ADD THIS DRUG TO MY LIST

Select the drug indication to add to your list

ZYTIGA
Prostate and other male cancers
Compare To Related Drugs
View/Edit/Compare Drugs In My List

Only 4 drugs may be compared at once

Drug Name:

ZYTIGA Rx

Generic Name and Formulations:
Abiraterone acetate 250mg, 500mg; tabs.

Company:
Janssen Biotech, Inc.

Therapeutic Use:

Indications for ZYTIGA:

In combination with prednisone for the treatment of metastatic castration-resistant prostate cancer (CRPC) and metastatic high-risk castration-sensitive prostate cancer (CSPC).

Adult:

Take on empty stomach. Swallow whole with water. 1g once daily (in combination with oral prednisone 5mg twice daily [CRPC] or 5mg once daily [CSPC]). Should also give concomitant GnRH analog or should have had bilateral orchiectomy. Baseline moderate hepatic impairment (Child-Pugh Class B): 250mg once daily; monitor closely; discontinue if ALT/AST >5xULN or total bilirubin >3xULN. If concomitant strong CYP3A4 inducer necessary, increase abiraterone dose frequency to twice daily during co-administration period (eg, from 1g once daily to 1g twice daily); reduce back to previous dose/frequency when CYP3A4 inducer is discontinued.

Children:

Not established.

Contraindications:

Pregnancy.

Warnings/Precautions:

Risk of mineralocorticoid excess; monitor BP, serum potassium, fluid retention at least monthly. Control hypertension and correct hypokalemia before and during treatment. Heart failure, recent MI, cardiovascular disease, ventricular arrhythmias; monitor closely. Monitor for adrenocortical insufficiency. Stress (may need higher corticosteroid dose). Monitor LFTs prior to starting treatment, every 2 weeks for the first 3 months, and monthly thereafter. Baseline moderate hepatic impairment (Child-Pugh Class B): monitor LFTs prior to initiation, weekly for the first month, every 2 weeks for the next 2 months, and monthly thereafter. Interrupt and reduce dose if hepatotoxicity (ALT/AST >5xULN or total bilirubin >3xULN) occurs; see full labeling. Permanently discontinue if concurrent ALT elevation >3xULN and total bilirubin >2xULN develops without biliary obstruction or other causes of elevation. Baseline severe hepatic impairment (Child-Pugh Class C): not recommended. Males with female partners of reproductive potential must use effective contraception during therapy and for 3 weeks after last dose. Nursing mothers: not recommended.

Pharmacological Class:

CYP17 inhibitor.

Interactions:

Antagonized by strong CYP3A4 inducers (eg, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital); avoid (see Adult). Avoid concomitant CYP2D6 substrates with narrow therapeutic index (eg, thioridazine); if no alternatives, use caution and consider dose reduction of substrate. Potentiates dextromethorphan. Concomitant CYP2C8 substrates (eg, pioglitazone): monitor closely for signs of toxicity.

Adverse Reactions:

Fatigue, arthralgia, hypertension, nausea, edema, hypokalemia, hot flush, diarrhea, vomiting, upper respiratory infection, cough, headache, anemia, elevated LFTs, dyslipidemia, lymphopenia, hyperglycemia; hepatotoxicity (may be severe).

Note:

Pregnant women and those of childbearing potential should not handle Zytiga tablets without protection (eg, gloves). Partners must use appropriate barrier contraception.

Metabolism:

Hepatic; >99% protein bound.

Elimination:

Fecal (primarily), renal.

Generic Availability:

NO

How Supplied:

Tabs 250mg—120; 500mg—60

Sign Up for Free e-newsletters



Regimen and Drug Listings

GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION

Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Genitourinary Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Rare Cancers Regimens
Skin Cancer Regimens Drugs