Generic Name:
Category: ONCOLOGY
Product Description
Abiraglob® contains Abiraterone Acetate USP 250 mg, an androgen biosynthesis inhibitor indicated for the treatment of advanced prostate cancer. Abiraterone selectively inhibits CYP17 (17α-hydroxylase/C17,20-lyase), a key enzyme involved in androgen production in the testes, adrenal glands, and prostate tumour tissue. By suppressing androgen synthesis, Abiraglob® slows the growth and progression of androgen-dependent prostate cancer.
Abiraglob® is administered in combination with prednisone or prednisolone to reduce the risk of mineralocorticoid-related adverse effects. It has demonstrated significant improvements in overall survival, radiographic progression-free survival, and disease control in patients with metastatic prostate cancer.
Indications
Abiraglob® is indicated, in combination with prednisolone, for the treatment of:
- Metastatic Castration-Resistant Prostate Cancer (mCRPC) in adult men.
- Metastatic High-Risk Castration-Sensitive Prostate Cancer (mCSPC) (also known as metastatic hormone-sensitive prostate cancer) in combination with androgen deprivation therapy (ADT).
- Advanced prostate cancer requiring androgen suppression as part of systemic therapy.
Patients receiving Abiraglob® should continue medical or surgical castration throughout treatment unless they have undergone bilateral orchiectomy.
Contraindications
Abiraglob® is contraindicated in patients with:
- Known hypersensitivity to abiraterone acetate or any component of the formulation.
- Severe hepatic impairment (Child-Pugh Class C).
- Women who are pregnant or may become pregnant, as Abiraterone may cause fetal harm.
- Concomitant use where contraindicated according to local prescribing information.
Use with caution in patients with:
- Hepatic impairment.
- Hypertension.
- Hypokalaemia.
- Heart failure or significant cardiovascular disease.
- Adrenocortical insufficiency.
- Diabetes mellitus receiving corticosteroids.
Regular monitoring of blood pressure, serum potassium, liver function tests, and fluid status is recommended during treatment.
Dosage and Administration
Abiraglob® should be taken on an empty stomach, at least 1 hour before or 2 hours after food. Food significantly increases the absorption of abiraterone and may increase the risk of adverse reactions.
Adults
- Recommended dose: 1,000 mg (four 250 mg tablets) once daily.
- Administer in combination with:
- Prednisolone 5 mg twice daily for metastatic castration-resistant prostate cancer (mCRPC), or
- Prednisolone 5 mg once daily for metastatic castration-sensitive prostate cancer (mCSPC), according to current treatment guidelines.
Patients should continue androgen deprivation therapy (ADT) unless surgically castrated.
Hepatic Impairment
- Mild hepatic impairment: No initial dose adjustment required.
- Moderate hepatic impairment: Use with caution and close monitoring.
- Severe hepatic impairment: Contraindicated.
Missed Dose
If a daily dose is missed, patients should take the next scheduled dose the following day. Do not take an extra dose to make up for a missed dose.
Key Features
- Potent CYP17 inhibitor that suppresses androgen production
- Indicated for metastatic castration-resistant and metastatic castration-sensitive prostate cancer
- Improves overall survival and delays disease progression
- Administered once daily
- Used in combination with prednisone/prednisolone and androgen deprivation therapy
- Convenient oral tablet formulation
- Supports long-term management of advanced prostate cancer
- Recommended as part of evidence-based treatment protocols for advanced prostate cancer