Abiraterone Acetate Tablets (ABIRACINE 250Mg)

Product Description

Abiraterone Acetate Tablets (ABIRACINE 250mg) is a medication used primarily in the treatment of prostate cancer, particularly metastatic castration-resistant prostate cancer (mCRPC). It works by blocking the production of testosterone, which is a key hormone that fuels the growth of prostate cancer cells.

Key Details about Abiraterone Acetate 250mg Tablets (ABIRACINE):

Active Ingredient:

• Abiraterone Acetate (250 mg per tablet) is the active ingredient in Abiracine tablets. It is a prodrug, which means it is converted into the active form (Abiraterone) in the body after being ingested.

Mechanism of Action:

Abiraterone is a potent CYP17 enzyme inhibitor. It works by blocking the enzyme CYP17, which is involved in the production of androgens (male hormones like testosterone) in the adrenal glands, testicles, and even within the tumor itself. Testosterone is the hormone that drives the growth of many prostate cancers, so reducing its levels can help slow the growth of cancer cells.

• CYP17 Inhibition: This prevents the synthesis of both testosterone and other androgens. As a result, the levels of androgens are reduced, leading to a decrease in prostate cancer growth.

Indications (Uses):

Abiraterone Acetate 250mg tablets is primarily used for:

1. Metastatic Castration-Resistant Prostate Cancer (mCRPC): This is prostate cancer that continues to grow despite low testosterone levels (through surgery or medical castration).
2. Castration-Sensitive Prostate Cancer (CSPC): It is used in combination with prednisone for patients with castration-sensitive prostate cancer.
3. Other potential uses: Abiraterone may be investigated in clinical trials for other cancers or conditions, but its main approved use is for prostate cancer.

Dosage:

• Recommended Dose: The usual recommended dose of Abiraterone 250mg tablets is 1,000 mg (four 250 mg tablets) once daily, taken with food.
• Prednisone/Prednisolone: Abiraterone is typically given alongside prednisone or prednisolone (5 mg twice daily). This helps to manage potential side effects related to cortisol production, which may be disrupted by abiraterone™s action.

Administration:

• Take Abiraterone 250mg tablets at the same time each day, with food (preferably after a meal).
• Do not crush or chew the tablets; swallow them whole with a glass of water.

Side Effects:

Common side effects of Abiraterone Acetate 250mg tablets include:

• Fatigue,
• Joint swelling or pain (arthralgia),
• Hot flashes,
• Diarrhea,
• Urinary tract infections,
• Increase in liver enzymes (indicating possible liver damage).

Serious side effects can occur, including:

• Adrenal insufficiency: Abiraterone can decrease cortisol production, leading to adrenal insufficiency, which may cause symptoms like fatigue, weakness, dizziness, or nausea.
• Cardiovascular issues: Some patients may experience high blood pressure (hypertension), fluid retention, or low potassium levels.
• Liver toxicity: Liver function should be monitored regularly, as abiraterone can cause elevated liver enzymes or damage.
• Bone fractures: Due to the impact on bone health, fractures or weakened bones may occur, especially in patients with advanced prostate cancer.

Serious Side Effects (Rare but critical):

• Heart problems: In some cases, abiraterone may lead to heart failure, arrhythmias, or severe hypertension.
• Liver damage: Signs of liver damage (such as yellowing of the skin or eyes, dark urine, or unusual fatigue) should be promptly reported.
• Electrolyte imbalances: Abiraterone can cause low potassium, high sodium, or fluid retention, which can lead to edema or high blood pressure.

Precautions:

• Adrenal insufficiency: As abiraterone affects adrenal gland function, it is important to take prednisone alongside it to help prevent this condition.
• Liver function: Liver function should be monitored, and dosage adjustments may be required if there is any indication of liver damage.
• Hypertension: Abiraterone can cause high blood pressure, so regular monitoring is essential. Treatment for high blood pressure may be necessary.
• Bone health: Monitor for bone health in patients on long-term therapy, as fractures can occur due to weakened bones.
• Pregnancy and breastfeeding: Abiraterone should not be used during pregnancy as it can harm the fetus. It is also not recommended for breastfeeding due to the risk of excretion in breast milk.
• Drug interactions: Abiraterone is metabolized by the liver enzyme CYP3A4, so drugs that inhibit or induce this enzyme (such as ketoconazole, rifampin) may alter the effectiveness of abiraterone. Additionally, certain medications can increase the risk of heart problems or liver toxicity.

Drug Interactions:

• CYP3A4 Inhibitors (e.g., ketoconazole, itraconazole, ritonavir): These can increase abiraterone blood levels, potentially leading to side effects.
• CYP3A4 Inducers (e.g., rifampin, phenytoin, carbamazepine): These can lower abiraterone blood levels, making it less effective.
• Anticoagulants: If you are taking blood thinners (e.g., warfarin), you may need to have your blood clotting levels monitored, as abiraterone can interact with these medications.

Storage:

• Room Temperature: Store the tablets at 20C to 25C (68F to 77F).
• Keep in a dry place and out of reach of children.

Conclusion:

Abiraterone Acetate 250mg Tablets (ABIRACINE) is an important treatment for metastatic castration-resistant prostate cancer and other advanced prostate cancers. It works by lowering androgen production, which can slow the growth of prostate cancer cells. While highly effective, it can cause side effects such as fatigue, hypertension, joint pain, and liver toxicity, so it requires regular monitoring by healthcare professionals.