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Bdenza 40mg - Enzalutamide Capsules

Bdenza 40 mg Capsules contain Enzalutamide, a potent androgen‑receptor inhibitor used to treat castration‑resistant prostate cancer by blocking androgen signaling and slowing tumor progression.

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General Information:
Generic Name: Enzalutamide Olamine
Brand Name: Bdenza
Packing: Bottle of 30 capsules
Strength: 40 mg per capsule
Manufacturer: Cadila Pharmaceuticals Ltd.
Form: Hard gelatin capsule
Category: Androgen‑Receptor Inhibitor / Antiandrogen
Product Introduction:
Bdenza (Enzalutamide) is an oral antiandrogen indicated for the treatment of:
  1. Metastatic castration‑resistant prostate cancer (mCRPC), both pre‑ and post‑chemotherapy
  2. Non‑metastatic castration‑resistant prostate cancer (nmCRPC) to delay metastasis
    It works by inhibiting androgen‑receptor nuclear translocation, DNA binding, and co‑activator recruitment, thereby reducing prostate tumor cell growth and improving survival.

Uses of Bdenza 40 mg Capsules:
  1. mCRPC (pre‑chemotherapy): Improves radiographic progression‑free and overall survival.
  2. mCRPC (post‑chemotherapy): Offers survival benefit after docetaxel failure.
  3. nmCRPC: Delays onset of metastasis and prolongs metastasis‑free survival.
  4. mHSPC (off‑label): Used with androgen‑deprivation therapy in hormone‑sensitive disease.
  5. Biochemical recurrence (investigational): For rising PSA post‑local therapy.
  6. Combination regimens (off‑label): 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 the original container with desiccant.
  4. Do not freeze.
  5. Keep out of reach of children.

How Bdenza 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, induces apoptosis, and reduces prostate tumor growth.

Side Effects:
Common:
  1. Fatigue
  2. Hot flashes
  3. Headache
  4. Hypertension
  5. Diarrhea
  6. Arthralgia
Severe (Rare):
  1. Seizures – Monitor in patients with predisposing factors
  2. Posterior reversible encephalopathy syndrome (PRES)
  3. Cardiac ischemic events – Monitor blood pressure and ECG
  4. Falls and fractures – Assess bone health and supplement as needed
  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/vitamin D; consider bisphosphonates if high fracture risk.
  5. Contraception: Use effective methods 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: 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 liver dysfunction.
  3. Maintain a treatment diary for adverse events and concomitant medications.

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