Abiraxen 250 mg (Abiraterone Acetate) Tablet is a highly effective oral treatment for advanced stages of prostate cancer. Designed as a CYP17 enzyme inhibitor, Abiraxen is used in combination with prednisone to manage both metastatic castration-resistant prostate cancer (mCRPC) and metastatic high-risk castration-sensitive prostate cancer (mCSPC). Manufactured by Everest Pharmaceuticals Ltd., a WHO-GMP-certified company, and supplied globally by Makkaa Pharma, this therapy targets androgen production crucial to the progression of prostate tumors.

Key Benefits and Mechanism of Action

• Inhibition of CYP17: Blocks 17 α-hydroxylase and C17,20-lyase, enzymes necessary for androgen production in the testes, adrenal glands, and tumor tissue.
• Reduces Testosterone Levels: Drastically lowers serum testosterone and other androgen precursors.
• Enhances Survival Rates: When used with prednisone and either surgical or chemical castration, Abiraxen significantly delays disease progression and improves overall survival.

Abiraxen works by inhibiting the enzyme CYP17, which plays a critical role in androgen biosynthesis. Androgens like testosterone are known to fuel the growth of prostate cancer cells.

Indications

Abiraxen 250 mg is indicated for use with prednisone for the treatment of:

• Metastatic Castration-Resistant Prostate Cancer (mCRPC)
• Metastatic High-Risk Castration-Sensitive Prostate Cancer (mCSPC)

Use only under the supervision of a registered physician.

Dosage and Administration

• Standard Dose: 1,000 mg (four 250 mg tablets) taken once daily on an empty stomach, alongside prednisone 5 mg orally twice daily (mCRPC) or once daily (mCSPC).
• Concurrent Therapy: Administer with a GnRH analog or after bilateral orchiectomy.

Important Guidelines:

• Take on an empty stomach (at least 1 hour before or 2 hours after meals).
• Swallow tablets whole with water.
• Do not crush or chew.

Dose Adjustment:

• Hepatic Impairment (Child-Pugh B): Start with 250 mg once daily.
• Hepatotoxicity: Interrupt and resume at reduced dose upon recovery.

Pharmacology

Abiraterone Acetate is rapidly converted in vivo to abiraterone, which inhibits androgen biosynthesis at the CYP17 enzyme level. This leads to a significant reduction in circulating androgens and improved disease control in androgen-sensitive prostate cancer.

While testosterone levels are not required to be monitored during treatment, PSA levels may vary and are not directly indicative of clinical outcomes.

Contraindications

• Known hypersensitivity to abiraterone or any of its excipients.
• Not indicated for use in women or pediatric patients.

Drug Interactions

• CYP3A4 Inducers: Strong inducers (e.g., rifampin) decrease Abiraxen levels by ~55%. Avoid if possible.
• CYP2D6 Substrates: Increases AUC and Cmax of substrates like dextromethorphan. Use with caution.
• CYP2C8 Substrates: Increases pioglitazone levels by 46%. Monitor closely if used concurrently.

Side Effects

Common Adverse Reactions:

• Fatigue
• Hypertension
• Hypokalemia
• Arthralgia
• Edema
• Diarrhea
• Hot flashes
• Nausea
• Vomiting
• Upper respiratory infections
• Cough
• Headache

Precautions and Warnings

• Hypertension, Hypokalemia, Fluid Retention: Monitor monthly. Manage before and during therapy.
• Liver Function: Monitor ALT, AST, and bilirubin levels at baseline, every 2 weeks for the first 3 months, and monthly thereafter.
• Adrenocortical Insufficiency: Monitor symptoms and signs regularly.

Use in Special Populations

• Pregnancy & Lactation: Contraindicated. Based on mechanism and animal data, may cause fetal harm.
• Pediatric: Not established.
• Renal Impairment: No dosage adjustment required.
• Hepatic Impairment: Use caution; initiate at reduced dose.

Overdose Management

There is no known antidote. Supportive care includes monitoring for liver function, arrhythmias, and cardiac failure.

Therapeutic Class

Cytotoxic Chemotherapy / CYP17 Enzyme Inhibitor

Storage Conditions

• Store below 25°C
• Protect from light and moisture
• Keep out of reach of children

Manufacturer: Everest Pharmaceuticals Ltd.

Everest Pharmaceuticals Ltd. is a globally recognized manufacturer based in Bangladesh with WHO-GMP-certified facilities. Renowned for its high-quality oncology products, Everest ensures that Abiraxen 250 mg meets stringent international standards.
Learn more at: www.everestpharmabd.com

Supplier: Makkaa Pharma

Makkaa Pharma is a trusted global supplier of oncology medicines. By sourcing directly from Everest Pharmaceuticals, Makkaa Pharma provides:

• Reliable, bulk procurement
• Cold-chain logistics and global delivery
• Medical guidance via Makkaa Pharma

Makkaa Pharma ensures access to affordable and high-quality cancer therapies in over 50 countries.

Conclusion

Abiraxen 250 mg (Abiraterone Acetate) Tablet is a cornerstone therapy for advanced prostate cancer. Its dual role in blocking androgen synthesis and improving survival outcomes makes it indispensable in modern oncology. With Everest Pharmaceuticals Ltd. ensuring manufacturing excellence and Makkaa Pharma facilitating global access, patients and providers can trust in the quality, safety, and availability of Abiraxen.

Visitwww.makkaapharma.com to order or learn more.