Product Introduction:
Zybiraa is a next-generation hormonal therapy used for advanced prostate cancer. It is a CYP17 inhibitor, designed to block androgen production not only in the testes but also in the adrenal glands and tumor itself. Zybiraa, when combined with low-dose corticosteroids, helps prolong survival and manage disease progression in patients with advanced-stage prostate cancer.
Uses:
Zybiraa is used for the treatment of:
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Metastatic Castration-Resistant Prostate Cancer (mCRPC)
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Metastatic High-Risk Castration-Sensitive Prostate Cancer (mCSPC)
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Prostate cancer progressing after androgen deprivation therapy
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As part of combination therapy with prednisone
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For patients not responding to luteinizing hormone-releasing hormone (LHRH) analogues
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Alternative to chemotherapy in hormone-sensitive metastatic prostate cancer
Storage Instructions:
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Store below 30°C in a cool, dry place
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Protect from moisture and direct sunlight
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Keep out of reach of children
How It Works (Mechanism of Action):
Abiraterone Acetate selectively inhibits the enzyme CYP17 (17α-hydroxylase/C17,20-lyase), which is essential for androgen biosynthesis. By inhibiting this enzyme, Zybiraa reduces the production of testosterone and other androgens from the testes, adrenal glands, and prostate tumor tissues, which are known to fuel the growth of prostate cancer cells.
Side Effects:
Common side effects:
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Fatigue
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Joint swelling or pain
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Edema (fluid retention)
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Hot flashes
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Hypertension
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Diarrhea
Severe side effects:
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Liver function abnormalities
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Adrenal insufficiency
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Cardiac disorders (e.g., arrhythmia, heart failure)
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Severe hypokalemia (low potassium)
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Increased risk of fractures
Dosage (Typical Recommended Dose):
- For 250mg tablets: 1000mg once daily (i.e., 4 tablets of 250mg)
- For 500mg tablets: 1000mg once daily (i.e., 2 tablets of 500mg)
- Must be taken in combination with Prednisone 5mg twice daily
Dose adjustments may be required in case of liver impairment or adverse reactions.
Method of Administration:
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Take by mouth on an empty stomach (at least 1 hour before or 2 hours after a meal)
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Swallow whole with water, do not crush or chew
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Must be taken daily, preferably at the same time each day
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Taken in conjunction with prednisone
Precautions:
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Monitor liver function tests regularly
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Caution in patients with cardiovascular disease or hypertension
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Not recommended in women or children
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Use effective contraception if partner is of childbearing potential
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Do not use in patients with hypokalemia or adrenal insufficiency unless corrected
Drug Interactions:
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Strong inhibitors/inducers of CYP3A4 (e.g., ketoconazole, rifampin)
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Drugs affecting corticosteroid metabolism
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Warfarin and other anticoagulants (monitor INR closely)
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Caution with diuretics, ACE inhibitors, and NSAIDs due to risk of hypokalemia
Allergies:
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Contraindicated in patients with known hypersensitivity to Abiraterone or any excipients
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Watch for symptoms like rash, itching, breathing difficulties, or swelling
Overdose Information:
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No specific antidote; treat symptomatically
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Monitor vital signs and perform supportive care
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Discontinue temporarily and assess liver function, electrolytes, and blood pressure
Missed Dose Instructions:
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If a dose is missed, take it as soon as remembered on the same day
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If you miss a whole day’s dose, do not double the dose the next day
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Resume regular dosing schedule
Additional Notes:
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Zybiraa improves overall survival and progression-free survival in prostate cancer
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Must be used with prednisone to reduce risk of corticosteroid insufficiency
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Regular monitoring of electrolytes, blood pressure, and liver enzymes is essential
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Patients should be educated on signs of fluid retention, liver toxicity, or cardiac issues
