Abirapro 250mg Tablet
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Manufactured By Glenmark Pharmaceuticals Limited
Composition Abiraterone Acetate 250mg
RS 15750.00
MRP RS 26250.00
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Description:
Abirapro 250mg Tablet
(Abiraterone Acetate 250mg) is a potent androgen biosynthesis inhibitor manufactured by Glenmark Pharmaceuticals Limited, indicated for the treatment of metastatic castration-resistant prostate cancer (mCRPC) and metastatic high-risk castration-sensitive prostate cancer (mCSPC). It works by blocking CYP17, an enzyme critical for androgen (testosterone) production in the testes, adrenal glands, and prostate tumour tissue itself, thereby depriving prostate cancer cells of the hormones that drive their growth. Available from Shabbir Medical Hall at the best price in India, this genuine prescription tablet is available online with fast delivery nationwide.
BENEFITS: Abirapro 250mg offers a highly targeted mechanism of androgen suppression beyond conventional androgen deprivation therapy (ADT). By inhibiting CYP17A1 (17α-hydroxylase/C17,20-lyase), it reduces testosterone and oestrogen production in all androgen-secreting tissues, including the tumour itself. Clinical trials (COU-AA-301 and COU-AA-302) demonstrated significantly improved overall survival, radiographic progression-free survival, and quality of life in patients with mCRPC. It is also approved in combination with enzalutamide-free regimens for mCSPC.
USAGE OVERVIEW: Abirapro 250mg Tablets are taken orally, on an empty stomach (at least one hour before or two hours after food), as food significantly increases drug absorption and risk of side effects. The standard dose is 1,000 mg (four tablets of 250 mg) once daily, always used in combination with prednisone or prednisolone 5 mg twice daily to reduce mineralocorticoid excess side effects. Dosage and duration are strictly determined by the treating oncologist/urologist.
SAFETY OVERVIEW: The most common side effects include hypertension, hypokalaemia (low potassium), fluid retention, and elevated liver enzymes. Serious hepatotoxicity, adrenocortical insufficiency, and cardiac conditions have been reported. Regular blood pressure monitoring, liver function tests, and potassium checks are mandatory during therapy. This medicine is NOT for use in women or children.
Uses / Indications:
Metastatic Castration-Resistant Prostate Cancer (mCRPC): used in combination with prednisone/prednisolone for patients who have progressed after docetaxel chemotherapy or in chemotherapy-naïve settings
Metastatic Castration-Sensitive Prostate Cancer (mCSPC): prescribed along with androgen deprivation therapy (ADT) in newly diagnosed high-risk metastatic prostate cancer patients
ADDITIONAL / OFF-LABEL USES:
Locally advanced prostate cancer as part of combination hormone therapy regimens under specialist oncology guidance
Non-metastatic castration-resistant prostate cancer (nmCRPC) in selected off-label treatment protocols
Interactions / Warnings:
HEPATOTOXICITY WARNING:
- Liver function tests (ALT, AST, bilirubin) MUST be monitored every 2 weeks for the first 3 months, then monthly thereafter
- Abirapro should be withheld or permanently discontinued if severe hepatotoxicity occurs
ADRENOCORTICAL INSUFFICIENCY:
- Risk increases if steroid (prednisone) is interrupted, reduced, or stopped — NEVER self-adjust steroid dose
- Supplemental corticosteroids may be required in periods of stress (surgery, infection)
CARDIOVASCULAR RISK:
- Use with caution in patients with cardiovascular disease, heart failure, or history of arrhythmia
- Monitor blood pressure, serum potassium, and fluid retention monthly
RENAL / HEPATIC IMPAIRMENT:
- Mild-moderate hepatic impairment: use with caution; no dose adjustment for mild impairment
- Severe hepatic impairment (Child-Pugh C): CONTRAINDICATED
- Renal impairment: use with caution; no specific dose adjustment required but limited data available
FOOD INTERACTION:
- Must be taken on an EMPTY STOMACH — food dramatically increases absorption and toxicity risk
DRIVING & MACHINERY:
- May cause fatigue and dizziness; assess personal response before driving
ELDERLY USE (>=65 years):
- Commonly used in elderly patients (prostate cancer typically affects older men); monitor cardiovascular and hepatic parameters closely
Pregnancy interaction:
* Abirapro 250mg Tablet is NOT indicated for use in women.
* Abiraterone Acetate may cause foetal harm if exposure occurs during pregnancy and is considered potentially teratogenic.
* Women who are pregnant or may become pregnant must NOT handle crushed, broken, or damaged tablets without protective gloves.
* Male patients with pregnant partners or partners of childbearing potential must use effective contraception (condom plus an additional contraceptive method) during treatment and for at least 3 weeks after the final dose.
BREASTFEEDING:
* Not applicable, as Abirapro 250mg is intended for use in male patients only.
CONTRACEPTION WARNING:
* Male patients should avoid fathering a child while receiving Abirapro 250mg treatment.
* Discuss fertility preservation and reproductive planning with your oncologist before starting therapy.
Expert advice:
1. STRICT EMPTY STOMACH RULE:
Abirapro 250mg MUST be taken on an empty stomach. Taking it with food can significantly increase Abiraterone absorption and raise the risk of serious side effects such as hypertension, hypokalaemia, and fluid retention. Take the tablets at least 1 hour before food or 2 hours after meals.
2. NEVER SKIP PREDNISONE / PREDNISOLONE:
Abiraterone suppresses adrenal hormone production, including cortisol. The prescribed steroid (prednisone or prednisolone) is essential to prevent adrenal insufficiency. Abruptly stopping the steroid may cause adrenal crisis with symptoms such as severe weakness, nausea, vomiting, dizziness, or collapse.
3. MONITOR BLOOD PRESSURE DAILY:
High blood pressure is a common side effect. Monitor blood pressure regularly at home and maintain a written log. Inform your oncologist if readings consistently exceed 140/90 mmHg.
4. WATCH FOR LIVER WARNING SIGNS:
Abiraterone may cause liver toxicity. Seek immediate medical advice if you notice yellowing of the skin/eyes, dark urine, severe abdominal pain, or unusual tiredness. Avoid self-medicating with OTC liver supplements or excess paracetamol without doctor approval.
5. POTASSIUM MONITORING IS CRITICAL:
Low potassium levels may occur and can lead to muscle cramps, weakness, palpitations, or irregular heartbeat. Attend all scheduled blood tests and follow dietary or supplement advice given by your doctor.
MONITORING ADVICE:
* Liver Function Tests (ALT, AST, bilirubin): Every 2 weeks for first 3 months, then monthly
* Serum potassium: Monthly or more frequently if required
* Blood pressure: Daily home monitoring recommended
* Blood glucose and phosphate: Periodically monitored
* PSA levels: Usually every 1–3 months to assess treatment response
* CT scan / Bone scan: Per oncologist schedule to evaluate disease progression
* ECG / cardiac monitoring: Recommended in patients with heart disease
COMPLIANCE TIPS:
* Take Abirapro at the same time every day on an empty stomach
* Use reminders or medication alarms to maintain consistency
* Swallow tablets whole with water — do not crush or chew
* Keep a treatment diary with BP readings and side effects
* Store tablets in the original bottle away from heat and moisture
* Women and children should avoid touching broken or crushed tablets
SAFETY TIPS:
* Do NOT stop Abirapro or steroids without oncologist guidance
* Maintain all oncology appointments and scheduled blood tests
* Inform every healthcare provider that you are taking Abiraterone Acetate
* Additional steroid support may be required during surgery, infection, or severe stress
* Seek urgent medical help if you experience chest pain, severe weakness, fainting, or severe swelling
Side Effects:
Hypertension (high blood pressure) — regular BP monitoring is essential
Hypokalaemia (low potassium) — may cause weakness, muscle cramps, or palpitations
Peripheral oedema (fluid retention / swelling of legs or ankles)
Urinary tract infections (UTIs)
Elevated liver enzymes (ALT, AST) — requires regular liver function monitoring
Fatigue, joint pain (arthralgia), muscle aches or discomfort
Hot flushes, diarrhoea, indigestion (dyspepsia)
Low phosphate levels (hypophosphataemia) and raised blood sugar (hyperglycaemia), especially in diabetic patients
SERIOUS SIDE EFFECTS (contact your doctor immediately):
Hepatotoxicity: yellowing of skin/eyes (jaundice), dark urine, severe upper abdominal pain
Adrenocortical insufficiency: nausea, vomiting, dizziness, low blood pressure, severe weakness, confusion — particularly if steroids are stopped suddenly
Cardiac complications: chest pain (angina), irregular heartbeat (arrhythmia), or heart failure symptoms
Severe hypokalaemia with QT prolongation — may increase risk of dangerous heart rhythm abnormalities
EMERGENCY WARNING SIGNS — SEEK IMMEDIATE MEDICAL HELP:
Sudden chest pain, severe palpitations, or breathing difficulty
Jaundice or severe pain in the upper right abdomen
Severe weakness, fainting, dizziness, or collapse (possible adrenal crisis)
Rapid swelling of legs, severe shortness of breath, or sudden irregular heartbeat
How to use:
• mCRPC (post-chemo or chemo-naive): 1,000 mg (4 x 250 mg tablets) orally ONCE DAILY + prednisone 5 mg TWICE DAILY
• mCSPC: 1,000 mg (4 x 250 mg tablets) orally ONCE DAILY + prednisone or prednisolone 5 mg ONCE DAILY
ROUTE OF ADMINISTRATION:
• Oral (tablet) — swallow whole with water
• Must be taken on an EMPTY STOMACH: at least 1 hour before or 2 hours after food
• Food significantly increases abiraterone absorption and risk of adverse effects — do NOT take with meals
TIMING:
• Take at the same time each day for consistency
• Take with the prescribed dose of prednisone/prednisolone daily — never omit steroid co-medication without oncologist approval
MISSED DOSE:
• If a dose is missed, take the next scheduled dose at the usual time. Do NOT double up.
STORAGE:
• Store below 30°C in a dry place, away from moisture and sunlight
• Keep in original bottle with lid tightly closed
• Keep out of reach of children
• Do not use after the expiry date printed on the label
How it works:
Abirapro 250mg contains Abiraterone Acetate, a prodrug that is converted in the body into its active form, abiraterone.
Prostate cancer growth is strongly driven by male hormones called androgens, mainly testosterone and dihydrotestosterone (DHT). Even after surgical or medical castration, the adrenal glands and prostate tumour tissue can continue producing small amounts of androgens that help cancer cells survive and grow.
Abiraterone works by selectively and irreversibly inhibiting the CYP17A1 enzyme (17α-hydroxylase / 17,20-lyase), which is essential for androgen synthesis in:
Testes
Adrenal glands
Prostate tumour tissue
This results in:
Near-complete suppression of testosterone levels
Reduction of androgen precursors such as DHEA and androstenedione
Deprivation of androgen-dependent prostate cancer cells of their growth signals
KEY ADVANTAGES:
Targets androgen production across all major hormone-producing tissues
Proven to improve overall survival in metastatic castration-resistant prostate cancer (mCRPC)
Convenient once-daily oral dosing
Effective in both chemotherapy-naïve and post-chemotherapy patients
Commonly prescribed with prednisone/prednisolone to reduce treatment-related hormonal side effects
Faq for medicine:
Abirapro 250mg (Abiraterone Acetate) is used to treat metastatic castration-resistant prostate cancer (mCRPC). It is typically prescribed in combination with prednisone for patients whose cancer has progressed despite androgen deprivation therapy. Abirapro reduces androgen production from the adrenal glands, tumor tissue, and testes.
2.How does Abirapro 250mg reduce androgen levels in prostate cancer?
Abirapro 250mg inhibits CYP17A1, an enzyme involved in androgen biosynthesis in the adrenal glands, testes, and tumor tissue. By blocking testosterone and other androgen production at multiple sites, Abiraterone starves prostate cancer cells of hormonal fuel that drives their growth and proliferation.
3.Why must Abirapro 250mg be taken with prednisone?
Abirapro 250mg is always co-prescribed with low-dose prednisone (5–10mg daily) because inhibiting CYP17A1 also blocks cortisol synthesis, leading to compensatory ACTH elevation and mineralocorticoid excess. Prednisone replaces cortisol, preventing adrenal insufficiency and managing side effects like hypertension, hypokalemia, and edema.
4.What dietary restrictions apply when taking Abirapro 250mg?
Abirapro 250mg must not be taken with food. The tablet should be taken on an empty stomach at least one hour before or two hours after eating, as food significantly increases Abiraterone absorption and causes unpredictable drug levels and increased toxicity risk. Water is the only acceptable liquid for taking Abirapro.
5.What are the common side effects of Abirapro 250mg in prostate cancer patients?
Common side effects of Abirapro 250mg include fluid retention, hypertension, hypokalemia (low potassium), fatigue, elevated liver enzymes, and hot flashes. Cardiac complications may occur in patients with underlying heart disease. Monthly liver function tests and blood pressure monitoring are recommended during Abirapro therapy.
6.How long is Abirapro 250mg treatment typically continued?
Abirapro 250mg is continued until disease progression, unacceptable toxicity, or as determined by the oncologist. Some patients benefit from Abiraterone therapy for several years. Regular PSA monitoring, imaging, and clinical assessment guide treatment decisions. Discontinuation without medical advice is strongly discouraged.
Medicine interaction:
Strong CYP3A4 inducers (rifampicin, phenytoin, carbamazepine, St. John’s Wort): may significantly reduce Abiraterone levels and decrease effectiveness — avoid or use only under specialist supervision
Strong CYP2D6 substrate medicines (dextromethorphan, thioridazine, certain antidepressants): Abiraterone may increase blood levels of these medicines — toxicity monitoring may be required
Spironolactone: may stimulate androgen receptors and interfere with prostate cancer treatment — generally avoided
Ketoconazole: may increase adrenal suppression risk when combined — concurrent use usually avoided
Warfarin and other anticoagulants: monitor INR and bleeding risk closely during treatment
Prednisone / Prednisolone: essential co-medication with Abirapro — never stop steroids abruptly without oncologist advice
VACCINE INTERACTIONS:
Consult your oncologist before receiving any vaccines during treatment, especially live vaccines or immunisations during active cancer therapy.
SUPPLEMENT INTERACTIONS:
St. John’s Wort: contraindicated because it strongly reduces Abiraterone blood levels through CYP3A4 induction
Always inform your doctor about all herbal products, protein supplements, vitamins, Ayurvedic medicines, or OTC products before use
