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EnzaTech 40mg - Enzalutamide Capsules

EnzaTech contains Enzalutamide, a second-generation androgen receptor inhibitor used primarily in the treatment of prostate cancer. It works by blocking androgen signaling, a key driver of prostate cancer progression.

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General Information:
Generic Name: Enzalutamide
Brand Name: EnzaTech
Packing: 28 capsules
Strength: 40mg per capsule
Manufacturer: Smithways Health Care Pvt. Ltd.
Form: Oral capsules
Category: Anti-androgen, Hormonal Antineoplastic Agent
Product Introduction:
EnzaTech 40mg is an oral anti-cancer medication used to treat castration-resistant and metastatic prostate cancer. It belongs to a newer class of androgen receptor (AR) antagonists and is highly effective when used alone or in combination with other hormonal therapies. It offers extended survival and delayed disease progression, particularly in advanced stages.

Uses (Indications):
EnzaTech (Enzalutamide) is used to treat:
  1. Metastatic Castration-Resistant Prostate Cancer (mCRPC)
  2. Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC)
  3. Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
  4. Prostate cancer after progression on docetaxel chemotherapy
  5. Patients with rising PSA levels despite androgen deprivation therapy (ADT)
  6. Off-label use may include combination regimens under clinical trials

Storage Instructions:
  1. Store at room temperature below 30°C
  2. Protect from moisture and direct sunlight
  3. Keep in original packaging until use
  4. Keep out of reach of children
  5. Do not use beyond expiry date

How It Works (Mechanism of Action):
Enzalutamide is a potent androgen receptor (AR) signaling inhibitor. It blocks several steps in the androgen receptor pathway:
  1. Prevents androgen (like testosterone or DHT) from binding to the androgen receptor
  2. Inhibits translocation of the AR complex to the cell nucleus
  3. Prevents binding of the AR to DNA and recruitment of coactivators
  4. Results in reduced expression of AR-regulated genes, thereby suppressing prostate cancer cell proliferation and survival
    This makes it superior to older anti-androgens like bicalutamide, especially in resistant cancers.

Side Effects:
Common Side Effects:
  1. Fatigue
  2. Hot flashes
  3. Hypertension (high blood pressure)
  4. Musculoskeletal pain
  5. Diarrhea
  6. Peripheral edema (swelling)
Severe or Less Common Side Effects:
  1. Seizures – rare but serious; occurs in less than 1% of patients
  2. Falls and fractures – due to muscular weakness or dizziness
  3. Cognitive effects – memory impairment, confusion
  4. Posterior reversible encephalopathy syndrome (PRES) – extremely rare
  5. Increased risk of cardiovascular events in older patients
  6. Hepatotoxicity – requires liver function monitoring

Dosage (Typical Recommended Dose):
  1. The standard adult dose is 160 mg orally once daily, which equals four 40mg capsules
  2. Should be taken at the same time each day, with or without food
  3. Continue treatment until disease progression or unacceptable toxicity
  4. Dose modification may be required for adverse reactions or hepatic impairment

Method of Administration:
  1. Administer orally, whole with water
  2. Do not crush, chew, or open the capsules
  3. Can be taken with or without food
  4. Must be taken once daily at approximately the same time each day
  5. If vomiting occurs after a dose, do not re-dose, wait until the next scheduled time

Precautions:
  1. Risk of seizure – avoid driving or operating heavy machinery until response is known
  2. Hepatic impairment – monitor liver function regularly
  3. Blood pressure – monitor periodically as hypertension can occur
  4. Falls and fractures – assess bone health, especially in elderly
  5. Cognitive function – watch for signs of confusion, agitation, or memory loss
  6. Use in men only – not indicated for women or children

Drug Interactions:
  1. CYP3A4 inducers (e.g., rifampin, carbamazepine) – may reduce enzalutamide levels
  2. CYP2C8 inhibitors (e.g., gemfibrozil) – may increase enzalutamide exposure and toxicity
  3. Warfarin and other CYP2C9 substrates – monitor INR closely
  4. CNS-active drugs – may increase seizure risk
  5. St. John’s Wort – avoid as it reduces efficacy
  6. Statins, antihypertensives – potential interactions requiring monitoring

Allergies (Warnings for Allergic Reactions):
  1. Hypersensitivity reactions are rare but possible
  2. Signs of allergy include rash, itching, swelling, dizziness, or trouble breathing
  3. Discontinue and seek immediate medical attention if symptoms occur
  4. Not recommended in patients with known allergy to enzalutamide or any capsule excipients

Overdose Information:
  1. Symptoms of overdose may include fatigue, dizziness, seizures, confusion
  2. No specific antidote; treatment is supportive and symptomatic
  3. In the event of overdose, seek immediate emergency medical attention
  4. Hospitalization and seizure management may be necessary in severe cases

Missed Dose Instructions:
  1. If a dose is missed, take it as soon as remembered on the same day
  2. If it's close to the next dose, skip the missed dosedo not double dose
  3. Resume normal dosing the following day
  4. Maintain a consistent daily schedule to avoid missed doses

Additional Notes:
  1. Enzalutamide prolongs survival and delays progression in advanced prostate cancer
  2. Does not require concurrent prednisone, unlike abiraterone
  3. Requires regular monitoring of PSA levels, liver function, and blood pressure
  4. Avoid fathering children during and for at least 3 months after treatment—use contraception
  5. Enzalutamide has a long half-life (~5.8 days), making steady plasma levels easier to maintain
  6. Inform all healthcare providers before starting new medications due to interaction risk

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