Product image of Kalufar (Bicalutamide) supplied by GNH India

Kalufar

Active Ingredient:
Bicalutamide
Origin:
EU

Kalufar (Bicalutamide)

Bicalutamide, the active ingredient in Kalufar, is a nonsteroidal antiandrogen presented as an oral formulation for oral use. It is employed in the management of advanced and hormone‑sensitive prostate cancer, where it blocks androgen‑driven tumor growth.

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

Manufacturer / TM Owner

Makpharm D.O.O.

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Indications & Clinical Uses

Bicalutamide acts on androgen‑dependent pathways and is indicated for several forms of prostate cancer.

  • Advanced prostate cancer: slows disease progression by inhibiting androgen signaling.
  • Metastatic prostate cancer: reduces tumor growth and spread.
  • Hormone‑sensitive prostate cancer: blocks testosterone‑driven cell proliferation.

How It Works

  • Bicalutamide is a selective competitive antagonist of the androgen receptor. By binding to the receptor, it prevents testosterone and dihydrotestosterone from activating the receptor, thereby inhibiting androgen‑dependent transcription and tumor cell proliferation in prostate tissue.

Side Effects

Bicalutamide may cause a range of adverse reactions, from mild to severe.

Common Side Effects

  • Hot flashes: transient feeling of warmth.
  • Gynecomastia: enlargement of breast tissue in males.
  • Decreased libido: reduced sexual desire.
  • Fatigue: persistent tiredness.
  • Nausea: upset stomach and urge to vomit.
  • Diarrhea: loose stools.

Serious or Rare Side Effects

  • Liver toxicity: elevated liver enzymes or hepatitis.
  • Severe allergic reaction: rash, swelling, or anaphylaxis.
  • Pulmonary embolism: blood clot in the lungs.
  • Severe skin rash: Stevens‑Johnson syndrome.
  • Blood clotting disorders: deep vein thrombosis.
  • Adrenal insufficiency: abnormal cortisol production.

Precautions & Warnings

Before initiating therapy, several safety considerations are recommended.

  • Liver monitoring: assess hepatic function regularly.
  • Cardiovascular assessment: evaluate risk of thrombosis.
  • Hormone level checks: monitor testosterone and estrogen changes.
  • Hypersensitivity avoidance: discontinue if allergic reaction occurs.
  • Elderly caution: adjust monitoring due to comorbidities.
  • Store at ambient temperature: keep in the original pack, protect from moisture.

Avoid Interactions

Bicalutamide can interact with other medicines, altering its effectiveness or safety.

Major Interactions (Avoid)

  • Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce drug levels.
  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may increase toxicity.
  • Warfarin: may enhance anticoagulant effect and raise INR.
  • LHRH agonists: additive antiandrogen effect may increase side‑effects.
  • Hormonal contraceptives: reduced efficacy due to altered hormone metabolism.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inhibitors (e.g., erythromycin): may modestly raise plasma concentrations.
  • Other antiandrogens (e.g., flutamide): risk of cumulative toxicity.
  • Statins metabolized by CYP3A4: monitor for muscle symptoms.
  • Antidepressants (SSRIs): watch for increased fatigue.
  • Diuretics: monitor electrolyte balance.

Frequently Asked Questions

Kalufar contains bicalutamide, an antiandrogen used to treat advanced, metastatic, and hormone‑sensitive prostate cancer. It works by blocking the androgen receptor, thereby slowing tumor growth that depends on testosterone and dihydrotestosterone.

Bicalutamide is a selective competitive antagonist of the androgen receptor. By binding to the receptor, it prevents natural androgens from activating it, which stops the downstream signaling that drives prostate cancer cell proliferation.

The dosage of Kalufar is determined by the prescribing physician based on the patient’s clinical condition, disease stage, and other therapies. Only a qualified healthcare professional should set the dose and schedule.

Safety of bicalutamide in pregnancy or while breastfeeding has not been established. It is generally avoided in these situations because it may affect fetal development and pass into breast milk. Consultation with a specialist is essential.

To order Kalufar, 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 required import documentation.

Kalufar (bicalutamide) is a nonsteroidal antiandrogen that offers once‑daily oral dosing, unlike some alternatives that may require multiple daily doses or injectable forms. Its safety profile is well‑characterized, and it is often combined with LHRH agonists for maximal androgen suppression.

Kalufar should be stored at ambient temperature, below 25 °C, in its original packaging to protect from moisture and light. Keep the product out of reach of children and avoid storing in humid or excessively hot environments.

Kalufar is taken orally, usually as a whole tablet with water. It is generally taken once daily, but the exact timing and whether it should be taken with food are determined by the prescribing clinician.

Serious risks include liver toxicity, severe allergic reactions, pulmonary embolism, and rare blood‑clotting disorders. Patients should be monitored regularly for liver function, signs of allergic response, and any unexpected respiratory or circulatory symptoms.

Kalufar should not be used by patients with known hypersensitivity to bicalutamide or any component of the formulation, those with severe liver impairment, or individuals for whom androgen blockade is contraindicated. A healthcare professional must evaluate suitability before prescribing.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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