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Bdenza (40mg / 80mg / 160mg) - Enzalutamide Capsules

Bdenza (40mg / 80mg / 160mg) - Enzalutamide Capsules

Bdenza is a potent androgen receptor inhibitor used in the treatment of advanced prostate cancer. It blocks the effect of androgens (male hormones), slowing the growth of cancer cells in patients with castration-resistant or metastatic prostate cancer.

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Description Product Details
General Information:
Generic Name: Enzalutamide
Brand Name: Bdenza
Strengths Available: 40mg, 80mg, 160mg
Packing: 7, 14, 28 capsules
Manufacturer: Bdr Pharmaceuticals Internationals Pvt Ltd
Form: Oral capsules
Category: Anti-cancer / Hormonal therapy / Androgen Receptor Inhibitor
Product Introduction:
Bdenza contains Enzalutamide, an orally administered anti-androgen therapy. It is indicated for the treatment of metastatic castration-resistant prostate cancer (mCRPC), non-metastatic CRPC, and metastatic hormone-sensitive prostate cancer (mHSPC). It may be used alone or in combination with androgen deprivation therapy (ADT).
Uses:
Bdenza is indicated for the treatment of:
  1. Metastatic castration-resistant prostate cancer (mCRPC)
  2. Non-metastatic CRPC
  3. Metastatic hormone-sensitive prostate cancer (mHSPC)
  4. Prostate cancer in patients progressing on surgical or medical castration
  5. Hormone-refractory prostate cancer
  6. Combination therapy with LHRH analogs or surgical castration
Storage Instructions:
  1. Store below 30°C, away from direct sunlight and moisture
  2. Keep in original container
  3. Keep out of reach of children
  4. Do not use beyond expiry date
How It Works (Mechanism of Action):
Enzalutamide competitively inhibits androgen receptors, preventing the binding of testosterone and dihydrotestosterone (DHT). It blocks receptor translocation to the nucleus and inhibits DNA binding and gene expression, thereby halting the growth of prostate cancer cells that depend on androgen signaling.
Side Effects:
Common side effects:
  1. Fatigue
  2. High blood pressure
  3. Hot flashes
  4. Constipation
  5. Joint pain
  6. Decreased appetite
Serious side effects:
  1. Seizures (rare but notable)
  2. Falls and fractures
  3. Cognitive disturbances (e.g., memory issues, confusion)
  4. Heart issues (e.g., ischemic heart disease)
  5. Liver dysfunction
Dosage (Typical Recommended Dose):
  1. 160mg once daily, taken as four 40mg capsules, two 80mg capsules, or one 160mg capsule
  2. No need to adjust dose based on food
  3. Dose modifications may be required based on tolerance or adverse events
Method of Administration:
  1. Take orally once daily, with or without food
  2. Swallow the capsules whole with water
  3. Take at the same time each day to maintain consistent blood levels
Precautions:
  1. Not indicated for use in women or pediatric patients
  2. Use caution in patients with a history of seizures, stroke, or traumatic brain injury
  3. Monitor blood pressure, mental status, and liver function regularly
  4. Use effective contraception during treatment and for at least 3 months after the last dose
  5. Avoid driving or operating machinery until you know how the medicine affects you
Drug Interactions:
  1. Enzalutamide is a strong inducer of CYP3A4, CYP2C9, and CYP2C19
  2. May reduce the efficacy of drugs like warfarin, phenytoin, clopidogrel, and midazolam
  3. Avoid strong CYP2C8 inhibitors (e.g., gemfibrozil) unless benefit outweighs risk
  4. Monitor for interactions with antidepressants, antiepileptics, and statins
Allergies:
  1. Contraindicated in patients with known hypersensitivity to Enzalutamide or excipients
  2. Seek medical help immediately in case of rash, swelling, or difficulty breathing
Overdose Information:
  1. Symptoms may include seizures, tremors, confusion, and other neurological effects
  2. No specific antidote; provide supportive treatment and monitoring
  3. Seek emergency medical attention immediately
Missed Dose Instructions:
  1. If a dose is missed, take it as soon as remembered on the same day
  2. If the entire day has passed, skip the missed dose and resume the next day
  3. Do not double the dose
Additional Notes:
  1. Regular monitoring of vital signs, liver function, and cognition is recommended during long-term use
  2. Treatment is continued until disease progression or unacceptable toxicity
  3. Patient counseling regarding seizure risk and drug interactions is essential
  4. Maintain adequate hydration and nutrition during therapy

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