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Obnyx 40mg - Enzalutamide Tablets

Obnyx 40mg contains Enzalutamide, a next-generation oral antiandrogen used primarily to treat castration-resistant prostate cancer (CRPC). It works by blocking androgen receptors, helping to halt the growth of cancer cells dependent on androgens.

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General Information:
Generic Name: Enzalutamide
Brand Name: Obnyx
Packing: Bottle of 28 or 30 tablets
Strength: 40mg per tablet
Manufacturer: Zydus Lifesciences Ltd.
Form: Oral tablet
Category: Antiandrogen / Androgen Receptor Inhibitor / Hormonal Therapy
Product Intro:
Obnyx is a high-potency androgen receptor inhibitor designed for advanced prostate cancer treatment. It is used in both metastatic and non-metastatic CRPC, offering improved survival rates and delayed disease progression. Obnyx is especially suitable for patients who have progressed on or are ineligible for chemotherapy.

Uses:
  1. Metastatic Castration-Resistant Prostate Cancer (mCRPC) – before and after chemotherapy
  2. Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC) – to delay metastasis
  3. Off-label for Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
  4. Rising PSA after localized therapy (under research)
  5. Used in combination therapy in clinical trials
  6. Delaying prostate cancer progression in high-risk individuals

Storage Instructions:
  1. Store at 20°C to 25°C (68°F to 77°F)
  2. Keep away from light, heat, and moisture
  3. Store in the original container
  4. Keep out of reach of children
  5. Do not freeze

How it Works (Mechanism of Action):
Enzalutamide blocks androgen receptors and inhibits multiple steps in the androgen signaling pathway:
  1. Prevents androgen binding to receptors
  2. Inhibits receptor translocation to the nucleus
  3. Prevents DNA binding and gene transcription
    This results in reduced cancer cell proliferation and survival in androgen-driven prostate cancer.

Side Effects:
Common:
  1. Fatigue
  2. Headache
  3. Hot flashes
  4. Joint pain
  5. High blood pressure
  6. Back pain
  7. Constipation or diarrhea
Serious (Less Common):
  1. Seizures
  2. Posterior reversible encephalopathy syndrome (PRES)
  3. Falls and fractures
  4. Liver toxicity – Monitor LFTs
  5. Heart rhythm abnormalities

Dosage (Typical Recommended Dose):
  1. 160mg once daily (i.e., 4 tablets of 40mg)
  2. Taken at the same time every day, with or without food
  3. No adjustments typically needed for mild to moderate renal/hepatic impairment
  4. Monitor closely in severe hepatic impairment

Method of Administration:
  1. Take orally, swallowing whole with water
  2. Can be taken with or without food
  3. Do not crush, chew, or split tablets
  4. Take at the same time daily

Precautions:
  1. Monitor blood pressure regularly
  2. Avoid in patients with history of seizures or neurological conditions
  3. Use with caution in patients with liver impairment
  4. Use effective contraception during and for 3 months after treatment
  5. Monitor for bone loss – supplement with vitamin D and calcium

Drug Interactions:
  1. CYP2C8 inhibitors (e.g., gemfibrozil) – may increase enzalutamide levels
  2. CYP3A4 inducers (e.g., phenytoin, rifampin) – may decrease effectiveness
  3. Warfarin or other CYP2C9 substrates – monitor INR
  4. CNS depressants or seizure threshold-lowering agents – increased seizure risk
  5. Opioids – may reduce analgesic effect

Allergies:
  1. Contraindicated in patients with known hypersensitivity to Enzalutamide or its components
  2. Signs of allergic reaction: rash, swelling, difficulty breathing, dizziness – seek immediate medical attention

Overdose Information:
  1. Symptoms: Seizures, dizziness, drowsiness, fatigue
  2. Management: Supportive care; monitor neurological and cardiovascular status
  3. No specific antidote exists

Missed Dose Instructions:
  1. If missed and less than 12 hours late, take the dose as soon as possible
  2. If more than 12 hours, skip the dose and resume as scheduled
  3. Do not double dose to make up for a missed one

Additional Notes:
  1. Regularly check PSA levels, liver function, and blood pressure
  2. Advise patient on recognizing seizure signs or neurological symptoms
  3. Discuss potential impact on fertility – sperm preservation might be considered
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