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

Glenza contains Enzalutamide, an oral anti-androgen used primarily to treat advanced prostate cancer. It works by blocking androgen receptors, which slows the growth and spread of prostate cancer cells.

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General Information:
Generic Name: Enzalutamide
Brand Name: Glenza
Packing: 7, 14 Capsules
Strengths: 40mg, 80mg, 160mg
Manufacturer: Glenmark Pharmaceuticals Ltd
Form: Capsules
Category: Anti-neoplastic, Anti-androgen
Route of Administration: Oral
Prescription Status: Rx-only
Product Introduction:
Glenza is a novel androgen receptor inhibitor developed for the treatment of metastatic castration-resistant prostate cancer (mCRPC) and non-metastatic castration-resistant prostate cancer (nmCRPC). It is commonly prescribed along with medical or surgical castration to reduce testosterone activity.

Uses:
Glenza (Enzalutamide) is prescribed for:
  1. Metastatic castration-resistant prostate cancer (mCRPC)
  2. Non-metastatic castration-resistant prostate cancer (nmCRPC)
  3. Metastatic hormone-sensitive prostate cancer (mHSPC)
  4. As part of combination hormonal therapy
  5. Androgen-driven tumor suppression (investigational uses)
  6. Delaying disease progression in prostate cancer

Storage Instructions:
  1. Store at room temperature (20°C to 25°C)
  2. Protect from moisture and direct sunlight
  3. Keep tightly closed in original container
  4. Keep out of reach of children and pets

How It Works (Mechanism of Action):
Enzalutamide is a non-steroidal androgen receptor inhibitor that blocks multiple steps in the androgen receptor signaling pathway. It inhibits androgen binding, nuclear translocation, and DNA interaction, thereby suppressing the growth of prostate cancer cells that rely on androgens for development.

Side Effects:
Common side effects:
  1. Fatigue
  2. Hot flashes
  3. Joint pain
  4. Headache
  5. Back pain
  6. Constipation
  7. High blood pressure
Severe side effects:
  1. Seizures (rare but serious)
  2. Falls and fractures in elderly patients
  3. Posterior reversible encephalopathy syndrome (PRES)
  4. Cognitive impairment
  5. Cardiovascular risks (rare cases of ischemic heart disease)

Dosage (Typical Recommended Dose):
  1. Standard dose: 160 mg orally once daily (can be taken as 4 x 40 mg or as per strength available)
  2. No requirement for food timing
  3. Dose may be adjusted based on tolerability and side effects
  4. Always follow the prescribing doctor’s specific instructions

Method of Administration:
  1. Take orally once daily at the same time each day
  2. Can be taken with or without food
  3. Swallow capsules whole with water; do not chew or open
  4. If a dose is missed, take it as soon as remembered unless it's close to the next dose

Precautions:
  1. Not recommended for use in females or children
  2. Use caution in patients with a history of seizures or brain injury
  3. Monitor regularly for blood pressure, liver function, and neurological symptoms
  4. May impair male fertility
  5. Avoid driving or operating machinery if experiencing dizziness or seizures

Drug Interactions:
  1. Strong CYP2C8 inhibitors (e.g., gemfibrozil) may increase enzalutamide levels
  2. CYP3A4 inducers (e.g., rifampin, phenytoin) may reduce effectiveness
  3. May reduce levels of warfarin, midazolam, omeprazole, and other CYP substrates
  4. Always inform your doctor about all prescription, OTC, or herbal medications

Allergies:
  1. Contraindicated in patients with known hypersensitivity to enzalutamide
  2. Symptoms of allergic reaction: rash, itching, swelling, trouble breathing

Overdose Information:
  1. Symptoms may include agitation, unconsciousness, or seizures
  2. Seek immediate medical attention if overdose is suspected
  3. Supportive care is the main treatment—no specific antidote

Missed Dose Instructions:
  1. If you miss a dose, take it as soon as remembered on the same day
  2. Do not take extra doses to make up for a missed one
  3. Skip missed dose if it's almost time for the next dose

Additional Notes:
  1. Use with surgical or medical castration (e.g., GnRH agonists) unless surgically castrated
  2. Routine monitoring of disease progression and lab values is necessary
  3. Effective contraception should be used by male patients with partners of childbearing potential
  4. Keep a regular follow-up schedule with your oncologist

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