Product Introduction
Abiranamo 500mg Tablet is an oral anticancer agent containing the high-strength formulation of Abiraterone Acetate. This essential medication functions as a potent androgen biosynthesis inhibitor ( inhibitor), designed for the management of advanced prostate cancer. The strength is clinically preferred for its convenience, reducing the required daily pill count for the standard therapeutic dose.
Uses of Abiranamo 500mg Tablet
Abiranamo 500mg Tablet is indicated for use, always in combination with a low-dose corticosteroid (prednisone or prednisolone), for the treatment of:
- Metastatic Castration-Resistant Prostate Cancer (mCRPC): For men whose prostate cancer has spread to other areas of the body and has progressed despite prior treatments that lower testosterone (Androgen Deprivation Therapy, ).
- Metastatic High-Risk Castration-Sensitive Prostate Cancer (mHSPC): For newly diagnosed men with high-risk metastatic prostate cancer, used as part of a combination regimen with .
Benefits of Abiranamo 500mg Tablet
The tablet offers substantial benefits in oncology care:
- Simplified Dosing Regimen: The standard daily dose of is achieved with two tablets, significantly reducing the pill burden compared to the formulation, which enhances patient compliance and streamlines dispensing operations.
- Profound Hormonal Blockade: It ensures near-complete suppression of androgen production by inhibiting the enzyme in all key sites (, , ), which is vital for slowing disease progression.
- Clinically Validated: Its active ingredient, Abiraterone Acetate, is supported by pivotal clinical trials demonstrating superior overall survival and disease control rates.
Side Effects of Abiranamo 500mg Tablet
Adverse effects are often linked to the resulting mineralocorticoid excess.
- Common Side Effects: Hypertension (high blood pressure), Hypokalemia (low blood potassium), Edema (fluid retention, peripheral swelling), fatigue, joint pain/swelling, and hot flashes.
- Serious Side Effects (Requires immediate medical attention): Hepatotoxicity (severe liver injury, indicated by jaundice, dark urine), Adrenocortical Insufficiency (symptoms like severe fatigue, dizziness), and cardiovascular events (e.g., irregular heartbeat).
How to Use Abiranamo 500mg Tablet
- Dosage: The recommended daily dose of Abiraterone Acetate is (two tablets) taken as a single dose once daily, in combination with a prescribed corticosteroid (e.g., prednisone orally once or twice daily).
- Administration: The tablets must be swallowed whole with water and should not be crushed, chewed, or split.
- Crucial Empty Stomach Rule: Abiranamo 500mg Tablet must be taken on an empty stomach. Patients must not eat food for at least two hours before and one hour after taking the dose. Taking the medication with food significantly increases drug exposure and the risk of adverse effects.
How Abiranamo 500mg Tablet Works
Abiranamo 500mg Tablet contains the prodrug Abiraterone Acetate, which is converted to the active compound Abiraterone. Abiraterone acts as a potent, irreversible, and selective inhibitor of the enzyme (17$\alpha$-hydroxylase/-lyase). This enzyme is crucial for the biosynthesis of androgens. By blocking in the adrenal glands, testes, and prostate tumor tissue, Abiranamo drastically reduces the synthesis of androgens, thereby depriving the prostate cancer cells of the necessary hormonal stimulus for growth and proliferation and effectively slowing the disease’s progression.
- Women and Pregnancy: Abiranamo is strictly contraindicated in women, particularly those who are pregnant or may become pregnant, due to the risk of fetal harm. Women should avoid handling the tablets without protective gloves.
- Monitoring: Close and frequent monitoring of Liver Function Tests (), blood pressure, and serum potassium is mandatory throughout the course of treatment.
- Hepatic Impairment: Abiranamo is not recommended for use in patients with severe hepatic impairment. Dose adjustments (requiring the strength) are necessary for moderate hepatic impairment.
- Drug Combinations: The combination of Abiraterone Acetate and is contraindicated.
What if You Forget to Take Abiranamo 500mg Tablet?
If a dose is missed, the patient should skip the missed dose and take the next dose at the regularly scheduled time the following day. Patients must be warned not to take a double dose to compensate for the missed tablet.
Quick Tips
- Minimize Pill Count: The tablets reduce the number of pills needed daily (two tablets) compared to the strength (four tablets).
- Strict Fasting: Adhere rigorously to the 2-hour-before/1-hour-after food restriction for consistent drug exposure.
- Steroid Requirement: Emphasize the mandatory co-administration of prednisone/prednisolone to manage side effects related to mineralocorticoid excess.
FAQs
Q1: What is the primary advantage of the 500mg strength for bulk pharmaceutical buyers and clinical use?
A: The strength is highly advantageous as it reduces the required number of tablets for the standard daily dose from four to two, significantly enhancing patient adherence and simplifying inventory and dispensing procedures for high-volume supply chains.
Q2: How does UnnatiPharmax ensure the quality and compliance of Abiranamo 500mg Tablet for international export?
A: We guarantee a -grade product manufactured under strict guidelines. All bulk orders include the necessary Certificate of Analysis () and compliant packaging that maintains stability (Store below ) for all international shipments.
Q3: Is Abiranamo 500mg Tablet recommended for patients with moderate liver impairment?
A: No. The standard dose (two tablets) is not recommended for patients with moderate baseline hepatic impairment. For these patients, the dose must be reduced to once daily, requiring the use of the lower-strength tablets.
Q4: What specific safety risk is dramatically increased if Abiranamo 500mg Tablet is taken with food?
A: Taking the tablet with food causes a massive, unpredictable increase in Abiraterone absorption, which can lead to dangerously high plasma levels. This sharply increases the risk of severe, dose-related toxicities, particularly uncontrolled hypertension and hepatotoxicity.
Q5: What are the risks of drug interactions with Abiranamo due to its enzyme inhibition properties?
A: Abiraterone is an inhibitor of . Co-administration with substrate drugs that have a narrow therapeutic index (e.g., thioridazine, propafenone) must be avoided or managed with careful dose reduction of the co-administered drug.
Q6: Why is therapy always combined with a corticosteroid, and what should patients know about it?
A: The co-administered corticosteroid (prednisone/prednisolone) is medically essential to counteract the mineralocorticoid excess (, ) caused by Abiraterone’s inhibition of . Patients must never stop or change the steroid dose abruptly, as it risks severe adverse effects, including adrenal crisis.
A Note to Our Bulk Buyers:
UnnatiPharmax is committed to delivering pharmaceutical-grade Abiranamo 500mg Tablet. We guarantee a secure and efficient supply chain with compliant international shipping to our valued partners in Australia, Germany, Singapore, the UK, the US, and the Philippines.
References:-
- U.S. National Library of Medicine (NIH – MedlinePlus):
- https://medlineplus.gov/druginfo/meds/a611046.html
- (General Drug Information on Abiraterone)
- U.S. Food and Drug Administration (FDA) – Drug Label:
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202379s035lbl.pdf
- (Full Prescribing Information for Zytiga/Abiraterone Acetate, includes 500mg details)
- European Medicines Agency (EMA) – Product Overview (EPAR):
- https://www.ema.europa.eu/en/medicines/human/EPAR/zytiga
- (Summary of Zytiga’s authorization in the EU)
- NIH – PubMed Central (PMC) – Research Review:
- https://pmc.ncbi.nlm.nih.gov/articles/PMC11597628/
- (Review of Abiraterone and its mechanism/usage)
- NIH – National Cancer Institute (NCI) – Clinical Trials:
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