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Indenza 40mg - Enzalutamide Tablets

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Indenza 40mg - Enzalutamide Tablets

Indenza 40 mg Tablets contain Enzalutamide, a powerful androgen receptor inhibitor used in the treatment of castration-resistant prostate cancer (CRPC). It works by blocking multiple steps in the androgen receptor signaling pathway, helping to reduce tumor growth and improve survival outcomes.

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Description Product Details
General Information:
Generic Name: Enzalutamide
Brand Name: Indenza
Packing: Bottle of 28 or 30 tablets (depending on market)
Strength: 40 mg per tablet
Manufacturer: Aprazer Healthcare Pvt. Ltd.
Form: Oral tablet
Category: Androgen Receptor Inhibitor / Antiandrogen
Product Introduction:
Indenza (Enzalutamide) is an oral antiandrogen therapy indicated for:
  1. Metastatic castration-resistant prostate cancer (mCRPC)
  2. Non-metastatic castration-resistant prostate cancer (nmCRPC)
It inhibits androgen receptor signaling by preventing androgen binding, nuclear translocation, DNA binding, and transcriptional activation, making it highly effective in advanced prostate cancer settings.
Uses of Indenza 40 mg Tablets:
  1. mCRPC (pre- and post-chemotherapy): Improves progression-free and overall survival.
  2. nmCRPC: Delays the development of metastatic disease.
  3. mHSPC (off-label use): Combined with androgen deprivation therapy in select cases.
  4. Investigation in early-stage or biochemical relapse prostate cancer (off-label).
Storage Instructions:
  1. Store at 20 °C to 25 °C (68–77 °F).
  2. Protect from light and moisture.
  3. Keep in original packaging until use.
  4. Do not freeze.
  5. Keep out of reach of children.
How Indenza Works (Mechanism of Action):
Enzalutamide is a non-steroidal androgen receptor inhibitor that:
  1. Blocks androgen binding to its receptor
  2. Prevents nuclear translocation of the receptor
  3. Inhibits DNA binding and recruitment of co-activators
    This inhibits prostate cancer cell growth and induces apoptosis.
Side Effects:
Common Side Effects:
  1. Fatigue
  2. Hot flashes
  3. Joint pain
  4. Hypertension
  5. Constipation or diarrhea
  6. Headache
Serious Side Effects:
  1. Seizures
  2. Posterior reversible encephalopathy syndrome (PRES)
  3. Falls and fractures
  4. Liver toxicity – monitor liver enzymes
  5. Heart-related issues – monitor BP and ECG as needed
Dosage (Typical Recommended Dose):
  1. 160 mg once daily (i.e., four 40 mg tablets) with or without food.
  2. No dosage adjustment required in mild/moderate renal or hepatic impairment.
  3. Avoid use in severe hepatic impairment without close monitoring.
Method of Administration:
  1. Oral use only.
  2. Swallow whole tablets with water, do not crush or chew.
  3. Take at the same time each day, with or without food.
Precautions:
  1. Seizure risk: Caution in patients with prior seizures, brain injury, or on medications that lower seizure threshold.
  2. Blood pressure monitoring: Due to risk of hypertension.
  3. Bone health assessment: Especially in older adults – consider calcium & vitamin D supplementation.
  4. Fertility/contraception: Use effective contraception during and for 3 months after treatment.
Drug Interactions:
  1. CYP2C8 inhibitors (e.g., gemfibrozil): May increase enzalutamide levels.
  2. CYP3A4 inducers (e.g., carbamazepine, rifampin): May reduce enzalutamide effectiveness.
  3. Warfarin and other CYP2C9 substrates: Monitor INR closely.
  4. CNS-active drugs: May increase seizure risk – use with caution.
Allergy Warning:
Do not use Indenza if allergic to Enzalutamide or any of the tablet’s components.
Seek urgent medical help if signs of allergic reaction occur:
  1. Swelling of face/lips/throat
  2. Severe rash
  3. Breathing difficulty
Overdose Information:
  1. Symptoms: Drowsiness, fatigue, dizziness, possible seizures
  2. Action: Provide supportive care. No specific antidote. Monitor neurological and cardiac function.
Missed Dose Instructions:
  1. If missed and <12 hours have passed, take the dose as soon as remembered.
  2. If >12 hours, skip and continue the next day.
  3. Do not double dose to make up for a missed one.
Additional Notes:
  1. Regularly monitor PSA levels, imaging, and blood pressure during treatment.
  2. Inform your doctor of all medications and supplements you're taking.
  3. May cause infertility in men – consider sperm banking if future fertility is a concern.
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