ABIRAMED

ABIRAMED

Abiraterone Acetate 250mg
Net Qty- 120 Tablets
Self-Life- 2 Years

Abiramed (Abiraterone Acetate 250mg) is a prescription medication used primarily in the treatment of prostate cancer, especially metastatic castration-resistant prostate cancer (mCRPC) or metastatic high-risk castration-sensitive prostate cancer (mCSPC).

USE

Abiramed (Abiraterone Acetate 250mg) is used in the treatment of prostate cancer. Specifically, it is prescribed for:

🔹 Metastatic Castration-Resistant Prostate Cancer (mCRPC)

  • Prostate cancer that has spread to other parts of the body and is not responding to hormone therapy or surgical castration.
  • Abiramed (Abiraterone Acetate 250mg) helps slow cancer growth by blocking androgen production, which fuels prostate cancer.

🔹 Metastatic High-Risk Castration-Sensitive Prostate Cancer (mCSPC)

  • For newly diagnosed patients whose prostate cancer has but still responds to hormonal therapy..
  • Used in combination with prednisone and androgen deprivation therapy (ADT).

🔹 Metastatic Castration-Resistant Prostate Cancer (mCRPC)

  • Abiramed (Abiraterone Acetate 250mg) inhibits the enzyme CYP17A1, which is crucial in the production of testosterone and other androgens. Lower androgen levels slow the growth of prostate cancer cells.

🔹 Additional Notes:

  • Always taken with corticosteroids (usually prednisone) to prevent side effects related to hormone imbalance.
  • Must be taken on an empty stomach.

Key Benefits

✅ Key Benefits of Abiraterone Acetate 250mg

Abiramed (Abiraterone Acetate 250mg) offers several important benefits in the management of advanced prostate cancer, particularly in patients with metastatic castration-resistant prostate cancer (mCRPC) and metastatic castration-sensitive prostate cancer (mCSPC).

🔹 Slows Cancer Progression

  • Abiramed (Abiraterone) blocks androgen production, which fuels prostate cancer growth — effectively slowing or stopping tumor progression.
🔹 Improves Survival Rates
  • Clinical studies show that Abiramed (Abiraterone Acetate 250mg), when used with prednisone and hormonal therapy, can extend overall survival and delay disease progression in advanced prostate cancer.

🔹 Reduces Symptoms

  • By suppressing androgen levels, Abiramed (Abiraterone Acetate 250mg) helps relieve pain, fatigue, and urinary symptoms, improving quality of life.

🔹 Delays the Need for Chemotherapy

  • In many cases, Abiramed (Abiraterone Acetate 250mg) can postpone the need for cytotoxic chemotherapy, allowing patients to maintain daily activities longer.

🔹 Well-Tolerated Oral Therapy

  • Taken as oral tablets (usually 4 tablets of 250 mg once daily), making it convenient.
  • Non-invasive alternative compared to injections or infusions.

Mechanism
of Action

Abiramed (Abiraterone Acetate 250mg) is a selective and irreversible inhibitor of the enzyme CYP17A1, which is essential for androgen production.

🔹 How It Works:

  1. Inhibition of CYP17A1:
    Abiramed (Abiraterone Acetate 250mg) targets and blocks the enzyme 17α-hydroxylase/C17,20-lyase (CYP17A1) in the adrenal glands, testes, and prostate tumor tissues.

  2. Prevents Androgen Synthesis:
    CYP17A1 is involved in the biosynthesis of androgens (like testosterone and dihydrotestosterone or DHT), which fuel prostate cancer growth. By blocking this enzyme, Abiramed (Abiraterone Acetate 250mg) reduces androgen production at all major sources:

    • Testes

    • Adrenal glands

    • Prostate tumor itself

  3. Androgen Deprivation:
    The result is a significant decrease in serum androgen levels, leading to suppression of tumor growth in androgen-dependent prostate cancer.

  4. Cortisol Suppression and Compensation:
    Since Abiramed (Abiraterone Acetate 250mg) also reduces cortisol production, the body compensates by increasing ACTH (Adrenocorticotropic hormone), which can lead to mineralocorticoid excess (e.g., fluid retention, hypertension).
    👉 Prednisone is co-administered to prevent this side effect and restore hormonal balance.

Dosage and Administration

💊 Dosage and Administration of Abiramed (Abiraterone Acetate 250mg)

Abiramed (Abiraterone Acetate 250mg) is an oral medication used primarily for treating advanced prostate cancer. It is always used in combination with corticosteroids (usually prednisone) to reduce the risk of side effects from hormone imbalance.

🔹 Standard Adult Dose:

✅ Metastatic Castration-Resistant or Sensitive Prostate Cancer (mCRPC or mCSPC)

  • Abiramed (Abiraterone Acetate 250mg):

1,000 mg orally once daily

→ Typically taken as four 250 mg tablets

  • Prednisone:

5 mg orally twice daily (or as prescribed)

🔹 Important Administration Instructions:

💧 Take on an empty stomach

— Do NOT eat for at least 2 hours before and 1 hour after taking Abiramed (Abiraterone Acetate 250mg).

— Taking it with food can increase drug absorption unpredictably and lead to side effects.

📆 Take at the same time each day

💊 Swallow tablets whole with water — do not crush, chew, or split.

🔹 With Androgen Deprivation Therapy (ADT):

  • Abiramed (Abiraterone Acetate 250mg) should be used alongside ongoing ADT (e.g., GnRH analogues or surgical castration), as it does not suppress testicular androgen production on its own.

⚠️ Monitoring During Treatment:

  • Liver function tests (ALT, AST, bilirubin)
  • Blood pressure
  • Serum potassium
  • Fluid retention and signs of adrenal insufficiency

Common Side Effects

⚠️ Common Side Effects of Abiramed (Abiraterone Acetate 250mg) 

While Abiraterone Acetate 250mg is effective in treating advanced prostate cancer, it may cause side effects due to its impact on hormone levels — especially cortisol and androgens.

🔹 Most Common Side Effects: 

  1. High Blood Pressure (Hypertension)
    – Due to mineralocorticoid excess (caused by suppressed cortisol levels)

  2. Low Blood Potassium (Hypokalemia)
    – May cause muscle weakness, cramps, or irregular heartbeat

  3. Fluid Retention / Swelling (Edema)
    – Usually in legs, ankles, or feet

  4. Fatigue / Weakness
    – Often reported due to hormonal changes or disease progression

  5. Joint Pain or Muscle Aches (Arthralgia / Myalgia)

  6. Elevated Liver Enzymes (Hepatotoxicity)
    – May require dose adjustment or temporary discontinuation

🔸 Other Reported Side Effects: 

  • Hot flashes

  • Increased cholesterol or triglycerides

  • Urinary tract infections

  • Cough

  • Insomnia

  • Diarrhea

🩺 Serious but Less Common: 

  • Adrenal insufficiency (especially if prednisone is missed or stopped suddenly)

  • Cardiac disorders (arrhythmias, heart failure in susceptible individuals)

🔍 Monitoring Required: 

Patients on Abiramed (Abiraterone Acetate 250mg) should have regular checks for:

  • Blood pressure

  • Serum potassium levels

  • Liver function tests (ALT, AST, bilirubin)

Monitoring

🩺 Monitoring of Abiramed (Abiraterone Acetate 250mg)

Regular monitoring is essential during Abiramed (Abiraterone Acetate 250mg) therapy to ensure safety, detect adverse effects early, and evaluate treatment response — especially because it affects hormone pathways and liver function.

 

🔹 1. Liver Function Tests (LFTs)

➡️ ALT, AST, and bilirubin

  • Baseline before starting treatment
  • Every 2 weeks for the first 3 months
  • Monthly thereafter
  • If liver enzymes rise significantly, dose adjustment or discontinuation may be necessary.

🔹 2. Serum Potassium

➡️ Monitor for hypokalemia (low potassium)

  • Baseline and then at least monthly
  • More frequently if patient is on diuretics or has cardiac risk

🔹 3. Blood Pressure

➡️ Monitor for hypertension (common due to mineralocorticoid excess)

  • Baseline and then monthly or more often if elevated

🔹 4. Fluid Retention / Weight Gain

➡️ Check for signs of edema, shortness of breath, or rapid weight gain

  • Evaluate at each visit

🔹 5. Cardiac Monitoring (If Indicated)

  • For patients with a history of cardiovascular disease, consider ECG and ejection fraction (EF) monitoring
  • Monitor for arrhythmias, angina, or heart failure symptoms

🔹 6. Prostate-Specific Antigen (PSA) Levels

➡️ Track treatment response

  • Typically monitored every 1–3 months

🔹 7. Adrenal Function (if symptoms appear)

➡️ Especially if prednisone is missed or tapered

  • Monitor for signs of adrenal insufficiency: fatigue, low BP, nausea

Precautions

⚠️ Precautions of Abiramed (Abiraterone Acetate 250mg)

When using Abiramed (Abiraterone Acetate 250mg) for prostate cancer, several precautions must be taken to ensure patient safety and treatment effectiveness.

🔹 Liver Impairment

  • Use with caution in patients with liver dysfunction.
  • Avoid in patients with severe hepatic impairment (Child-Pugh Class C).
  • Monitor liver enzymes (ALT, AST, bilirubin) frequently, especially during the first 3 months.

🔹 Hypertension, Hypokalemia, and Fluid Retention

  • Abiramed (Abiraterone Acetate 250mg) can lead to mineralocorticoid excess causing:
    • High blood pressure
    • Low potassium
    • Edema
  • Co-administer prednisone to reduce these risks.
  • Regularly monitor blood pressure, serum potassium, and weight.

🔹 Adrenal Insufficiency

  • May occur if prednisone is not taken as prescribed or is abruptly stopped.
  • Symptoms include fatigue, low blood pressure, nausea, and confusion.
  • Never stop corticosteroids suddenly.

🔹 Cardiac Disorders

  • Use cautiously in patients with a history of cardiovascular disease, including:
    • Arrhythmias
    • Congestive heart failure
    • Recent myocardial infarction
  • Monitor for signs of heart failure and QT prolongation.

🔹 Drug Interactions

  • Abiramed (Abiraterone Acetate 250mg) is metabolized by CYP3A4 and inhibits CYP2D6.
  • It can interact with drugs like:
    • Warfarin
    • Beta-blockers
    • Antiepileptics
    • Antidepressants
  • Always review current medications for possible interactions.

🔹 Use in Women and Children

  • Not for use in women or children.
  • Can be harmful to a developing fetus.
  • Pregnant women should avoid handling crushed or broken tablets.

🔹 Take on an Empty Stomach

  • Food significantly increases absorption and can raise the risk of side effects.
  • Take at least 1 hour before or 2 hours after a meal.

Drug Interactions

💊 Drug Interactions of Abiramed (Abiraterone Acetate)

Abiramed (Abiraterone Acetate) is metabolized in the liver and can affect, or be affected by, several other drugs. It acts mainly as a CYP3A4 substrate and a CYP2D6 inhibitor, which means it may alter the blood levels of other medications or be altered by them.

🔹 CYP2D6 Substrate Interactions (Inhibition by Abiraterone)

Abiramed (Abiraterone Acetate 250mg) inhibits CYP2D6, increasing the effects or side effects of drugs metabolized by this enzyme.

⚠️ Monitor or adjust dose of:

      • Metoprolol (beta-blocker)
      • Propranolol
      • Tricyclic antidepressants (e.g., amitriptyline, imipramine)
      • SSRIs (e.g., fluoxetine, paroxetine)
      • Codeine and tramadol (risk of reduced efficacy or increased side effects)
      • Antipsychotics (e.g., haloperidol, risperidone)

🔹 CYP3A4 Interactions

Abiramed (Abiraterone Acetate) is a substrate of CYP3A4, so its levels can be affected by drugs that induce or inhibit CYP3A4.

🔸 CYP3A4 Inducers (may reduce Abiraterone effectiveness)

      • Rifampin
      • Phenytoin
      • Carbamazepine
      • St. John’s Wort

✅ Avoid strong inducers, or monitor response closely.

🔸 CYP3A4 Inhibitors (may increase Abiraterone levels)

      • Ketoconazole
      • Itraconazole
      • Clarithromycin
      • Ritonavir

✅ Monitor for increased side effects like hypertension or liver toxicity.

🔹 Drugs That Can Interact Due to Hypokalemia Risk

Abiramed (Abiraterone Acetate) may cause low potassium, which can enhance the risk of cardiac arrhythmias, especially with:

  • Digoxin
  • Diuretics (loop or thiazide)
  • Amphotericin B
  • Certain antiarrhythmics (e.g., sotalol, amiodarone)

🔹 Corticosteroid Interaction (Prednisone)

  • Must be co-administered with prednisone to avoid adrenal insufficiency.
  • Monitor for corticosteroid-related side effects (hyperglycemia, immunosuppression).

🔹 Warfarin (Coumadin)

  • Abiramed (Abiraterone Acetate) may increase INR when used with warfarin.
  • Frequent INR monitoring is necessary.

📌 General Advice:

  • Always review the full medication list before initiating Abiramed (Abiraterone Acetate).
  • Avoid crushed or broken tablets being handled by pregnant women (teratogenic risk).

Clinical Effectiveness

✅ Clinical Effectiveness of Abiramed (Abiraterone Acetate)

Abiramed (Abiraterone Acetate) has shown strong clinical effectiveness in the treatment of prostate cancer, particularly:

  • Metastatic Castration-Resistant Prostate Cancer (mCRPC)

  • Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

It is widely used in combination with prednisone and has become a standard of care in advanced prostate cancer therapy.

🔬 Key Clinical Findings

🔹 LATITUDE Trial (2017) 

  • Population: Men with newly diagnosed high-risk mHSPC.

  • Result:

    • Abiramed (Abiraterone Acetate) + prednisone significantly improved overall survival (OS) compared to placebo + ADT.

    • 38% reduction in risk of death.

🔹 COU-AA-301 Trial (2011) 

  • Population: mCRPC patients post-chemotherapy (docetaxel).

  • Result:

    • Median overall survival: 14.8 months vs. 10.9 months (placebo).

    • 35% reduction in risk of death.

🔹 COU-AA-302 Trial (2012) 

  • Population: Chemotherapy-naïve mCRPC patients.

  • Result:

    • Improved radiographic progression-free survival (rPFS) and delayed pain progression.

    • Delayed need for chemotherapy.

📈 Benefits Observed Clinically 

  • Improved overall survival (OS)

  • Delayed disease progression

  • Reduced PSA levels

  • Improved pain control

  • Preserved quality of life

  • Lower skeletal-related events (when combined with bone protection)

💊 Summary 

ParameterAbiraterone Effectiveness
Overall Survival (OS)Significantly prolonged in mCRPC and mHSPC
Time to ProgressionMarkedly delayed
PSA Response>50% reduction in a majority of patients
Quality of LifeMaintained or improved with fewer complications
Pain ManagementMore effective than placebo
 

Tips for Patients

🧑‍⚕️ Tips for Patients Taking Abiramed (Abiraterone Acetate)  

If you’re prescribed Abiramed (Abiraterone Acetate) for prostate cancer, it’s important to follow some key guidelines to maximize the benefit and reduce side effects.

✅ Take It on an Empty Stomach 

  • Very important: Take Abiramed (Abiraterone Acetate) 1 hour before or 2 hours after meals.

  • Food can greatly increase drug levels, raising the risk of side effects.

💊 Always Take Prednisone as Prescribed 

  • You’ll likely be prescribed prednisone with abiraterone.

  • It prevents hormone imbalances and reduces side effects like:

    • Low potassium

    • High blood pressure

    • Adrenal insufficiency

  • Never stop prednisone suddenly.

🕒 Take the Medication at the Same Time Daily 

  • Helps maintain consistent blood levels and improves effectiveness.

💧 Stay Hydrated & Monitor for Side Effects 

  • Watch for signs of fluid retention:

    • Swelling in legs or ankles

    • Shortness of breath

  • Other side effects to report:

    • Fatigue

    • Muscle cramps

    • Dizziness

    • Yellowing of skin (possible liver issue)

🩺 Regular Monitoring is Important 

  • Your doctor will monitor:

    • Liver function (ALT, AST, bilirubin)

    • Potassium levels

    • Blood pressure

    • PSA levels

  • Never skip appointments or lab tests.

⚠️ Inform Your Doctor About Other Medications 

  • Abiramed (Abiraterone Acetate) may interact with many drugs.

  • Include herbal supplements and over-the-counter meds.

🚫 Not for Use in Women or Children  

  • Pregnant women should not handle crushed tablets—may cause birth defects.

  • Keep away from children.

🧳 Plan Ahead for Travel 

  • Carry your medications and a list of prescriptions.

  • Avoid missing doses during trips or time changes.

📞 Call Your Doctor If You Notice:  

  • Persistent fatigue or weakness

  • Swelling or rapid weight gain

  • Unusual bruising or bleeding

  • Confusion or fainting