Abiron
Generic Name
abiraterone acetate
Manufacturer
Beacon Pharmaceuticals Ltd.
Country
Bangladesh
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Description
Overview of the medicine
Abiraterone acetate, sold under the brand name Abiron, is an oral medication used to treat metastatic castration-resistant prostate cancer (mCRPC) and metastatic high-risk castration-sensitive prostate cancer (mCSPC). It works by decreasing the production of androgens (male hormones) in the body.
Uses & Indications
Dosage
Adults
1000 mg (four 250 mg tablets or two 500 mg tablets) orally once daily, in combination with 5 mg prednisone or prednisolone orally once daily.
Elderly
No specific dose adjustment is required for elderly patients based on age alone.
Renal_impairment
No dose adjustment is required for patients with mild to moderate renal impairment. Use with caution in severe renal impairment (eGFR < 30 mL/min/1.73m²), as there is no clinical experience.
How to Take
Take orally once daily on an empty stomach (at least 1 hour before or 2 hours after food). Swallow tablets whole with water, do not crush or chew. Administer with concomitant prednisone or prednisolone as prescribed.
Mechanism of Action
Abiraterone acetate is converted in vivo to abiraterone, an androgen biosynthesis inhibitor that selectively inhibits the enzyme CYP17 (17α-hydroxylase/C17,20-lyase). This enzyme is expressed in testicular, adrenal, and prostatic tumor tissues and is required for androgen biosynthesis. By inhibiting CYP17, abiraterone reduces serum androgen levels, which can slow the growth of prostate cancer cells.
Pharmacokinetics
Onset
Reduction in serum testosterone levels observed within 3 days of initiation.
Excretion
Excreted primarily in feces (approximately 88%) and to a lesser extent in urine (approximately 5%).
Half life
Approximately 12-15 hours.
Absorption
Rapidly absorbed after oral administration. Peak plasma concentrations are achieved within 2 hours. Absorption is significantly increased when taken with food (up to 10-fold), hence it should be taken on an empty stomach.
Metabolism
Primarily metabolized in the liver by CYP3A4 and SULT2A1 enzymes to inactive and active metabolites.
Side Effects
Contraindications
- Women who are pregnant or may become pregnant.
- Patients with severe hepatic impairment (Child-Pugh Class C).
Drug Interactions
Drugs metabolized by CYP2C8 (e.g., pioglitazone, repaglinide)
Abiraterone is a moderate CYP2C8 inhibitor. Caution is advised.
Drugs metabolized by CYP2D6 (e.g., thioridazine, propafenone, metoprolol)
Abiraterone is a CYP2D6 inhibitor, potentially increasing exposure to these drugs. Monitor patients and consider dose reduction for CYP2D6 substrates with a narrow therapeutic index.
Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin)
May increase abiraterone exposure; co-administration should be avoided or used with caution.
Strong CYP3A4 inducers (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital)
May decrease abiraterone exposure; co-administration should be avoided.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
There is no specific antidote for abiraterone acetate overdose. In case of overdose, discontinue the drug and provide general supportive care, including monitoring of electrolytes, liver function, and adrenal function. Manage symptoms as appropriate.
Pregnancy & Lactation
Abiraterone acetate is contraindicated in pregnant women or women who may become pregnant. It is not indicated for use in women and can cause fetal harm. Not applicable for lactation as it is not for use in women.
Side Effects
Contraindications
- Women who are pregnant or may become pregnant.
- Patients with severe hepatic impairment (Child-Pugh Class C).
Drug Interactions
Drugs metabolized by CYP2C8 (e.g., pioglitazone, repaglinide)
Abiraterone is a moderate CYP2C8 inhibitor. Caution is advised.
Drugs metabolized by CYP2D6 (e.g., thioridazine, propafenone, metoprolol)
Abiraterone is a CYP2D6 inhibitor, potentially increasing exposure to these drugs. Monitor patients and consider dose reduction for CYP2D6 substrates with a narrow therapeutic index.
Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin)
May increase abiraterone exposure; co-administration should be avoided or used with caution.
Strong CYP3A4 inducers (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital)
May decrease abiraterone exposure; co-administration should be avoided.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
There is no specific antidote for abiraterone acetate overdose. In case of overdose, discontinue the drug and provide general supportive care, including monitoring of electrolytes, liver function, and adrenal function. Manage symptoms as appropriate.
Pregnancy & Lactation
Abiraterone acetate is contraindicated in pregnant women or women who may become pregnant. It is not indicated for use in women and can cause fetal harm. Not applicable for lactation as it is not for use in women.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2-3 years from manufacturing date.
Availability
Available in pharmacies worldwide
Approval Status
FDA Approved
Patent Status
Generic versions available
Clinical Trials
Abiraterone acetate has been extensively studied in large, randomized, placebo-controlled clinical trials (e.g., COU-AA-301, COU-AA-302, LATITUDE, STAMPEDE) demonstrating significant improvements in overall survival and radiographic progression-free survival in patients with mCRPC and mCSPC.
Lab Monitoring
- Liver function tests (ALT, AST, bilirubin) prior to treatment, every two weeks for the first three months, then monthly thereafter.
- Serum potassium and blood pressure monitoring prior to treatment, every two weeks for the first three months, then monthly thereafter.
- Serum testosterone levels.
Doctor Notes
- Emphasize strict adherence to empty stomach administration to optimize drug exposure and minimize variability.
- Concomitant prednisone/prednisolone is crucial to mitigate mineralocorticoid excess.
- Monitor LFTs, serum potassium, and blood pressure diligently due to potential for hepatotoxicity and mineralocorticoid effects.
Patient Guidelines
- Always take this medicine on an empty stomach (at least 1 hour before or 2 hours after food).
- Take Abiraterone acetate with prednisone or prednisolone as prescribed by your doctor.
- Do not stop taking Abiraterone acetate or prednisone/prednisolone without consulting your doctor.
- Report any signs of liver problems (e.g., yellowing of skin/eyes, dark urine, severe nausea/vomiting), severe fatigue, or symptoms of low potassium (e.g., muscle weakness) to your doctor immediately.
Missed Dose Advice
If you miss a dose, take your next scheduled dose at the usual time. Do not take a double dose to make up for a missed one.
Driving Precautions
Abiraterone acetate may cause fatigue or dizziness. If you experience these symptoms, avoid driving or operating machinery.
Lifestyle Advice
- Maintain a healthy lifestyle, including a balanced diet and regular exercise, as tolerated.
- Manage blood pressure and other cardiovascular risk factors as advised by your doctor.
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