Calupros 50 mg (Bicalutamide) Tablet

Introduction

Calupros 50 mg, manufactured by Everest Pharmaceuticals Ltd. and globally distributed by Saif Pharma, is a potent oral non-steroidal anti-androgen used in combination with LHRH analogs for the treatment of Stage D2 metastatic prostate cancer. As an essential hormonal chemotherapy agent, Calupros 50 mg (Bicalutamide) is a critical component of androgen deprivation therapy (ADT), widely used by oncologists and urologists worldwide.

Saif Pharma, a leading global supplier of oncology medications, ensures that Calupros reaches hospitals, cancer centers, and pharmacies with uncompromised quality, reliable supply, and WHO-GMP-compliant manufacturing standards. With Everest Pharmaceuticals’ advanced production infrastructure and Saif Pharma’s global logistics capability, Calupros 50 mg is readily available for effective prostate cancer treatment worldwide.

Key Indications and Therapeutic Uses

Calupros 50 mg (Bicalutamide) is primarily indicated for:

• Stage D2 Metastatic Carcinoma of the Prostate, in combination with a luteinizing hormone-releasing hormone (LHRH) analog.
  This dual approach effectively blocks androgen production from both testicular and peripheral sources, slowing disease progression and reducing tumor burden.

The use of Bicalutamide as part of combination hormonal therapy has demonstrated significant benefit in delaying cancer progression, reducing prostate-specific antigen (PSA) levels, and improving patient survival.

Mechanism of Action

Bicalutamide, the active component of Calupros, is a non-steroidal androgen receptor antagonist. It works through the following mechanisms:

• Competitive Androgen Receptor Inhibition: Binds to cytosolic androgen receptors in prostate tissue, thereby blocking the action of endogenous androgens like testosterone and dihydrotestosterone (DHT).
• Inhibition of Tumor Growth: Since prostate cancer cells are androgen-dependent, Bicalutamide-induced androgen blockade reduces cell proliferation and induces tumor regression.
• Selective Activity: Bicalutamide acts peripherally without reducing circulating androgen levels, minimizing the risk of severe hormonal imbalances.

This targeted hormonal suppression is central to the modern management of advanced prostate cancer.

Pharmacology and Pharmacokinetics

• Therapeutic Class: Hormonal Chemotherapy (Anti-androgen)
• Chemical Category: Non-steroidal anti-androgen
• Bioavailability: High oral bioavailability with once-daily dosing
• Metabolism: Extensively metabolized in the liver via cytochrome P450 enzymes (mainly CYP3A4)
• Elimination: Predominantly hepatic, with fecal and urinary excretion of metabolites
• Half-life: 5–7 days, allowing for stable plasma levels with once-daily administration
• Protein Binding: Greater than 95%

Due to its pharmacokinetics, Calupros allows for consistent therapeutic levels with minimal dosing complexity.

Dosage and Administration

• Standard Dosage: One tablet (50 mg) orally once daily, with or without food.
• Combination Therapy: Should always be administered with a LHRH analog (e.g., leuprolide or goserelin) for androgen deprivation.
• Timing: Can be taken in the morning or evening; time consistency is preferred.

Special Populations:

• Pediatric Use: Not indicated. Safety and efficacy in children have not been established.
• Hepatic Impairment: Use with caution in moderate-to-severe impairment. Periodic liver function monitoring is advised.
• Renal Impairment: No significant adjustment required; elimination is not substantially affected by renal dysfunction.

Contraindications

• Known hypersensitivity to Bicalutamide or any component of the formulation.
• Use in females or children: Not indicated due to potential fetal harm and lack of clinical benefit.
• Pregnancy and Lactation: Contraindicated in pregnancy. Should not be used in women of childbearing potential.

Drug Interactions

• CYP3A4 Substrates: Bicalutamide is a moderate inhibitor; concurrent use with CYP3A4 substrates should be closely monitored.
• Coumarin Anticoagulants (e.g., Warfarin): May enhance anticoagulant effect. Frequent monitoring of PT/INR is recommended with dose adjustment as needed.

Adverse Effects

The most frequently reported side effects (occurring in >10% of patients) during combination therapy include:

• Vasomotor: Hot flashes
• Musculoskeletal: Back pain, general pain, pelvic discomfort
• General: Asthenia, fatigue
• Gastrointestinal: Constipation, nausea, diarrhea
• Urinary: Nocturia, hematuria
• Respiratory: Dyspnea
• Dermatologic: Skin rash, breast tenderness
• Hematologic: Anemia, rare thrombocytopenia
• Other: Peripheral edema, infection

These effects are generally manageable and tend to stabilize over time with supportive care.

Warnings and Precautions

• Gynecomastia and Breast Pain: Common with long-term use, especially at higher doses.
• Cardiovascular and Glucose Tolerance: May reduce insulin sensitivity; monitor blood glucose in diabetic or prediabetic patients.
• Hepatic Function: Monitor liver enzymes periodically in patients with existing liver disease or prolonged use.
• PSA Monitoring: Rising PSA levels may indicate treatment resistance or disease progression. Clinical assessment is necessary if PSA rises during treatment.
• Coumarin Interaction: Frequent INR monitoring when used with warfarin or similar anticoagulants.

Overdose Management

Clinical trials have tolerated doses up to 200 mg/day without severe toxicity. Symptoms of overdose are generally limited to increased side effects. No specific antidote exists.

Management is symptomatic, including monitoring of vital signs and supportive therapy.

Storage and Handling

• Storage Temperature: Store below 30°C
• Conditions: Keep in a dry place; protect from light and moisture.
• Packaging: Supplied in blister strips in labeled cartons to maintain stability and ensure traceability.

Why Choose Calupros 50 mg from Saif Pharma?

Saif Pharma is a globally trusted distributor of oncology medications, delivering to over 60 countries including the USA, Canada, UAE, UK, and India. By partnering with Everest Pharmaceuticals Ltd, a WHO-GMP and ISO-certified manufacturer, Saif Pharma guarantees product authenticity, regulatory compliance, and global quality standards.

Key advantages include:

• Consistent Availability of high-demand oncology medications
• Robust Global Distribution Network with fast delivery timelines
• Competitive Pricing for hospitals and cancer centers
• Technical and Regulatory Support for professionals and procurement teams

Clinical Advantages of Bicalutamide

• Effective Androgen Blockade in prostate cancer
• Convenient Oral Administration without invasive procedures
• Synergistic with LHRH Analogues for full androgen deprivation
• Tolerable Safety Profile, especially in elderly or comorbid populations

Calupros plays a pivotal role in improving outcomes for prostate cancer patients globally.

Patient Counseling Tips

• Take one tablet daily at the same time each day.
• Use effective contraception if applicable (though not used in women).
• Monitor for breast tenderness, skin rash, or persistent fatigue.
• Attend regular follow-ups for PSA levels and liver function tests.
• Report any signs of blood in urine or unusual swelling.

Conclusion

Calupros 50 mg (Bicalutamide), manufactured by Everest Pharmaceuticals Ltd. and globally supplied by Saif Pharma, is a clinically proven, well-tolerated, and effective oral therapy for advanced prostate cancer. Designed for combination hormonal therapy, it forms the cornerstone of androgen deprivation protocols for Stage D2 metastatic disease. With high global demand and Saif Pharm’s reliable supply chain, Calupros 50 mg remains a trusted choice for oncology professionals worldwide seeking quality, affordability, and therapeutic consistency.