Generic Name:
Category: ONCOLOGY
Product Description
Isobase® contains Bicalutamide USP 50 mg, a non-steroidal anti-androgen indicated for the treatment of advanced prostate cancer. Bicalutamide competitively binds to androgen receptors, inhibiting the action of testosterone and dihydrotestosterone (DHT) on prostate cancer cells, thereby slowing tumour growth and disease progression.
Isobase® is primarily used in combination with Luteinising Hormone-Releasing Hormone (LHRH) analogues or following surgical castration (orchiectomy) as part of maximum androgen blockade in patients with advanced prostate cancer.
Indications
Isobase® is indicated for:
- Treatment of advanced (Stage D2) prostate cancer in combination with a LHRH analogue.
- Treatment of advanced prostate cancer following surgical castration (bilateral orchiectomy).
- Maximum androgen blockade in patients with metastatic prostate cancer.
- Hormonal management of androgen-dependent prostate cancer as recommended by current clinical guidelines.
Contraindications
Isobase® is contraindicated in patients with:
- Known hypersensitivity to bicalutamide or any component of the formulation.
- Women, including those who are pregnant or breastfeeding.
- Children and adolescents.
- Concomitant use with terfenadine, astemizole, or cisapride due to the risk of serious drug interactions.
Use with caution in patients with:
- Moderate to severe hepatic impairment.
- Cardiovascular disease.
- Diabetes mellitus (particularly when used in combination with LHRH agonists).
- Lactose intolerance (where applicable to the formulation).
Liver function tests should be performed before initiating treatment and monitored periodically during therapy.
Dosage and Administration
Isobase® should be taken orally once daily, with or without food, preferably at the same time each day.
Adults
- Recommended dose: One 50 mg tablet once daily.
- Treatment should be initiated at the same time as an LHRH analogue or immediately following surgical castration.
Elderly Patients
- No dosage adjustment is required.
Patients with Renal Impairment
- No dosage adjustment is generally required.
Patients with Hepatic Impairment
- No dose adjustment is required in mild hepatic impairment.
- Use with caution in moderate to severe hepatic impairment due to reduced drug clearance.
Treatment should be continued for as long as clinically indicated by the treating physician.
Key Features
- Non-steroidal anti-androgen for advanced prostate cancer
- Blocks androgen receptors and inhibits tumour growth
- Used in combination with LHRH agonists or after surgical castration
- Once-daily oral dosing
- Well-established role in maximum androgen blockade
- Helps delay disease progression in androgen-dependent prostate cancer
- Convenient 50 mg tablet formulation
- Suitable for long-term management under specialist supervision