Abiron 250

Abiraterone Acetate is an anti-androgen anticancer medicine that inhibits the CYP17 enzyme, reducing androgen production. It is used with prednisone to treat advanced prostate cancer.

• Metastatic Castration-Resistant Prostate Cancer (mCRPC) • Metastatic High-Risk Castration-Sensitive Prostate Cancer (mCSPC)

Cytotoxic Chemotherapy

CYP17 (17α-hydroxylase/C17,20-lyase) Inhibitor; Androgen Biosynthesis Inhibitor

Abiraterone Acetate is converted to Abiraterone, which inhibits CYP17, reducing androgen production in the testes, adrenal glands and tumour tissues, thereby slowing prostate cancer growth.

Blocks CYP17 enzyme, reducing DHEA, androstenedione and testosterone production, thereby inhibiting androgen-dependent prostate cancer growth.

mCRPC: 1000 mg once daily + Prednisone 5 mg twice daily. mCSPC: 1000 mg once daily + Prednisone 5 mg once daily. Moderate hepatic impairment (Child-Pugh B): Start with 250 mg once daily.

Take on an empty stomach, at least 1 hour before or 2 hours after meals. Swallow tablets whole with water. Do not crush or chew.

If a dose is missed, take the next scheduled dose. Do not take a double dose.

Fatigue, arthralgia, hypertension, nausea, oedema, hypokalaemia, hot flushes, diarrhoea, vomiting, upper respiratory tract infection, cough and headache.

Monitor blood pressure, potassium levels, liver function (ALT, AST, bilirubin) and signs of adrenal insufficiency during treatment.

Contraindicated in patients with hypersensitivity to Abiraterone Acetate or any of its ingredients.

Avoid strong CYP3A4 inducers such as Rifampin, Carbamazepine, Phenytoin and Phenobarbital. Use caution with CYP2D6 and CYP2C8 substrates such as Dextromethorphan, Thioridazine and Pioglitazone.

Food significantly increases drug absorption. Therefore, it must be taken on an empty stomach.

Not recommended during pregnancy. It may cause fetal harm.

Safety during breastfeeding has not been established. Use is not recommended.

Safety and effectiveness have not been established in children.

No routine dose adjustment is required in elderly patients, but clinical monitoring is recommended.

Reduce the starting dose in moderate hepatic impairment. Discontinue in severe hepatotoxicity. Use with caution in renal impairment as advised by a physician.

There is no specific antidote. Stop treatment and provide supportive care with cardiac monitoring and liver function assessment.

Store below 25°C. Protect from light and keep out of the reach of children.

Molecular Formula: C₂₆H₃₃NO₂ Molecular Weight: 391.55 g/mol Drug Class: Steroidal Androgen Biosynthesis Inhibitor

Q: What is Abiraterone Acetate used for? A: It is used with prednisone to treat advanced prostate cancer, including metastatic castration-resistant prostate cancer (mCRPC) and metastatic high-risk castration-sensitive prostate cancer (mCSPC). Q: Can it be taken with food? A: No. It must be taken on an empty stomach, at least 1 hour before or 2 hours after a meal. Q: Why is it given with prednisone? A: It is given with prednisone to reduce mineralocorticoid-related side effects (such as hypertension, hypokalaemia and fluid retention) and to optimise treatment outcomes. Q: What monitoring is required during treatment? A: Blood pressure, serum potassium, liver function tests (ALT, AST and bilirubin), and PSA levels when appropriate should be monitored regularly. Q: Can pregnant women use this medicine? A: No. Abiraterone Acetate should not be used during pregnancy because it may cause fetal harm.