Product image of Melediz (Enzalutamide) supplied by GNH India

Melediz

Active Ingredient:
Enzalutamide
Origin:
EU

Melediz (Enzalutamide)

Enzalutamide, the active ingredient in Melediz, is a nonsteroidal antiandrogen presented as an oral tablet for oral use. It is employed in the management of advanced prostate cancer that no longer responds to hormonal castration, including both metastatic and non‑metastatic castration‑resistant disease.

GNH India supplies Melediz as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.

Manufacturer / TM Owner

Elpen Pharmaceutical Co. Inc.

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Indications & Clinical Uses

Enzalutamide is used to treat prostate cancer that has progressed despite hormonal therapy.

  • Metastatic castration‑resistant prostate cancer: prolongs overall survival and delays disease progression.
  • Non‑metastatic castration‑resistant prostate cancer: extends metastasis‑free survival.
  • Metastatic hormone‑sensitive prostate cancer (in combination with androgen deprivation therapy): improves radiographic progression‑free survival.

How It Works

  • Enzalutamide selectively binds to the androgen receptor, preventing its translocation to the nucleus, DNA binding, and recruitment of co‑activators. By blocking these steps, the drug inhibits androgen‑driven transcriptional activity in prostate cancer cells, thereby reducing tumor growth and survival signals.

Side Effects

Adverse reactions may vary in frequency and severity.

Common Side Effects

  • Fatigue: persistent tiredness reported by many patients.
  • Hot flashes: sudden feeling of warmth and sweating.
  • Diarrhea: loose stools occurring intermittently.
  • Nausea: mild to moderate upset stomach.
  • Decreased appetite: reduced desire to eat.
  • Hypertension: elevated blood pressure readings.

Serious or Rare Side Effects

  • Seizures: rare convulsive episodes, especially in patients with pre‑existing risk factors.
  • Severe hepatic injury: marked elevation of liver enzymes or jaundice.
  • Interstitial lung disease: inflammation of lung tissue causing cough and breathlessness.
  • Allergic reactions: rash, angioedema, or anaphylaxis.
  • Posterior reversible encephalopathy syndrome: neurological emergency with headache, visual changes, and seizures.

Precautions & Warnings

Before initiating therapy, clinicians should assess several safety parameters.

  • Monitor blood pressure: check regularly due to risk of hypertension.
  • Assess liver function: perform baseline and periodic hepatic enzyme tests.
  • Evaluate seizure risk: avoid in patients with a history of seizures.
  • Contraindicated in pregnancy: drug is teratogenic; ensure effective contraception.
  • Review concomitant medications: avoid strong CYP3A4 inducers or inhibitors.
  • Store at room temperature: keep in the original container, protect from moisture and direct sunlight.

Avoid Interactions

Enzalutamide may interact with other medicines through metabolic pathways.

Major Interactions (Avoid)

  • Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): may markedly reduce enzalutamide exposure.
  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): can increase drug levels and toxicity.
  • Anticoagulants (e.g., warfarin): may enhance anticoagulant effect, raising bleeding risk.

Moderate Interactions (Monitor Closely)

  • CYP2C8 inhibitors (e.g., gemfibrozil): may raise enzalutamide concentrations.
  • CYP2C9 inhibitors (e.g., fluconazole): require periodic monitoring of drug levels.
  • CYP2C19 inhibitors (e.g., omeprazole): may modestly increase exposure.
  • Other antiandrogens (e.g., bicalutamide): combined effect on androgen blockade should be evaluated.

Frequently Asked Questions

Melediz contains enzalutamide and is prescribed for advanced prostate cancer that no longer responds to hormonal castration, including metastatic castration‑resistant, non‑metastatic castration‑resistant, and metastatic hormone‑sensitive disease when used with androgen deprivation therapy.

Enzalutamide blocks the androgen receptor by preventing its movement into the cell nucleus, stopping DNA binding and recruitment of co‑activators. This interruption halts androgen‑driven gene expression, reducing tumor cell growth and survival in prostate cancer.

The specific dose and schedule of Melediz are determined by the treating physician based on the patient’s clinical condition, disease stage, and concurrent therapies. Prescribers follow approved labeling and individual patient factors when selecting the regimen.

Melediz is classified as pregnancy category X because it can cause fetal harm. It is contraindicated in pregnant women, and effective contraception is required for both men and women of reproductive potential. Safety during breastfeeding has not been established, and nursing is generally discouraged.

To request Melediz, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Compared with older antiandrogens such as bicalutamide, enzalutamide offers higher affinity for the androgen receptor and blocks additional steps of receptor signaling, leading to greater efficacy in resistant prostate cancer. However, it may have a distinct safety profile, including a higher risk of seizures.

Melediz should be stored at room temperature, below 25 °C, in the original packaging to protect it from moisture and light. Do not store in areas with high humidity or extreme temperature fluctuations.

Melediz is taken orally, usually once daily, with or without food, as directed by the prescribing clinician. Swallow the tablet whole with a glass of water; do not crush or split unless specifically instructed.

The most serious adverse events include seizures, severe liver injury, and rare but potentially fatal hypersensitivity reactions such as anaphylaxis or interstitial lung disease. Patients should be monitored closely for neurological symptoms, liver function abnormalities, and respiratory changes.

Melediz should not be used by individuals with known hypersensitivity to enzalutamide or any tablet excipients, patients with uncontrolled seizures, pregnant women, or anyone for whom effective contraception cannot be ensured. Clinicians must also avoid use in patients receiving strong CYP3A4 inducers without dose adjustment.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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