Abiraterone Vivanta
Androgen biosynthesis inhibitor for the treatment of metastatic prostate cancer
Abiraterone Vivanta contains abiraterone acetate, a medication that blocks the production of androgens (male hormones including testosterone) in the body. It is used together with prednisone or prednisolone to treat metastatic prostate cancer in adult men. By suppressing androgen production from all sources — the testes, adrenal glands, and tumour tissue itself — Abiraterone Vivanta helps slow or stop cancer growth when the disease has become resistant to standard hormone therapy.
Quick Facts
Key Takeaways
- Abiraterone Vivanta is a generic form of abiraterone acetate, bioequivalent to the originator product, used to treat metastatic prostate cancer in adult men.
- It must always be taken on an empty stomach (at least 1 hour before or 2 hours after food) and in combination with prednisone or prednisolone.
- Regular monitoring of liver function, blood potassium, and blood pressure is essential throughout treatment.
- Common side effects include high blood pressure, low potassium, urinary tract infection, elevated liver enzymes, and peripheral oedema.
- Women who are pregnant or may become pregnant should not handle broken or crushed tablets due to risk of foetal harm.
What Is Abiraterone Vivanta and What Is It Used For?
Quick Answer: Abiraterone Vivanta is an oral anti-cancer medicine containing abiraterone acetate. It works by blocking the enzyme CYP17A1, which is essential for producing androgens (male hormones). By eliminating the testosterone that fuels prostate cancer growth, it helps control metastatic disease when combined with prednisone or prednisolone and androgen deprivation therapy.
Abiraterone Vivanta belongs to a class of drugs known as androgen biosynthesis inhibitors. The active substance, abiraterone acetate, is a prodrug that is rapidly converted in the body to abiraterone. Abiraterone selectively and irreversibly inhibits the enzyme 17α-hydroxylase/C17,20-lyase (CYP17A1), which plays a central role in the production of testosterone and other androgens in the testes, adrenal glands, and prostate tumour tissue.
Prostate cancer is one of the most common cancers among men worldwide. While early-stage prostate cancer is often treated successfully with surgery or radiation, advanced disease that has spread to other parts of the body (metastatic prostate cancer) requires systemic treatment. Many prostate cancers depend on testosterone for growth. Standard androgen deprivation therapy (ADT), which suppresses testicular testosterone production, is initially effective but most patients eventually develop castration-resistant prostate cancer (CRPC), where the cancer continues to grow despite very low blood testosterone levels.
Research has shown that in CRPC, residual androgen production from the adrenal glands and from the tumour itself can sustain cancer growth. Abiraterone addresses this by blocking androgen synthesis at all three sources. Landmark clinical trials, including the COU-AA-301 and COU-AA-302 studies, demonstrated that abiraterone combined with prednisone significantly improved overall survival in men with metastatic CRPC, both before and after chemotherapy with docetaxel.
More recently, the LATITUDE and STAMPEDE trials showed that adding abiraterone to ADT in newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC) also confers a substantial survival advantage. Based on this evidence, abiraterone is now recommended by major guidelines, including those from the European Society for Medical Oncology (ESMO) and the National Comprehensive Cancer Network (NCCN), as a standard-of-care treatment in these settings.
Approved Indications
Abiraterone Vivanta is approved for use in adult men for the following conditions:
- Newly diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHSPC) — in combination with ADT and prednisone or prednisolone.
- Metastatic castration-resistant prostate cancer (mCRPC) — in patients who are asymptomatic or mildly symptomatic after failure of ADT, where chemotherapy is not yet clinically indicated.
- Metastatic castration-resistant prostate cancer (mCRPC) — in patients whose disease has progressed on or after a docetaxel-based chemotherapy regimen.
What Should You Know Before Taking Abiraterone Vivanta?
Quick Answer: Do not take Abiraterone Vivanta if you have severe liver disease, if you are female, or if you are under 18 years of age. Your doctor must check your liver function, potassium levels, and blood pressure before starting treatment and regularly throughout. Inform your doctor about all other medications you are taking.
Contraindications
Abiraterone Vivanta must not be used in the following situations:
- Known hypersensitivity to abiraterone acetate or any of the excipients in the formulation.
- Severe hepatic impairment (Child-Pugh Class C), as the drug is extensively metabolised by the liver and accumulation could lead to dangerous toxicity.
- Women, especially those who are pregnant or may become pregnant. Abiraterone acetate can cause foetal harm due to its mechanism of action on androgen synthesis.
- Paediatric patients (under 18 years), as safety and efficacy have not been established in this population.
Warnings and Precautions
Abiraterone can cause severe liver injury, including fulminant hepatitis and acute liver failure, which can be fatal. Liver function tests (ALT, AST, bilirubin) must be measured before starting treatment, every two weeks for the first three months, and monthly thereafter. If ALT or AST rises above 5 times the upper limit of normal, treatment must be interrupted immediately. Treatment may only be resumed at a reduced dose once liver function has recovered.
CYP17A1 inhibition by abiraterone also blocks cortisol production, leading to a compensatory increase in ACTH. This can cause hypertension, hypokalaemia (low potassium), and fluid retention due to elevated mineralocorticoid levels. Co-administration of prednisone or prednisolone mitigates these effects. Monitor blood pressure, serum potassium, and fluid balance at least monthly.
Additional precautions include:
- Cardiovascular risk: Patients with a history of cardiovascular disease, heart failure, or uncontrolled hypertension require careful monitoring. The LATITUDE trial reported a higher incidence of cardiac events in the abiraterone group compared to placebo.
- Adrenocortical insufficiency: If prednisone or prednisolone is interrupted, withdrawn, or the patient experiences unusual stress (surgery, infection), adrenal crisis can occur. Signs include fatigue, nausea, vomiting, and hypotension.
- Bone density: Long-term androgen deprivation may increase the risk of osteoporosis and bone fractures. Bone mineral density should be assessed and preventive measures considered.
- Hyperglycaemia: Glucocorticoid co-medication may worsen blood sugar control in diabetic patients. Blood glucose should be monitored regularly.
- QT prolongation: Use with caution in patients with a history of QT prolongation or those taking medications known to prolong the QT interval.
Pregnancy and Breastfeeding
Abiraterone Vivanta is not indicated for use in women. However, it is critical to understand the safety considerations for female contacts of patients:
- Women who are pregnant or may become pregnant must not handle broken, crushed, or damaged Abiraterone Vivanta tablets without protective gloves, as the active substance can be absorbed through the skin and may harm the developing foetus.
- Men taking abiraterone who have female partners of childbearing potential must use effective contraception (condom plus another method) during treatment and for 3 weeks after the last dose.
- It is not known whether abiraterone or its metabolites are present in semen. A condom is required during sexual intercourse with a pregnant woman.
How Does Abiraterone Vivanta Interact with Other Drugs?
Quick Answer: Abiraterone inhibits the liver enzymes CYP2D6 and CYP2C8, which means it can increase blood levels of many common medications. Strong CYP3A4 inducers can reduce abiraterone effectiveness. Spironolactone should be avoided because it can stimulate the androgen receptor. Always inform your doctor about all medicines, supplements, and herbal products you are taking.
Abiraterone is primarily metabolised by the liver, and its metabolites can inhibit or be affected by several cytochrome P450 enzymes. Understanding these interactions is essential for safe prescribing. In clinical studies, co-administration with CYP2D6 substrates such as dextromethorphan resulted in a significant increase (approximately 2.9-fold) in systemic exposure to those drugs.
Major Interactions
| Drug / Class | Mechanism | Clinical Effect | Recommendation |
|---|---|---|---|
| CYP2D6 substrates (e.g., metoprolol, propranolol, desipramine, venlafaxine, codeine) | Abiraterone inhibits CYP2D6 | Increased plasma levels of CYP2D6 substrates; risk of toxicity | Avoid or dose-reduce; choose alternatives where possible |
| CYP2C8 substrates (e.g., pioglitazone, repaglinide, paclitaxel) | Abiraterone inhibits CYP2C8 | Increased levels of CYP2C8 substrates | Use with caution; monitor for adverse effects |
| Strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampicin, phenobarbital, St John’s Wort) | Increased metabolism of abiraterone | Reduced abiraterone exposure; potential loss of efficacy | Avoid concomitant use; if unavoidable, increase monitoring for disease progression |
| Spironolactone | Binds to and can activate the androgen receptor | May counteract the anti-androgen effect of abiraterone | Contraindicated during abiraterone treatment |
Minor Interactions
Several other interactions are noteworthy, though generally manageable with monitoring:
- CYP1A2 substrates (e.g., theophylline, tizanidine): Abiraterone may inhibit CYP1A2 in vitro, but the clinical significance is uncertain. Use caution with narrow therapeutic index CYP1A2 substrates.
- Opioid analgesics metabolised by CYP2D6 (e.g., codeine, tramadol): Inhibition of CYP2D6 by abiraterone may reduce conversion of codeine and tramadol to their active metabolites, potentially decreasing analgesic efficacy.
- Warfarin and other coumarin anticoagulants: While no direct pharmacokinetic interaction has been demonstrated, the concurrent use of prednisone may alter anticoagulant response. Monitor INR more frequently.
- Proton pump inhibitors and H2-receptor antagonists: These do not significantly affect abiraterone absorption and can be used concomitantly.
Food dramatically increases abiraterone absorption. In pharmacokinetic studies, taking abiraterone with a low-fat meal increased systemic exposure by approximately 5-fold, and a high-fat meal increased it by approximately 10-fold. This unpredictable increase can lead to heightened toxicity. Therefore, no food should be consumed for at least 1 hour before and 2 hours after taking Abiraterone Vivanta.
What Is the Correct Dosage of Abiraterone Vivanta?
Quick Answer: The standard dose is 1,000 mg (four 250 mg tablets) taken once daily on an empty stomach. It must always be taken with prednisone 5 mg twice daily (for mCRPC) or prednisone 5 mg once daily (for mHSPC). Tablets must be swallowed whole with water.
Adults
Standard Dosing
The recommended dose of Abiraterone Vivanta is 1,000 mg (four 250 mg tablets) taken as a single daily dose. The tablets must be taken on an empty stomach — at least 1 hour before or at least 2 hours after eating. Swallow tablets whole with water; do not crush, break, or chew them.
| Indication | Abiraterone Dose | Prednisone/Prednisolone | Duration |
|---|---|---|---|
| mCRPC (pre- or post-chemotherapy) | 1,000 mg once daily | 5 mg twice daily | Until disease progression or unacceptable toxicity |
| mHSPC (newly diagnosed high-risk) | 1,000 mg once daily | 5 mg once daily | Until disease progression or unacceptable toxicity |
Hepatic Impairment Dose Adjustments
| Liver Status | Baseline Recommendation | If ALT/AST Elevated During Treatment |
|---|---|---|
| Mild (Child-Pugh A) | No dose adjustment needed | Follow standard monitoring protocol |
| Moderate (Child-Pugh B) | Reduce dose to 250 mg once daily; close monitoring required | Interrupt treatment; resume only if benefit outweighs risk |
| Severe (Child-Pugh C) | Contraindicated | N/A — do not use |
Children
Abiraterone Vivanta is not indicated for use in children or adolescents under 18 years of age. Prostate cancer does not occur in children, and the safety and efficacy of abiraterone in the paediatric population have not been studied. The drug should be kept out of reach of children.
Elderly
No dose adjustment is required for elderly patients. In clinical trials, a substantial proportion of patients were aged 65 years and older. Efficacy and safety profiles were generally comparable across age groups. However, elderly patients may have higher rates of pre-existing cardiovascular disease and hepatic impairment, which warrant closer monitoring when starting treatment.
Missed Dose
If a dose of Abiraterone Vivanta or prednisone/prednisolone is missed, the normal prescribed dose should be taken the following day. Do not take a double dose to make up for a missed one. If more than one daily dose is missed consecutively, patients should contact their healthcare provider for guidance, as interruption of prednisone/prednisolone may cause adrenal insufficiency symptoms.
Overdose
There is no specific antidote for abiraterone acetate overdose. In the event of an overdose, treatment should be stopped and the patient monitored for signs of adrenal insufficiency, liver toxicity, and mineralocorticoid excess (hypertension, hypokalaemia, oedema). General supportive measures should be instituted as clinically indicated. There is limited experience with overdose in clinical settings, but single doses of up to 2,000 mg have been studied without dose-limiting toxicities.
What Are the Side Effects of Abiraterone Vivanta?
Quick Answer: The most frequently reported side effects of abiraterone include urinary tract infection, hypokalaemia (low potassium), hypertension, peripheral oedema, diarrhoea, and elevated liver enzymes. Many side effects relate to the drug’s mechanism of action (mineralocorticoid excess) and are managed by co-administered prednisone/prednisolone.
Like all medicines, Abiraterone Vivanta can cause side effects, although not everybody gets them. The side effects listed below are based on pooled data from Phase III clinical trials involving over 4,000 patients treated with abiraterone plus prednisone/prednisolone. The frequencies are classified according to the internationally accepted convention.
Very Common
May affect more than 1 in 10 patients
- Urinary tract infection
- Hypokalaemia (low potassium levels)
- Hypertension (high blood pressure)
- Diarrhoea
- Peripheral oedema (swelling in legs, ankles, feet)
- Fatigue
- Elevated ALT and/or AST (liver enzymes)
Common
May affect 1 to 10 in 100 patients
- Sepsis (serious blood infection)
- Bone fractures
- Heart failure or cardiac disorder
- Angina pectoris (chest pain)
- Atrial fibrillation or tachycardia
- Dyspepsia (indigestion), nausea
- Rash, skin reactions
- Haematuria (blood in urine)
- Muscle spasms, musculoskeletal pain
- Hot flush
- Elevated bilirubin
- Elevated triglycerides or cholesterol
Uncommon
May affect 1 to 10 in 1,000 patients
- Adrenocortical insufficiency (adrenal crisis)
- Myopathy (muscle disease) or rhabdomyolysis
- QT prolongation on electrocardiogram
- Allergic alveolitis (lung inflammation)
- Pancreatitis
Rare
May affect fewer than 1 in 1,000 patients
- Fulminant hepatitis (severe liver inflammation)
- Acute liver failure
- Stevens-Johnson syndrome / toxic epidermal necrolysis
Contact your doctor or go to the emergency department immediately if you experience: yellowing of the skin or eyes (jaundice), severe abdominal pain, persistent vomiting, very dark urine, sudden weight gain with severe swelling, chest pain or difficulty breathing, irregular heartbeat, or signs of infection such as high fever with rigors.
It is important to note that many side effects of abiraterone, particularly hypertension, hypokalaemia, and fluid retention, are a predictable consequence of its mechanism of action. The mineralocorticoid excess that results from CYP17A1 inhibition is substantially mitigated by the concurrent use of low-dose glucocorticoids (prednisone or prednisolone). This is why it is critical never to stop or reduce the glucocorticoid component without medical supervision.
Hepatotoxicity requires particular attention. In the pivotal COU-AA-302 trial, grade 3-4 ALT elevations occurred in approximately 6% of abiraterone-treated patients compared with 1% in the placebo group. Most cases were reversible with dose interruption or modification. However, rare cases of fulminant hepatitis with fatal outcome have been reported in post-marketing surveillance. The liver function monitoring schedule recommended in the prescribing information is designed to detect early signs of injury before they become clinically significant.
Cardiovascular events, including heart failure, myocardial infarction, and arrhythmias, have been reported at higher rates in abiraterone-treated patients, particularly those with pre-existing cardiac conditions. The LATITUDE trial (mHSPC) reported cardiac events in approximately 10% of patients in the abiraterone arm. Careful pre-treatment cardiovascular assessment and ongoing monitoring are essential, especially in patients with New York Heart Association (NYHA) class III-IV heart failure, which was an exclusion criterion in pivotal trials.
How Should You Store Abiraterone Vivanta?
Quick Answer: Store at room temperature below 30°C in the original packaging to protect from moisture. Keep out of the reach and sight of children. Do not use after the expiry date printed on the packaging.
Proper storage of medications is essential to maintain their effectiveness and safety. Abiraterone Vivanta film-coated tablets should be stored according to the following guidelines:
- Temperature: Store below 30°C (86°F). No special temperature precautions beyond avoiding excessive heat.
- Moisture protection: Keep the tablets in the original blister packaging or bottle to protect them from moisture. Do not transfer tablets to other containers unless they provide equivalent protection.
- Light: No specific light protection is required, but storing in the original carton is advisable.
- Shelf life: Do not use Abiraterone Vivanta after the expiry date stated on the carton and blister after “EXP.” The expiry date refers to the last day of that month.
- Disposal: Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures help protect the environment.
If you notice any visible deterioration of the tablets (discolouration, crumbling, or unusual odour), do not take them and consult your pharmacist for a replacement.
What Does Abiraterone Vivanta Contain?
Quick Answer: Each film-coated tablet contains 250 mg of abiraterone acetate as the active ingredient, along with pharmaceutical excipients that form the tablet core and film coating.
Active Ingredient
Each tablet contains 250 mg of abiraterone acetate, equivalent to approximately 223 mg of abiraterone free base. Abiraterone acetate is the ester prodrug form, which is rapidly hydrolysed to the active moiety abiraterone following oral administration.
Excipients
The inactive ingredients (excipients) in Abiraterone Vivanta tablets serve important pharmaceutical functions:
- Tablet core: Lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, povidone, colloidal anhydrous silica, magnesium stearate.
- Film coating: The coating typically contains hypromellose, titanium dioxide (E171), macrogol, and iron oxide pigments for colour.
Abiraterone Vivanta tablets contain lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine. The amount of lactose per tablet is generally small, but patients should discuss any concerns about lactose intolerance with their healthcare provider.
Abiraterone acetate is a white to off-white powder with the molecular formula C26H33NO2 (acetate ester) and a molecular weight of 391.55 g/mol. It has low aqueous solubility, which is why it must be taken on an empty stomach — food enhances its solubility and absorption unpredictably.
Frequently Asked Questions
Abiraterone Vivanta is used to treat metastatic prostate cancer in adult men. It is prescribed for two main clinical situations: newly diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHSPC) and metastatic castration-resistant prostate cancer (mCRPC), both before and after chemotherapy. It is always used in combination with prednisone or prednisolone and with ongoing androgen deprivation therapy (such as a GnRH agonist or after surgical castration).
Taking abiraterone with food dramatically and unpredictably increases how much drug is absorbed into the bloodstream. A low-fat meal can increase absorption by about 5-fold, and a high-fat meal by about 10-fold. This excessive absorption raises the risk of serious side effects, particularly liver damage and cardiovascular complications. To ensure safe and consistent drug levels, you must take the tablets at least 1 hour before or 2 hours after any food.
The most common side effects (occurring in more than 1 in 10 patients) include urinary tract infection, low potassium levels (hypokalaemia), high blood pressure (hypertension), diarrhoea, swelling in the legs and feet (peripheral oedema), fatigue, and elevated liver enzymes. Many of these effects are related to the drug's mechanism and are partially controlled by the concurrent prednisone/prednisolone. Your doctor will monitor you regularly with blood tests and blood pressure checks.
No. Abiraterone Vivanta is exclusively for adult men with prostate cancer. It has no approved indication for use in women, children, or adolescents. Pregnant women or those who may become pregnant must not handle broken or crushed tablets, as the drug can be absorbed through the skin and may cause harm to the developing foetus. Men treated with abiraterone must use effective contraception if their partner is of childbearing potential.
Abiraterone Vivanta is a generic version of abiraterone acetate (originator brand: Zytiga). It contains the same active ingredient at the same strength (250 mg) and has been demonstrated to be bioequivalent, meaning it delivers the same amount of drug into the bloodstream as the originator. The safety profile, efficacy, dosing instructions, and monitoring requirements are identical. The main difference is the manufacturer and potentially the price, as generic medications are typically more affordable.
Regular monitoring is essential. Liver function tests (ALT, AST, and bilirubin) must be checked before starting treatment, every two weeks for the first three months, and then monthly. Serum potassium, blood pressure, and signs of fluid retention should be monitored at least monthly. Blood glucose should be checked periodically, especially in patients with diabetes. Cardiac function monitoring may be needed in patients with pre-existing heart conditions. Bone mineral density assessments should be considered in patients on long-term androgen deprivation therapy.
References
This article is based on the following peer-reviewed sources and authoritative guidelines:
- European Medicines Agency (EMA). Abiraterone acetate – Summary of Product Characteristics. EMA Product Information. Available at: www.ema.europa.eu
- de Bono JS, Logothetis CJ, Molina A, et al. Abiraterone and Increased Survival in Metastatic Prostate Cancer. N Engl J Med. 2011;364(21):1995-2005. doi:10.1056/NEJMoa1014618
- Ryan CJ, Smith MR, de Bono JS, et al. Abiraterone in Metastatic Prostate Cancer without Previous Chemotherapy. N Engl J Med. 2013;368(2):138-148. doi:10.1056/NEJMoa1209096
- Fizazi K, Tran N, Fein L, et al. Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer (LATITUDE). N Engl J Med. 2017;377(4):352-360. doi:10.1056/NEJMoa1704174
- James ND, de Bono JS, Spears MR, et al. Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy (STAMPEDE). N Engl J Med. 2017;377(4):338-351. doi:10.1056/NEJMoa1702900
- National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: Prostate Cancer. Version 1.2026. Available at: www.nccn.org
- European Society for Medical Oncology (ESMO). Prostate Cancer: ESMO Clinical Practice Guidelines. Annals of Oncology. 2025. doi:10.1016/j.annonc.2024.09.026
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List. Geneva: WHO; 2023.
- British National Formulary (BNF). Abiraterone Acetate. NICE BNF. Available at: bnf.nice.org.uk
- U.S. Food and Drug Administration (FDA). Zytiga (abiraterone acetate) Label and Prescribing Information. www.accessdata.fda.gov
Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, comprising board-certified specialists in oncology, urology, and clinical pharmacology. Our editorial process follows the GRADE evidence framework and adheres to the principles set out by the World Association of Medical Editors (WAME).
iMedic Medical Editorial Team — Specialists in Oncology and Clinical Pharmacology
iMedic Medical Review Board — Independent panel following WHO, EMA, FDA, and ESMO guidelines
Conflicts of interest: None. iMedic receives no funding from pharmaceutical companies and maintains full editorial independence. All content is based exclusively on peer-reviewed evidence and international clinical guidelines.
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