Enzalutamide Accordpharma: Uses, Dosage & Side Effects
Androgen Receptor Inhibitor — Blocks testosterone signaling in prostate cancer
Quick Facts About Enzalutamide Accordpharma
Key Takeaways About Enzalutamide Accordpharma
- Broad prostate cancer indication: Enzalutamide Accordpharma is approved for metastatic castration-resistant prostate cancer (mCRPC), non-metastatic castration-resistant prostate cancer (nmCRPC) at high risk of metastasis, and metastatic hormone-sensitive prostate cancer (mHSPC)
- Can be taken with or without food: Unlike abiraterone, enzalutamide absorption is not significantly affected by food. Take 160 mg (four 40 mg tablets) once daily at approximately the same time each day
- No corticosteroid required: Enzalutamide does not require concomitant prednisone or prednisolone, as it does not affect cortisol synthesis — it blocks the androgen receptor rather than inhibiting hormone production
- Seizure risk: Enzalutamide may rarely cause seizures. Inform your doctor about any history of seizures, brain injury, stroke, or conditions that may lower the seizure threshold before starting treatment
- Strong enzyme inducer: Enzalutamide is a potent CYP3A4 inducer and can significantly reduce the blood levels and effectiveness of many common medications, including blood thinners, antifungals, and certain heart medications
What Is Enzalutamide Accordpharma and What Is It Used For?
Enzalutamide Accordpharma contains enzalutamide, a potent androgen receptor signaling inhibitor that blocks the action of testosterone and other androgens at the receptor level. By preventing androgens from binding to the androgen receptor, inhibiting receptor nuclear translocation, and blocking DNA binding, enzalutamide disrupts the signaling that drives prostate cancer cell growth and survival.
Enzalutamide Accordpharma is a prescription-only medication used to treat prostate cancer in adult men. 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 many cases of early-stage prostate cancer can be cured with surgery or radiotherapy, advanced prostate cancer that has progressed on initial hormone therapy represents a significant clinical challenge requiring more potent treatments.
Prostate cancer cells rely on androgens — particularly testosterone and its more potent derivative, dihydrotestosterone (DHT) — to grow, divide, and survive. These androgens exert their effects by binding to the androgen receptor (AR), a nuclear transcription factor. When testosterone or DHT binds to the AR, the receptor translocates into the cell nucleus, binds to specific DNA sequences, and activates genes that promote cancer cell proliferation and survival. Standard androgen deprivation therapy (ADT) using GnRH agonists or antagonists reduces testosterone production from the testes to castrate levels. However, even at castrate testosterone levels, the androgen receptor can still be activated by residual androgens from the adrenal glands, by intratumoral androgen synthesis, or through AR overexpression and mutations — a condition termed castration-resistant prostate cancer (CRPC).
Enzalutamide addresses this challenge through a fundamentally different mechanism compared to traditional hormonal therapies. Rather than reducing androgen production (as abiraterone does), enzalutamide directly targets the androgen receptor itself at three distinct points in its signaling pathway. First, it competitively inhibits the binding of androgens to the AR with approximately 5 to 8 times greater affinity than the first-generation antiandrogen bicalutamide. Second, it prevents the nuclear translocation of the activated AR complex. Third, it inhibits the binding of the AR to DNA, thereby blocking the transcription of AR-target genes. This triple-action mechanism provides more comprehensive AR signaling blockade than older antiandrogens and remains effective even in the setting of AR overexpression, which is a common resistance mechanism in castration-resistant disease.
The clinical efficacy of enzalutamide has been established in several landmark phase 3 clinical trials. The AFFIRM trial demonstrated a significant overall survival benefit in men with mCRPC who had previously received docetaxel chemotherapy. The PREVAIL trial showed similar survival benefits in chemotherapy-naive mCRPC patients. The PROSPER trial established efficacy in non-metastatic CRPC at high risk of metastasis, and the ARCHES trial demonstrated improved outcomes in metastatic hormone-sensitive prostate cancer. Together, these trials have positioned enzalutamide as a cornerstone of prostate cancer treatment across multiple disease stages.
Approved Indications
Enzalutamide Accordpharma is approved for the treatment of prostate cancer in adult men in the following clinical settings:
- Metastatic castration-resistant prostate cancer (mCRPC): For men whose cancer has spread to other parts of the body and has progressed despite surgical or medical castration. Enzalutamide may be used both before and after docetaxel chemotherapy, always in combination with ongoing androgen deprivation therapy.
- Non-metastatic castration-resistant prostate cancer (nmCRPC): For men whose PSA (prostate-specific antigen) is rising despite castrate testosterone levels, but who do not yet have visible metastases on imaging. In this setting, enzalutamide is used in patients at high risk of developing metastatic disease (defined as a PSA doubling time of 10 months or less), together with ongoing ADT.
- Metastatic hormone-sensitive prostate cancer (mHSPC): For men with newly diagnosed or recurrent metastatic prostate cancer that still responds to hormonal manipulation. Enzalutamide is used in combination with ADT to achieve more comprehensive androgen signaling blockade from the outset of treatment.
Enzalutamide is a second-generation androgen receptor (AR) signaling inhibitor that targets three key steps in the AR signaling cascade. (1) Competitive binding inhibition: Enzalutamide competes with testosterone and DHT for binding to the ligand-binding domain of the AR, with approximately 5–8 times greater affinity than first-generation antiandrogens such as bicalutamide. (2) Nuclear translocation blockade: Even if some AR activation occurs, enzalutamide prevents the receptor-ligand complex from being transported into the cell nucleus. (3) DNA binding inhibition: Enzalutamide prevents the activated AR from associating with androgen response elements on DNA, thereby blocking the transcription of genes that promote cancer cell proliferation. Unlike first-generation antiandrogens, enzalutamide does not exhibit agonist activity at the AR, even in the setting of AR overexpression, making it effective in castration-resistant disease where older drugs may paradoxically stimulate cancer growth.
Enzalutamide vs. Abiraterone: Key Differences
Enzalutamide and abiraterone are both used to treat advanced prostate cancer, but they work through fundamentally different mechanisms and have distinct practical considerations:
- Mechanism: Enzalutamide blocks the androgen receptor directly. Abiraterone inhibits the enzyme CYP17A1, reducing androgen production.
- Corticosteroid requirement: Enzalutamide does not require co-administration with prednisone or prednisolone. Abiraterone must always be taken with a corticosteroid to prevent mineralocorticoid excess.
- Food interaction: Enzalutamide can be taken with or without food. Abiraterone must be taken on an empty stomach, as food dramatically increases its absorption.
- Drug interactions: Enzalutamide is a strong CYP3A4 inducer (reduces levels of other drugs). Abiraterone is a CYP2D6 and CYP2C8 inhibitor (increases levels of other drugs).
- Seizure risk: Enzalutamide carries a small but recognized seizure risk. This is not a concern with abiraterone.
What Should You Know Before Taking Enzalutamide Accordpharma?
Before starting enzalutamide, your doctor will assess your history of seizures or conditions that may lower the seizure threshold, your cardiovascular health, bone density, and current medications. Enzalutamide is contraindicated in women (especially pregnant women). Its strong enzyme-inducing properties mean that many concomitant medications will need to be reviewed and potentially adjusted.
Enzalutamide Accordpharma is a potent medication that requires careful medical assessment before initiation and ongoing monitoring throughout treatment. Understanding the contraindications, warnings, and precautions ensures both safety and optimal therapeutic benefit.
Contraindications
You must not take Enzalutamide Accordpharma if any of the following apply:
- Allergy to enzalutamide: If you have a known hypersensitivity to enzalutamide or any of the excipients in the formulation. Signs of an allergic reaction may include rash, itching, facial swelling, or difficulty breathing.
- Women and children: Enzalutamide Accordpharma is intended exclusively for adult male patients. It must never be taken by women, particularly those who are pregnant or may become pregnant, as the drug can inhibit androgen receptor signaling in the developing fetus and cause fetal harm or loss of pregnancy.
Warnings and Precautions
Discuss the following conditions with your oncologist or urologist before starting Enzalutamide Accordpharma. These situations require careful evaluation and may necessitate dose adjustments, additional monitoring, or selection of an alternative treatment:
- A seizure (convulsion, fit, loss of consciousness with uncontrolled body movements)
- Severe headache, confusion, visual disturbances, or seizure — possible signs of posterior reversible encephalopathy syndrome (PRES)
- Sudden swelling of the face, lips, tongue, or throat, or severe difficulty breathing — signs of severe allergic reaction
- Chest pain, sudden shortness of breath, or irregular heartbeat
- Severe skin reactions such as widespread rash, blistering, or peeling of the skin
- Seizures: Enzalutamide may cause seizures, which occurred in approximately 0.5% of patients in clinical trials. The risk is elevated in patients with a history of seizures, prior traumatic brain injury, stroke, brain tumors, brain metastases, or those taking medications that lower the seizure threshold (such as certain antidepressants, antipsychotics, or tramadol). If you experience a seizure during treatment, enzalutamide must be permanently discontinued.
- Posterior reversible encephalopathy syndrome (PRES): Rare cases of PRES have been reported with enzalutamide. Symptoms include seizure, headache, confusion, blindness, and other visual or neurological disturbances, with hypertension. If PRES is suspected, enzalutamide must be discontinued.
- Falls and fractures: Enzalutamide increases the risk of falls and fractures. This is partly due to the combined effects of enzalutamide and androgen deprivation therapy on bone mineral density, muscle mass, and balance. Elderly patients and those with osteoporosis are at highest risk. Your doctor may recommend calcium and vitamin D supplementation, bone density monitoring, and fall prevention strategies.
- Ischemic heart disease: Cases of ischemic heart disease, including fatal events, have been reported in patients treated with enzalutamide. Patients with pre-existing cardiovascular conditions (history of heart attack, unstable angina, heart failure, or stroke within the preceding 6 months) were generally excluded from clinical trials. Your doctor will monitor your cardiovascular health during treatment.
- Hypersensitivity reactions: Rare cases of angioedema and serious skin reactions have been reported. If severe hypersensitivity symptoms occur, enzalutamide should be permanently discontinued.
- Cognitive effects: Some patients report difficulty concentrating, memory problems, or other cognitive changes during enzalutamide treatment. Inform your doctor if you notice any changes in mental function.
Blood Test Monitoring
While enzalutamide does not require the same intensive liver monitoring as abiraterone, your doctor will still order regular blood tests throughout treatment. A typical monitoring schedule includes:
- PSA (prostate-specific antigen): at regular intervals to assess treatment response
- Testosterone levels: to confirm ongoing castrate-level suppression
- Full blood count: periodically
- Blood pressure monitoring: at regular visits
- Bone density assessment: as clinically appropriate, especially in patients at risk of osteoporosis
- Blood glucose and lipids: as standard cardiovascular risk monitoring
Pregnancy, Fertility, and Handling Precautions
Enzalutamide Accordpharma is not intended for use by women. This medication can cause serious harm to an unborn child. The following precautions are essential:
- Women who are pregnant or may become pregnant should avoid handling enzalutamide tablets without protective gloves, as the active substance may be absorbed through the skin
- Male patients having sex with a woman of childbearing potential must use a condom and another effective method of contraception during treatment and for 3 months after the last dose of enzalutamide
- Male patients having sex with a pregnant woman must use a condom throughout treatment to protect the fetus from potential drug exposure through seminal fluid
- Enzalutamide may impair male fertility. Animal studies have shown effects on the male reproductive system. Discuss fertility preservation options with your oncologist before starting treatment
Driving and Operating Machinery
Enzalutamide may affect your ability to drive and use machines. Fatigue, cognitive impairment, dizziness, and seizures have been reported as side effects. There is also a risk of seizure associated with enzalutamide use. If you experience any of these symptoms, or if you feel your ability to concentrate or react may be affected, do not drive, use tools, or operate machinery until these effects resolve. Discuss with your doctor whether it is safe for you to continue driving during treatment.
How Does Enzalutamide Accordpharma Interact with Other Drugs?
Enzalutamide is a strong inducer of the liver enzyme CYP3A4 and a moderate inducer of CYP2C9 and CYP2C19. This means it can significantly reduce the blood levels and therapeutic effectiveness of many commonly used medications. Additionally, strong CYP2C8 inhibitors can increase enzalutamide levels, while strong CYP3A4 inducers may decrease its levels. Always inform your doctor about all medications you take.
Drug interactions with enzalutamide are clinically significant and widespread due to its potent enzyme-inducing properties. Unlike many cancer medications that inhibit drug-metabolizing enzymes (leading to increased levels of co-administered drugs), enzalutamide primarily induces these enzymes, causing accelerated metabolism and reduced effectiveness of many concomitant medications. This unique interaction profile requires careful review of all medications when enzalutamide is started or discontinued.
Enzalutamide is metabolized primarily by CYP2C8 and, to a lesser extent, by CYP3A4. Its active metabolite, N-desmethyl enzalutamide, has similar potency to the parent compound. Both enzalutamide and its active metabolite are strong inducers of CYP3A4 and moderate inducers of CYP2C9 and CYP2C19. This means that blood levels of drugs metabolized by these enzymes may be substantially reduced during enzalutamide treatment.
Major Interactions
The following interactions are considered clinically significant and may require dose adjustments, alternative medications, or careful monitoring:
| Drug / Class | Interaction Mechanism | Clinical Action |
|---|---|---|
| Warfarin | CYP3A4 and CYP2C9 induction reduces warfarin levels and anticoagulant effect | Monitor INR frequently; significant dose increases may be needed. Consider switching to a DOAC with specialist guidance |
| Midazolam and other benzodiazepines (CYP3A4 substrates) | CYP3A4 induction reduces midazolam AUC by up to 86% | Consider alternative sedatives not metabolized by CYP3A4; significant dose increases may be needed |
| Omeprazole and other proton pump inhibitors (CYP2C19 substrates) | CYP2C19 induction reduces omeprazole AUC by approximately 70% | Consider alternative acid-suppressing therapy; may need dose increase or switch |
| Immunosuppressants (cyclosporine, tacrolimus, sirolimus) | CYP3A4 induction significantly reduces immunosuppressant levels | Monitor drug levels closely; substantial dose increases may be needed. Organ transplant recipients require specialist coordination |
| Certain HIV medications (protease inhibitors, NNRTIs) | CYP3A4 induction can substantially reduce antiretroviral drug levels | Specialist coordination between oncologist and HIV specialist essential; may compromise viral suppression |
| Gemfibrozil (strong CYP2C8 inhibitor) | Inhibits enzalutamide metabolism, increasing enzalutamide exposure | If concurrent use is necessary, consider reducing enzalutamide dose to 80 mg once daily |
| Strong CYP3A4 inducers (rifampicin, carbamazepine, phenytoin, St. John’s Wort) | May reduce enzalutamide and active metabolite levels, potentially reducing efficacy | Avoid concomitant use if possible; may reduce enzalutamide effectiveness |
Other Notable Interactions
Enzalutamide induces CYP3A4, CYP2C9, and CYP2C19 enzymes. Medications primarily metabolized by these pathways may have reduced blood levels and therapeutic effectiveness when taken concurrently. Your doctor should be informed if you are taking any of the following:
| Drug | Effect | Action Required |
|---|---|---|
| Oral contraceptives | Reduced effectiveness via CYP3A4 induction | Not directly relevant for the male patient, but important for female partners — use barrier contraception |
| Statins (atorvastatin, simvastatin) | Reduced levels via CYP3A4 induction | Monitor lipid levels; may need higher doses or switch to rosuvastatin (less CYP3A4-dependent) |
| Calcium channel blockers (amlodipine, felodipine) | Reduced levels via CYP3A4 induction | Monitor blood pressure; dose adjustment may be needed |
| Opioid analgesics (fentanyl, oxycodone) | Reduced levels via CYP3A4 induction | Monitor pain control; may need dose increase or alternative analgesic |
| Antifungals (itraconazole, voriconazole) | Complex bidirectional interaction — azoles inhibit CYP3A4 (increasing enzalutamide) while enzalutamide induces CYP3A4 (reducing azoles) | Avoid if possible; if necessary, monitor antifungal levels and clinical response |
| Clopidogrel | CYP2C19 induction may affect activation of this prodrug (complex, unpredictable) | Consider alternative antiplatelet or monitor clinical response |
The enzyme-inducing effects of enzalutamide take approximately one month to reach full effect after starting treatment, and persist for approximately one month after discontinuation. This means that drug interactions may not be immediately apparent when enzalutamide is started, and dose adjustments to concomitant medications may need to be reversed gradually after enzalutamide is stopped.
What Is the Correct Dosage of Enzalutamide Accordpharma?
The recommended dose is 160 mg (four 40 mg tablets) taken once daily. Enzalutamide can be taken with or without food. Swallow the tablets whole with water. Do not crush, dissolve, or chew the tablets. Continue androgen deprivation therapy concurrently unless your doctor advises otherwise.
Enzalutamide Accordpharma is prescribed by oncologists or urologists experienced in the treatment of prostate cancer. The dosing regimen is standardized for adult male patients. Enzalutamide has a long half-life (approximately 5.8 days), which supports once-daily dosing and means that steady-state drug levels are achieved within approximately one month of daily treatment.
Adults
| Component | Dose | Instructions |
|---|---|---|
| Enzalutamide Accordpharma | 160 mg (4 × 40 mg tablets) once daily | With or without food; swallow whole with water; take at approximately the same time each day |
| Androgen deprivation therapy | As per separate prescription | Must continue concurrently with enzalutamide (GnRH agonist/antagonist or prior surgical castration) |
How to Take Enzalutamide Accordpharma
Follow these instructions for safe and effective treatment:
- With or without food: Enzalutamide can be taken at any time relative to meals. Food does not significantly affect absorption.
- Swallow whole: Do not split, crush, dissolve, or chew the tablets. Swallow them whole with a glass of water.
- Once daily: Take all four tablets at approximately the same time each day to maintain consistent drug levels.
- Continue ADT: Do not stop your androgen deprivation therapy unless instructed by your oncologist.
- Duration: Continue treatment for as long as your doctor prescribes. Treatment typically continues until disease progression or unacceptable toxicity.
Children and Adolescents
Enzalutamide Accordpharma is not intended for use in children or adolescents. There is no relevant use of enzalutamide in the pediatric population for the indication of prostate cancer. If a child accidentally ingests enzalutamide 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. In the pivotal clinical trials, the median age of patients was approximately 69 years, and a substantial proportion of patients were aged 75 years and older. No overall differences in safety or efficacy were observed between older and younger patients. However, elderly patients may be at increased risk for certain side effects, particularly falls, fractures, cognitive impairment, and cardiovascular events, and should be monitored accordingly.
Patients with Hepatic Impairment
Hepatic Impairment Dosing
- Mild impairment (Child-Pugh Class A): No dose adjustment required.
- Moderate impairment (Child-Pugh Class B): No dose adjustment required. However, an increase in the half-life of enzalutamide has been observed, meaning the drug may stay in the body longer.
- Severe impairment (Child-Pugh Class C): Enzalutamide has not been studied in patients with severe hepatic impairment. Use is not recommended unless the potential benefit justifies the potential risk. Closer monitoring is advised if used.
Patients with Renal Impairment
Renal Impairment Dosing
- Mild to moderate impairment: No dose adjustment required.
- Severe impairment: No dose adjustment required, but use with caution.
- End-stage renal disease (dialysis): Enzalutamide has not been studied in patients on dialysis. Use with caution as protein binding changes may affect drug exposure.
Dose Modification for Concomitant Strong CYP2C8 Inhibitors
If enzalutamide must be co-administered with a strong CYP2C8 inhibitor (such as gemfibrozil), the dose of enzalutamide should be reduced to 80 mg (two 40 mg tablets) once daily. If the CYP2C8 inhibitor is discontinued, the enzalutamide dose should be returned to the dose used prior to initiation of the CYP2C8 inhibitor.
Missed Dose
If you forget to take your daily dose of Enzalutamide Accordpharma, take your usual dose as soon as you remember on the same day. If you miss an entire day, take your normal dose the next day at your usual time. Do not take a double dose to make up for a missed dose. If you miss more than one day of treatment, contact your oncologist for advice.
Overdose
There is no specific antidote for enzalutamide overdose. If you take more than the prescribed dose, contact your oncologist or go to a hospital emergency department immediately. In clinical studies, doses up to 600 mg daily were administered. At higher doses, no additional safety concerns were identified compared to the 160 mg dose, but the risk of seizure may be dose-dependent. Treatment of overdose will be symptomatic and supportive, with particular attention to the risk of seizures.
Do not stop taking Enzalutamide Accordpharma unless your oncologist tells you to do so. Stopping treatment without medical guidance may allow your cancer to progress. If you experience side effects that concern you, contact your doctor to discuss your options before discontinuing the medication.
What Are the Side Effects of Enzalutamide Accordpharma?
Like all medications, Enzalutamide Accordpharma can cause side effects, though not everyone experiences them. The most common side effects include fatigue, hot flushes, high blood pressure, fractures, and falls. Serious but rare side effects include seizures, posterior reversible encephalopathy syndrome (PRES), and ischemic heart disease. Most side effects are manageable with appropriate monitoring and supportive care.
The side effect profile of enzalutamide reflects both its mechanism of action (androgen receptor blockade) and its enzyme-inducing properties. Many of the common side effects, such as fatigue, hot flushes, and musculoskeletal effects, are related to the combined effects of enzalutamide and androgen deprivation therapy on the body. Falls and fractures are a particular concern in older patients and those already at risk of osteoporosis. The seizure risk, while low, is a distinctive and important safety consideration that distinguishes enzalutamide from some other prostate cancer therapies.
The following side effect frequencies are based on clinical trial data from the pooled safety dataset across the AFFIRM, PREVAIL, PROSPER, and ARCHES trials, involving thousands of patients treated with enzalutamide 160 mg daily.
- A seizure (convulsion, fit, or loss of consciousness with uncontrolled body movements)
- Severe headache, confusion, blindness, or other vision changes with high blood pressure — possible signs of PRES
- Severe chest pain, sudden shortness of breath, or feeling faint — possible signs of heart attack or cardiovascular event
- Sudden swelling of the face, lips, tongue, or throat, severe difficulty breathing — signs of anaphylaxis
- Widespread skin rash with blisters and peeling skin — possible toxic epidermal necrolysis or Stevens-Johnson syndrome
Very Common Side Effects
- Fatigue and asthenic conditions (tiredness, weakness, lack of energy)
- Hot flushes (sudden sensation of heat, flushing)
- High blood pressure (hypertension)
- Fractures (bone fractures at various sites)
- Falls
Common Side Effects
- Headache
- Dizziness
- Cognitive disorder (memory problems, difficulty concentrating, impaired attention)
- Anxiety
- Restless legs syndrome
- Dry skin
- Itching (pruritus)
- Skin rash
- Joint pain (arthralgia)
- Muscle pain (myalgia)
- Muscle spasms
- Musculoskeletal pain
- Decreased appetite
- Diarrhea
- Ischemic heart disease (reduced blood supply to the heart)
- Gynecomastia (breast tissue enlargement)
- Decreased white blood cell count (neutropenia)
Uncommon Side Effects
- Seizures (convulsions)
- Hallucinations (visual)
- Disturbance in attention
- Leukopenia (low white blood cell count)
Rare or Very Rare Side Effects
- Posterior reversible encephalopathy syndrome (PRES)
- Toxic epidermal necrolysis (severe skin reaction)
- Stevens-Johnson syndrome (severe skin reaction with blistering)
- Drug reaction with eosinophilia and systemic symptoms (DRESS)
- Myasthenia gravis (muscle weakness disorder)
Managing Common Side Effects
Many of the common side effects of enzalutamide can be effectively managed with supportive care and lifestyle modifications:
- Fatigue: Mild to moderate physical exercise (such as daily walking) has been shown to reduce cancer-related fatigue. Maintain a regular sleep schedule, stay hydrated, and discuss persistent fatigue with your doctor.
- Hot flushes: Avoid triggers such as hot drinks, spicy food, alcohol, and hot environments. Dress in layers and keep your room cool. Medications such as venlafaxine or gabapentin may help if hot flushes are severe.
- Falls and fractures: Regular weight-bearing exercise, calcium and vitamin D supplementation, and environmental modifications (removing trip hazards, installing grab bars) can reduce fall risk. Report any falls to your medical team.
- High blood pressure: Blood pressure should be monitored regularly. Your doctor may prescribe antihypertensive medications if needed.
- Cognitive changes: Keep a routine, use calendars and reminders, stay mentally active, and inform your doctor about any noticeable changes in memory or concentration.
Reporting Side Effects
If you experience any side effects, including any not listed above, tell your doctor or pharmacist. You can also report side effects directly to your national pharmacovigilance agency (such as the EMA EudraVigilance system in Europe, the FDA MedWatch program in the United States, or the MHRA Yellow Card scheme in the United Kingdom). By reporting side effects, you help provide more information on the safety of this medicine.
How Should You Store Enzalutamide Accordpharma?
Store Enzalutamide Accordpharma below 30°C in the original packaging to protect from moisture. Keep out of the sight and reach of children. Do not use after the expiry date printed on the packaging.
Proper storage of Enzalutamide Accordpharma is important to ensure the medication remains effective and safe throughout your treatment. Follow these storage guidelines:
- Temperature: Store below 30°C. Do not freeze. Do not store in the bathroom or near a sink where humidity is high.
- Packaging: Keep the tablets in the original blister packaging to protect from moisture. Do not remove tablets from their blister pack until you are ready to take them.
- Children: Keep out of the sight and reach of children. Accidental ingestion by children or women can be harmful.
- Expiry date: Do not use after the expiry date stated on the carton and blister after “EXP”. The expiry date refers to the last day of that month.
- Disposal: Do not dispose of unused medication via household waste or wastewater. Return unused or expired tablets to your pharmacy for safe disposal. This helps protect the environment from pharmaceutical contamination.
What Does Enzalutamide Accordpharma Contain?
Each film-coated tablet contains 40 mg of enzalutamide as the active substance, along with inactive ingredients (excipients) that aid in the manufacturing, stability, and appearance of the tablets.
Active Ingredient
Each film-coated tablet contains 40 mg of enzalutamide. Enzalutamide (chemical name: 4-{3-[4-cyano-3-(trifluoromethyl)phenyl]-5,5-dimethyl-4-oxo-2-thioxoimidazolidin-1-yl}-2-fluoro-N-methylbenzamide) is a non-steroidal androgen receptor inhibitor with a molecular weight of 464.44 Da. It is a white to off-white crystalline powder that is practically insoluble in water.
Excipients (Inactive Ingredients)
The excipients in the tablet core and film coating may include:
- Tablet core: Hypromellose acetate succinate, microcrystalline cellulose, colloidal anhydrous silica, croscarmellose sodium, magnesium stearate
- Film coating: Hypromellose, talc, macrogol (polyethylene glycol), titanium dioxide (E171), iron oxide yellow (E172)
If you have known allergies or intolerances to any of the excipients listed above, discuss this with your pharmacist or doctor before starting treatment. The tablets are round, film-coated, and marked to identify the strength.
Enzalutamide Accordpharma 40 mg tablets contain less than 1 mmol sodium (23 mg) per dose, meaning they are essentially sodium-free.
Frequently Asked Questions About Enzalutamide Accordpharma
Medical References & Sources
This article is based on the following peer-reviewed sources, regulatory documents, and international clinical guidelines:
- Scher HI, Fizazi K, Saad F, et al. Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy. New England Journal of Medicine. 2012;367(13):1187-1197. doi:10.1056/NEJMoa1207506 (AFFIRM trial)
- Beer TM, Armstrong AJ, Rathkopf DE, et al. Enzalutamide in Metastatic Prostate Cancer before Chemotherapy. New England Journal of Medicine. 2014;371(5):424-433. doi:10.1056/NEJMoa1405095 (PREVAIL trial)
- Hussain M, Fizazi K, Saad F, et al. Enzalutamide in Men with Nonmetastatic, Castration-Resistant Prostate Cancer. New England Journal of Medicine. 2018;378(26):2465-2474. doi:10.1056/NEJMoa1800536 (PROSPER trial)
- 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. Journal of Clinical Oncology. 2019;37(32):2974-2986. doi:10.1200/JCO.19.00799
- European Medicines Agency (EMA). Xtandi — Summary of Product Characteristics. Updated 2025.
- US Food and Drug Administration (FDA). XTANDI (enzalutamide) Prescribing Information. Updated 2024.
- Parker C, Castro E, Fizazi K, et al. Prostate cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology. 2020;31(9):1119-1134. doi:10.1016/j.annonc.2020.06.011
- National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: Prostate Cancer. Version 1.2026.
- World Health Organization (WHO). World Cancer Report 2024. International Agency for Research on Cancer.
- British National Formulary (BNF). Enzalutamide monograph. National Institute for Health and Care Excellence (NICE). Updated 2025.
Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, comprising licensed specialist physicians with expertise in oncology, urology, and clinical pharmacology.
iMedic Medical Editorial Team — Specialists in Oncology and Pharmacology
iMedic Medical Review Board — Independent panel following GRADE evidence framework
All medical information is evidence-based and reviewed according to international guidelines from the WHO, EMA, FDA, ESMO, and NCCN. Our editorial team follows strict standards of medical accuracy, transparency, and independence. We receive no pharmaceutical company funding or sponsorship.