Enzalutamide Sandoz: Uses, Dosage & Side Effects
A potent androgen receptor inhibitor for the treatment of metastatic and non-metastatic castration-resistant prostate cancer and metastatic hormone-sensitive prostate cancer in adult men
Enzalutamide Sandoz contains the active substance enzalutamide, a potent androgen receptor signaling inhibitor used in the treatment of prostate cancer in adult men. It works by blocking the androgen receptor at multiple steps in its signaling pathway, preventing testosterone and other androgens from driving cancer cell growth. Enzalutamide Sandoz is a generic version of the originator product and is approved for metastatic castration-resistant prostate cancer, non-metastatic castration-resistant prostate cancer with high risk of metastatic disease, and metastatic hormone-sensitive prostate cancer. It is taken orally as four 40 mg tablets (160 mg total) once daily, alongside androgen deprivation therapy. Enzalutamide has been one of the most significant advances in prostate cancer treatment over the past decade, with multiple large randomized trials demonstrating improved survival outcomes across all stages of the disease.
Quick Facts: Enzalutamide Sandoz
Key Takeaways
- Enzalutamide Sandoz is a potent androgen receptor inhibitor that blocks testosterone signaling at multiple steps, used in the treatment of prostate cancer at various stages including metastatic castration-resistant (mCRPC), non-metastatic castration-resistant (nmCRPC), and metastatic hormone-sensitive (mHSPC) disease.
- The standard dose is 160 mg (four 40 mg tablets) taken orally once daily with or without food, always in combination with androgen deprivation therapy (medical or surgical castration).
- Enzalutamide is a strong CYP3A4 inducer and can significantly reduce the effectiveness of many other medications – always inform your doctor about all drugs you are taking, including supplements and over-the-counter medicines.
- Seizures are a known but uncommon risk; patients with a history of seizures or predisposing conditions should be carefully evaluated before starting treatment, and driving safety should be discussed.
- Common side effects include fatigue, hot flushes, hypertension, falls, and fractures – many of these overlap with effects of concurrent androgen deprivation therapy and are manageable with appropriate monitoring and supportive care.
What Is Enzalutamide Sandoz and What Is It Used For?
Enzalutamide Sandoz contains the active substance enzalutamide, belonging to a class of medications known as androgen receptor inhibitors or next-generation antiandrogens. Prostate cancer is one of the most common cancers in men worldwide, and its growth is primarily driven by male sex hormones called androgens, principally testosterone and dihydrotestosterone (DHT). These androgens bind to the androgen receptor (AR) on prostate cancer cells, triggering a cascade of events that promote cell survival, growth, and division. Enzalutamide was developed to comprehensively block this androgen receptor signaling pathway, even in the setting of castration-resistant disease where cancer continues to grow despite very low testosterone levels.
The mechanism of action of enzalutamide is distinct from older antiandrogens such as bicalutamide. While first-generation antiandrogens act primarily by competing with androgens for binding to the receptor, enzalutamide is a more potent and comprehensive inhibitor that targets the androgen receptor pathway at three critical steps. First, it competitively inhibits the binding of androgens to the androgen receptor with a five- to eight-fold greater affinity than bicalutamide. Second, it prevents the nuclear translocation of the androgen receptor – meaning that even if androgens manage to bind, the receptor cannot move into the cell nucleus where it would normally activate gene transcription. Third, it blocks the association of the activated androgen receptor with DNA and co-activator proteins, thereby preventing the transcription of genes that promote cancer cell survival and proliferation.
This triple blockade is particularly important in castration-resistant prostate cancer (CRPC), a stage of the disease where cancer cells have developed mechanisms to continue utilizing the androgen receptor pathway despite castrate levels of circulating testosterone. These mechanisms include androgen receptor overexpression, receptor mutations, intracrine androgen synthesis within the tumor itself, and constitutively active receptor splice variants. By targeting multiple steps in the AR pathway, enzalutamide can overcome several of these resistance mechanisms more effectively than older antiandrogens.
Enzalutamide Sandoz is a generic formulation of the originator product Xtandi (manufactured by Astellas Pharma/Pfizer). Generic medicines undergo rigorous regulatory review to demonstrate pharmaceutical equivalence and bioequivalence, meaning they deliver the same amount of active drug to the body as the reference product. The clinical effects and safety profile of Enzalutamide Sandoz are therefore the same as those established in the extensive clinical trial program for the originator product.
Enzalutamide Sandoz is approved by regulatory authorities including the European Medicines Agency (EMA) and is indicated for the following conditions:
- Metastatic castration-resistant prostate cancer (mCRPC): For adult men whose cancer has spread to other parts of the body and continues to progress despite treatment with androgen deprivation therapy. The pivotal AFFIRM trial demonstrated that enzalutamide significantly improved overall survival compared with placebo in patients who had previously received docetaxel chemotherapy, while the PREVAIL trial showed similar benefits in chemotherapy-naïve patients.
- Non-metastatic castration-resistant prostate cancer (nmCRPC): For adult men at high risk of developing metastatic disease, defined by a rapidly rising prostate-specific antigen (PSA) level (PSA doubling time of 10 months or less). The PROSPER trial demonstrated that enzalutamide significantly prolonged metastasis-free survival by a median of 22 months compared with placebo.
- Metastatic hormone-sensitive prostate cancer (mHSPC): For adult men with newly diagnosed metastatic prostate cancer who have not yet developed castration resistance. The ARCHES and ENZAMET trials demonstrated significant improvements in radiographic progression-free survival and overall survival when enzalutamide was added to androgen deprivation therapy in this earlier disease setting.
Prostate cancer affects approximately 1.4 million men worldwide each year and is the second most common cancer in males globally, according to the World Health Organization (WHO). While many prostate cancers are slow-growing and may require only active surveillance, advanced and metastatic forms remain a leading cause of cancer mortality. The development of enzalutamide and other next-generation antiandrogens has significantly expanded the treatment options available across the entire spectrum of advanced prostate cancer, leading to meaningful improvements in survival and quality of life.
Enzalutamide Sandoz is a generic version of Xtandi. Generic medicines contain the same active substance at the same dose and have been demonstrated to be bioequivalent to the reference product. They undergo thorough regulatory review before approval. Choosing a generic medicine offers the same therapeutic benefit while potentially reducing treatment costs.
What Should You Know Before Taking Enzalutamide Sandoz?
Contraindications
Enzalutamide Sandoz should not be used in certain situations. Understanding these absolute contraindications is essential before treatment begins.
- Hypersensitivity: Do not take Enzalutamide Sandoz if you are allergic to enzalutamide or any of the other ingredients in the tablet (see the contents section below). Signs of a severe allergic reaction may include swelling of the face, tongue, lip, or throat, difficulty breathing, or skin rash.
- Women: Enzalutamide Sandoz is not indicated for use in women. It must not be taken by women who are pregnant or who may become pregnant, as enzalutamide may cause harm to the developing fetus. Women who are or may be pregnant should not handle broken or crushed enzalutamide tablets without protective gloves, as the drug can be absorbed through the skin.
Warnings and Precautions
Enzalutamide has been associated with seizures in approximately 0.5% of patients in clinical trials. The risk is higher in patients with a history of seizures, traumatic brain injury, stroke, brain tumors or metastases, or alcoholism. If you have any of these risk factors, discuss the benefits and risks of enzalutamide treatment carefully with your doctor. Seek immediate medical attention if you experience a seizure during treatment.
Before and during treatment with Enzalutamide Sandoz, inform your doctor if any of the following apply to you:
- Seizures or risk factors for seizures: History of seizures, brain injury, stroke, brain tumors or brain metastases, or underlying brain conditions. Also inform your doctor if you have a history of alcoholism or are taking medications that lower the seizure threshold (such as certain antidepressants, antipsychotics, or tramadol).
- Cardiovascular disease: Heart disease, previous heart attack, stroke, mini-stroke (transient ischemic attack), or uncontrolled high blood pressure. Enzalutamide may increase the risk of ischemic heart disease. Patients with cardiovascular risk factors should be monitored appropriately.
- Posterior reversible encephalopathy syndrome (PRES): A rare brain condition that can occur with enzalutamide. Symptoms include headache, confusion, seizures, visual changes, and high blood pressure. If PRES is suspected, enzalutamide must be discontinued.
- Falls and fractures: Enzalutamide treatment, combined with androgen deprivation therapy, can increase the risk of falls and bone fractures. Use caution if you are at increased risk of falls due to mobility issues, medication side effects, or osteoporosis. Your doctor may recommend bone density monitoring and calcium/vitamin D supplementation.
- Hypersensitivity reactions: Allergic reactions ranging from mild to severe (including facial edema, tongue edema, lip edema, pharyngeal edema, and rash) have been reported. If you experience severe allergic symptoms, stop taking the medicine and contact your doctor immediately.
- Liver problems: If you have hepatic impairment, your doctor will monitor your liver function during treatment. Cases of drug-induced liver injury, including some with fatal outcomes, have been reported rarely with enzalutamide.
- Kidney problems: Inform your doctor if you have renal impairment. No dose adjustment is needed for mild to moderate kidney disease, but caution is advised in severe renal impairment.
- Concomitant use of other medications: Enzalutamide is a potent enzyme inducer and can significantly affect the metabolism of many other drugs (see Drug Interactions section). This is one of the most important practical considerations when prescribing enzalutamide.
- Recent cardiovascular events: In clinical trials, an increased incidence of ischemic heart disease (including myocardial infarction and coronary artery disease) has been observed with enzalutamide. Your doctor will assess your cardiovascular risk before starting treatment.
Women, Pregnancy, and Fertility
Enzalutamide Sandoz is for use in adult men only. It must not be used by women, particularly those who are or may become pregnant. Based on the mechanism of action and findings in animal studies, enzalutamide may cause fetal harm. Women who are or may be pregnant should not handle broken, dissolved, or crushed enzalutamide tablets without wearing protective gloves. Intact film-coated tablets do not pose a risk with brief skin contact.
Men who are sexually active with partners of childbearing potential should use condoms together with another effective method of contraception during treatment and for 3 months after the last dose of enzalutamide. Enzalutamide may affect male fertility; the effects on human sperm have not been fully characterized. If you are concerned about future fertility, discuss this with your doctor before starting treatment.
Driving and Operating Machinery
Enzalutamide Sandoz may have a moderate influence on the ability to drive and use machines. Seizures have been reported in patients taking this medicine. If you experience a seizure, you should stop driving and operating machines and contact your doctor. Additionally, fatigue, dizziness, and cognitive disturbance have been reported as side effects, which may impair your ability to drive or operate machinery safely.
How Does Enzalutamide Sandoz Interact with Other Drugs?
Drug interactions are one of the most clinically significant aspects of enzalutamide therapy. Enzalutamide and its active metabolite N-desmethyl enzalutamide are potent inducers of several cytochrome P450 (CYP) enzymes that are responsible for metabolizing many other drugs. This induction effect means that enzalutamide accelerates the breakdown of co-administered medications, potentially reducing their blood levels to sub-therapeutic concentrations. This is a critically important consideration, particularly for patients taking multiple medications for comorbid conditions such as cardiovascular disease, diabetes, or pain management.
Major Interactions
| Interacting Drug / Class | Effect | Clinical Significance |
|---|---|---|
| Gemfibrozil (strong CYP2C8 inhibitor) | Increases enzalutamide AUC by approximately 4.3-fold | Avoid combination; if unavoidable, reduce enzalutamide dose to 80 mg once daily |
| Warfarin (CYP2C9 substrate) | Reduced warfarin levels due to CYP2C9 induction; decreased anticoagulant effect | Monitor INR closely; dose adjustment of warfarin likely needed |
| Midazolam and other CYP3A4 substrates | Reduced levels of CYP3A4 substrates by up to 86% | Avoid or use alternatives; many drugs affected including some statins, calcium channel blockers, immunosuppressants |
| Omeprazole and other CYP2C19 substrates | Reduced omeprazole levels by approximately 70% | Proton pump inhibitors may be less effective; consider dose increases or alternatives |
| Itraconazole (strong CYP3A4 inhibitor) | Increases composite active moiety AUC by approximately 1.3-fold | No dose adjustment needed; the magnitude of effect is modest |
Minor Interactions and Additional Considerations
| Interacting Drug / Class | Effect | Clinical Significance |
|---|---|---|
| P-glycoprotein substrates (e.g., digoxin, dabigatran) | Enzalutamide may reduce levels of P-gp substrates via induction of P-glycoprotein transporter | Monitor therapeutic effect; dose adjustment may be needed |
| BCRP/MRP2 substrates (e.g., methotrexate, rosuvastatin) | Possible induction of these transporters, reducing substrate levels | Monitor and adjust doses as clinically indicated |
| UGT1A1 substrates (e.g., levothyroxine) | Enzalutamide may induce UGT1A1, increasing glucuronidation of substrates | Monitor thyroid function if on levothyroxine; dose adjustment may be required |
| Seizure threshold–lowering drugs (e.g., SSRIs, tramadol, antipsychotics) | Additive risk of seizures when combined with enzalutamide | Carefully evaluate benefit-risk; consider alternatives where possible |
The extensive enzyme-inducing properties of enzalutamide mean that virtually any co-administered medication should be evaluated for potential interactions. This is particularly relevant for medications with narrow therapeutic indices (such as warfarin, certain anticonvulsants, and immunosuppressants) where even modest changes in blood levels can lead to therapeutic failure or toxicity. Your oncologist or pharmacist should conduct a thorough medication review before starting enzalutamide and whenever new medications are added to your regimen.
Because enzalutamide affects so many drug-metabolizing enzymes and transporters, it is essential that your doctor reviews all your current medications, including prescription drugs, over-the-counter medicines, and herbal supplements (especially St. John’s wort), before starting and during treatment. Never start or stop any medication without consulting your doctor.
What Is the Correct Dosage of Enzalutamide Sandoz?
Enzalutamide Sandoz is a self-administered oral medication taken at home. Unlike some cancer treatments that require hospital visits for infusions, enzalutamide offers the convenience of daily oral dosing. However, it is essential to follow your doctor’s instructions carefully and to take the medication consistently to maintain effective drug levels in your body.
Adults
Standard Dose for All Approved Indications
Dose: 160 mg orally once daily (four 40 mg film-coated tablets)
Administration: Swallow tablets whole with water. Do not crush, chew, dissolve, or split tablets.
Timing: At the same time each day, with or without food
Duration: Continuous treatment until disease progression or unacceptable toxicity
Note: Medical or surgical castration (androgen deprivation therapy) must be continued during enzalutamide treatment, unless the patient has undergone bilateral orchiectomy. If a patient receiving a GnRH agonist or antagonist starts enzalutamide, the GnRH therapy must not be stopped.
Dose Adjustments
Your doctor may need to adjust the dose of Enzalutamide Sandoz in certain situations:
- Concomitant use with strong CYP2C8 inhibitors: If enzalutamide must be given together with gemfibrozil or another strong CYP2C8 inhibitor, the dose should be reduced to 80 mg (two 40 mg tablets) once daily. If the strong CYP2C8 inhibitor is discontinued, the enzalutamide dose should be returned to 160 mg.
- Intolerable side effects: If you experience grade 3 or higher toxicity or an intolerable side effect, your doctor may temporarily withhold the dose for one week or until symptoms improve, then resume at the same or a reduced dose (120 mg or 80 mg once daily).
- Mild to moderate hepatic impairment: No dose adjustment is necessary for patients with mild or moderate liver impairment. However, an increased half-life has been observed in patients with severe hepatic impairment, and the effect has not been fully evaluated in this population; caution is advised.
- Renal impairment: No dose adjustment is needed for mild to moderate kidney disease. Caution is advised in patients with severe renal impairment or end-stage renal disease, as enzalutamide has not been studied in these populations.
Children and Adolescents
There is no relevant use of Enzalutamide Sandoz in the pediatric population. Prostate cancer does not occur in children and adolescents, and enzalutamide should not be used in patients under 18 years of age.
Elderly Patients
No dose adjustment is required for elderly patients. The majority of patients treated with enzalutamide in clinical trials were 65 years of age or older. The safety and efficacy of enzalutamide in elderly patients are well established, with no clinically meaningful differences in pharmacokinetics observed between younger and older adults. However, elderly patients should be monitored carefully for falls, fractures, and cardiovascular events, as these risks may be higher in this age group.
Missed Dose
If you miss a dose of Enzalutamide Sandoz, take it as soon as you remember on the same day. If you have missed the entire day’s dose, take your usual dose the next day at the regular time. Do not take a double dose to make up for a missed one. If you miss more than one dose, contact your doctor for advice.
Overdose
There is no specific antidote for enzalutamide overdose. In the event that you take more than the prescribed dose, stop taking the medicine and contact your doctor or go to the nearest emergency department immediately. In clinical trials, patients receiving doses up to 480 mg per day were studied, and the most notable risk of overdose is an increased likelihood of seizures. Treatment is supportive and symptomatic. In the event of a seizure, provide appropriate medical care and ensure the patient’s safety.
What Are the Side Effects of Enzalutamide Sandoz?
Like all medicines, Enzalutamide Sandoz can cause side effects, although not everybody gets them. Many of the side effects experienced during enzalutamide treatment overlap with or are compounded by the effects of concurrent androgen deprivation therapy (ADT), which also causes fatigue, hot flushes, bone loss, and metabolic changes. Your medical team will monitor you regularly to detect and manage side effects promptly.
The side effect profile of enzalutamide has been extensively characterized in large phase III clinical trials (AFFIRM, PREVAIL, PROSPER, ARCHES, and ENZAMET) involving thousands of patients. The following side effects are organized by frequency based on pooled clinical trial data.
Very Common
May affect more than 1 in 10 people
- Fatigue and asthenia (tiredness and weakness)
- Hot flushes
- Hypertension (high blood pressure)
- Falls
- Fractures
- Headache
- Diarrhea
- Decreased appetite
- Peripheral edema (swelling in hands, feet, or ankles)
Common
May affect up to 1 in 10 people
- Ischemic heart disease (including angina, myocardial infarction)
- Dry skin and pruritus (itching)
- Memory impairment and cognitive disturbance
- Dizziness
- Gynecomastia (breast tissue enlargement)
- Restless legs syndrome
- Musculoskeletal pain (back pain, bone pain, joint pain)
- Weight loss
- Anxiety
- Spinal cord compression and cauda equina syndrome
- Neutropenia (low white blood cell count)
- Hallucinations (visual)
Uncommon
May affect up to 1 in 100 people
- Seizure
- Leukopenia (low total white blood cells)
- Drug-induced liver injury (hepatotoxicity)
Rare
May affect up to 1 in 1,000 people
- Posterior reversible encephalopathy syndrome (PRES)
- Toxic epidermal necrolysis (severe skin reaction)
Not Known
Frequency cannot be estimated from available data
- Myalgia (muscle pain as a hypersensitivity reaction)
- Severe hypersensitivity reactions (facial edema, tongue edema, lip edema, pharyngeal edema)
- Drug reaction with eosinophilia and systemic symptoms (DRESS)
- Stevens-Johnson syndrome
Falls and Fractures
Falls and fractures deserve particular attention because they are among the most clinically impactful side effects. In the PROSPER trial for non-metastatic castration-resistant prostate cancer, falls occurred in approximately 17% of patients receiving enzalutamide compared with 8% in the placebo group, while fractures occurred in approximately 12% versus 3% respectively. The combination of enzalutamide and androgen deprivation therapy leads to profound androgen suppression, which accelerates bone loss and can worsen existing osteoporosis. Your doctor may recommend a DEXA bone density scan before or during treatment, along with calcium and vitamin D supplementation and possibly bisphosphonate or denosumab therapy to protect bone health.
Cardiovascular Safety
Cardiovascular events, including ischemic heart disease, have been observed at a higher rate in enzalutamide-treated patients compared with placebo in clinical trials. In pooled data, ischemic heart disease occurred in approximately 3.7% of enzalutamide patients versus 1.3% in placebo groups. Patients with pre-existing cardiovascular disease or risk factors should be monitored closely. Blood pressure should be measured regularly, and hypertension should be treated according to standard guidelines. Your doctor will weigh the cardiovascular risk against the benefit of cancer treatment.
Seek immediate medical attention if you experience: a seizure (sudden loss of consciousness with convulsions), severe headache with confusion or visual changes (possible PRES), chest pain, difficulty breathing, or sudden severe skin reaction with blistering. Also contact your doctor if you notice yellowing of the skin or eyes (jaundice), which could indicate liver injury.
If you experience any side effects, including those not listed here, tell your doctor or pharmacist. You can also report side effects directly to your national pharmacovigilance authority (e.g., the EMA in Europe, the FDA MedWatch program in the United States, or the MHRA Yellow Card Scheme in the United Kingdom) to help monitor the ongoing safety profile of this medicine.
How Should You Store Enzalutamide Sandoz?
Proper storage of your medication is important to ensure it remains effective and safe throughout your treatment course. The following storage instructions should be observed:
- Temperature: Store below 30°C (86°F). Do not refrigerate or freeze.
- Moisture protection: Keep the tablets in the original blister packaging to protect from moisture.
- Light: No special precautions needed for light protection, but keep in the original carton when not in use.
- Children: Keep out of the sight and reach of children.
- Expiry date: Do not use this medicine after the expiry date which is stated on the carton and blister foil after “EXP.” The expiry date refers to the last day of that month.
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 will help protect the environment. Do not use Enzalutamide Sandoz if you notice any visible signs of deterioration (such as discoloration or damaged tablets).
What Does Enzalutamide Sandoz Contain?
Active Substance
The active substance is enzalutamide. Each film-coated tablet contains 40 mg of enzalutamide. The daily dose of four tablets provides a total of 160 mg of enzalutamide.
Inactive Ingredients (Excipients)
The other ingredients in the tablet core and film coating may include:
- Tablet core: Hypromellose acetate succinate, microcrystalline cellulose, silica colloidal anhydrous, croscarmellose sodium, magnesium stearate, sodium laurilsulfate
- Film coating: Hypromellose, talc, macrogol 8000, titanium dioxide (E171), iron oxide yellow (E172)
Enzalutamide Sandoz film-coated tablets are round, biconvex, yellow tablets. They are available in blister packs.
Manufacturer
Enzalutamide Sandoz is manufactured and marketed by Sandoz, a division of Novartis. For specific information about the manufacturer and batch release site, refer to the packaging or contact your local Sandoz representative.
Frequently Asked Questions About Enzalutamide Sandoz
Enzalutamide Sandoz is used to treat prostate cancer in adult men. It is approved for three distinct clinical settings: metastatic castration-resistant prostate cancer (mCRPC), where the cancer has spread and continues to grow despite castrate testosterone levels; non-metastatic castration-resistant prostate cancer (nmCRPC) at high risk of developing metastases; and metastatic hormone-sensitive prostate cancer (mHSPC), where the cancer has spread but is still responsive to initial hormonal therapy. In all settings, it is used alongside androgen deprivation therapy.
Yes, Enzalutamide Sandoz is a generic version of Xtandi (the originator product by Astellas Pharma/Pfizer). Both contain the same active ingredient (enzalutamide) at the same strength (40 mg per tablet). Enzalutamide Sandoz has been approved by regulatory authorities after demonstrating pharmaceutical equivalence and bioequivalence to Xtandi, meaning it delivers the same amount of drug to the body and produces the same clinical effects. The safety and efficacy profile is identical.
Yes, Enzalutamide Sandoz can be taken with or without food. Food does not significantly affect the absorption of enzalutamide. The key recommendation is to take the four tablets at the same time each day, consistently. Swallow the tablets whole with water – do not crush, chew, or dissolve them. If you prefer, you can take them with a meal to help establish a consistent routine.
If you forget to take your dose at the usual time, take it as soon as you remember on the same day. If you miss the entire day, take your normal dose the next day at the usual time. Do not take a double dose to make up for the forgotten tablets. If you frequently forget doses, consider setting a daily alarm or using a pill organizer. If you miss multiple doses, contact your doctor for advice on how to resume treatment.
Enzalutamide Sandoz is taken continuously – there is no predetermined fixed duration of treatment. You should continue taking it for as long as your doctor advises, which is typically until the cancer progresses (as determined by PSA levels, imaging, or clinical assessment) or until side effects become unacceptable. Some patients take enzalutamide for many months or years. Do not stop taking the medication without discussing it with your oncologist, even if you feel well, as stopping treatment prematurely could allow the cancer to progress.
Yes, this is one of the most important practical considerations with enzalutamide. It is a potent enzyme inducer, meaning it accelerates the breakdown of many other medications in your body. This can reduce the effectiveness of blood thinners (like warfarin), acid-reducing medications (like omeprazole), some blood pressure medications, certain statins, some anti-anxiety drugs (like midazolam), and many others. Always inform every doctor, pharmacist, or dentist that you are taking enzalutamide, and never start or stop any medication without consulting your oncologist first.
References
- European Medicines Agency (EMA). Xtandi (enzalutamide) – Summary of Product Characteristics. Last updated 2025. Available from: EMA EPAR.
- U.S. Food and Drug Administration (FDA). XTANDI (enzalutamide) Prescribing Information. Revised 2024. Available from: FDA Drug Label.
- Scher HI, Fizazi K, Saad F, et al. Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy (AFFIRM). N Engl J Med. 2012;367(13):1187–1197. doi:10.1056/NEJMoa1207506.
- Beer TM, Armstrong AJ, Rathkopf DE, et al. Enzalutamide in Metastatic Prostate Cancer before Chemotherapy (PREVAIL). N Engl J Med. 2014;371(5):424–433. doi:10.1056/NEJMoa1405095.
- Hussain M, Fizazi K, Saad F, et al. Enzalutamide in Men with Nonmetastatic, Castration-Resistant Prostate Cancer (PROSPER). N Engl J Med. 2018;378(26):2465–2474. doi:10.1056/NEJMoa1800536.
- Armstrong AJ, Szmulewitz RZ, Petrylak DP, et al. ARCHES: A Randomized, Phase III Study of Androgen Deprivation Therapy with Enzalutamide or Placebo in Men with Metastatic Hormone-Sensitive Prostate Cancer. J Clin Oncol. 2019;37(32):2974–2986. doi:10.1200/JCO.19.00799.
- Davis ID, Martin AJ, Stockler MR, et al. Enzalutamide with Standard First-Line Therapy in Metastatic Prostate Cancer (ENZAMET). N Engl J Med. 2019;381(2):121–131. doi:10.1056/NEJMoa1903835.
- National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Prostate Cancer. Version 1.2025.
- Mottet N, van den Bergh RCN, Briers E, et al. EAU-EANM-ESTRO-ESUR-ISUP-SIOG Guidelines on Prostate Cancer. European Association of Urology; 2025.
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List. Geneva: WHO; 2023.
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This article was written and reviewed by the iMedic Medical Editorial Team, comprising licensed specialist physicians with expertise in urology, oncology, and clinical pharmacology.
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