Introduction

Calupros 50 mg, formulated with the active ingredient Bicalutamide, is a non-steroidal anti-androgen used in the management of advanced prostate cancer. It acts by blocking the action of androgens (male hormones), which play a key role in stimulating the growth of prostate cancer cells. Calupros is manufactured by Everest Pharmaceuticals Ltd, a recognized name in oncology medicine production, and offered by Orio Pharma, a global name in oncology-focused pharmaceutical supply.

Calupros is commonly used as part of combination therapy with luteinizing hormone-releasing hormone (LHRH) analogs or surgical castration. It is also used as monotherapy in selected patients. Its oral formulation and favorable safety profile make it a practical option for long-term androgen deprivation therapy.

Key Indications

Calupros 50 mg (Bicalutamide) is primarily indicated for:

1. Advanced Prostate Cancer

Used in combination with an LHRH analog (medical castration) or bilateral orchiectomy (surgical castration) to suppress androgen-stimulated tumor growth. It is part of first-line treatment regimens in metastatic prostate cancer.

2. Locally Advanced Prostate Cancer

Bicalutamide may be used as adjuvant therapy following radical prostatectomy or radiotherapy in patients at high risk of disease progression.

3. Monotherapy in Prostate Cancer

Although less common, Bicalutamide may be used alone in patients who prefer to avoid castration-based therapies, offering some clinical benefit with preservation of libido and physical vigor.

Mechanism of Action

Bicalutamide is a potent non-steroidal anti-androgen. It selectively binds to androgen receptors in prostate cancer cells, thereby preventing the binding of endogenous androgens like testosterone and dihydrotestosterone (DHT). This inhibition blocks the androgen-mediated cellular proliferation and induces apoptosis in androgen-dependent tumor cells.

Unlike steroidal anti-androgens, Bicalutamide does not exhibit significant hormonal side effects such as gynecomastia, fluid retention, or cardiovascular toxicity. It is well tolerated and exhibits a long half-life, permitting once-daily dosing.

Dosage and Administration

Standard Dosage:

• Adult males: 50 mg orally once daily, with or without food.
  

In combination therapy, Calupros 50 mg should be initiated concurrently with an LHRH analog or after surgical castration. In monotherapy settings, continuation depends on clinical response and tolerance.

Route: Oral
Frequency: Once daily
Administration Time: Preferably at the same time each day
Duration: As prescribed by a healthcare provider, typically until disease progression or unacceptable toxicity

Pharmacokinetics

• Absorption: Rapidly absorbed from the gastrointestinal tract
  
• Bioavailability: High oral bioavailability; not significantly affected by food
  
• Plasma Half-life: Approximately 6 days, enabling steady-state concentrations with once-daily dosing
  
• Metabolism: Hepatic, primarily via CYP3A4
  
• Excretion: Mainly fecal; minor renal elimination
  

Contraindications

• Known hypersensitivity to Bicalutamide or any component of the tablet
  
• Use in females or children
  
• Severe hepatic impairment
  
• Concomitant use with cisapride, astemizole, or terfenadine due to potential QT prolongation
  

Warnings and Precautions

1. Hepatic Function

Cases of severe hepatic injury, including liver failure, have been reported. Liver function tests should be performed before and during therapy.

2. Gynecomastia and Breast Pain

Commonly observed with monotherapy. These symptoms may resolve with discontinuation.

3. Cardiovascular Risk

Caution in patients with pre-existing heart disease. Monitor for signs of heart failure and QT prolongation.

4. Glucose Metabolism

Bicalutamide may influence blood glucose control; monitor diabetic patients accordingly.

5. Photosensitivity

Patients should be advised to avoid excessive sunlight and use sun protection.

Side Effects

Common Adverse Reactions:

• Hot flashes
  
• Breast tenderness or enlargement
  
• Gastrointestinal disturbances (nausea, constipation)
  
• Fatigue
  
• Dizziness
  
• Hepatic enzyme elevation
  

Less Common but Serious:

• Hepatotoxicity
  
• Interstitial lung disease
  
• Cardiac arrhythmia (QT prolongation)
  
• Anemia
  

Regular monitoring of liver function, complete blood count, and electrocardiogram (ECG) is recommended for long-term users.

Drug Interactions

• Warfarin: Bicalutamide may enhance the anticoagulant effect; monitor INR closely.
  
• Cytochrome P450 substrates: Caution with drugs metabolized by CYP3A4.
  
• LHRH analogs: Safe and effective when used concomitantly in androgen deprivation therapy.
  

Avoid simultaneous use with drugs that are known to prolong QT interval.

Use in Special Populations

Pregnancy and Lactation

Not intended for use in women. Contraindicated in pregnancy and lactation.

Pediatric Use

Safety and efficacy have not been established in children and adolescents.

Geriatric Use

No dosage adjustment required based on age. Monitor liver and cardiovascular function more closely.

Renal Impairment

No significant dose adjustment is required.

Hepatic Impairment

Use with caution in mild to moderate hepatic impairment. Contraindicated in severe hepatic dysfunction.

Storage and Handling

• Store below 30°C in a cool, dry place
  
• Protect from light and moisture
  
• Keep out of reach of children
  
• Do not use after the expiration date indicated on the packaging
  

Packaging

Calupros 50 mg is supplied in high-quality blister packaging designed to maintain stability and ensure product safety. Each tablet is clearly labeled with dose strength and batch information, compliant with international pharmaceutical standards.

Clinical Efficacy

Bicalutamide has demonstrated non-inferiority to surgical castration when used in combination with LHRH analogs. In randomized trials, patients receiving Bicalutamide showed improved PSA control, delayed disease progression, and maintained quality of life. In monotherapy trials, symptom control was evident, although not as robust as with combination regimens.

Conclusion

Calupros 50 mg (Bicalutamide) is a clinically proven anti-androgen therapy that forms a cornerstone of advanced prostate cancer treatment. Its once-daily oral dosing, favorable safety profile, and proven effectiveness make it a valuable therapeutic tool in urologic oncology. Supplied by Orio Pharma and manufactured by Everest Pharmaceuticals Ltd, Calupros meets stringent quality benchmarks and is accessible for clinical use in prostate cancer management worldwide.

It offers both healthcare providers and patients a reliable and well-tolerated option for long-term androgen suppression without the need for invasive procedures or severe hormonal side effects.