Enzalieva — Enzalutamide 40 mg (112 Capsules)

Enzalieva is available in the form of capsules designed to ensure a stable concentration of the active substance in the blood:

• Active Compound: Enzalutamide — 40 mg in each capsule. This is a non-steroidal anti-androgen that targets the tumor with high precision.
• Excipients: Caprylocaproyl polyoxylglycerides (ensuring solubility and absorption), butylhydroxyanisole, and butylhydroxytoluene (antioxidants preserving the formula).
• Capsule Shell: Pharmaceutical gelatin, sorbitol (sorbitan solution), titanium dioxide, and iron oxide. The capsules have a smooth coating for easy swallowing.

Pharmacodynamics: Enzalutamide is a selective antagonist of androgen receptors. It inhibits the growth of prostate cancer cells by blocking testosterone signaling. The drug induces apoptosis (programmed cell death) of cancer cells and reduces the size of tumor masses and metastases, effectively slowing down the disease.

Pharmacokinetics: After oral administration, enzalutamide is rapidly absorbed and reaches peak plasma concentration within 1–2 hours. The drug has a long half-life, which allows for a therapeutic window to be maintained throughout the day with just one daily dose. Metabolism occurs in the liver with the participation of enzymes CYP2C8 and CYP3A4.

Enzalieva 40 mg is a specialized prescription medication and is prescribed for the following clinical conditions:

• 🔹 Metastatic Castration-Resistant Prostate Cancer (mCRPC): In patients where the disease progresses despite chemotherapy or surgical castration.
• 🔹 Non-metastatic CRPC: To reduce the risk of distant metastases in patients with rapidly rising PSA levels.
• 🔹 Metastatic Hormone-Sensitive Prostate Cancer (mHSPC): In combination with androgen deprivation therapy to achieve deep and stable remission.

Adhering to the correct dosage regimen is critically important for the effectiveness of anti-tumor therapy:

• Standard Regimen: The recommended daily dose is 160 mg (exactly 4 capsules of 40 mg each) once daily.
• Method of Intake: Capsules should be swallowed whole, not chewed, crushed, or opened. Can be taken regardless of food intake.
• Regularity: It is highly recommended to take the medication at the same time each day. If you miss a dose, take it as soon as possible. If it is close to the next dose, skip the missed one.
• Duration: Treatment is usually long-term. The decision to adjust the dose or stop treatment is made only by the attending oncologist based on clinical data.

Despite its high efficiency, the drug has several strict limitations:

• ⛔ Gender and Age: The drug is not intended for use in women or children. It is strictly prohibited for pregnant women due to the risk of severe fetal pathologies.
• ⛔ Seizure Risk: Use with extreme caution (or contraindicated) in patients with epilepsy or a history of seizure predisposition.
• ⛔ Organ Impairment: Severe forms of renal or hepatic failure require careful dose adjustment or drug withdrawal.
• ⛔ Hypersensitivity: Allergy to enzalutamide or any other component of the capsule.

Enzalieva actively interacts with liver enzymes, which requires special attention when combined with other drugs:

• ❌ Warfarin: Enzalutamide may reduce its effectiveness, increasing the risk of blood clots (requires regular INR monitoring).
• ❌ Anticonvulsants: Drugs like phenytoin and carbamazepine can significantly lower the concentration of Enzalieva.
• ❌ CYP3A4 Inducers: Rifampicin or St. John's wort-based products can make the treatment ineffective.
• ⚠️ Consultation: Always inform your doctor if you are taking statins, antibiotics, or heart medications while on this therapy.

Even though this is a medication for men, family planning issues are vital:

• Impact on Partner: Enzalutamide passes into semen. If your partner is pregnant or may become pregnant, the use of a condom is mandatory throughout the entire course and for 3 months after the final dose.
• Reproduction: The drug may significantly affect male fertility. Before starting therapy, it is recommended to discuss sperm cryopreservation with your doctor.

Most patients tolerate Enzalieva well, but the following reactions may occur during therapy:

• 🟢 Common: Increased fatigue (asthenia), hot flashes, and headache are the most frequent symptoms.
• 🟡 Musculoskeletal: Joint pain and an increased risk of bone fractures (supplements of calcium and vitamin D are often recommended).
• 🟡 Cardiovascular: Possible increase in blood pressure (hypertension).
• 🟠 Rare: Confusion and seizures (observed in less than 1% of cases).
• ⚠️ Urgent: Seek medical help immediately if you experience sudden dizziness, loss of coordination, or loss of consciousness.

Taking a dose significantly higher than the recommended 160 mg is dangerous and requires immediate action:

• Symptoms: Exacerbation of side effects, severe nausea, and a high risk of triggering a seizure.
• First Aid: Gastric lavage and the administration of activated charcoal or other sorbents are necessary.
• Hospital Treatment: There is no specific antidote. Symptomatic therapy is performed in a hospital setting.
• Observation: Due to the drug's long half-life, the patient must remain under medical supervision for several days.

Compliance with storage rules guarantees the preservation of the therapeutic properties of the capsules:

• 🌡️ Temperature: Store in a cool, dry place at temperatures between 15°C and 30°C. Avoid humidity.
• 📦 Packaging: Keep the capsules in their original box, protected from direct sunlight.
• 👶 Safety: Store in a dark place that is absolutely inaccessible to children and pets.
• ⏳ Pack Content: Each pack contains 4x28 Capsules (a total of 112 capsules), which is intended for a full treatment cycle as prescribed.