Niraparib Abiraterone Application Scope

Indication: Adult patients with BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC), in combination with prednisone/prednisolone.

Niraparib Abiraterone Characteristics

Ingredients: Each film-coated tablet contains niraparib 100 mg + abiraterone acetate 500 mg.
Properties:
- PARP inhibitor (niraparib) + androgen biosynthesis inhibitor (abiraterone).
- Yellow, film-coated, oral tablets.
Packaging Specification: Bottles or blister packs; commonly 60 tablets/bottle (market-dependent).
Storage:
- Store at 20–25 °C (68–77 °F); excursions 15–30 °C.
- Keep in original container, protect from moisture and light.
Expiry Date: As printed on the package (market-dependent shelf life).
Executive Standard: In-house/marketed product standard (varies by market).
Approval Number: Market-specific registration number (fill per local label).
Date of Revision: Per local label (e.g., latest revision year/month).
Manufacturer: Janssen-Cilag / Johnson & Johnson Innovative Medicine (market entity varies).

Guidelines for the Use of Akeega

Dosage and Administration:
- Recommended Dose: 2 tablets once daily (total niraparib 100 mg + abiraterone acetate 1000 mg).
- Administration:
  - Oral, on an empty stomach (no food for ≥2 h before and ≥1 h after).
  - Swallow tablets whole.
- Missed Dose: If a dose is missed, take the next dose at the usual time. Do not double up.
Adverse Reactions:
- Common Adverse Reactions: Fatigue/asthenia, hypertension, nausea, vomiting, decreased appetite, anemia, thrombocytopenia, constipation, diarrhea, back pain, hypokalemia, edema, cough, elevated liver enzymes.
- Serious Adverse Reactions: Myelosuppression (severe thrombocytopenia/anemia), MDS/AML (rare), hepatotoxicity, adrenal insufficiency, severe hypertension, cardiac events (rare), serious infections.
Contraindications:
- Pregnancy (embryo-fetal toxicity).
- Known hypersensitivity to components.
- Severe hepatic impairment for abiraterone component (use not recommended).
Precautions:
- Monitor CBC (platelets, hemoglobin, neutrophils).
- Monitor BP, serum potassium, and liver function (ALT/AST, bilirubin).
- Risk of mineralocorticoid excess (hypertension, hypokalemia, edema) — prednisone/prednisolone required.
- Avoid grapefruit/Seville orange (CYP3A interactions).
- Embryo-fetal toxicity: use effective contraception for partners.
- Dose modifications/interruption for hematologic or hepatic toxicity per label.

Niraparib Abiraterone Interactions

Strong CYP3A inducers (e.g., rifampin, carbamazepine, phenytoin, St. John’s wort) ↓ abiraterone exposure — avoid.
Strong CYP3A inhibitors (e.g., ketoconazole, itraconazole) ↑ abiraterone exposure — avoid/monitor.
Abiraterone inhibits CYP2D6 and CYP2C8 → ↑ levels of substrates (e.g., metoprolol, propafenone, tricyclics) — monitor/adjust.
Niraparib is a substrate of P-gp/BCRP; strong inhibitors may ↑ exposure — monitor for toxicity.
QT-prolonging or myelosuppressive agents: additive effects — use caution.
Mineralocorticoid effects may be exacerbated by potassium-wasting diuretics — monitor K⁺ and BP.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.