Abiraxen 250 Mg (Abiraterone Acetate) Tablet

Introduction

Abiraxen 250 mg, manufactured by Everest Pharmaceuticals Ltd and globally distributed by Saif Pharma, is a high-efficacy androgen biosynthesis inhibitor used in combination with prednisone for the treatment of advanced stages of prostate cancer. Specifically indicated for both metastatic castration-resistant prostate cancer (CRPC) and metastatic high-risk castration-sensitive prostate cancer (CSPC), Abiraxen targets the androgen production pathway at multiple levels, providing powerful disease control.

As a global oncology medicine supplier, Saif Pharma ensures that Abiraxen 250 mg is delivered to cancer centers, hospitals, and pharmacies across over 60 countries. Manufactured under WHO-GMP standards, this formulation offers reliable therapeutic consistency for oncologists worldwide.

Indications and Clinical Uses

Abiraxen 250 mg (Abiraterone Acetate) is indicated in combination with corticosteroid therapy for:

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

In both indications, Abiraxen is prescribed alongside prednisone to mitigate mineralocorticoid excess and enhance treatment outcomes. This dual approach prolongs survival and delays disease progression.

Mechanism of Action

Abiraterone Acetate is a selective CYP17 inhibitor, acting through the following biochemical pathways:

• Inhibition of 17α-Hydroxylase and C17,20-Lyase (CYP17): These enzymes are essential for androgen synthesis in the testes, adrenal glands, and prostate tumor tissue.
• Suppression of Testosterone & DHEA: Prevents the conversion of pregnenolone and progesterone to androgen precursors, significantly reducing systemic androgen levels.
• Tumor Regression: Androgen deprivation leads to reduced tumor growth and progression in androgen-sensitive prostate carcinomas.

Abiraterone uniquely suppresses extragonadal androgen production, making it especially effective when testicular production is already medically or surgically suppressed.

Pharmacology and Pharmacokinetics

• Therapeutic Class: Cytotoxic Chemotherapy / Endocrine therapy
• Conversion: Prodrug converted to active abiraterone in vivo
• Metabolism: Extensively hepatic via CYP3A4
• Half-life: Approximately 12 hours
• Elimination: Fecal (major), renal (minor)
• Bioavailability: Significantly increased with food; therefore, must be taken on an empty stomach

This profile ensures potent and sustained androgen suppression with convenient once-daily dosing.

Recommended Dosage and Administration

For mCRPC:

• Abiraterone Acetate: 1,000 mg once daily (4 tablets of 250 mg)
• Prednisone: 5 mg orally twice daily

For mCSPC:

• Abiraterone Acetate: 1,000 mg once daily (4 tablets of 250 mg)
• Prednisone: 5 mg orally once daily

Important Administration Notes:

• Administer at least 1 hour before or 2 hours after meals
• Swallow tablets whole with water; do not crush or chew
• Use concurrently with GnRH analog or after bilateral orchiectomy

Dose Modifications

• Moderate Hepatic Impairment (Child-Pugh B): Start at 250 mg once daily
• Hepatotoxicity During Therapy: Temporarily discontinue, resume at reduced dose if recovered
• Concomitant Strong CYP3A4 Inducers: May increase dosing frequency to 1,000 mg twice daily during co-administration
• Reassess and reduce back to standard dose once the inducer is withdrawn

Drug Interactions

CYP3A4 Interactions:

• Avoid strong inducers (e.g., rifampin, carbamazepine, phenytoin)
• Minimal effect from strong inhibitors (e.g., ketoconazole)

CYP2D6 & CYP2C8 Inhibition:

• Increases exposure of substrates (e.g., dextromethorphan, pioglitazone)
• Avoid co-administration with narrow therapeutic index drugs metabolized via these pathways
• Dose adjustments or monitoring may be necessary

Contraindications

• Known hypersensitivity to Abiraterone Acetate or its excipients
• Use in females or children is contraindicated
• Pregnancy: Category X – May cause fetal harm

Common Side Effects

• General: Fatigue, edema, arthralgia
• Gastrointestinal: Nausea, diarrhea, vomiting
• Cardiovascular/Metabolic: Hypertension, hypokalemia, fluid retention
• Infectious: Upper respiratory tract infection, cough
• Neurologic: Headache

These adverse effects are primarily linked to mineralocorticoid excess due to CYP17 inhibition and are generally managed by corticosteroid co-administration and clinical monitoring.

Warnings and Precautions

• Hypertension, Hypokalemia, Edema: Monitor monthly. Manage with appropriate antihypertensives, potassium supplements, and diuretics.
• Liver Toxicity: Monitor ALT, AST, and bilirubin every 2 weeks for the first 3 months, then monthly
• Adrenocortical Insufficiency: Monitor for symptoms (fatigue, hypotension, nausea)
• Pregnancy Risk: Contraindicated in women of childbearing age. Men with partners of childbearing potential should use contraception during and for 3 months post-treatment

Use in Special Populations

• Pediatric Use: Not established; not indicated
• Hepatic Impairment: Adjust dose and monitor liver function
• Renal Impairment: No dose adjustment required

Overdose Management

There is no specific antidote to abiraterone overdose. Supportive care includes:

• Cardiac monitoring for arrhythmias or heart failure
• Liver function assessment
• Discontinuation of drug and symptomatic treatment

Storage & Handling

• Store Below: 25°C (77°F)
• Protect From: Light and moisture
• Keep Out of Reach: Of children
• Shelf Life: Refer to the packaging for expiry date

Why Choose Abiraxen 250 mg from Saif Pharma?

Saif Pharma is a globally recognized distributor of oncology medications. In partnership with Everest Pharmaceuticals Ltd, a WHO-GMP-certified manufacturer, Saif Pharma ensures the authenticity, efficacy, and accessibility of critical anticancer medicines such as Abiraxen 250 mg.

Key Benefits:

• Delivered to 60+ countries including the USA, UAE, UK, and India
• Competitive pricing for institutions and government procurement
• Full compliance with international regulatory frameworks
• Efficient logistics for cold-chain and specialty pharmaceutical products

Clinical Advantages of Abiraterone Acetate

• Targets both gonadal and extragonadal androgen production
• Well-established survival benefits in prostate cancer
• Oral therapy for ease of administration and patient compliance
• Integrated into major international treatment guidelines (NCCN, EAU, AUA)

Patient Counseling Tips

• Take on an empty stomach, do not skip prednisone co-therapy
• Regularly check blood pressure, liver enzymes, and potassium
• Inform healthcare providers about all other medications in use
• Avoid alcohol and over-the-counter supplements without medical advice
• Men should use contraception during and for 3 months after treatment

Conclusion

Abiraxen 250 mg (Abiraterone Acetate) by Everest Pharmaceuticals Ltd, supplied globally by Saif Pharma, represents a gold standard in hormonal chemotherapy for advanced prostate cancer. Its ability to suppress androgen production at all sources makes it highly effective in both mCRPC and mCSPC. Saif Pharma ensures its global availability, cost-effective delivery, and clinical reliability, making it the trusted choice for oncologists, pharmacists, and procurement teams around the world.