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Enzana 40mg - Enzalutamide Capsules

Enzana 40 mg Capsules contain Enzalutamide, a potent androgen‑receptor inhibitor used to treat castration‑resistant prostate cancer. It blocks androgen signaling in tumor cells to slow disease progression and improve survival.

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General Information:
Generic Name: Enzalutamide
Brand Name: Enzana
Packing: Bottle of 30 capsules
Strength: 40 mg
Manufacturer: Torrent Pharmaceuticals Ltd.
Form: Hard gelatin capsule
Category: Androgen‑Receptor Inhibitor / Antiandrogen
Product Introduction:
Enzana (Enzalutamide) is an oral antiandrogen indicated for:
  1. Metastatic castration‑resistant prostate cancer (mCRPC) both before and after chemotherapy
  2. Non‑metastatic castration‑resistant prostate cancer (nmCRPC) to delay the development of metastases
    It works by preventing androgen receptor activation, nuclear translocation, DNA binding, and co‑activator recruitment, thereby inhibiting prostate cancer cell growth.

Uses of Enzana 40 mg Capsules:
  1. mCRPC (pre‑chemotherapy): Improves progression‑free and overall survival.
  2. mCRPC (post‑chemotherapy): Extends survival after docetaxel failure.
  3. nmCRPC: Delays metastasis and prolongs metastasis‑free survival.
  4. Metastatic hormone‑sensitive prostate cancer (mHSPC) (off‑label): In combination with androgen‑deprivation therapy.
  5. Biochemical recurrence (investigational): For rising PSA post‑local therapy.
  6. Combination regimens (off‑label): Being evaluated alongside novel hormonal agents and immunotherapies.

Storage Instructions:
  1. Store at 20 °C to 25 °C (room temperature).
  2. Protect from light and moisture.
  3. Keep in the original container with desiccant.
  4. Do not freeze.
  5. Keep out of reach of children.

How It Works (Mechanism of Action):
Enzalutamide is a potent androgen‑receptor inhibitor that:
  1. Prevents androgen binding to the receptor
  2. Inhibits receptor nuclear translocation
  3. Blocks DNA binding and co‑activator recruitment
    This triple blockade disrupts androgen‑driven gene transcription and induces apoptosis in prostate cancer cells.

Side Effects:
Common:
  1. Fatigue
  2. Hot flashes
  3. Headache
  4. Hypertension
  5. Diarrhea
  6. Arthralgia
Severe (Rare):
  1. Seizures – Monitor in patients with risk factors
  2. Posterior reversible encephalopathy syndrome (PRES)
  3. Cardiac ischemic events – Monitor blood pressure and ECG
  4. Falls and fractures – Assess bone health
  5. Hepatotoxicity – Monitor liver function tests

Dosage (Typical Recommended Dose):
  1. 160 mg once daily (four 40 mg capsules) with or without food.
  2. Do not exceed 160 mg per day.
  3. No adjustment needed for mild to moderate renal impairment.
  4. Use with caution in severe hepatic impairment; monitor closely.

Method of Administration:
  1. Oral, swallow capsules whole with water.
  2. Take at the same time each day.
  3. May be taken with or without food.
  4. Do not open, crush, or chew capsules.

Precautions:
  1. Monitor blood pressure regularly; manage hypertension per guidelines.
  2. Assess seizure risk; use caution in patients with prior seizures or head trauma.
  3. Evaluate liver function at baseline and periodically.
  4. Support bone health with calcium and vitamin D; consider bisphosphonates if at high fracture risk.
  5. Contraception: Men and women of childbearing potential must use effective contraception during treatment and for 3 months after discontinuation.

Drug Interactions:
  1. CYP2C8 inhibitors (e.g., gemfibrozil): ↑ Enzalutamide levels – avoid or reduce dose.
  2. CYP3A4 inducers (e.g., rifampin): ↓ Enzalutamide levels – avoid concomitant use.
  3. CYP3A4 substrates (e.g., midazolam): ↓ substrate exposure – monitor and adjust dose.
  4. Anticoagulants (warfarin): Monitor INR; Enzalutamide may ↓ warfarin levels.
  5. Opioids: Enzalutamide may ↓ opioid efficacy; monitor analgesic effect.

Allergies (Warnings for Allergic Reactions):
  1. Contraindicated in hypersensitivity to Enzalutamide or any excipients.
  2. Signs of allergy: rash, pruritus, angioedema, bronchospasm – discontinue and seek urgent care.

Overdose Information:
  1. Symptoms: Nausea, vomiting, dizziness, seizures.
  2. Management: Provide supportive care; no specific antidote exists. Monitor vital signs and neurological status.

Missed Dose Instructions:
  1. If <12 hours late, take as soon as remembered.
  2. If >12 hours late, skip and resume next scheduled dose.
  3. Do not double doses to compensate.

Additional Notes:
  1. Regular PSA and imaging to monitor treatment response.
  2. Educate patients on signs of hypertension, seizures, and hepatotoxicity.
  3. Maintain a treatment diary for adverse events and concomitant medications.
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