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Azel 40mg - Enzalutamide Capsules

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Azel 40mg - Enzalutamide Capsules

Azel 40 mg Capsules contain Enzalutamide, an androgen‑receptor inhibitor used in the treatment of prostate cancer. It blocks androgen signaling in prostate tumor cells, slowing disease progression in castration‑resistant settings.

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Description Product Details
General Information:
Generic Name: Enzalutamide
Brand Name: Azel
Packing: Bottle of 30 capsules
Strength: 40 mg per capsule
Manufacturer: Sun Pharmaceutical Industries Ltd.
Form: Hard gelatin capsule
Category: Androgen‑Receptor Inhibitor / Antiandrogen
Product Introduction:
Azel (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 metastasis
    By inhibiting androgen receptor nuclear translocation, DNA binding, and co‑activator recruitment, Azel reduces tumor growth and prolongs survival.
Uses of Azel 40 mg Capsules:
  1. Metastatic Castration‑Resistant Prostate Cancer (mCRPC):
    1. Pre‑chemotherapy: Improves radiographic progression‑free and overall survival.
    2. Post‑chemotherapy: Offers survival benefit after docetaxel failure.
  2. Non‑Metastatic Castration‑Resistant Prostate Cancer (nmCRPC):
    1. Delays metastasis and prolongs metastasis‑free survival.
  3. Metastatic Hormone‑Sensitive Prostate Cancer (mHSPC) (Off‑Label):
    1. Used in combination with androgen‑deprivation therapy.
  4. Biochemical Recurrence (Investigational):
    1. Under study in patients with rising PSA post‑local therapy.
  5. Combination Regimens (Off‑Label):
    1. Being evaluated with novel hormonal agents or immunotherapies.
Storage Instructions:
  1. Store at 20 °C to 25 °C (room temperature).
  2. Protect from light and moisture.
  3. Keep in 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. Inhibits receptor nuclear translocation
  3. Blocks DNA binding and co‑activator recruitment
    This triple blockade disrupts androgen‑driven gene transcription and induces tumor cell apoptosis.
Side Effects:
Common:
  1. Fatigue
  2. Hot flashes
  3. Headache
  4. Hypertension
  5. Diarrhea
  6. Arthralgia
Serious (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
Report severe or persistent adverse events to your oncologist immediately.
Dosage (Typical Recommended Dose):
  1. 160 mg (four 40 mg capsules) once daily with or without food.
  2. Do not exceed 160 mg per day.
  3. Dose adjustment is not required for mild to moderate renal impairment.
  4. Avoid in severe hepatic impairment; use with caution and 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 history of seizures or head trauma.
  3. Evaluate liver function at baseline and periodically.
  4. Supplement 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 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 pain control.
Allergies (Warnings):
  1. Contraindicated in hypersensitivity to enzalutamide or any excipients.
  2. Signs of allergy: rash, pruritus, swelling, difficulty breathing – discontinue and seek urgent care.
Overdose Information:
  1. Symptoms: Nausea, vomiting, dizziness, seizures.
  2. Management: Provide 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 the missed dose and resume next scheduled dose.
  3. Do not double doses to compensate.
Additional Notes:
  1. Regular PSA and radiographic assessments to monitor response.
  2. Educate patients on signs of hypertension, seizures, and hepatotoxicity.
  3. Store patient diary for adverse events and concomitant medications.
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