Enzishil Enzalutamide 80 MG (Xtandi)

Enzishil 40mg Capsule is an oral anticancer agent containing the active ingredient Enzalutamide $40\text{ mg}$. This medication is a potent, second-generation Androgen Receptor ($\text{AR}$) Inhibitor and is crucial for the systemic hormonal management of advanced prostate cancer that has developed resistance to traditional hormone therapies. Enzishil 40 works by achieving a comprehensive blockade of the androgen signaling pathway.

Uses of Enzishil 40mg Capsule

Enzishil 40mg Capsule is indicated for the treatment of:

• Metastatic Castration-Resistant Prostate Cancer (mCRPC): Prostate cancer that has spread to other parts of the body and is progressing despite medical or surgical castration.
• Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC): For men whose cancer has not spread but is progressing based on rising $\text{PSA}$ levels.
• Metastatic Castration-Sensitive Prostate Cancer (mCSPC): Used in combination with Androgen Deprivation Therapy ($\text{ADT}$) for men with metastatic, hormone-sensitive disease.

Benefits of Enzishil 40mg Capsule

Enzishil 40mg Capsule offers significant clinical advantages in therapeutic management:

• Triple-Action $\text{AR}$ Blockade: It competitively inhibits androgen binding, blocks $\text{AR}$ nuclear translocation, and impairs $\text{AR}$ binding to $\text{DNA}$, providing a powerful anti-androgen effect.
• Clinically Proven Efficacy: Extensive clinical data supports its role in significantly prolonging overall survival and delaying disease progression across various stages of advanced prostate cancer.
• Precise Unit Dose: The $40\text{ mg}$ capsule provides the fundamental unit dose, allowing for the precise formulation of the standard $160\text{ mg}$ daily dose ($\text{four }40\text{ mg}$ capsules) and flexibility for any necessary dose adjustments.

Side Effects of Enzishil 40mg Capsule

Side effects associated with Enzishil 40mg Capsule are mainly neurological and constitutional.

• Common Side Effects: Fatigue/asthenia, musculoskeletal pain (including back pain and joint pain), hot flashes, diarrhea, headache, hypertension, and falls.
• Serious Side Effects (Requires prompt reporting): Seizures (rare, but severe; discontinue permanently if a seizure occurs), Posterior Reversible Encephalopathy Syndrome ($\text{PRES}$), Ischemic Heart Disease (e.g., heart attack, stroke), and non-pathologic fractures.

How to Use Enzishil 40mg Capsule

• Dosage: The recommended dose of Enzalutamide is $160\text{ mg}$ administered orally once daily. This is achieved by taking four $40\text{ mg}$ capsules.
• Administration: Enzishil 40 Capsules should be swallowed whole with water. They must not be chewed, dissolved, or opened.
• Food: The capsule can be taken with or without food as food does not have a clinically significant effect on the overall extent of absorption.
• Timing: It should be taken at the same time each day for consistency.

How Enzishil 40mg Capsule Works?

Enzishil 40mg Capsule contains Enzalutamide, a potent competitive inhibitor of the Androgen Receptor ($\text{AR}$). It exerts its anti-cancer effect by disrupting the $\text{AR}$ signaling pathway at three critical stages:

1. Inhibition of Ligand Binding: Prevents androgens from binding to the $\text{AR}$.
2. Impairment of Nuclear Translocation: Blocks the movement of the activated $\text{AR}$ into the cell nucleus.
3. Inhibition of $\text{DNA}$ Binding: Prevents the $\text{AR}$ complex from binding to $\text{DNA}$ and activating the genes required for cancer cell growth. This comprehensive, triple-action blockade is highly effective in treating prostate cancer that continues to rely on $\text{AR}$ signaling.

Safety Advice

• Seizure Risk: Permanently discontinue the drug if a seizure occurs. Counsel patients to avoid activities where sudden loss of consciousness could cause serious harm.
• Women and Pregnancy: Enzishil is strictly contraindicated in women, particularly those who are pregnant or may become pregnant, due to the risk of fetal harm. Women should avoid handling the capsules.
• Contraception: Male patients with female partners of reproductive potential must use effective contraception during treatment and for three months after the last dose.
• Drug Interactions (CYP Induction): Enzalutamide is a potent $\text{CYP}3\text{A}4$ inducer. It can rapidly decrease the concentration of many co-administered drugs.

What if You Forget to Take Enzishil 40mg Capsule?

If a patient misses a dose, they should take the prescribed dose as soon as they remember on the same day. If they only remember on the next day, they must skip the missed dose and take the next dose at the regular time. Patients must not take a double dose.

Quick Tips

• Take Whole: Capsules must be swallowed whole to ensure proper dosing and prevent exposure.
• Monitor for $\text{CNS}$ Signs: Patients should be warned to immediately report severe headache, confusion, or visual changes, which may signal a seizure or $\text{PRES}$.
• No Food Restriction: The capsule can be taken with or without food for ease of daily scheduling.

FAQs

Q1: What are the key logistical considerations for bulk buyers of Enzishil 40mg Capsule?

A: The $40\text{ mg}$ capsule is the established unit dose, meaning four capsules are used for the standard $160\text{ mg}$ daily dose. Bulk logistics must manage the volume, ensure stability (Store below 30∘C), and provide full regulatory compliance ($\text{CoA}$) for international shipment to all specified countries.

Q2: Is dose adjustment of Enzishil 40mg Capsule required for patients with liver or kidney impairment?

A: The $160\text{ mg}$ dose ($\text{four }40\text{ mg}$ capsules) requires no initial dosage adjustment for patients with mild to severe hepatic impairment or mild to moderate renal impairment. Caution and careful monitoring are advised, particularly in cases of severe impairment.

Q3: What is the most critical interaction risk associated with Enzishil 40mg Capsule for co-administered drugs?

A: Enzalutamide is a potent $\text{CYP}3\text{A}4$ inducer. This enzyme induction can significantly decrease the concentration of many co-administered drugs (e.g., certain $\text{HIV}$ medications, anti-epileptics, $\text{opioids}$, and $\text{warfarin}$), potentially leading to therapeutic failure of the secondary medication.

Q4: What are the storage requirements for Enzishil 40mg Capsule in a bulk warehouse setting? A: The capsules should be stored at controlled room temperature, ideally between 20∘C to 25∘C (up to 30∘C) and protected from moisture and light. Bulk packaging is designed to maintain product integrity over its approved shelf life.

Q5: What is the risk associated with Enzishil and falls/fractures?

A: Enzishil increases the risk of falls and non-pathologic fractures due to central nervous system effects (dizziness, fatigue) and potential effects on bone health. Patients with existing risk factors (e.g., osteoporosis) should be evaluated and managed with bone-targeted agents as needed.

Q6: What should patients know about the potential for seizures while taking Enzishil 40mg Capsule?

A: Seizures are a rare but serious risk (approximately $0.6\%$ of patients). The risk is dose-dependent, and the drug should be permanently discontinued if a seizure occurs. Patients must avoid activities where a sudden loss of consciousness could cause harm.

A Note to Our Bulk Buyers:

UnnatiPharmax guarantees a secure supply of pharmaceutical-grade Enzishil 40mg Capsule. We assure an efficient supply chain with compliant international shipping to our valued partners in Australia, Germany, Singapore, the UK, the US, and the Philippines.

References:-

• Philippines Food and Drug Administration (FDA) – Drug Registration (Example):
  • https://verification.fda.gov.ph/drug_productsview.php?showdetail=&registration_number=DRP-11417
  • (Registration entry for ENZASTIK 40mg Softgel Capsule (Enzalutamide) in the Philippines FDA portal, confirming local approval and generic name.)
• U.S. Food and Drug Administration (FDA) – Drug Label (Full Prescribing Info):
  • https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213674s002lbl.pdf
  • (Full Prescribing Information for Xtandi, confirming the 160mg daily dosage)
• NIH – PubMed Central (PMC) – Survival Study (ARCHES Trial):
  • https://pmc.ncbi.nlm.nih.gov/articles/PMC9113211/
  • (Improved Survival With Enzalutamide in Patients With Metastatic Hormone-Sensitive Prostate Cancer)
• NIH – PubMed Central (PMC) – Efficacy and Safety Review:
  • https://pmc.ncbi.nlm.nih.gov/articles/PMC4407758/
  • (Enzalutamide for patients with metastatic castration-resistant prostate cancer)
• NIH – ClinicalTrials.gov – Safety/Efficacy Study:
  • https://clinicaltrials.gov/study/NCT02003924?tab=results
  • (Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer, using the 160mg dose)