Zytix 500mg

Generic: Abiraterone Acetate

Manufacturer

Beacon Pharmaceuticals PLC

৳ 923

Contraindications

Hypersensitivity to the Abiraterone acetate or to any of the excipients of Abiraterone.

Pregnancy & Lactation

The safety and efficacy of Abiraterone have not been established in females. Based on findings from animal studies and the mechanism of action, Abiraterone can cause fetal harm and potential loss of pregnancy. There are no human data on the use of Abiraterone in pregnant women. The safety and efficacy of Abiraterone have not been established in females. There is no information available on the presence of abiraterone acetate in human milk, or on the effects on the breastfed child or milk production.

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Description

Indications

Zytix is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with

  • Metastatic castration-resistant prostate cancer (CRPC).
  • Metastatic high-risk castration-sensitive prostate cancer (CSPC).

Pharmacology

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.

Side Effects

The most common adverse reactions are fatigue, arthalgia, hypertension, nausea, edema, hypokalemia, hot flush, diarrhea, vomiting, upper respiratory infection, cough, and headache.

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