Abirateron Teva: Uses, Dosage & Side Effects
Androgen Biosynthesis Inhibitor — Blocks testosterone production in metastatic prostate cancer
Quick Facts About Abirateron Teva
Key Takeaways About Abirateron Teva
- Generic equivalent of ZYTIGA: Abirateron Teva contains the same active ingredient (abiraterone acetate 500 mg) as ZYTIGA, with bioequivalence confirmed by the EMA. It offers the same clinical efficacy and safety profile at a more accessible cost
- 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 Abirateron Teva and What Is It Used For?
Abirateron Teva 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.
Abirateron Teva is a prescription-only medication manufactured by Teva Pharmaceutical Industries, one of the world's largest generic drug manufacturers. It contains the same active ingredient — abiraterone acetate — as the originator product ZYTIGA, and has been approved by the European Medicines Agency (EMA) through a comprehensive bioequivalence assessment. This means Abirateron Teva has been scientifically demonstrated to deliver the same amount of active drug to the body at the same rate as the reference product, ensuring equivalent therapeutic outcomes.
Prostate cancer is the second most commonly diagnosed cancer in men worldwide, with approximately 1.4 million new cases identified annually according to the World Health Organization (WHO). While early-stage prostate cancer is often curable through surgery or radiation therapy, metastatic disease — cancer that has spread to distant organs such as bones, lymph nodes, or other tissues — requires systemic treatments that target the hormonal pathways fueling tumor growth. Abirateron Teva plays a critical role in this treatment landscape by addressing a fundamental weakness of prostate cancer: its dependence on androgens (male sex hormones).
Prostate cancer cells depend heavily on testosterone and its more potent derivative, dihydrotestosterone (DHT), to grow and proliferate. Traditional androgen deprivation therapy (ADT) works by suppressing testosterone production from the testes, typically through GnRH agonists (such as leuprolide or goserelin), GnRH antagonists (such as degarelix), or surgical orchiectomy. However, even after these interventions reduce testicular testosterone production to castrate levels (below 50 ng/dL or 1.7 nmol/L), residual androgens continue to be synthesized by the adrenal glands and, in many cases, by the prostate tumor cells themselves. This residual androgen production can fuel continued tumor growth, leading to a condition known as castration-resistant prostate cancer (CRPC).
Abirateron Teva addresses this clinical challenge by targeting CYP17A1, the key enzyme responsible for androgen biosynthesis at all three anatomical 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. The landmark COU-AA-301 trial published in the New England Journal of Medicine demonstrated that abiraterone significantly improved overall survival in men with metastatic castration-resistant prostate cancer (mCRPC) who had previously received docetaxel chemotherapy. Subsequently, the COU-AA-302 and LATITUDE trials expanded the evidence base, confirming survival benefits in both pre-chemotherapy mCRPC and newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC).
Approved Indications
Abirateron Teva 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. Abirateron Teva is used in combination with prednisone or prednisolone, with ongoing androgen deprivation therapy. It may be administered before or after docetaxel-based 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, Abirateron Teva is used in combination with androgen deprivation therapy and prednisone or prednisolone to achieve deeper androgen suppression from the beginning of treatment, thereby delaying disease progression and improving survival.
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.
Generic Equivalence and Quality Assurance
As a generic medicine, Abirateron Teva has undergone rigorous regulatory review by the European Medicines Agency. The approval process requires demonstration of bioequivalence to the reference product (ZYTIGA), meaning that the generic formulation must deliver the same amount of active substance to the bloodstream at the same rate. This is confirmed through pharmacokinetic studies measuring parameters such as the area under the plasma concentration-time curve (AUC) and peak plasma concentration (Cmax). The EMA requires that the 90% confidence interval for the ratio of these parameters falls within the 80–125% acceptance range.
Teva Pharmaceutical Industries, headquartered in Israel, is one of the largest pharmaceutical companies in the world and a leading manufacturer of generic medicines. The company adheres to Good Manufacturing Practice (GMP) standards as enforced by the EMA and other international regulatory agencies, ensuring that Abirateron Teva meets the same quality, purity, and potency requirements as the originator product.
The Role of Prednisone or Prednisolone
When your doctor prescribes Abirateron Teva, they will also prescribe a low dose of prednisone or prednisolone (typically 5 mg twice daily for mCRPC or 5 mg once daily for mHSPC). 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 of adverse effects.
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 characterized by severe hypotension, dehydration, and electrolyte imbalances. 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 Abirateron Teva?
Before starting Abirateron Teva, your doctor will assess your liver function, cardiovascular status, electrolyte levels, and overall health. Abirateron Teva 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.
Abirateron Teva 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. Your oncologist will conduct a thorough evaluation before prescribing this medication.
Contraindications
You must not take Abirateron Teva 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 Teva formulation, including lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, or sodium lauryl sulfate, you must not take this medication.
- Women and children: Abirateron Teva 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. Even skin contact with broken or crushed tablets should be avoided.
- 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 and increased toxicity.
- Combination with radium-223 (Ra-223): The concurrent use of abiraterone with radium-223 dichloride is strictly contraindicated. Clinical data from the ERA-223 trial demonstrated a significantly 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 Abirateron Teva. 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 (ALT, AST) and, in rare cases, acute liver failure that can be fatal. Liver function tests must be performed 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 (myocardial infarction), or any cardiac arrhythmia, inform your oncologist. 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 in post-marketing surveillance.
- Low potassium (hypokalemia): Abiraterone-induced mineralocorticoid excess can cause dangerously low potassium levels, which increases the risk of life-threatening cardiac arrhythmias. Potassium levels should be monitored regularly and supplemented if necessary. Patients taking concurrent medications that can also lower potassium levels require particular vigilance.
- High blood sugar: Corticosteroid co-therapy and abiraterone itself may affect blood sugar control. Patients with diabetes mellitus or prediabetes should monitor their blood glucose more frequently and may require adjustment of their antidiabetic medications.
- Bone health: Androgen deprivation therapy combined with 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 (DEXA scans), or additional bone-protective therapy such as denosumab or bisphosphonates.
- Adrenal insufficiency: Although prednisone/prednisolone reduces the risk, adrenal insufficiency can still occur, particularly during periods of physical stress such as infections, surgery, or trauma. Corticosteroid doses may need to be temporarily increased during these events. Symptoms of adrenal insufficiency include fatigue, muscle weakness, dizziness, nausea, and low blood pressure.
Blood Test Monitoring Schedule
Abiraterone can affect your liver function without causing any noticeable symptoms initially. 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, to monitor for anemia
- PSA (prostate-specific antigen): at regular intervals to assess treatment response
- Blood glucose: periodically, especially in patients with diabetes
- Bone density assessment (DEXA scan): at baseline and periodically thereafter
Pregnancy, Fertility, and Handling Precautions
Abirateron Teva 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 to protect against accidental exposure:
- Women who are pregnant or may become pregnant should wear protective gloves if they need to touch or handle abiraterone tablets, and should avoid contact with broken or crushed 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. If future fatherhood is important, discuss fertility preservation options (such as sperm banking) with your oncologist before starting treatment
Driving and Operating Machinery
Abirateron Teva 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, you should avoid driving or operating heavy machinery until those symptoms resolve. Discuss any concerns with your medical team.
Important Information About Excipients
Abirateron Teva 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 sodium. Each daily dose (two 500 mg tablets) contains a small amount of sodium, which should be taken into account by patients on a controlled sodium diet.
How Does Abirateron Teva 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. These interactions apply equally to Abirateron Teva and all other abiraterone acetate products, as they contain the same active substance.
Always inform your oncologist and pharmacist about all medications you are taking, including over-the-counter drugs, dietary supplements, vitamins, and herbal remedies, both before starting and throughout treatment with Abirateron Teva.
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 (ERA-223 trial) | 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 required; correct electrolytes before and during treatment |
| Methadone | CYP2D6 inhibition by abiraterone increases methadone levels; additional QT prolongation risk | Monitor ECG; consider dose adjustment of methadone |
| Moxifloxacin | Known QT-prolonging antibiotic; risk compounded with ADT and abiraterone | Use alternative antibiotic if possible; ECG monitoring if necessary |
| Antipsychotics (haloperidol, pimozide) | CYP2D6 substrates with QT-prolonging potential; blood 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 blood levels through accelerated metabolism | Avoid concomitant use; may reduce abiraterone efficacy substantially |
Other Notable Interactions
Abiraterone inhibits the CYP2D6 and CYP2C8 enzymes in the liver. Medications primarily metabolized by these pathways may accumulate to higher-than-expected 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 closely; 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 |
| Tamoxifen | Reduced conversion to active metabolite endoxifen (CYP2D6) | Not typically co-prescribed; inform doctor if relevant |
Abirateron Teva 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 impossible to control. Take abiraterone at least one hour before eating or at least two hours after a meal, swallowed whole with water.
What Is the Correct Dosage of Abirateron Teva?
The recommended dose is 1,000 mg (two 500 mg tablets) taken once daily on an empty stomach. Abirateron Teva must be taken together with prednisone or prednisolone as prescribed by your oncologist. Do not split, crush, or chew the tablets — swallow them whole with water.
Abirateron Teva 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. Strict adherence to dosing instructions is essential for both efficacy and safety, as deviations — particularly taking the medication with food — can dramatically alter drug exposure.
Adults
| Component | Dose | Instructions |
|---|---|---|
| Abirateron Teva | 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 (GnRH agonist/antagonist or prior surgical castration) |
How to Take Abirateron Teva
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 by up to 5–10 times, 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. Crushing or breaking the tablets may expose caregivers or family members to the active substance.
- Once daily: Take the full dose (two 500 mg tablets) at the same time each day to maintain consistent drug levels in your body.
- With corticosteroid: Always take prednisone or prednisolone as prescribed alongside abiraterone. Follow your doctor's instructions regarding the timing and dose of your corticosteroid carefully.
- Continue ADT: Do not stop your androgen deprivation therapy (GnRH agonist or antagonist injections) unless instructed by your oncologist.
Children and Adolescents
Abirateron Teva is not intended for use in children or adolescents. This medication is approved exclusively for adult male patients with metastatic prostate cancer. There is no relevant use in the pediatric population. If a child or adolescent accidentally ingests abiraterone tablets, seek immediate medical attention at a hospital emergency department and bring the medication packaging for identification.
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 clinically meaningful 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 (hypertension, fluid retention, heart failure), bone loss, and fatigue, and should be monitored accordingly with appropriate frequency.
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 with more frequent blood tests.
- Moderate impairment (Child-Pugh Class B): Abiraterone should be used with extreme 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 (ALT or AST greater than 5 times the upper limit of normal), treatment should be interrupted and may be resumed at a reduced dose after enzyme normalization, as directed by your oncologist.
Patients with Kidney Impairment
No dose adjustment is necessary for patients with renal impairment, including those on dialysis. Abiraterone and its metabolites are not significantly excreted by the kidneys. However, patients with renal impairment should be monitored for fluid retention and electrolyte imbalances, which may require supportive management.
Missed Dose
If you forget to take Abirateron Teva 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 Abirateron Teva or prednisone/prednisolone, contact your oncologist promptly, as interruption of corticosteroid therapy in particular can have serious consequences including adrenal crisis.
Overdose
If you take more Abirateron Teva 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, liver function, and cardiac rhythm monitoring. Bring your medication packaging to help healthcare providers identify the drug and dose involved.
Do not stop taking Abirateron Teva 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 unchecked.
What Are the Side Effects of Abirateron Teva?
Like all medications, Abirateron Teva 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, cardiac events, 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 and are identical regardless of whether you are taking the Teva generic or the originator product. 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. Hepatotoxicity is another well-recognized risk that requires vigilant laboratory monitoring.
It is important to report all side effects to your oncologist, even those that seem minor. Early detection allows for timely intervention and dose adjustments that can prevent more serious complications. The following frequency categories are based on data from large clinical trials involving thousands of patients.
- 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, including elevated triglycerides and cholesterol)
- Chest pain (angina pectoris)
- Irregular heartbeat (atrial fibrillation)
- Heart failure (including congestive heart failure)
- Rapid heartbeat (tachycardia)
- Serious infection (sepsis)
- Bone fractures (including pathological and compression 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, rhabdomyolysis)
Rare Side Effects
- Lung irritation (allergic alveolitis)
- Acute liver failure (potentially fatal — requires immediate medical intervention)
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 over time. This increases the risk of osteoporosis and skeletal fractures, which can significantly impact quality of life. Your oncologist may recommend the following protective measures:
- Baseline and periodic bone density assessments (DEXA scans)
- Daily calcium (1,000–1,200 mg) and vitamin D (800–1,000 IU) supplementation
- Bisphosphonates (e.g., zoledronic acid) or denosumab for bone protection in patients at high risk of fractures
- Regular weight-bearing exercise, as tolerated, to maintain bone strength and muscle mass
- Fall prevention strategies, particularly in elderly patients
Additional Long-Term Considerations
Patients receiving long-term abiraterone therapy should also be aware of the following effects, which are related to profound androgen suppression:
- Reduced libido and erectile dysfunction: Significant androgen suppression commonly leads to decreased sexual desire and erectile dysfunction. This is an expected pharmacological effect related to the mechanism of action.
- Decreased red blood cell count: Mild to moderate anemia may develop during treatment, contributing to fatigue. 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, as it may be multifactorial and addressable.
- Body composition changes: Androgen deprivation can lead to increased body fat, decreased lean muscle mass, and metabolic changes including insulin resistance.
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 EudraVigilance system in the European Union). Reporting side effects helps ensure the ongoing safety monitoring of all medications, including generic products.
How Should You Store Abirateron Teva?
Store Abirateron Teva in its original packaging at room temperature, out of reach and sight of children. No special temperature storage conditions are required. Do not use after the expiration date printed on the packaging.
Proper storage of Abirateron Teva ensures the medication maintains its quality, potency, and effectiveness throughout its shelf life. The film-coated tablet formulation is designed to be stable under normal household conditions, but certain precautions should be followed.
- Temperature: No special temperature storage requirements. Store at normal room temperature (below 30°C / 86°F). Do not freeze.
- Packaging: Keep the tablets in the original blister pack to protect them from moisture and light. Do not remove tablets from blisters until you are ready to take them.
- Children: Keep out of sight and reach of children. Accidental ingestion by children requires immediate emergency medical attention.
- Expiration: Do not use Abirateron Teva 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 with potential reproductive toxicity, return any unused tablets to a pharmacy for proper disposal according to local regulations. This protects the environment and prevents accidental exposure to others.
- Handling: Women who are pregnant or who may become pregnant should not handle the tablets without protective gloves, as abiraterone can potentially be absorbed through the skin and may harm a developing fetus. Do not handle broken or crushed tablets.
What Does Abirateron Teva Contain?
Each Abirateron Teva film-coated tablet contains 500 mg of abiraterone acetate as the active ingredient. The tablets are designed for oral administration and must be swallowed whole.
Understanding the composition of your medication helps identify potential allergens or intolerances, and provides useful information when discussing your treatment with healthcare providers or pharmacists.
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 hydrolyzed (broken down) in the body to its active metabolite, abiraterone, which selectively and irreversibly inhibits the CYP17A1 enzyme. The acetate ester form improves oral bioavailability compared to abiraterone itself.
Excipients (Inactive Ingredients)
The other ingredients in Abirateron Teva 500 mg film-coated tablets include:
- Tablet core: Lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, povidone, colloidal anhydrous silica, and magnesium stearate
- Film coating: Polyvinyl alcohol, titanium dioxide (E171), macrogol (polyethylene glycol), talc, and iron oxide pigments (E172)
Patients with known lactose intolerance should discuss this with their oncologist before starting treatment, as each tablet contains lactose monohydrate. The sodium content per daily dose is minimal but should be noted by patients on sodium-restricted diets.
Appearance and Pack Sizes
Abirateron Teva 500 mg film-coated tablets are designed for easy identification. They are supplied in blister packs containing 56 or 60 film-coated tablets per carton. A typical month's supply consists of 60 tablets (providing 30 daily doses of two tablets each). Not all pack sizes may be marketed in every country. Always check the packaging and labeling before taking your medication.
Marketing Authorization Holder
Teva B.V., Swensweg 5, 2031 GA Haarlem, Netherlands. Teva Pharmaceutical Industries Ltd. is one of the world's largest generic pharmaceutical companies, with manufacturing facilities operating under GMP standards across multiple countries.
Frequently Asked Questions About Abirateron Teva
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). "Abirateron Teva — Summary of Product Characteristics (SmPC)." EMA Official European regulatory documentation for Abirateron Teva (abiraterone acetate).
- U.S. Food and Drug Administration (FDA). "ZYTIGA (abiraterone acetate) — Prescribing Information." FDA FDA-approved labeling and safety information for the originator abiraterone acetate product.
- 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 worldwide.
- Smith MR, et al. (2019). "ERA 223: a Phase 3 Trial of Radium-223 Dichloride (Ra-223) in Combination with Abiraterone Acetate and Prednisone." Journal of Clinical Oncology. 37(2):73. Key trial demonstrating the danger of combining abiraterone with radium-223.
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.
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