1. Indications and Usage
\nMetastatic Castration-Resistant Prostate Cancer (mCRPC):
\nIndicated for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) who have germ-line and\/or somatic BRCA gene mutations.
\nCombination Therapy:
\nThis indication is approved in combination with prednisone or prednisolone and androgen deprivation therapy (ADT).
\n2. Dosage and Administration
\nRecommended Dosage:
\nStandard Dose: 200 mg Niraparib + 1000 mg Abiraterone Acetate administered orally once daily.
\nConcomitant Medication: Must be taken with 10 mg of Prednisone or Prednisolone once daily.
\nADT: Patients must continue ADT (e.g., GnRH analogues or bilateral orchiectomy).
\nAdministration Instructions:
\nFasting: Must be taken on an empty stomach. No food for at least 2 hours before and at least 1 hour after taking the tablet.
\nSwallow tablets whole with water.
\n3. Mechanism of Action
\nDual Inhibition Strategy:
\nNiraparib (PARP Inhibitor): Inhibits PARP-1 and PARP-2 enzymes, preventing the repair of single-strand DNA breaks. In cells with BRCA mutations (homologous recombination deficiency), this leads to double-strand breaks and cell death (synthetic lethality).
\nAbiraterone Acetate (Androgen Biosynthesis Inhibitor): Inhibits CYP17A1 (17\u03b1-hydroxylase\/C17,20-lyase), an enzyme essential for androgen synthesis in the testes, adrenal glands, and prostate tumor tissue.
\n4. Safety and Warnings
\nHematologic Toxicity:
\nNiraparib can cause severe and life-threatening hematologic toxicities, including thrombocytopenia, anemia, and neutropenia. Regular monitoring of blood counts is required.
\nMDS\/AML:
\nDevelopment of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) has been observed in patients treated with PARP inhibitors.
\nHepatotoxicity:
\nLiver toxicity (elevated ALT\/AST or bilirubin) may occur. Monitor liver function tests periodically.
\nHypertension:
\nNiraparib may cause hypertension. Patients should have blood pressure well-controlled before starting treatment.
\nContraindications:
\nContraindicated in patients with moderate or severe hepatic impairment (Child-Pugh B or C).
\n5. Adverse Reactions
\nMost Common:
\nFatigue, nausea, thrombocytopenia, anemia, vomiting, constipation, abdominal pain, hypertension, and decreased appetite.
\n6. Drug Interactions
\nCYP3A Inducers:
\nAvoid co-administration with strong CYP3A inducers (e.g., rifampin), as they may significantly decrease abiraterone exposure.
\nCYP2D6 Substrates:
\nAbiraterone is a CYP2D6 inhibitor. Use caution when co-administering with CYP2D6 substrates.
\n7. Pharmaceutical Information
\nChemical Description:
\nA fixed-dose combination tablet containing Niraparib Tosylate and Abiraterone Acetate.
\nStorage:
\nStore at room temperature (controlled room temperature 20\u00b0C to 25\u00b0C). Protect from moisture.<\/p>\n","protected":false},"excerpt":{"rendered":"
Brand Name: \u6cfd\u500d\u73c2 \u00ae(Akeega\u00ae)
\nGeneric Name: Niraparib Tosylate and Abiraterone Acetate
\nStrength: 50 mg Niraparib Tosylate \/ 500 mg Abiraterone Acetate per tablet; 28 tablets per blister, 2 blisters per box (total 56 tablets\/box)
\nManufacturer: Janssen-Cilag S.p.A
\nMarketing Authorization Holder: Janssen Pharmaceuticals, Inc.\uff1b\u5883\u5185\u6301\u8bc1\u53ca\u5546\u4e1a\u5316\u4e3b\u4f53\uff1a\u897f\u5b89\u6768\u68ee\u5236\u836f\u6709\u9650\u516c\u53f8
\nApproval Date in China: October 21, 2024
\nRegistration Number: \u56fd\u836f\u51c6\u5b57 HJ20240110
\nStorage: Store at 20\u00b0C\uff5e25\u00b0C, allow excursions between 15\u00b0C and 30\u00b0C; keep tightly closed, protect from moisture, store out of reach of children.<\/p>\n
Price&Cost:Contact Us now for the best price of Niraparib Tosylate and Abiraterone Acetate \uff08Akeega\uff09<\/p>\n","protected":false},"featured_media":3236,"comment_status":"open","ping_status":"closed","template":"","meta":[],"product_brand":[],"product_cat":[27],"product_tag":[],"class_list":["post-3235","product","type-product","status-publish","has-post-thumbnail","product_cat-tablets","first","instock","shipping-taxable","product-type-simple"],"yoast_head":"\n