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Glenza 80mg - Enzalutamide Capsules

Glenza 80 mg Capsules contain Enzalutamide, a next‑generation androgen‑receptor inhibitor used to treat castration‑resistant prostate cancer. By blocking androgen signaling at multiple steps, it slows tumor growth and prolongs survival.

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General Information:
Generic Name: Enzalutamide
Brand Name: Glenza
Packing: Bottle of 30 capsules
Strength: 80 mg per capsule
Manufacturer: Glenmark Pharmaceuticals Ltd.
Form: Hard gelatin capsule
Category: Androgen‑Receptor Inhibitor / Antiandrogen
Product Introduction:
Glenza (Enzalutamide) is an oral antiandrogen indicated for:
  1. Metastatic castration‑resistant prostate cancer (mCRPC), both pre‑ and post‑chemotherapy
  2. Non‑metastatic castration‑resistant prostate cancer (nmCRPC), to delay metastasis
It inhibits androgen‑receptor binding, nuclear translocation, DNA binding, and co‑activator recruitment, effectively shutting down androgen‑driven gene transcription in prostate tumor cells.

Uses of Glenza 80 mg Capsules:
  1. mCRPC (pre‑chemotherapy): Improves radiographic progression‑free survival 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): With androgen‑deprivation therapy.
  5. Biochemical recurrence (investigational): Rising PSA after local therapy.
  6. Combination regimens (off‑label): Under evaluation with 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.

Mechanism of Action:
Enzalutamide is a potent androgen‑receptor inhibitor that:
  1. Prevents androgen binding to the receptor
  2. Blocks receptor nuclear translocation
  3. Inhibits DNA binding and co‑activator recruitment
This triple blockade disrupts androgen‑driven transcription, leading to tumor cell apoptosis and reduced proliferation.

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

Dosage (Typical Recommended Dose):
  1. 160 mg once daily (two 80 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; 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 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 exposure – 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):
  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: Supportive care; no specific antidote. 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 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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