Abirapro® (Abiraterone Acetate) — CYP17 Inhibitor Transforming Prostate Cancer Survival

The First Oral Therapy to Improve Survival in Metastatic Castration-Resistant Prostate Cancer — Now Standard of Care in Multiple Settings

Abirapro® (Abiraterone Acetate) is a selective, irreversible inhibitor of CYP17A1 — a bifunctional enzyme (17α-hydroxylase and C17,20-lyase) essential for androgen biosynthesis in the testes, adrenal glands, and within prostate tumour tissue itself. Standard androgen deprivation therapy (ADT) with GnRH agonists or antagonists suppresses testicular androgen production — but adrenal and intratumoral androgen synthesis continues, driving castration-resistant prostate cancer (CRPC) growth. By inhibiting CYP17A1, Abirapro suppresses all three sources of androgen production — testicular, adrenal, and intratumoral — providing more complete androgen deprivation than ADT alone.

This deeper androgen suppression translates into meaningful survival benefit across multiple prostate cancer settings — from high-risk metastatic hormone-sensitive prostate cancer (mHSPC) to post-chemotherapy metastatic castration-resistant prostate cancer (mCRPC) — making Abiraterone one of the most important advances in prostate cancer treatment in the past two decades.

A.K. Pharma is a trusted medicine distributor in Delhi supplying genuine Abirapro (Abiraterone Acetate) to hospitals, oncology centres, urology clinics, and pharmacies across India. Abiraterone Acetate is available as a branded generic in India — delivering the same proven efficacy as the originator Zytiga at more accessible pricing for Indian patients and healthcare providers.

What is Abirapro (Abiraterone Acetate)?

Abirapro contains Abiraterone Acetate — a prodrug that is rapidly converted in vivo to Abiraterone, the active moiety. Abiraterone is a selective, irreversible inhibitor of CYP17A1 — a cytochrome P450 enzyme that catalyses two sequential reactions in androgen biosynthesis:

17α-hydroxylase reaction: Pregnenolone → 17α-hydroxypregnenolone Progesterone → 17α-hydroxyprogesterone

C17,20-lyase reaction: 17α-hydroxypregnenolone → DHEA (dehydroepiandrosterone) 17α-hydroxyprogesterone → Androstenedione

Both reactions are essential for testosterone and dihydrotestosterone (DHT) synthesis. By irreversibly blocking CYP17A1, Abirapro:

• Suppresses adrenal androgen production — DHEA, androstenedione → testosterone conversion is blocked
• Suppresses intratumoral androgen synthesis — within prostate cancer cells themselves
• Significantly reduces circulating testosterone, DHEA, and oestradiol
• Causes compensatory increases in ACTH and mineralocorticoid precursors (requires low-dose Prednisone co-administration to prevent mineralocorticoid excess side effects)

Full prescribing information is available at the FDA label for Abiraterone Acetate.

Clinical Studies and Evidence

COU-AA-301 Trial (Abiraterone in Post-Docetaxel mCRPC) Published in the New England Journal of Medicine (2011), the pivotal COU-AA-301 trial was a Phase 3 randomised controlled trial of 1,195 patients with mCRPC who had progressed after Docetaxel chemotherapy. Key results at final analysis:

• Abiraterone + Prednisone significantly improved overall survival vs placebo + Prednisone — median OS 15.8 months vs 11.2 months (HR 0.74, p<0.0001)
• Significantly improved PSA response rate — 29.5% vs 5.5%
• Significantly improved time to PSA progression, objective response rate, and time to skeletal-related events
• Established Abiraterone as the standard of care in post-chemotherapy mCRPC — a setting where few effective options existed

COU-AA-302 Trial (Abiraterone in Chemotherapy-Naive mCRPC) Published in the New England Journal of Medicine (2013), COU-AA-302 was a Phase 3 trial of 1,088 asymptomatic or mildly symptomatic chemotherapy-naive mCRPC patients. Key results at updated analysis:

• Abiraterone + Prednisone significantly improved overall survival — median OS 34.7 months vs 30.3 months (HR 0.81, p=0.0033)
• Significantly improved radiographic progression-free survival — median rPFS 16.5 months vs 8.3 months (HR 0.53, p<0.001)
• Significantly improved time to chemotherapy initiation, pain progression, and functional status decline
• Established Abiraterone as effective and approved in chemotherapy-naive mCRPC — expanding its use to earlier disease

LATITUDE Trial (Abiraterone in High-Risk mHSPC) Published in the New England Journal of Medicine (2017), the landmark LATITUDE trial was a Phase 3 trial of 1,199 patients with newly diagnosed high-risk metastatic hormone-sensitive prostate cancer — defined by at least 2 of 3 high-risk factors: Gleason score ≥8, ≥3 bone metastases, presence of visceral metastases. Key results at updated analysis:

• Abiraterone + Prednisone + ADT significantly improved overall survival vs ADT alone — median OS 53.3 months vs 36.5 months (HR 0.66, p<0.0001) — a remarkable 16.8-month OS improvement
• Significantly improved radiographic PFS — median rPFS 33.0 months vs 14.8 months (HR 0.47, p<0.0001)
• Significantly reduced time to pain progression, next symptomatic skeletal event, and initiation of chemotherapy
• Established Abiraterone + ADT as the standard of care for high-risk mHSPC — a paradigm-shifting trial

STAMPEDE Trial (Abiraterone in mHSPC and High-Risk Localised) Published in the New England Journal of Medicine (2017), the STAMPEDE trial — a large multi-arm platform trial — demonstrated Abiraterone + Prednisolone added to standard of care (ADT ± radiotherapy) significantly improved failure-free survival and overall survival across a broad population including metastatic and high-risk localised prostate cancer — confirming and expanding LATITUDE findings.

Long-Term LATITUDE and COU-AA Data 5-year follow-up from LATITUDE confirmed maintained OS benefit — with 5-year OS rate of 49.3% vs 35.2% for Abiraterone vs ADT alone. Long-term COU-AA data similarly confirmed durable OS benefit — supporting indefinite continuation of Abiraterone until disease progression.

Available Strengths

Abirapro is available in the following strengths:

Standard dose: 1000mg orally once daily — taken as either four 250mg tablets or two 500mg tablets.

Critical — Must be taken on an empty stomach: Abiraterone absorption is dramatically increased by food — taking with a meal can increase plasma exposure by 5-10 fold, causing toxic plasma levels and severe side effects. Abiraterone must be taken on an empty stomach — no food for at least 2 hours before and 1 hour after each dose. This is the most important patient counselling point for Abiraterone.

Always with Prednisone: Abiraterone must always be taken with low-dose Prednisone 5mg twice daily — to prevent mineralocorticoid excess syndrome caused by compensatory ACTH rise and accumulation of mineralocorticoid precursors (deoxycorticosterone, corticosterone) proximal to the CYP17A1 block.

Indications — What Abirapro is Used For

Metastatic Castration-Resistant Prostate Cancer (mCRPC):

• In combination with Prednisone for treatment of mCRPC — both pre-chemotherapy (COU-AA-302) and post-Docetaxel chemotherapy (COU-AA-301)
• Always in combination with ongoing ADT (castration — GnRH agonist/antagonist or bilateral orchiectomy)

Metastatic Hormone-Sensitive Prostate Cancer (mHSPC):

• In combination with Prednisone/Prednisolone and ADT for treatment of newly diagnosed high-risk mHSPC — per LATITUDE trial
• In combination with ADT for treatment of metastatic HSPC — per STAMPEDE trial

For detailed indication information refer to MedlinePlus Abiraterone.

Key Benefits of Abirapro

Superior Androgen Suppression Beyond Standard ADT Standard ADT suppresses only testicular androgen production — adrenal and intratumoral androgen synthesis continues and drives CRPC emergence and progression. Abirapro blocks all three sources of androgen production — achieving near-complete androgen suppression that standard ADT alone cannot provide.

Proven OS Benefit in Multiple Settings Abiraterone demonstrates overall survival benefit in three major clinical settings — post-chemotherapy mCRPC (COU-AA-301), chemotherapy-naive mCRPC (COU-AA-302), and high-risk mHSPC (LATITUDE) — making it one of the most broadly proven prostate cancer treatments and an essential medicine across the prostate cancer treatment continuum.

Landmark 16.8-Month OS Improvement in mHSPC The LATITUDE trial demonstrated a 16.8-month median OS improvement with Abiraterone in high-risk mHSPC — one of the largest OS improvements ever demonstrated in a prostate cancer clinical trial — transforming the approach to newly diagnosed high-risk metastatic disease.

Oral Once-Daily Treatment Once-daily oral tablet regimen maintains patient quality of life and independence — avoiding the need for regular clinic visits for parenteral therapy while delivering profound androgen suppression.

Delays Chemotherapy In chemotherapy-naive mCRPC, Abiraterone significantly delays the time to chemotherapy initiation — preserving quality of life and deferring the toxicities of cytotoxic chemotherapy.

Well Characterised and Manageable Safety Profile Extensive trial data across over 3,000 patients in pivotal trials provides comprehensive safety characterisation — with mineralocorticoid excess (managed by Prednisone), liver enzyme elevation (monitored monthly), and hypertension the primary concerns, all of which are manageable with appropriate monitoring.

How Abirapro Works

The Problem — Incomplete Androgen Deprivation With Standard ADT:

Standard ADT (GnRH agonist or antagonist, surgical castration) suppresses testicular androgen production — reducing plasma testosterone to castration levels. However:

• Adrenal androgen synthesis continues — the adrenal glands produce DHEA and androstenedione through CYP17A1-dependent pathways → these androgens are converted to testosterone in peripheral tissues including tumour tissue
• Intratumoral androgen synthesis — prostate cancer cells themselves can synthesise testosterone from adrenal precursors and cholesterol through CYP17A1 — driving ligand-dependent AR activation even at castration testosterone levels
• These residual androgens maintain AR signalling → prostate cancer cell survival and proliferation → emergence of castration-resistant disease

Abirapro’s Solution — CYP17A1 Inhibition:

1. Abiraterone Acetate is absorbed and converted to Abiraterone in vivo
2. Abiraterone irreversibly binds to and inhibits CYP17A1 in the adrenal glands, testes, and within prostate tumour cells
3. Both 17α-hydroxylase and C17,20-lyase activities are blocked — preventing androgen precursor synthesis at all sites
4. DHEA and androstenedione production falls dramatically → testosterone and DHT levels fall to near-undetectable levels
5. AR signalling in prostate cancer cells is profoundly suppressed — depriving cancer cells of their principal growth driver
6. CYP17A1 block also reduces oestradiol production — contributing to lipid and cardiovascular effects requiring monitoring

Compensatory Mineralocorticoid Excess: Blocking CYP17A1 causes accumulation of upstream mineralocorticoid precursors (deoxycorticosterone) → fluid retention, hypertension, hypokalaemia. Low-dose Prednisone (5mg twice daily) suppresses ACTH and prevents this mineralocorticoid excess — making Prednisone co-administration mandatory.

For a detailed mechanism overview refer to EAU Prostate Cancer Guidelines and AUA Advanced Prostate Cancer Guidelines.

Abirapro vs Glenza (Enzalutamide) — Comparison in mCRPC

Dosage and Administration

Standard Dose:

• 1000mg orally once daily — on an empty stomach
• With Prednisone 5mg orally twice daily — mandatory co-administration

Critical Administration Rules:

• Take at least 2 hours after any food
• Take at least 1 hour before any food
• If a dose is missed — take the next scheduled dose at the regular time. Do not take a double dose
• Swallow tablets whole — do not crush, split, or chew

Duration:

• mCRPC: Continue until disease progression or unacceptable toxicity
• mHSPC: Continue as per treating oncologist guidance — typically until progression

Monitoring Schedule:

• Liver function tests (ALT, AST, bilirubin) — at baseline, then every 2 weeks for the first 3 months, then monthly thereafter. Dose reduce or discontinue for significant LFT elevation
• Blood pressure — at each clinic visit — Abiraterone can cause or worsen hypertension
• Serum potassium — monthly — hypokalaemia is common; supplement as needed
• Fluid retention — monitor for oedema, weight gain
• Fasting blood glucose and HbA1c — Prednisone co-administration increases diabetes risk
• PSA — every 3 months
• Testosterone — confirm castration levels are maintained

Full dosing and monitoring guidelines available at Drugs.com Abiraterone Dosage.

Combination Therapy — Abirapro in Current Treatment Algorithms

High-Risk mHSPC (Newly Diagnosed):

• Abirapro + Prednisone + Zoladex/Firmagon (ADT) — per LATITUDE/STAMPEDE — standard of care
• Triplet therapy: Abirapro + ADT + Docetaxel — emerging data supports further benefit in very high-volume disease

mCRPC (Pre-Chemotherapy):

• Abirapro + Prednisone + ongoing ADT — standard first-line mCRPC option per COU-AA-302

mCRPC (Post-Docetaxel):

• Abirapro + Prednisone + ongoing ADT — standard post-chemotherapy option per COU-AA-301

Sequencing — After Abiraterone: When disease progresses on Abiraterone — Glenza (Enzalutamide) has reduced activity due to cross-resistance at the AR level. Pivikto (Lutetium-177 PSMA) is the preferred subsequent therapy in PSMA-positive mCRPC patients who have received both AR pathway inhibitor and chemotherapy.

Who Should Use Abirapro

Abirapro is prescribed for:

• Men with high-risk metastatic hormone-sensitive prostate cancer — newly diagnosed — in combination with ADT
• Men with asymptomatic or mildly symptomatic chemotherapy-naive mCRPC — in combination with ADT and Prednisone
• Men with mCRPC who have progressed after Docetaxel chemotherapy — in combination with ADT and Prednisone
• Patients where oral once-daily therapy is clinically preferred over parenteral novel hormonal agents

Abirapro is prescribed by urologists, medical oncologists, and radiation oncologists. A.K. Pharma supplies Abirapro to hospitals, oncology centres, urology clinics, and pharmacies across Delhi and India.

Possible Side Effects

Common side effects include peripheral oedema (fluid retention — 26-30%), hypertension (22-26%), hypokalaemia (17-20%), fatigue (18-22%), hot flushes (19-22%), diarrhoea (17-22%), and urinary tract infection.

Serious side effects include:

• Hepatotoxicity — ALT/AST elevation occurs in approximately 4-5% at Grade 3/4 — requires mandatory monthly LFT monitoring; rare cases of acute liver failure reported
• Adrenal insufficiency — particularly during stress (intercurrent illness, surgery) — Prednisone dose may need to be increased temporarily
• Cardiovascular events — hypertension and fluid retention can precipitate or worsen heart failure; increased cardiovascular event risk with long-term ADT
• Mineralocorticoid excess — without Prednisone co-administration — hypertension, hypokalaemia, fluid retention — managed by mandatory Prednisone

Full side effect information available at FDA Abiraterone Safety Information.

Precautions

• Mandatory liver function monitoring — monthly LFTs for the duration of treatment; dose reduce for Grade ≥3 LFT elevation
• Prednisone co-administration is mandatory — never use Abiraterone without Prednisone
• Empty stomach administration is mandatory — food dramatically increases absorption and toxicity
• Cardiovascular assessment — baseline ECG, blood pressure, and cardiac function; use with caution in NYHA Class III-IV heart failure
• Hypertension management — monitor and treat hypertension throughout
• Hypokalaemia — monitor and supplement potassium throughout
• Drug interactions — Abiraterone is a strong CYP2D6 inhibitor and moderate CYP3A4 inducer; review all concomitant medications for interactions
• Not for use in women or children
• Refer to EAU Prostate Cancer Guidelines for complete management context

Storage and Handling

• Store at room temperature below 30°C
• Keep in original packaging — protect from moisture and light
• Keep out of reach of children
• No special temperature requirements — straightforward oral tablet formulation

As a responsible medicine distributor in Delhi, A.K. Pharma stores all oncology medicines including Abirapro under manufacturer-recommended conditions ensuring product integrity for every supply to oncology centres and urology clinics.

Manufacturer Information

Abirapro (Abiraterone Acetate) is a branded generic containing the same active ingredient as the originator Zytiga — originally developed by Janssen Oncology (Johnson & Johnson). Abiraterone Acetate received FDA approval in April 2011 for post-chemotherapy mCRPC, with subsequent approvals for chemotherapy-naive mCRPC (2012) and mHSPC (2018). A.K. Pharma supplies only genuine Abirapro sourced from authorised distributors.

Related Prostate Cancer Medicines Available at A.K. Pharma

• Glenza 160mg (Enzalutamide) — androgen receptor inhibitor for mCRPC and mHSPC
• Zoladex (Goserelin) — GnRH agonist ADT backbone — used with Abirapro
• Firmagon (Degarelix) — GnRH antagonist ADT — no testosterone flare
• Pivikto (Lutetium-177) — PSMA radioligand therapy for post-ARPI mCRPC
• Browse all Cancer Medicines available at A.K. Pharma

Frequently Asked Questions

Q. What is Abirapro used for? Abirapro (Abiraterone Acetate) is used to treat metastatic castration-resistant prostate cancer (mCRPC) — both pre and post-chemotherapy — and high-risk metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy. More information available at MedlinePlus.

Q. What is the generic name of Abirapro? The generic name of Abirapro is Abiraterone Acetate. It is a selective CYP17A1 inhibitor that blocks androgen synthesis in the adrenal glands, testes, and prostate tumour tissue.

Q. Why must Abirapro be taken on an empty stomach? Food — particularly high-fat meals — dramatically increases Abiraterone absorption, with plasma exposure increasing 5-10 fold compared to fasted state. Taking Abiraterone with food causes toxic drug levels — significantly increasing side effects including hepatotoxicity and cardiovascular effects. Abiraterone must be taken at least 2 hours after and 1 hour before food — this is mandatory.

Q. Why is Prednisone required with Abirapro? Blocking CYP17A1 causes accumulation of mineralocorticoid precursors (deoxycorticosterone) — leading to hypertension, hypokalaemia, and fluid retention. Low-dose Prednisone 5mg twice daily suppresses ACTH, preventing this mineralocorticoid excess. Prednisone co-administration is mandatory — Abirapro should never be used without it.

Q. How is Abirapro different from Glenza (Enzalutamide)? Abirapro blocks androgen synthesis through CYP17A1 inhibition. Glenza (Enzalutamide) blocks the androgen receptor through AR signalling inhibition. Both are effective in mCRPC but work through different mechanisms — they are not used together due to overlapping toxicity and lack of additive benefit. Abirapro requires Prednisone and empty stomach dosing; Glenza does not.

Q. Can Abirapro be used in hormone-sensitive prostate cancer? Yes — the LATITUDE and STAMPEDE trials demonstrated Abiraterone + Prednisone + ADT significantly improves overall survival in high-risk metastatic hormone-sensitive prostate cancer — making it standard of care in this setting.

Q. What monitoring is required during Abirapro treatment? Liver function tests monthly, blood pressure at every visit, serum potassium monthly, PSA every 3 months, and testosterone to confirm castration. See the dosage section above for full monitoring schedule.

Q. Is Abirapro available in India? Abirapro can be supplied to hospitals, oncology centres, and pharmacies across India through licensed pharmaceutical distributors. Contact A.K. Pharma — medicine distributor in Delhi — for availability and pricing.

Q. What is the price of Abirapro in India? Abirapro price in India varies by strength and pack size. Contact A.K. Pharma at 011 4172 6999 or WhatsApp +91 9810034827 for current pricing and bulk supply rates.

Q. How to order Abirapro from A.K. Pharma? You can request a quote directly from this page, call us at 011 4172 6999, or WhatsApp us at +91 9810034827 with your requirements and we will respond promptly.

Q. Does A.K. Pharma supply Abirapro in bulk? Yes. A.K. Pharma supplies Abirapro in bulk to oncology centres, urology clinics, hospitals, and pharmacies across Delhi and India. Contact us for bulk pricing and availability.

Why Order Abirapro from A.K. Pharma?

• Licensed medicine distributor in Delhi with all required drug licenses
• 100% genuine Abirapro sourced from authorised distributors
• Available alongside companion prostate cancer medicines — Zoladex, Firmagon, Glenza, Pivikto — simplifying oncology procurement
• Both 250mg and 500mg presentations available
• Bulk supply available for hospitals and oncology centres
• Prompt response to all quote requests
• Serving urologists and oncologists across Delhi NCR and India

Contact A.K. Pharma for Abirapro Supply 📍 E-2/257A, 2nd Floor, Shastri Nagar, New Delhi 110052 📞 011 4172 6999 📱 WhatsApp: +91 9810034827 🌐 akpharma.in