Introduction
Calupros 50 mg (Bicalutamide) Tablet is a hormonal chemotherapy used in combination with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic prostate cancer. Manufactured by Everest Pharmaceuticals Ltd., a WHO-GMP certified pharmaceutical company, and distributed worldwide by Onco Solution, Calupros delivers targeted antiandrogen therapy designed to slow the progression of prostate carcinoma. Its once-daily oral dosing and well-characterized safety profile make it a standard in advanced prostate cancer management.
Key Benefits and Mechanism of Action
Calupros contains Bicalutamide, a non-steroidal antiandrogen that works by selectively binding to androgen receptors in prostate tissue, thereby blocking the effects of testosterone and dihydrotestosterone, which are known to fuel prostate tumor growth.
Mechanism of Action:
- Bicalutamide binds to cytosolic androgen receptors and inhibits androgen-driven cellular proliferation in prostate cancer cells.
- When used in combination with an LHRH analog, it provides complete androgen blockade, enhancing treatment outcomes in advanced prostate cancer.
- Unlike surgical castration, it offers a non-invasive approach with reversible effects and minimal impact on quality of life.
Indications
Calupros is indicated for:
- Stage D2 Metastatic Carcinoma of the Prostate: In combination with an LHRH analog, Calupros is used to reduce tumor burden and slow progression in patients with advanced prostate cancer.
Calupros should only be used under the guidance of a registered medical practitioner.
Dosage and Administration
Recommended Dose:
- One tablet (50 mg) once daily, with or without food.
- Can be administered in the morning or evening.
- Treatment is initiated simultaneously with an LHRH analog.
Special Population Dosage Considerations:
- Pediatric Use: Not recommended; safety and efficacy have not been established.
- Hepatic Impairment: Use with caution; periodic liver function tests are advised.
- Renal Impairment: No dose adjustment required.
Missed Dose: If a dose is missed, patients should skip it and continue with the next scheduled dose. Do not double up.
Pharmacology
Bicalutamide is a selective antiandrogen that binds competitively to androgen receptors, preventing testosterone and dihydrotestosterone from activating these receptors in the prostate gland and surrounding tissues.
- Absorption: Rapid and complete after oral administration
- Metabolism: Extensively metabolized in the liver
- Elimination: Eliminated primarily via hepatic metabolism; minimal impact from renal function
This pharmacological profile supports its use in a once-daily dosing regimen and makes it suitable for long-term use in prostate cancer therapy.
Contraindications
Calupros is contraindicated in the following:
- Known hypersensitivity to Bicalutamide or any tablet components
- Females: Not indicated for use in women, especially during pregnancy
- Concomitant use with cisapride, terfenadine, or astemizole due to potential interactions
Drug Interactions
- CYP3A4 Substrates: Bicalutamide is a moderate inhibitor of CYP3A4; caution is advised when co-administered with medications metabolized by this enzyme.
- Coumarin Anticoagulants (e.g., warfarin): PT/INR should be closely monitored, and dose adjustments may be needed.
- Avoid St. John’s wort and other herbal products that affect liver enzymes.
Side Effects
Common adverse reactions (reported in >10% of patients):
- Vasomotor symptoms: Hot flashes
- Gastrointestinal: Nausea, diarrhea, constipation
- Musculoskeletal: General pain, back pain, pelvic discomfort
- Fatigue: Asthenia
- Urinary: Hematuria, nocturia
- Infections: Upper respiratory or urinary tract infections
- Edema: Peripheral swelling
- Respiratory: Dyspnea
- Hematologic: Anemia
These side effects are generally manageable and may reduce over time with continued treatment.
Precautions and Warnings
- Hepatotoxicity: Liver function should be monitored during long-term therapy, especially in patients with hepatic impairment.
- Glucose Tolerance: May reduce glucose tolerance; monitor blood glucose levels in patients with or at risk of diabetes.
- Breast Effects: Gynecomastia and breast tenderness may occur.
- Bleeding Risk: Monitor INR and PT in patients receiving anticoagulants.
- PSA Monitoring: Regular testing is recommended to assess treatment efficacy and disease progression.
Use in Special Populations
- Pediatric: Not approved for pediatric use.
- Pregnancy and Lactation: Contraindicated due to the potential for fetal harm. Calupros is not intended for use in females.
- Elderly: No dosage adjustment necessary; well tolerated in geriatric populations.
- Renal Impairment: No significant impact on drug elimination.
- Hepatic Impairment: Caution required; increased drug exposure possible.
Overdose Management
There is no specific antidote for Bicalutamide overdose. However, doses up to 200 mg/day have been well tolerated in clinical studies. Management should be symptomatic and supportive.
Therapeutic Class
Hormonal Chemotherapy / Antiandrogens
Calupros falls under the category of hormonal antineoplastic agents, specifically non-steroidal antiandrogens used for treating androgen-sensitive prostate tumors.
Storage Conditions
- Store below 30°C
- Keep in a dry place, protected from light and moisture
- Keep out of reach of children
- Do not use after the expiration date printed on the packaging
Manufacturer Information
Calupros 50 mg (Bicalutamide) Tablet is manufactured by Everest Pharmaceuticals Ltd., a Bangladesh-based pharmaceutical company recognized for its commitment to oncology excellence. Their WHO-GMP-certified facilities ensure global quality compliance, and their oncology division delivers innovative treatments for cancer worldwide.
Visit manufacturer website: www.everestpharmabd.com
Supplier Profile: Onco Solution
Onco Solution is a trusted worldwide supplier of oncology and specialty medicines. By working with leading manufacturers like Everest Pharmaceuticals, Onco Solution ensures the reliable supply of high-quality cancer therapies to hospitals, clinics, and pharmacies across more than 50 countries.
Our Services Include:
- Global bulk supply of Calupros 50 mg tablets
- Regulatory-compliant logistics and cold-chain delivery
- Online resources and product support via www.oncosolution.com
We empower healthcare professionals with reliable access to essential cancer treatments.
Conclusion
Calupros 50 mg (Bicalutamide) Tablet is a well-tolerated and effective oral antiandrogen for managing advanced prostate cancer in combination with LHRH analogs. With its selective action, once-daily dosing, and global availability through Onco Solution, Calupros is a dependable choice for prostate cancer therapy.To place an order or get more clinical guidance, visit www.oncosolution.com today.
