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Zytiga (Abiraterone) 250 mg is converted in vivo to Abiraterone, an androgen biosynthesis inhibitor, that inhibits 17 α-hydroxylase/C17, 20-lyase (CYP17). This enzyme is expressed in testicular, adrenal, and prostatic tumor tissues and is required for androgen biosynthesis. CYP17 catalyzes two sequential reactions. Abiron is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients.
Abiron is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with
Abiraterone Acetate is converted in vivo to Abiraterone, an androgen biosynthesis inhibitor, that inhibits 17 α-hydroxylase/C17, 20-lyase (CYP17). This enzyme is expressed in testicular, adrenal, and prostatic tumor tissues and is required for androgen biosynthesis. CYP17 catalyzes two sequential reactions:
1. The conversion of pregnenolone and progesterone to their 17 α-hydroxy derivatives by 17 α-hydroxylase activity and
2. The subsequent formation of dehydroepiandrosterone (DHEA) and androstenedione, respectively, by C17, 20 lyase activity. DHEA and androstenedione are androgens and are precursors of testosterone. Inhibition of CYP17 by Abiraterone can also result in increased mineralocorticoid production by the adrenals. Androgen sensitive prostatic carcinoma responds to treatment that decreases androgen levels. Androgen deprivation therapies, such as treatment with GnRH agonists or orchiectomy, decrease androgen production in the testes but do not affect androgen production by the adrenals or in the tumor.
Abiraterone Acetate decreased serum testosterone and other androgens in patients in the placebo-controlled clinical trial. It is not necessary to monitor the effect of Abiraterone Acetate on serum testosterone levels. Changes in serum prostate specific antigen (PSA) levels may be observed but have not been shown to correlate with clinical benefit in individual patients.
Recommended Dose For Metastatic CRPC: The recommended dose of Abiraterone Acetate is 1,000 mg (two 500 mg tablets or four 250 mg tablets) orally once daily with Prednisone 5 mg orally twice daily.
Recommended Dose For Metastatic High-Risk CSPC: The recommended dose of Abiraterone Acetate is 1,000 mg (two 500 mg tablets or four 250 mg tablets) orally once daily with Prednisone 5 mg administered orally once daily.
Patients receiving Abiraterone Acetate should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. Abiraterone Acetate must be taken on an empty stomach, at least one hour before or at least two hours atier a meal. The tablets should be swallowed whole with water. Do not crush or chew tablets.
Dose Modification:
Pediatric Use: The safety and effectiveness in pediatric patients have not been established.
Drugs That Inhibit Or Induce CYP3A4 Enzymes: Based on in vitro data, Abiron is a substrate of CYP3A4. In a dedicated drug interaction trial, co-administration of Rifampin, a strong CYP3A4 inducer, decreased exposure of Abiron by 55%. Avoid concomitant strong CYP3A4 inducers during Abiron treatment. If a strong CYP3A4 inducer must be co-administered, increase the Abiron dosing frequency. In a dedicated drug interaction trial, co-administration of ketoconazole, a strong inhibitor of CYP3A4, had no clinically meaningful effect on the pharmacokinetics of Abiron.
Effects Of Abiron On Drug Metabolizing Enzymes: Abiron is an inhibitor of the hepatic drug-metabolizing enzymes CYP2D6 and CYP2C8. In a CYP2D6 drug-drug interaction trial, the Cmax and AUC of Dextromethorphan (CYP2D6 substrate) were increased 2.8- and 2.9-fold, respectively, when Dextromethorphan was given with Abiron 1,000 mg daily and Prednisone 5 mg twice daily. Avoid co-administration of Abiron with substrates of CYP2D6 with a narrow therapeutic index (e.g., Thioridazine). If alternative treatments cannot be used, consider a dose reduction of the concomitant CYP2D6 substrate drug. In a CYP2C8 drug-drug interaction trial in healthy subjects, the AUC of Pioglitazone (CYP2C8 substrate) was increased by 46% when Pioglitazone was given together with a single dose of 1,000 mg Abiron. Therefore, patients should be monitored closely for signs of toxicity related to a CYP2C8 substrate with a narrow therapeutic index if used concomitantly with Abiron.
Generic Name: | Abiraterone Acetate Usp |
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Theraputic Category: | Anti-Cancer |
Pack Size: | 28’s |
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