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Guide, Feedback, and Issue Reporting
 * IMPORTANT SAFETY INFORMATION
 * PRESCRIBING INFORMATION
 * MEDICAL INQUIRIES
 * FOR PATIENTS

Togg
 * HOW ZYTIGA® WORKS
 * EFFICACY & SAFETY
   
   * Metastatic High-Risk CSPC
   * mCRPC Prior to Chemotherapy
   * Metastatic CRPC Following Chemotherapy
 * DOSING & MONITORING
 * RESOURCES
   
   * Support for ZYTIGA®
   * Additional Questions
 * CONTACT



ZYTIGA® (abiraterone acetate) & PREDNISONE

STRONG TOGETHER
LET’S DO THIS
LEARN MORE


METASTATIC HIGH-RISK CSPC EFFICACY & SAFETY

 * LATITUDE Study Final Analysis
 * Efficacy endpoints
 * Safety Profile

CSPC = Castration-Sensitive Prostate Cancer

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METASTATIC CRPC EFFICACY & SAFETY

 * Final analysis for COU-AA-302 and COU-AA-301 studies
 * Co-primary and secondary endpoint data
 * Established safety and tolerability profile
 * Discontinuation criteria

CRPC = Castration-Resistant Prostate Cancer

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DOSING & MONITORING

 * Recommended dosage and administration
 * Dose modification guidelines
 * Patient monitoring considerations and schedule



OR

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RESOURCES

 * Comprehensive access support for your patients
 * Identifying cost support options

 * Helpful answers to common questions about ZYTIGA®

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Indication

ZYTIGA® (abiraterone acetate) is 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)

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hypokalemia, Fluid Retention, and Cardiovascular Adverse Reactions Due to
Mineralocorticoid Excess - ZYTIGA® may cause hypertension, hypokalemia, and
fluid retention as a consequence of increased mineralocorticoid levels resulting
from CYP17 inhibition [see Clinical Pharmacology (12.1)]. Monitor patients for
hypertension, hypokalemia, and fluid retention at least once a month. Control
hypertension and correct hypokalemia before and during treatment.

Closely monitor patients whose underlying medical conditions might be
compromised by increases in blood pressure, hypokalemia, or fluid retention,
such as those with heart failure, recent myocardial infarction, cardiovascular
disease, or ventricular arrhythmia. In postmarketing experience, QT
prolongation, and Torsades de Pointes have been observed in patients who develop
hypokalemia while taking ZYTIGA®.

The safety of ZYTIGA® in patients with left ventricular ejection fraction <50%
or New York Heart Association (NYHA) Class III or IV heart failure (in
COU-AA-301) or NYHA Class II to IV heart failure (in COU-AA-302 and LATITUDE)
has not been established because these patients were excluded from these
randomized clinical trials [see Clinical Studies (14)].

Adrenocortical Insufficiency - Adrenocortical insufficiency was reported in
patients receiving ZYTIGA® in combination with prednisone, after an interruption
of daily steroids and/or with concurrent infection or stress. Monitor patients
for symptoms and signs of adrenocortical insufficiency if prednisone is stopped
or withdrawn, if the prednisone dose is reduced, or if the patient experiences
unusual stress. Symptoms and signs of adrenocortical insufficiency may be masked
by adverse reactions associated with mineralocorticoid excess seen in patients
treated with ZYTIGA®. Perform appropriate tests, if clinically indicated, to
confirm adrenocortical insufficiency. Increased dosages of corticosteroids may
be used before, during, and after stressful situations [see Warnings and
Precautions (5.1)].

Hepatotoxicity - In postmarketing experience, there have been ZYTIGA®-associated
severe hepatic toxicities, including fulminant hepatitis, acute liver failure,
and deaths. Measure serum transaminases (ALT and AST) and bilirubin levels prior
to starting treatment with ZYTIGA®, every two weeks for the first three months
of treatment, and monthly thereafter. In patients with baseline moderate hepatic
impairment receiving a reduced ZYTIGA® dose of 250 mg, measure ALT, AST, and
bilirubin prior to the start of treatment, every week for the first month, every
two weeks for the following two months of treatment, and monthly thereafter.
Promptly measure serum total bilirubin, AST, and ALT if clinical symptoms or
signs suggestive of hepatotoxicity develop. Elevations of AST, ALT, or bilirubin
from the patient’s baseline should prompt more frequent monitoring. If at any
time AST or ALT rise above five times the upper limit of normal (ULN) or the
bilirubin rises above three times the ULN, interrupt ZYTIGA® treatment and
closely monitor liver function. Re-treatment with ZYTIGA® at a reduced dose
level may take place only after return of liver function tests to the patient’s
baseline or to AST and ALT less than or equal to 2.5 x ULN and total bilirubin
less than or equal to 1.5 x ULN [see Dosage and Administration (2.4)].

Permanently discontinue ZYTIGA® for patients who develop a concurrent elevation
of ALT greater than 3 x ULN and total bilirubin greater than 2 x ULN in the
absence of biliary obstruction or other causes responsible for the concurrent
elevation.

The safety of ZYTIGA® re-treatment of patients who develop AST or ALT greater
than or equal to 20 x ULN and/or bilirubin greater than or equal to 10 x ULN is
unknown.

Increased Fractures and Mortality in Combination With Radium Ra 223 Dichloride -
ZYTIGA® plus prednisone/prednisolone is not recommended for use in combination
with radium Ra 223 dichloride outside of clinical trials. Increased incidences
of fractures (28.6% vs 11.4%) and deaths (38.5% vs 35.5%) have been observed in
patients who received ZYTIGA® plus prednisone/prednisolone in combination with
radium Ra 223 dichloride compared to patients who received placebo in
combination with ZYTIGA® plus prednisone/prednisolone [see Warnings and
Precautions (5.4)].

Embryo-Fetal Toxicity - The safety and efficacy of ZYTIGA® have not been
established in females. Based on animal reproductive studies and mechanism of
action, ZYTIGA® can cause fetal harm and loss of pregnancy when administered to
a pregnant female. Advise males with female partners of reproductive potential
to use effective contraception during treatment with ZYTIGA® and for 3 weeks
after the last dose of ZYTIGA® [see Use in Specific Populations (8.1, 8.3)].
ZYTIGA® should not be handled by females who are or may become pregnant [see How
Supplied/Storage and Handling (16)].

Hypoglycemia - Severe hypoglycemia has been reported when ZYTIGA® was
administered to patients with pre-existing diabetes receiving medications
containing thiazolidinediones (including pioglitazone) or repaglinide [see Drug
Interactions (7.2)]. Monitor blood glucose in patients with diabetes during and
after discontinuation of treatment with ZYTIGA®. Assess if antidiabetic drug
dosage needs to be adjusted to minimize the risk of hypoglycemia.

ADVERSE REACTIONS

Adverse Reactions - The most common adverse reactions (≥10%) are fatigue,
arthralgia, hypertension, nausea, edema, hypokalemia, hot flush, diarrhea,
vomiting, upper respiratory tract infection, cough, and headache.

Laboratory Abnormalities - The most common laboratory abnormalities (>20%) are
anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia,
hypercholesterolemia, hyperglycemia, and hypokalemia.

DRUG INTERACTIONS

Drugs That Inhibit or Induce CYP3A4 Enzymes - Based on in vitro data, ZYTIGA® is
a substrate of CYP3A4. In a drug interaction trial, co-administration of
rifampin, a strong CYP3A4 inducer, decreased exposure of abiraterone by 55%.
Avoid concomitant strong CYP3A4 inducers during ZYTIGA® treatment. If a strong
CYP3A4 inducer must be co-administered, increase the ZYTIGA® dosing frequency
only during the co-administration period [see Dosage and Administration (2.5)].
In a dedicated drug interaction trial, co-administration of ketoconazole, a
strong inhibitor of CYP3A4, had no clinically meaningful effect on the
pharmacokinetics of abiraterone [see Clinical Pharmacology (12.3)].

Effects of Abiraterone on Drug-Metabolizing Enzymes - ZYTIGA® is an inhibitor of
the hepatic drug-metabolizing enzymes CYP2D6 and CYP2C8. Avoid co-administration
with CYP2D6 substrates with a narrow therapeutic index. If alternative
treatments cannot be used, consider a dose reduction of the CYP2D6 substrate
drug. In a CYP2C8 drug-drug interaction trial in healthy subjects, the AUC of
pioglitazone, a CYP2C8 substrate, was increased by 46% when administered with a
single dose of ZYTIGA®. Patients should be monitored closely for signs of
toxicity related to a CYP2C8 substrate with a narrow therapeutic index if used
concomitantly with ZYTIGA® [see Clinical Pharmacology (12.3) and Warnings and
Precautions (5.6)].

USE IN SPECIFIC POPULATIONS

Females and Males of Reproductive Potential - ZYTIGA® can cause fetal harm and
potential loss of pregnancy. Advise males with female partners of reproductive
potential to use effective contraception during treatment and for 3 weeks after
the final dose of ZYTIGA® [see Use in Specific Populations (8.1)]. ZYTIGA® may
impair reproductive function and fertility in males of reproductive potential
[see Nonclinical Toxicology (13.1)].

Hepatic Impairment - In patients with baseline moderate hepatic impairment
(Child-Pugh Class B), reduce the recommended dose of ZYTIGA® to 250 mg once
daily. Do not use ZYTIGA® in patients with baseline severe hepatic impairment
(Child-Pugh Class C). If elevations in ALT or AST >5 x ULN or total bilirubin >3
x ULN occur in patients with baseline moderate hepatic impairment, discontinue
ZYTIGA® treatment [see Dosage and Administration (2.4) and Clinical Pharmacology
(12.3)].

For patients who develop hepatotoxicity during treatment, interruption of
treatment and dosage adjustment may be required [see Dosage and Administration
(2.4), Warnings and Precautions (5.3), and Clinical Pharmacology (12.3)].

Please read the full Prescribing Information and Patient Information for
ZYTIGA®.

cp-54013v6

 

 * HOW ZYTIGA® WORKS
 * EFFICACY & SAFETY
   * Metastatic High-Risk CSPC
   * mCRPC Prior to Chemotherapy
   * mCRPC Following
     Chemotherapy
 * DOSING & MONITORING
 * RESOURCES
   * Janssen CarePath
   * Additional Questions
 * CONTACT

ADDITIONAL QUESTIONS

© Janssen Biotech, Inc. 2024

This site is published by Janssen Biotech, Inc., which is solely responsible for
its contents. This site is intended for use by healthcare professionals of the
United States and Puerto Rico. Janssen Biotech, Inc., recognizes that the
Internet is a global communications medium; however, laws, regulatory
requirements, and medical practices for pharmaceutical products vary from
country to country. The Prescribing Information included here may not be
appropriate for use outside the United States and Puerto Rico.

Third party trademarks used herein are trademarks of their respective owners.

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Last updated 04/24

cp-43928v8

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