (abiraterone). Mineralocorticoid excess — managed with methylprednisolone. Hepatotoxicity — LFT monitoring. Embryo-fetal toxicity. Hypertension. Cardiac disorders.

⛔ Serious Warnings & Precautions
  • Myelosuppression / MDS/AML (niraparib)
  • Adrenocortical insufficiency (abiraterone)
  • Hepatotoxicity
  • Hypertension
  • Cardiac toxicity
  • Embryo-fetal toxicity

Common Side Effects

  • Fatigue
  • Anemia
  • Nausea
  • Constipation
  • Thrombocytopenia
  • Hypertension
  • Arthralgia
  • Peripheral edema

This is not a complete list. Always report new or worsening symptoms to your healthcare provider promptly.

Storage & Handling

Store at room temperature 20°C to 25°C (68°F to 77°F).

BiologicHealthPlus provides temperature-monitored cold-chain specialty delivery for medications requiring refrigeration. Never use a medication if its storage conditions have been compromised.

Insurance Coverage, Prior Authorization & Patient Assistance

🛡️ Commercial Insurance

Akeega is covered by most major commercial insurance plans when medically necessary and prior authorized. Coverage tier and cost-sharing vary by plan.

✅ Prior Authorization

Prior authorization is required by virtually all insurance plans for Akeega. BiologicHealthPlus handles the complete prior authorization process at no cost to patients or providers.

🏥 Medicare Coverage

Medicare Part D covers this oral specialty medication. Medicaid coverage varies by state.

🆓 Patient Assistance

Manufacturer patient assistance programs may be available for eligible uninsured or underinsured patients. Contact BiologicHealthPlus for a confidential eligibility review.

Prior Authorization Patient Assistance Insurance & Savings Medication Costs

Frequently Asked Questions — Akeega

Akeega combines niraparib (PARP inhibitor) and abiraterone acetate (CYP17 inhibitor) in a single daily tablet for BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC). It targets both DNA repair pathways and androgen production simultaneously.

No — Akeega must be taken with methylprednisolone 4 mg twice daily, not prednisone. This is different from standard abiraterone regimens and is important to follow correctly.

Yes. BRCA1 or BRCA2 mutation testing (germline and/or somatic) using an FDA-approved companion diagnostic is required before starting Akeega.

Akeega is covered by most commercial insurance and Medicare Part D with prior authorization and BRCA mutation documentation.

Related Medications

Lynparza (olaparib)  ·  Abiraterone Acetate  ·  Erleada (apalutamide)  ·  Xtandi (enzalutamide)

Related Conditions

BRCA-mutated mCRPC  ·  Metastatic castration-resistant prostate cancer  ·  Prostate cancer

Comparisons

Abiraterone Acetate Lynparza

Authoritative References

Medical Disclaimer: This page is for general educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult your oncologist, hematologist, or licensed healthcare professional before making any treatment decisions. Last reviewed: August 2026 by the BiologicHealthPlus Clinical Team.