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Akeega

niraparib/abiraterone acetate
PARP + CYP17 Inhibitor FDA Approved 2023 Janssen
Route
Oral
Half-Life
~14 hrs
FDA Approved
2023
Manufacturer
Janssen
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1. Indications and Usage

Prostate cancer: BRCA-mutated mCRPC.

2. Dosage and Administration

Niraparib 200 mg/abiraterone 1000 mg orally once daily on empty stomach + prednisone 10 mg daily.

3. Dosage Forms and Strengths

Tablets: niraparib 100 mg/abiraterone 500 mg

4. Contraindications

None listed.

5. Warnings and Precautions
  • Bone Marrow Suppression: Monitor CBCs.
  • Hypertension: Monitor BP.
  • Hepatotoxicity: Monitor LFTs.
  • MDS/AML: Cases reported.
  • Embryo-Fetal Toxicity: Can cause fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Anemia (47%), Musculoskeletal Pain (42%), Fatigue (40%), Constipation (34%), Nausea (33%), Hypertension (28%), Thrombocytopenia (27%), Decreased Appetite (21%)

Anemia
47%
Musculoskeletal Pain
42%
Fatigue
40%
Constipation
34%
Nausea
33%
Hypertension
28%
Thrombocytopenia
27%
Decreased Appetite
21%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

CYP2D6 Substrates: Abiraterone inhibits CYP2D6.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Niraparib inhibits PARP-1/2 causing DNA damage in BRCA-mutated cells. Abiraterone inhibits CYP17A1 reducing androgen biosynthesis.

Pharmacokinetics

Niraparib: t½ 36h. Abiraterone: t½ 12h. Take on empty stomach.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
📋 All Akeega Trials on ClinicalTrials.gov ↗ 📚 PubMed: Akeega Clinical Trials ↗
FDA-Approved Tumor Types

Akeega has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

Prostate Cancer
External Resources
📋 DailyMed Label ↗ 🏛️ FDA Drugs@FDA ↗ 🔬 ClinicalTrials.gov ↗ 📚 PubMed Pivotal Trials ↗
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Akeega. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Akeega (niraparib/abiraterone acetate) approved for?

Akeega (niraparib/abiraterone acetate) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Akeega (niraparib/abiraterone acetate) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Akeega (niraparib/abiraterone acetate) work?

Niraparib inhibits PARP-1/2 causing DNA damage in BRCA-mutated cells. Abiraterone inhibits CYP17A1 reducing androgen biosynthesis.

What are the most common side effects?

Anemia (47%), Musculoskeletal Pain (42%), Fatigue (40%), Constipation (34%), Nausea (33%), Hypertension (28%), Thrombocytopenia (27%), Decreased Appetite (21%) Anemia 47% Musculoskeletal Pain 42% Fatigue 40% Constipation 34% Nausea 33% Hypertension 28% Thrombocytopenia 27% Decreased Appetite 21%

← All Therapies Full Prescribing Information ↗