MEDENZA

MEDENZA

Enzalutamide 40/60/80/120mg
Net Qty- 28 capsules
Self-Life- 2 Years

💊 Medenza (Enzalutamide) is an oral medication used in the treatment of prostate cancer. It is classified as an androgen receptor inhibitor, and it works by blocking the action of male hormones (androgens) like testosterone, which can promote the growth of prostate cancer cells.

📌 Drug Class:

Androgen Receptor Inhibitor

📋 Indications (Uses):

  • Enzalutamide is approved for use in:
  • Metastatic castration-resistant prostate cancer (mCRPC)
  • Non-metastatic castration-resistant prostate cancer (nmCRPC)
  • Metastatic castration-sensitive prostate cancer (mCSPC)

USE

✅ Medenza (Enzalutamide) is primarily used in the treatment of prostate cancer, especially in stages where the disease is resistant to standard hormone therapy. It helps slow disease progression and improve survival.

📌 Approved Uses:

  1. Metastatic Castration-Resistant Prostate Cancer (mCRPC)

    • For men whose prostate cancer has spread and is no longer responding to hormone therapy (castration-resistant).

    • Can be used with or without prior chemotherapy.

  2. Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC)

    • For men whose cancer has not spread but continues to grow despite low testosterone levels.

    • Helps delay the spread of the disease.

  3. Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

    • For newly diagnosed metastatic prostate cancer that is still responsive to androgen deprivation therapy (ADT).

    • Used in combination with ADT.

🧠 How It Helps:

  • Slows tumor growth.
  • Delays the need for chemotherapy.
  • Prolongs progression-free and overall survival.

Key Benefits

🌟 Medenza (Enzalutamide )offers several important clinical and quality-of-life benefits for men with advanced prostate cancer. Here’s what makes it a widely used and effective therapy:

✅ Delays Disease Progression

  • Slows the growth and spread of prostate cancer, especially in castration-resistant and metastatic stages.

  • Significantly improves progression-free survival (PFS).

✅ Extends Overall Survival

  • Clinical trials show Enzalutamide can prolong life in men with advanced prostate cancer.

  • Benefit seen both before and after chemotherapy.

✅ Delays the Need for Chemotherapy

  • In patients with non-metastatic castration-resistant prostate cancer (nmCRPC), Enzalutamide delays time to metastasis, potentially postponing the need for chemo.

✅ Oral and Convenient

  • Once-daily oral treatment, usually taken at home.

  • No need for infusions or hospital visits for administration.

✅ No Need for Steroids
  • Unlike some other therapies (e.g., abiraterone), Enzalutamide does not require co-administration of corticosteroids.
✅ Works Across Multiple Stages

  • Effective in:

    • Non-metastatic CRPC

    • Metastatic CRPC

    • Metastatic castration-sensitive prostate cancer (mCSPC)

✅ Improves Quality of Life

  • Can reduce symptoms like pain, urinary problems, and fatigue related to cancer progression.

  • Helps patients maintain daily functioning longer.

Mechanism
of Action

🧬 Medenza (Enzalutamide) is a second-generation androgen receptor inhibitor used in the treatment of prostate cancer. It works by blocking the effects of androgens (male hormones)—primarily testosterone and dihydrotestosterone (DHT)—that fuel the growth of prostate cancer cells.

 

🔑 How It Works:

  1. Inhibits Androgen Receptor (AR) Binding:

    • Enzalutamide blocks androgens from binding to androgen receptors inside prostate cancer cells.

  2. Prevents AR Activation and Translocation:

    • Normally, once an androgen binds to the receptor, the complex moves into the cell nucleus.

    • Enzalutamide prevents this translocation, halting the cascade that promotes cancer growth.

  3. Disrupts DNA Binding:

    • Enzalutamide also prevents the AR complex from binding to DNA, stopping the activation of genes that promote cancer cell survival and proliferation.

 🧠 What Makes It Different:

  • Unlike first-generation anti-androgens (e.g., bicalutamide), Enzalutamide:

    • Has higher binding affinity to the AR.

    • Does not act as a partial agonist (i.e., it doesn’t activate the receptor).

    • Remains effective even in low-testosterone environments (after ADT or surgical castration).

🎯 Result:

➡️ Starves cancer cells of growth signals, leading to slower tumor growth and improved survival in advanced prostate cancer.

Dosage and Administration

💊 Medenza (Enzalutamide) – Dosage and Administration

 
📌 Standard Adult Dose:

  • Recommended Dose:
    160 mg once daily (4 capsules of 40 mg each)

  • Route:
    Oral – swallow capsules whole, with or without food.

🕒 Administration Tips:

  • Take at the same time each day.

  • Do not crush, chew, or open the capsules.

  • Can be taken with or without food.

  • If you miss a dose and it’s within 12 hours of the usual time — take it.
    If it’s over 12 hours late — skip and resume normal schedule the next day. Do not double the dose.

⚖️ Dose Adjustments May Be Needed:

  1. Liver Impairment:

    • Mild: No change needed

    • Moderate to severe: Use with caution – data limited

  2. Drug Interactions:

    • Avoid strong CYP2C8 or CYP3A4 inhibitors/inducers.

    • If unavoidable, dose adjustment may be required.

  3. Severe Side Effects:

    • If seizures, significant fatigue, or falls occur, the dose may need to be reduced or temporarily stopped under medical supervision.

🚫 Not Recommended In:

  • Children or women – Enzalutamide is only for adult men with prostate cancer.

  • Women who are or may become pregnant should avoid handling the capsules, as it can be harmful to the fetus.

Common Side Effects

⚠️ Common Side Effects of Medenza (Enzalutamide)

While Enzalutamide is generally well-tolerated, like all cancer therapies, it can cause side effects. Here are the most commonly reported ones:

 

🧠 Fatigue

  • Most common side effect

  • Can range from mild tiredness to significant exhaustion

  • May improve over time or with dose adjustments

💥 Hot Flashes

  • Often described as sudden warmth, sweating, and flushing

  • Can be bothersome, especially at night

🦵 Musculoskeletal Pain

  • Joint pain, back pain, or muscle aches

🧍 Weakness (Asthenia)

  • General lack of energy

  • May overlap with fatigue

🌡️ Hypertension (High Blood Pressure)

  • Regular blood pressure monitoring is recommended

  • May require medication adjustments

🧠 Dizziness & Falls

  • Seen especially in older adults

  • Increases fall risk — exercise caution with sudden movements

🧪 Elevated Liver Enzymes

  • Mild, but regular liver function tests are advised

🧠 Seizures (Rare but Serious)

  • Reported in <1% of patients

  • Patients with a history of seizures or brain injury are at higher risk

  • Discontinue immediately if a seizure occurs

🔄 Other Possible Effects:

  • Diarrhea

  • Headache

  • Decreased appetite

  • Anxiety or mood changes (rare)

📋 Monitoring & Communication

  • Regular lab tests and blood pressure checks are important.

  • Always report any new or worsening symptoms to your healthcare provider.

 

Monitoring

🧪 Monitoring Parameters for Patients on Medenza (Enzalutamide)

Ongoing monitoring is essential to ensure effectiveness, detect side effects early, and maintain safety during Enzalutamide therapy.

📋 PSA Levels

  • Frequency: Every 1–3 months

  • Used to track treatment response and disease progression.

💉 Complete Blood Count (CBC)

  • To monitor for:

    • Anemia

    • Leukopenia (low white cells)

  • Especially important in older adults or those with prior therapies.

🧬 Liver Function Tests (LFTs)

  • ALT, AST, bilirubin

  • Check at baseline, then periodically during treatment.

  • Watch for signs of liver toxicity.

💓 Blood Pressure

  • Baseline and regularly during treatment

  • Enzalutamide can cause hypertension, which needs monitoring and management.

🧠 Neurological Assessment

  • Monitor for dizziness, confusion, falls, or seizures

  • Patients with seizure risk may need extra neurological evaluations

🦴 Bone Health

  • If patient is on androgen deprivation therapy (ADT) long-term, assess for osteopenia/osteoporosis

  • Consider DEXA scans, calcium/vitamin D supplementation

🧠 Mental and Cognitive Status

  • Rare cases of cognitive issues, anxiety, or depression reported

  • Screen and monitor, especially in older adults

✅ Summary Table:

ParameterFrequencyPurpose
PSAEvery 1–3 monthsTrack treatment response
CBCBaseline, then periodicallyDetect hematologic side effects
LFTsBaseline, then periodicallyMonitor liver toxicity
Blood PressureFrequentlyManage hypertension
Neurological SymptomsOngoingDetect seizure or cognitive effects
Bone Density (DEXA)If on long-term ADTAssess osteoporosis risk
 

Precautions

⚠️ Precautions While Taking Medenza (Enzalutamide)

Enzalutamide is a powerful and effective treatment for prostate cancer, but it requires careful use to minimize risks and optimize benefits.

🧠 Seizure Risk

  • Rare but serious side effect

  • Avoid in patients with a history of seizures, brain injury, stroke, or brain metastases

  • Discontinue immediately if a seizure occurs

💓 Hypertension

  • Enzalutamide can raise blood pressure

  • Monitor BP regularly and treat hypertension as needed

  • Caution in patients with cardiovascular disease

⚖️ Risk of Falls and Fractures

  • Due to fatigue, dizziness, and weakness

  • Particularly in older adults — use fall prevention strategies

⚠️ Use in Hepatic Impairment

  • Use with caution in moderate to severe liver disease

  • Regular liver function tests (LFTs) are recommended

🚫 Not for Use in Women or Children

  • Enzalutamide is not indicated for use in women, especially pregnant or breastfeeding women

  • Can cause fetal harm if handled or ingested during pregnancy

  • Avoid exposure (e.g., broken capsules)

💊 Drug Interactions

  • Strong inducer of CYP3A4 and other enzymes

  • May reduce effectiveness of many other drugs (e.g., warfarin, midazolam, opioids)

  • Always check for drug-drug interactions

🧬 Contraception

  • Men with female partners of childbearing potential should use effective contraception during treatment and for 3 months after stopping Enzalutamide.

🧠 Cognitive Effects

  • Rare cases of memory issues, confusion, or mood changes

  • Monitor mental health and report any concerns

📌 Additional Notes:

  • Do not drive or operate machinery if you feel drowsy or dizzy

  • Keep well hydrated and manage fatigue with balanced activity and rest

Drug Interactions

🔄Medenza (Enzalutamide) has a high potential for drug interactions, mainly because it affects several liver enzymes involved in drug metabolism. Caution is essential when co-administering it with other medications.

⚠️ Enzyme Induction (CYP450 Inducer)

Enzalutamide is a strong inducer of:

  • CYP3A4

  • CYP2C9

  • CYP2C19

This means it can decrease the effectiveness of many drugs by increasing their metabolism.

🔻 Drugs Affected (reduced effect):

  • Warfarin (monitor INR closely)

  • Clopidogrel

  • Antiepileptics (e.g., phenytoin, carbamazepine)

  • Benzodiazepines (e.g., midazolam)

  • Statins (e.g., simvastatin, atorvastatin)

  • Opioids (e.g., fentanyl, oxycodone)

  • Antifungals (e.g., itraconazole, ketoconazole)

  • HIV medications

⚠️ Drugs That Affect Enzalutamide Levels

  • CYP2C8 Inhibitors (↑ Enzalutamide levels):

    • Example: Gemfibrozil → May require dose reduction

  • CYP3A4 Inhibitors (↑ Enzalutamide levels):

    • Example: Ketoconazole, clarithromycin → Use caution

  • CYP Inducers (↓ Enzalutamide levels):

    • Example: Rifampin, St. John’s Wort → Avoid if possible

🧠 CNS Depressants

  • Caution with drugs that lower seizure threshold:

    • Antipsychotics

    • Tramadol

    • Bupropion

  • Combined use increases risk of seizures

📝 Clinical Advice:

  • Always review the full medication list (prescription, OTC, supplements)

  • Consider alternatives or dose adjustments when interactions are likely

  • Monitor for loss of efficacy or toxicity signs

Clinical Effectiveness

✅ Clinical Effectiveness of Medenza (Enzalutamide)

Medenza (Enzalutamide) has demonstrated strong clinical effectiveness across multiple stages of prostate cancer, especially in castration-resistant and metastatic disease. Its approval is backed by multiple large-scale clinical trials.


🔬 Metastatic Castration-Resistant Prostate Cancer (mCRPC)

▶️ AFFIRM Trial (Post-chemotherapy patients):

  • Survival Benefit: Median overall survival (OS) improved by 4.8 months vs placebo

  • Result: 18.4 months (Enzalutamide) vs 13.6 months (placebo)

  • Reduced PSA levels, pain, and disease progression

▶️ PREVAIL Trial (Chemotherapy-naïve patients):

  • Progression-Free Survival (PFS): 20 months (Enzalutamide) vs 5.4 months (placebo)

  • OS Benefit: 32.4 months vs 30.2 months

  • Delayed chemotherapy need significantly

🛑 Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC)

▶️ PROSPER Trial:

  • Metastasis-Free Survival (MFS): 36.6 months (Enzalutamide) vs 14.7 months (placebo)

  • Delayed time to first skeletal-related event and chemotherapy

  • Significant improvement in PSA response and radiographic progression

🌍 Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

 ▶️ ARCHES Trial:

  • Used in combination with ADT

  • PFS improvement with significant delay in disease progression

  • Enhanced radiographic response and quality of life

📈 Real-World Benefits:

  • Consistently improves time to progression, overall survival, and quality of life

  • Effective in both pre- and post-chemotherapy settings

  • Oral administration improves patient adherence

🧠 Summary Table:

Indication Trial Key Outcome
mCRPC (post-chemo) AFFIRM ↑ Overall survival by 4.8 months
mCRPC (pre-chemo) PREVAIL ↑ PFS by 15 months
nmCRPC PROSPER ↑ Metastasis-free survival by 22 mo
mCSPC (with ADT) ARCHES ↓ Risk of radiographic progression

Tips for Patients

💡 Tips for Patients Taking Medenza (Enzalutamide)

To get the most benefit from Enzalutamide while minimizing side effects, here are some practical and safety-focused tips for patients:

💊 Take Medication Consistently

  • Take 160 mg (4 x 40 mg capsules) once daily, at the same time each day

  • Can be taken with or without food

  • Swallow capsules whole — do not crush or chew

⏰ What to Do If You Miss a Dose

  • If missed and less than 12 hours late, take it as soon as possible

  • If more than 12 hours have passed, skip the dose — do not double up

🧠 Monitor for Side Effects

  • Fatigue, hot flashes, and joint pain are common

  • Report dizziness, confusion, seizures, or any falls immediately

  • Keep track of your blood pressure at home if possible

⚠️ Avoid Drug Interactions

  • Inform your doctor about all medications, including OTC and supplements

  • Avoid St. John’s Wort, phenytoin, rifampin, and certain antifungals unless approved

🍽️ Stay Active and Eat Well

  • Light exercise may help manage fatigue and mood

  • Stay hydrated and maintain a balanced diet to support strength

🩺 Keep Regular Appointments

  • Regular lab tests (e.g., PSA, LFTs, CBC) and check-ups are essential

  • Bring a list of questions or symptoms to each visit

👩‍⚕️ Special Safety Tips

  • Men with female partners of childbearing potential: use effective contraception

  • Not for use in women or children

  • Women who are pregnant or breastfeeding should avoid handling the capsules

🛌 Avoid Driving If Drowsy or Dizzy

  • Until you know how Enzalutamide affects you, use caution with driving or machinery