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

Azel is an oral anti-cancer medication used in the treatment of advanced prostate cancer. It functions as an androgen receptor inhibitor, blocking the effects of testosterone on prostate cancer cells and slowing their growth.

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General Information:
Generic Name: Enzalutamide
Brand Name: Azel
Strengths Available: 40mg, 80mg, 160mg
Packing: Strip of 28, 14, 7 capsules (varies by strength)
Manufacturer: Dr Reddy's Laboratories Ltd
Form: Oral capsules
Category: Anti-cancer / Hormonal therapy / Androgen receptor inhibitor
Product Introduction:
Azel contains Enzalutamide, a potent androgen receptor signaling inhibitor used in the treatment of metastatic castration-resistant prostate cancer (mCRPC) and non-metastatic CRPC. It is generally prescribed in combination with androgen deprivation therapy (ADT).

Uses:
Azel is used in the treatment of:
  1. Metastatic castration-resistant prostate cancer (mCRPC)
  2. Non-metastatic castration-resistant prostate cancer (nmCRPC)
  3. Metastatic hormone-sensitive prostate cancer (mHSPC)
  4. Prostate cancer resistant to initial hormone therapy
  5. Advanced prostate cancer as part of combination treatment
  6. Progressive prostate cancer despite surgical or chemical castration

Storage Instructions:
  1. Store below 30°C, away from moisture and direct sunlight
  2. Keep in original packaging
  3. Keep out of reach of children and pets
  4. Do not use after expiry date

How It Works (Mechanism of Action):
Enzalutamide competitively inhibits androgen receptors, blocking testosterone and dihydrotestosterone (DHT) from binding. This action prevents nuclear translocation, DNA binding, and transcriptional activity of androgen receptors, resulting in reduced cancer cell growth and survival in prostate tumors.

Side Effects:
Common side effects:
  1. Fatigue
  2. Hot flashes
  3. Back pain
  4. Hypertension
  5. Headache
  6. Decreased appetite
Serious side effects:
  1. Seizures (rare)
  2. Falls and fractures
  3. Cognitive disorders (e.g., memory loss, confusion)
  4. Heart issues (e.g., ischemic heart disease)
  5. Liver enzyme abnormalities

Dosage (Typical Recommended Dose):
  1. Standard adult dose: 160mg once daily (can be taken as four 40mg capsules, two 80mg capsules, or one 160mg capsule)
  2. Dose adjustments may be required based on tolerance, age, or comorbid conditions

Method of Administration:
  1. Take orally once daily, with or without food
  2. Swallow capsules whole with water – do not crush or open
  3. Take at the same time each day to maintain steady drug levels

Precautions:
  1. Not recommended for use in women or children
  2. Use with caution in patients with a history of seizures, brain injury, or stroke
  3. Monitor blood pressure, liver function, and mental health during therapy
  4. Effective contraception must be used during treatment and for 3 months after the last dose for male patients with female partners
  5. Avoid driving or operating heavy machinery until you know how the drug affects you

Drug Interactions:
  1. Enzalutamide is a strong inducer of CYP3A4, CYP2C9, and CYP2C19 – may reduce the effect of drugs like warfarin, phenytoin, midazolam, omeprazole
  2. Avoid concurrent use with CYP2C8 inhibitors (e.g., gemfibrozil) or adjust dosage accordingly
  3. May interact with immunosuppressants, antiepileptics, and some cardiovascular drugs

Allergies:
  1. Contraindicated in patients with known hypersensitivity to Enzalutamide or any of its components
  2. Seek immediate medical help in case of swelling, rash, or breathing difficulty

Overdose Information:
  1. Symptoms may include seizures, agitation, or other neurological effects
  2. In case of overdose, supportive treatment and close monitoring are recommended
  3. Contact emergency services or a poison control center immediately

Missed Dose Instructions:
  1. If a dose is missed, take it as soon as possible on the same day
  2. If missed for an entire day, skip the dose and resume the next day at the regular time
  3. Do not double the dose to make up for the missed one

Additional Notes:
  1. Patients should report any signs of seizure, confusion, or unusual behavior
  2. Blood pressure and liver enzymes should be checked regularly during therapy
  3. Treatment is often continued until disease progression or unacceptable toxicity occurs

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