Product image of Midelut (Bicalutamide) supplied by GNH India

Midelut

Active Ingredient:
Bicalutamide
Origin:
EU

Midelut (Bicalutamide)

Bicalutamide, the active ingredient in Midelut, is a nonsteroidal antiandrogen presented as an oral tablet for oral use. It is employed in the management of advanced prostate cancer, including locally advanced, metastatic and hormone‑sensitive disease in adult males.

GNH India supplies Midelut as a licensed, GDP‑compliant international pharmaceutical supplier, adhering to EU quality standards and providing the product to hospitals, oncology centres, pharmacies and clinics worldwide. The company ensures traceability, batch testing and secure logistics for each shipment. Customers benefit from dedicated technical support and regulatory documentation.

Manufacturer / TM Owner

Nextad Pharma S.R.L.

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Indications & Clinical Uses

  • Bicalutamide is used as an androgen receptor antagonist in prostate cancer treatment.
  • Locally advanced prostate cancer: delays disease progression and may improve survival when combined with hormonal therapy.
  • Metastatic prostate cancer: provides androgen blockade to control tumor growth in advanced disease.
  • Hormone‑sensitive prostate cancer: enhances the effectiveness of castration therapy by blocking residual androgen activity.
  • Adjuvant setting: used with luteinizing hormone‑releasing hormone analogues to achieve complete androgen blockade.

How It Works

  • Bicalutamide acts as a selective, competitive antagonist of the androgen receptor. By binding to the receptor’s ligand‑binding domain, it prevents testosterone and dihydrotestosterone from activating the receptor, thereby inhibiting androgen‑driven transcriptional activity and tumor cell proliferation in prostate tissue. The drug does not lower circulating androgen levels, allowing it to be combined with castration‑based therapies for maximal androgen blockade effectively.

Side Effects

Bicalutamide may cause a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects

  • Hot flashes: transient episodes of warmth, flushing and sweating that may occur at any time of day.
  • Gastrointestinal disturbances: nausea, abdominal discomfort, or diarrhea that can affect appetite.
  • Decreased libido: reduced sexual desire and possible erectile difficulties.
  • Fatigue: persistent tiredness that may interfere with daily activities.

Serious or Rare Side Effects

  • Liver toxicity: significant elevation of liver enzymes, hepatitis or jaundice requiring monitoring.
  • Severe allergic reaction: rash, angioedema, or anaphylaxis that may need emergency treatment.
  • Pulmonary embolism: sudden shortness of breath, chest pain and possible cardiovascular compromise.

Precautions & Warnings

Before and during treatment, several safety measures should be observed.

  • Liver monitoring: perform baseline and periodic liver function tests during therapy.
  • Cardiovascular assessment: evaluate for history of thromboembolic disease before initiating treatment.
  • Hormone‑related effects: monitor for breast tenderness, gynecomastia or changes in sexual function.
  • Pregnancy avoidance: contraindicated in pregnancy; ensure effective contraception for women of childbearing potential.
  • Drug interactions: review concomitant medications for CYP3A4 inducers or anticoagulants.
  • Store at room temperature: keep below 25 °C in the original container, protect from moisture and light.

Avoid Interactions

Bicalutamide can interact with several medicines, requiring attention to the level of risk.

Major Interactions (Avoid)

  • Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce bicalutamide exposure.
  • Warfarin: increased anticoagulant effect and INR elevation.
  • Certain anticonvulsants (e.g., phenobarbital): may lower plasma concentrations.

Moderate Interactions (Monitor Closely)

  • CYP2C9 substrates (e.g., phenytoin, tolbutamide): possible altered levels.
  • Hormone replacement therapy: additive antiandrogen effects may increase side‑effects.

Frequently Asked Questions

Midelut contains bicalutamide, an androgen receptor antagonist indicated for the treatment of locally advanced, metastatic and hormone‑sensitive prostate cancer in adult males. It is used as part of hormonal therapy to block the effects of testosterone on tumor growth.

Bicalutamide selectively binds to the androgen receptor’s ligand‑binding site, preventing testosterone and dihydrotestosterone from activating the receptor. This blocks androgen‑driven gene transcription and tumor cell proliferation, providing anti‑cancer activity when used alone or with castration‑based therapies.

The dosage of Midelut is determined by the prescribing clinician based on the patient’s condition, disease stage and treatment protocol. The prescriber will set the appropriate strength, frequency and duration according to current clinical guidelines.

Midelut is classified as pregnancy category X, meaning it is contraindicated in pregnancy because it can cause fetal harm. It is also not recommended for breastfeeding mothers, as it may be excreted in milk and affect the infant.

To request Midelut, 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.

Midelut (bicalutamide) is a nonsteroidal antiandrogen that offers selective androgen‑receptor blockade without lowering circulating testosterone. Compared with steroidal antiandrogens, it generally has a more favorable side‑effect profile and is often combined with luteinizing hormone‑releasing hormone analogues for complete androgen suppression.

Midelut tablets should be stored at room temperature, below 25 °C, in the original packaging. Protect them from moisture, light and extreme heat. Do not store in the refrigerator or freezer unless otherwise instructed by the supplier.

Midelut is taken orally, usually once daily, with or without food as directed by the prescriber. The tablet should be swallowed whole with a glass of water and not chewed or crushed unless specifically advised.

Serious risks include liver toxicity (elevated enzymes, hepatitis), severe allergic reactions such as anaphylaxis, and rare events like pulmonary embolism. Patients should be monitored regularly for signs of liver dysfunction, respiratory distress or severe skin reactions.

Midelut should not be used by individuals who are pregnant, may become pregnant, or are breastfeeding. It is also contraindicated in patients with known hypersensitivity to bicalutamide or any of the tablet’s excipients, and in those with severe liver impairment without close monitoring.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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