Abiraterone Accord: Uses, Dosage & Side Effects
Androgen Biosynthesis Inhibitor — Blocks testosterone production in prostate cancer
Quick Facts About Abiraterone Accord
Key Takeaways About Abiraterone Accord
- Prostate cancer treatment: Abiraterone Accord is used for metastatic prostate cancer that has spread to other parts of the body, both in hormone-sensitive and castration-resistant disease stages
- Must be taken on an empty stomach: Food dramatically increases absorption (up to 10-fold), leading to unpredictable drug levels and increased side effects. Take at least 1 hour before or 2 hours after meals
- Always with prednisone or prednisolone: A low-dose corticosteroid must be taken concurrently to prevent dangerous mineralocorticoid excess effects such as high blood pressure, fluid retention, and low potassium
- Regular monitoring required: Liver function tests, blood pressure, potassium levels, and fluid status must be checked regularly throughout treatment
- Do not combine with radium-223: Concurrent use with Ra-223 is contraindicated due to increased risk of bone fractures and death. A 5-day washout period is required when switching
What Is Abiraterone Accord and What Is It Used For?
Abiraterone Accord contains abiraterone acetate, a selective inhibitor of the enzyme CYP17A1 (17α-hydroxylase/C17,20-lyase). This enzyme is required for the biosynthesis of androgens, including testosterone, in the testes, adrenal glands, and prostate tumor tissue. By blocking this enzyme, abiraterone drastically reduces androgen levels and slows or halts the growth of androgen-dependent prostate cancer.
Abiraterone Accord is a prescription-only medication used to treat prostate cancer that has metastasized (spread) to other parts of the body. Prostate cancer is the second most commonly diagnosed cancer in men worldwide, with approximately 1.4 million new cases diagnosed annually according to the World Health Organization. While early-stage prostate cancer is often curable, metastatic disease requires systemic treatments that target the hormonal pathways driving tumor growth.
Prostate cancer cells depend on androgens (male sex hormones), particularly testosterone and dihydrotestosterone (DHT), to grow and survive. Traditional androgen deprivation therapy (ADT) works by suppressing testosterone production from the testes through the use of GnRH agonists or antagonists, or by surgical castration. However, even after these interventions reduce testicular testosterone production to castrate levels, residual androgens continue to be produced by the adrenal glands and, in some cases, by the tumor tissue itself. This residual androgen production can fuel continued tumor growth, leading to a condition known as castration-resistant prostate cancer (CRPC).
Abiraterone addresses this challenge by targeting CYP17A1, the key enzyme responsible for androgen biosynthesis at all three sites: the testes, adrenal glands, and tumor tissue. Unlike traditional hormonal therapies that act only at the testicular level, abiraterone provides more comprehensive androgen suppression. Clinical trials, including the landmark COU-AA-301 and COU-AA-302 studies, demonstrated that abiraterone significantly improves overall survival and delays disease progression in men with metastatic prostate cancer.
Approved Indications
Abiraterone Accord is approved for the treatment of metastatic prostate cancer in adult men in the following clinical settings:
- Metastatic castration-resistant prostate cancer (mCRPC): For men whose cancer has progressed despite surgical or medical castration. Abiraterone is used in combination with prednisone or prednisolone, with ongoing androgen deprivation therapy. It may be used before or after docetaxel chemotherapy.
- Metastatic hormone-sensitive prostate cancer (mHSPC): For men with newly diagnosed high-risk metastatic prostate cancer that still responds to hormonal manipulation. In this setting, abiraterone is used in combination with androgen deprivation therapy and prednisone or prednisolone to achieve deeper androgen suppression from the outset of treatment.
Abiraterone acetate is a prodrug that is rapidly converted in the body to its active form, abiraterone. Abiraterone selectively and irreversibly inhibits the enzyme CYP17A1 (17α-hydroxylase/C17,20-lyase). This enzyme catalyzes two critical steps in the steroidogenesis pathway: the conversion of pregnenolone to 17α-hydroxypregnenolone (hydroxylase activity) and the subsequent conversion to dehydroepiandrosterone, DHEA (lyase activity). Because DHEA is a key precursor of both testosterone and DHT, blocking CYP17A1 effectively shuts down androgen production at all anatomical sites — the testes, adrenal glands, and prostate tumor tissue. However, CYP17A1 inhibition also impairs cortisol synthesis, which is why concomitant corticosteroid therapy (prednisone or prednisolone) is essential to prevent adrenal insufficiency and mineralocorticoid excess.
The Role of Prednisone or Prednisolone
When your doctor prescribes Abiraterone Accord, they will also prescribe a low dose of prednisone or prednisolone (typically 5 mg twice daily or 10 mg once daily). This corticosteroid serves two essential purposes:
- Cortisol replacement: Because abiraterone blocks CYP17A1, which is also involved in cortisol synthesis in the adrenal glands, the body cannot produce adequate cortisol. Without cortisol replacement, the hypothalamic-pituitary-adrenal (HPA) axis compensates by increasing ACTH production, which in turn drives excess production of mineralocorticoids such as corticosterone and deoxycorticosterone.
- Prevention of mineralocorticoid excess: The overproduction of mineralocorticoids can cause fluid retention, hypertension (high blood pressure), and hypokalemia (low potassium levels). Prednisone or prednisolone suppresses ACTH through negative feedback, preventing this cascade.
It is critically important that you do not stop taking prednisone or prednisolone without your doctor's explicit instruction. Abrupt discontinuation can lead to adrenal crisis, a potentially life-threatening condition. If you need to undergo a medical procedure or experience acute illness, inform all healthcare providers that you are taking corticosteroids as part of your cancer treatment.
What Should You Know Before Taking Abiraterone Accord?
Before starting abiraterone, your doctor will assess your liver function, cardiovascular status, electrolyte levels, and overall health. Abiraterone is contraindicated in women (especially pregnant women), in patients with severe liver impairment, and must not be combined with radium-223. Regular blood monitoring is essential throughout treatment.
Abiraterone Accord is a potent medication used in the treatment of advanced prostate cancer, and its use requires careful medical assessment and ongoing monitoring. Understanding the contraindications, warnings, and precautions before starting treatment helps ensure both safety and optimal therapeutic benefit.
Contraindications
You must not take Abiraterone Accord if any of the following apply:
- Allergy to abiraterone acetate: If you have a known hypersensitivity to abiraterone acetate or any of the excipients in the formulation, including lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, or sodium lauryl sulfate.
- Women and children: Abiraterone Accord is intended exclusively for adult male patients. It must never be taken by women, particularly those who are pregnant or may become pregnant, as it can cause severe harm to the developing fetus by interfering with steroid hormone production.
- Severe hepatic impairment: Patients with severe liver dysfunction (Child-Pugh Class C) must not receive abiraterone, as the drug is extensively metabolized by the liver and impaired hepatic function can lead to dangerously elevated drug levels.
- Combination with radium-223 (Ra-223): The concurrent use of abiraterone with radium-223 dichloride is strictly contraindicated. Clinical data demonstrated an increased risk of bone fractures and mortality when these two agents were used together.
Warnings and Precautions
Discuss the following conditions with your oncologist before starting Abiraterone Accord. These situations require careful evaluation and may necessitate dose adjustments, additional monitoring, or alternative treatment approaches:
- Muscle weakness, muscle twitching, or palpitations (racing heartbeat) — these may indicate dangerously low potassium levels
- Yellowing of the skin or eyes, dark urine, or severe nausea/vomiting — signs of liver damage
- Sudden swelling of the face, lips, tongue, or throat, or difficulty breathing — signs of severe allergic reaction
- Chest pain, sudden shortness of breath, or irregular heartbeat
- Liver problems: Abiraterone can cause hepatotoxicity, including elevated liver enzymes and, in rare cases, acute liver failure that can be fatal. Liver function tests (ALT, AST, bilirubin) must be checked before starting treatment, every two weeks for the first three months, then monthly thereafter. Treatment may need to be interrupted or permanently discontinued if significant liver enzyme elevations occur.
- Cardiovascular conditions: If you have a history of high blood pressure, heart failure, recent heart attack, or any cardiac arrhythmia, inform your doctor. Abiraterone can cause or worsen hypertension, fluid retention, and hypokalemia, all of which place additional strain on the heart. QT prolongation has also been reported.
- Low potassium (hypokalemia): Abiraterone-induced mineralocorticoid excess can cause dangerously low potassium levels, which increases the risk of cardiac arrhythmias. Potassium levels should be monitored regularly and supplemented if necessary.
- High blood sugar: Corticosteroid co-therapy and abiraterone itself may affect blood sugar control. Patients with diabetes or prediabetes should monitor their blood glucose more frequently.
- Bone health: Androgen deprivation therapy and abiraterone treatment can reduce bone mineral density, increasing the risk of osteoporosis and fractures. Your doctor may recommend calcium and vitamin D supplementation, bone density monitoring, or additional bone-protective therapy.
- Adrenal insufficiency: Although prednisone/prednisolone reduces the risk, adrenal insufficiency can occur, particularly during periods of physical stress such as infections, surgery, or trauma. Corticosteroid doses may need to be temporarily increased during these events.
Blood Test Monitoring
Abiraterone can affect your liver function without causing any noticeable symptoms. Your doctor will order regular blood tests throughout treatment to monitor for potential liver damage and to check your electrolyte levels. A typical monitoring schedule includes:
- Liver function tests (ALT, AST, bilirubin): every 2 weeks for the first 3 months, then monthly
- Potassium and blood pressure: at least monthly
- Full blood count: periodically
- PSA (prostate-specific antigen): at regular intervals to assess treatment response
- Blood glucose: periodically, especially in patients with diabetes
Pregnancy, Fertility, and Handling Precautions
Abiraterone Accord is not intended for use by women. This medication can cause serious harm to an unborn child if taken by or handled by pregnant women. The following precautions are essential:
- Women who are pregnant or may become pregnant should wear gloves if they need to touch or handle abiraterone tablets
- Male patients having sex with a woman who could become pregnant must use a condom and another effective method of contraception throughout treatment and for one week after the last dose
- Male patients having sex with a pregnant woman must use a condom to protect the fetus from potential drug exposure through seminal fluid
- Abiraterone may impair fertility in males. Discuss fertility preservation options with your oncologist before starting treatment
Driving and Operating Machinery
Abiraterone Accord is not expected to significantly affect your ability to drive or operate machinery. However, if you experience fatigue, dizziness, or any other side effects that could impair your concentration or reaction time, avoid driving or operating heavy machinery until the symptoms resolve.
Important Information About Excipients
Abiraterone Accord film-coated tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to certain sugars, contact your doctor before taking this medicine. The tablets also contain approximately 24 mg sodium per dose (two 500 mg tablets), which is equivalent to 1.04% of the WHO-recommended maximum daily intake of sodium for adults.
How Does Abiraterone Accord Interact with Other Drugs?
Abiraterone can increase the effects of several medications including certain heart drugs, sedatives, diabetes medications, and herbal products. It inhibits CYP2D6 and CYP2C8 enzymes, affecting the metabolism of many common drugs. Additionally, androgen deprivation therapy may increase the risk of heart rhythm problems (QT prolongation) when combined with certain medications.
Drug interactions with abiraterone occur through multiple mechanisms. Abiraterone is a clinically relevant inhibitor of the hepatic enzymes CYP2D6 and CYP2C8, which are responsible for metabolizing numerous other medications. Additionally, some drugs can affect abiraterone's own metabolism (primarily through CYP3A4), either increasing or decreasing its effectiveness. The concurrent use of androgen deprivation therapy also introduces additional interaction risks, particularly concerning cardiac rhythm.
Always inform your oncologist and pharmacist about all medications you are taking, including over-the-counter drugs, dietary supplements, and herbal remedies, before starting and throughout treatment with Abiraterone Accord.
Major Interactions
The following interactions are considered clinically significant and may require dose adjustments, alternative medications, or additional cardiac monitoring:
| Drug / Class | Interaction Mechanism | Clinical Action |
|---|---|---|
| Radium-223 (Ra-223) | Increased risk of fractures and mortality in combination | Contraindicated — must not be used together. Wait 5 days after stopping abiraterone before starting Ra-223 |
| QT-prolonging drugs (quinidine, procainamide, amiodarone, sotalol) | ADT + abiraterone may increase QT prolongation risk; hypokalemia compounds this | ECG monitoring; correct electrolytes before and during treatment |
| Methadone | CYP2D6 inhibition by abiraterone increases methadone levels; QT prolongation risk | Monitor ECG; consider dose adjustment |
| Moxifloxacin | Known QT-prolonging antibiotic; risk compounded with ADT | Use alternative antibiotic if possible; ECG monitoring |
| Antipsychotics (haloperidol, pimozide) | CYP2D6 substrates with QT-prolonging potential; levels may increase | Consider dose reduction; monitor ECG and for extrapyramidal effects |
| Strong CYP3A4 inducers (rifampicin, phenytoin, carbamazepine, St. John’s Wort) | May significantly reduce abiraterone levels through increased metabolism | Avoid concomitant use; may reduce abiraterone efficacy |
Other Notable Interactions
Abiraterone inhibits CYP2D6 and CYP2C8 enzymes. Medications primarily metabolized by these pathways may have increased blood levels when taken with abiraterone. Your doctor should be informed if you are taking any of the following:
| Drug | Effect | Action Required |
|---|---|---|
| Dextromethorphan (cough suppressant) | Increased levels via CYP2D6 inhibition | Use with caution; consider alternatives |
| Thioridazine | Increased levels via CYP2D6; QT risk | Avoid concurrent use |
| Repaglinide (diabetes medication) | Increased levels via CYP2C8 inhibition | Monitor blood glucose; consider dose reduction |
| Pioglitazone (diabetes medication) | Increased levels via CYP2C8 inhibition | Monitor blood glucose; consider alternatives |
| Codeine, tramadol | Reduced conversion to active metabolites (CYP2D6) | May have reduced analgesic effect; consider alternative pain relief |
| Ketoconazole | Previously used for prostate cancer; abiraterone generally replaces it | Inform your doctor about prior ketoconazole use |
Abiraterone Accord must be taken on a completely empty stomach. When taken with food, the absorption of abiraterone increases by up to 5–10 times compared to the fasted state, depending on the fat content of the meal. This dramatic and unpredictable increase in drug levels can lead to increased side effects and makes the therapeutic dose difficult to control. Take abiraterone at least one hour before eating or at least two hours after a meal.
What Is the Correct Dosage of Abiraterone Accord?
The recommended dose is 1,000 mg (two 500 mg tablets) taken once daily on an empty stomach. Abiraterone must be taken together with prednisone or prednisolone as prescribed by your doctor. Do not split, crush, or chew the tablets — swallow them whole with water.
Abiraterone Accord is prescribed exclusively by oncologists or physicians experienced in the treatment of prostate cancer. The dosing regimen is standardized for adult male patients, and there are no approved indications for use in women or children. Adherence to dosing instructions is essential for both efficacy and safety.
Adults
| Component | Dose | Instructions |
|---|---|---|
| Abiraterone Accord | 1,000 mg (2 × 500 mg tablets) once daily | On an empty stomach; at least 1 hour before or 2 hours after food; swallow whole with water |
| Prednisone or prednisolone (mCRPC) | 5 mg twice daily (10 mg total) | As directed by your oncologist; do not stop without medical advice |
| Prednisone or prednisolone (mHSPC) | 5 mg once daily | As directed by your oncologist; do not stop without medical advice |
| Androgen deprivation therapy | As per separate prescription | Must continue concurrently with abiraterone (GnRH agonist/antagonist or prior surgical castration) |
How to Take Abiraterone Accord
Strict adherence to the following instructions is essential for safe and effective treatment:
- Empty stomach only: Take the tablets at least one hour before eating or at least two hours after eating. Food dramatically increases the absorption of abiraterone, leading to unpredictable drug levels and potentially dangerous side effects.
- Swallow whole: Do not split, crush, or chew the tablets. Swallow them whole with water.
- Once daily: Take the full dose (two tablets) at the same time each day to maintain consistent drug levels.
- With corticosteroid: Always take prednisone or prednisolone as prescribed alongside abiraterone. Follow your doctor's instructions regarding the timing and dose of your corticosteroid.
- Continue ADT: Do not stop your androgen deprivation therapy unless instructed by your oncologist.
Children and Adolescents
Abiraterone Accord is not intended for use in children or adolescents. This medication is approved exclusively for adult male patients with metastatic prostate cancer. If a child or adolescent accidentally ingests abiraterone tablets, seek immediate medical attention at a hospital emergency department and bring the medication packaging for reference.
Elderly Patients
No dose adjustment is required for elderly patients. The pivotal clinical trials of abiraterone included a substantial proportion of patients aged 65 years and older, and no overall differences in safety or efficacy were observed between older and younger patients. However, elderly patients may be more susceptible to certain side effects, particularly cardiovascular complications and bone loss, and should be monitored accordingly.
Patients with Liver Impairment
Dose adjustments are required based on the degree of hepatic impairment:
Hepatic Impairment Dosing
- Mild impairment (Child-Pugh Class A): No dose adjustment required. Monitor liver function closely.
- Moderate impairment (Child-Pugh Class B): Abiraterone should be used with caution. Dose reduction to 250 mg (one 500 mg tablet) once daily may be considered. More frequent liver function monitoring is essential.
- Severe impairment (Child-Pugh Class C): Abiraterone is contraindicated and must not be used.
If significant liver enzyme elevations develop during treatment, treatment should be interrupted and may be resumed at a reduced dose after enzyme normalization, as directed by your oncologist.
Missed Dose
If you forget to take Abiraterone Accord or prednisone/prednisolone, take your usual dose the next day at your normal time. Do not take a double dose to make up for a missed dose. If you miss more than one day of either Abiraterone Accord or prednisone/prednisolone, contact your oncologist without delay, as interruption of corticosteroid therapy in particular can have serious consequences.
Overdose
If you take more Abiraterone Accord than prescribed, contact your oncologist or go to a hospital emergency department immediately. There is no specific antidote for abiraterone overdose. Treatment will be symptomatic and supportive, with particular attention to blood pressure, fluid status, potassium levels, and cardiac rhythm monitoring.
Do not stop taking Abiraterone Accord or prednisone/prednisolone unless your oncologist tells you to do so. Stopping prednisone or prednisolone abruptly can lead to adrenal crisis (a life-threatening drop in cortisol levels), and stopping abiraterone without medical guidance may allow your cancer to progress.
What Are the Side Effects of Abiraterone Accord?
Like all medications, Abiraterone Accord can cause side effects, though not everyone experiences them. The most common side effects are related to mineralocorticoid excess (fluid retention, high blood pressure, low potassium) and liver function changes. Serious but rare side effects include acute liver failure, heart problems, and severe allergic reactions. Regular monitoring helps detect and manage side effects early.
The side effects of abiraterone are largely predictable from its mechanism of action. By inhibiting CYP17A1, abiraterone disrupts not only androgen synthesis but also the production of cortisol, leading to a compensatory increase in mineralocorticoid production. While prednisone or prednisolone mitigates this effect, some degree of mineralocorticoid-related side effects (hypertension, edema, hypokalemia) is common. Liver toxicity is another well-recognized risk that requires vigilant monitoring.
- Muscle weakness, muscle twitching, or pounding heartbeat (palpitations) — these may be signs of dangerously low potassium
- Yellowing of the skin or eyes, unusually dark urine, severe nausea, or vomiting — signs of liver damage or liver failure
- Sudden swelling of the face, lips, tongue, or throat, or severe difficulty breathing or swallowing — signs of severe allergic reaction (anaphylaxis)
- Severe chest pain, sudden shortness of breath, or fainting
Very Common Side Effects
- Fluid retention in the legs or feet (peripheral edema)
- Low potassium levels in the blood (hypokalemia)
- Elevated liver enzyme levels (transaminase increases)
- High blood pressure (hypertension)
- Urinary tract infection
- Diarrhea
Common Side Effects
- High blood lipid levels (dyslipidemia)
- Chest pain (angina pectoris)
- Irregular heartbeat (atrial fibrillation)
- Heart failure
- Rapid heartbeat (tachycardia)
- Serious infection (sepsis)
- Bone fractures
- Digestive discomfort (dyspepsia)
- Blood in the urine (hematuria)
- Skin rash
Uncommon Side Effects
- Adrenal gland problems (adrenal insufficiency)
- Abnormal heart rhythm (arrhythmia)
- Muscle weakness and/or muscle pain (myopathy)
Rare Side Effects
- Lung irritation (allergic alveolitis)
- Acute liver failure (potentially fatal)
Frequency Not Known
- Heart attack (myocardial infarction)
- ECG changes (QT prolongation)
- Severe allergic reactions with difficulty swallowing or breathing, swelling of the face, lips, tongue, or throat, or itchy rash (anaphylaxis)
Bone Health Considerations
Bone loss (decreased bone mineral density) is a recognized consequence of androgen deprivation therapy for prostate cancer, and treatment with abiraterone in combination with prednisone or prednisolone may further contribute to bone loss. This increases the risk of osteoporosis and skeletal fractures over time. Your oncologist may recommend:
- Baseline and periodic bone density assessments (DEXA scans)
- Calcium and vitamin D supplementation
- Bisphosphonates (e.g., zoledronic acid) or denosumab for bone protection in high-risk patients
- Regular weight-bearing exercise, as tolerated
Additional Long-Term Considerations
Patients receiving long-term abiraterone therapy should also be aware of:
- Reduced libido: Significant androgen suppression commonly leads to decreased sexual desire. This is expected and related to the mechanism of the medication.
- Decreased red blood cell count: Mild anemia may develop during treatment. Your doctor will monitor your blood counts regularly.
- Fatigue: Many patients experience fatigue during cancer treatment. Report persistent or worsening fatigue to your medical team.
If you experience any side effects, including those not listed above, report them to your oncologist or healthcare provider. You can also report side effects directly to your national pharmacovigilance authority (e.g., the FDA MedWatch program in the United States, the Yellow Card Scheme in the United Kingdom, or the EMA in the European Union). Reporting side effects helps ensure the ongoing safety monitoring of medications.
How Should You Store Abiraterone Accord?
Store Abiraterone Accord in its original packaging at room temperature, out of reach and sight of children. No special storage conditions are required. Do not use after the expiration date.
Proper storage of Abiraterone Accord ensures the medication maintains its quality and effectiveness throughout its shelf life. The film-coated tablet formulation is relatively stable under normal household conditions.
- Temperature: No special temperature storage requirements. Store at normal room temperature.
- Packaging: Keep the tablets in the original blister pack to protect them from moisture and light.
- Children: Keep out of sight and reach of children. Accidental ingestion by children requires immediate emergency medical attention.
- Expiration: Do not use Abiraterone Accord after the expiration date printed on the carton and blister pack (marked “EXP”). The expiration date refers to the last day of the indicated month.
- Disposal: Do not dispose of medications via wastewater or household waste. As an oncology drug, return any unused tablets to a pharmacy for proper disposal according to local regulations. This protects the environment and prevents accidental exposure.
- Handling: Women who are pregnant or who may become pregnant should not handle the tablets without protective gloves, as abiraterone can be absorbed through the skin and may harm a developing fetus.
What Does Abiraterone Accord Contain?
Each Abiraterone Accord film-coated tablet contains 500 mg of abiraterone acetate as the active ingredient. The tablets are oval, purple, approximately 19 mm long and 11 mm wide, imprinted with “A 7 TN” on one side and “500” on the other.
Understanding the composition of your medication helps identify potential allergens or intolerances, and can be useful when discussing your treatment with healthcare providers.
Active Ingredient
The active substance is abiraterone acetate. Each film-coated tablet contains 500 mg of abiraterone acetate. Abiraterone acetate is a prodrug that is rapidly converted in the body to its active metabolite, abiraterone, which inhibits the CYP17A1 enzyme.
Excipients (Inactive Ingredients)
The other ingredients in Abiraterone Accord 500 mg film-coated tablets are:
- Tablet core: Lactose monohydrate, microcrystalline cellulose (E460), croscarmellose sodium (E468), hypromellose, sodium lauryl sulfate, colloidal anhydrous silica, and magnesium stearate (E572)
- Film coating: Polyvinyl alcohol, titanium dioxide, macrogol, talc, black iron oxide (E172), and red iron oxide (E172)
Appearance and Pack Sizes
Abiraterone Accord tablets are oval, purple film-coated tablets approximately 19 mm long and 11 mm wide, embossed with “A 7 TN” on one side and “500” on the other. They are supplied in perforated unit-dose blisters (PVC/PVdC-aluminium) containing 56 × 1, 60 × 1, or 112 × 1 film-coated tablets per carton. Not all pack sizes may be marketed in every country.
Marketing Authorization Holder
Accord Healthcare S.L.U., World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a Planta, Barcelona, 08039, Spain.
Frequently Asked Questions About Abiraterone Accord
Medical References
All medical information in this article is based on peer-reviewed research, international clinical guidelines, and official drug regulatory documentation. Evidence level: 1A (systematic reviews and meta-analyses of randomized controlled trials).
- European Medicines Agency (EMA). "Abiraterone Accord — Summary of Product Characteristics (SmPC)." EMA Official European regulatory documentation for abiraterone acetate.
- U.S. Food and Drug Administration (FDA). "ZYTIGA (abiraterone acetate) — Prescribing Information." FDA FDA-approved labeling and safety information for abiraterone acetate.
- de Bono JS, et al. (2011). "Abiraterone and Increased Survival in Metastatic Prostate Cancer." New England Journal of Medicine. 364(21):1995–2005. doi:10.1056/NEJMoa1014618 Landmark COU-AA-301 trial demonstrating survival benefit in post-docetaxel mCRPC.
- Ryan CJ, et al. (2013). "Abiraterone in Metastatic Prostate Cancer without Previous Chemotherapy." New England Journal of Medicine. 368(2):138–148. doi:10.1056/NEJMoa1209096 COU-AA-302 trial showing benefit in chemotherapy-naive mCRPC patients.
- Fizazi K, et al. (2017). "Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer." New England Journal of Medicine. 377(4):352–360. doi:10.1056/NEJMoa1704174 LATITUDE trial demonstrating survival benefit in newly diagnosed mHSPC.
- Parker C, et al. (2020). "Prostate cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up." Annals of Oncology. 31(9):1119–1134. doi:10.1016/j.annonc.2020.06.011 European Society for Medical Oncology guidelines on prostate cancer management.
- World Health Organization (WHO) (2023). "Model List of Essential Medicines — 23rd list." WHO Essential Medicines Abiraterone listed as an essential medicine for cancer treatment.
Evidence grading: This article uses the GRADE framework (Grading of Recommendations Assessment, Development and Evaluation) for evidence-based medicine. Evidence level 1A represents the highest quality of evidence, based on systematic reviews of randomized controlled trials.
iMedic Medical Editorial Team
Specialists in oncology, pharmacology, and clinical medicine
Our Editorial Team
iMedic's medical content is produced by a team of licensed specialist physicians and medical experts with solid academic backgrounds and clinical experience. Our editorial team includes:
Oncology Specialists
Licensed physicians specializing in medical oncology and uro-oncology, with documented experience in advanced prostate cancer treatment.
Clinical Pharmacologists
Experts in clinical pharmacology with extensive knowledge of drug interactions, pharmacokinetics, and evidence-based prescribing in oncology.
Researchers
Academic researchers with published peer-reviewed articles on androgen receptor signaling, prostate cancer therapeutics, and clinical trial methodology.
Medical Review
Independent review panel that verifies all content against international medical guidelines, ESMO, NCCN, and current research.
Qualifications and Credentials
- Licensed specialist physicians with international specialist competence
- Documented research background with publications in peer-reviewed journals
- Continuous education according to WHO, EMA, ESMO, and international medical guidelines
- Follows the GRADE framework for evidence-based medicine
- No conflicts of interest or pharmaceutical industry funding
Transparency: Our team works according to strict editorial standards and follows international guidelines for medical information. All content undergoes multiple peer reviews before publication.
iMedic Editorial Standards
Peer Review Process
All medical content is reviewed by at least two licensed specialist physicians before publication.
Fact-Checking
All medical claims are verified against peer-reviewed sources and international guidelines.
Update Frequency
Content is reviewed and updated at least every 12 months or when new research emerges.
Corrections Policy
Any errors are corrected immediately with transparent changelog.
Medical Editorial Board: iMedic has an independent medical editorial board consisting of specialist physicians in oncology, pharmacology, internal medicine, and clinical research.