• ZYTIGA® (abiraterone acetate)

    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) 

    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 Monitor patients for symptoms and signs of adrenocortical insufficiency if prednisone is stopped or withdrawn, if the prednisone dose is reduced, or if the patient experiences unusual stress.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-54013v5

    INDICATION
Click on the left to see the Important Safety Information

INDICATIONS

IMPORTANT SAFETY INFORMATION

  • https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/ZYTIGA-pi.pdf
    https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/ZYTIGA-pi.pdf#page=10

Helping Patients Afford ZYTIGA®

Downloadable Forms
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JCP
Hover on a document on the left for a quick document preview
 
 
 

Helping Patients Afford ZYTIGA®

Janssen CarePath can help you find out what affordability assistance may be available for your patients taking ZYTIGA®. Download a summary of affordability options or see a full list of options below.

Select your patient’s coverage status for relevant resources. 

For Patients with Commercial or Private Insurance

Janssen CarePath Savings Program for ZYTIGA®
Eligible patients pay as little as
$10
per month
Your eligible patients with commercial or private insurance pay as little as $10 per month for their ZYTIGA® medication

There is a limit to savings each year. Savings may apply to co-pay, co-insurance, or deductible. 

Patients may participate without sharing their income information. Offer not valid in CA or MA or for prescriptions filled in CA or MA.

We provide cost support directly to patients through the Janssen CarePath Savings Program. This benefit is intended to help eligible patients afford their out-of-pocket obligations as set by their health plans. The cost support is meant solely for patients—not health plans and/or their partners.

If your patients are having any difficulty accessing cost support through the Janssen CarePath Savings Program, please have them contact us at 877-CarePath (877-227-3728).

Sign your patients up for the Janssen CarePath Savings Program only or create a Provider Portal account.
Janssen CarePath Savings Program Savings Program Only
Janssen CarePath Provider Portal Provider Portal
Sign Patients Up for the Janssen CarePath Savings Program and Get a Savings Card
 
 
View Savings Program Transactions
 
 
Requires Business Associate Agreement / Patient Authorizations
 
 
Get Benefits Investigations
 
 
Get Prior Authorization Support
 
 
Create Medical Necessity Letters
 
 
Request Exceptions and Appeals Information
 
 
View Patient Dashboard
 
 
Get Timely Notifications
 
 
24-hour Online Access to Your Account
 
 
Get Started with the Option That Works Best for You and Your Patients
Sign your patients up for the Janssen CarePath Savings Program only or create a Provider Portal account.
Janssen CarePath Savings Program
  • Sign Patients Up for the Janssen CarePath Savings Program and Get a Savings Card

Sign Up for the Savings Program Only

Janssen CarePath Provider Portal
  • Sign Patients Up for the Janssen CarePath Savings Program and Get a Savings Card
  • View Savings Program Transactions
  • Requires Business Associate Agreement / Patient Authorizations
  • Get Benefits Investigations
  • Get Prior Authorization Support
  • Create Medical Necessity Letters
  • Request Exceptions and Appeals Information
  • View Patient Dashboard
  • Get Timely Notifications
  • 24-hour Online Access to Your Account

Create a Provider Portal Account

In addition to the Janssen CarePath Savings Program, here are some independent programs that may be right for your patients.

State-Sponsored Programs
Some states have financial assistance programs, each with its own eligibility requirements. Find out if your state has a program that can help your patients.
Independent Co-Pay Assistance Foundations
Learn about foundations that may be able to help your patients. We have listed programs that give support to patients with a condition treated by this medication. There may be others that can help that are not listed here. These foundations are independent and have their own rules for eligibility, which are subject to change. We have no control over these foundations. We do not endorse any particular foundation.

For Patients with Government Coverage

Even if your patients have government coverage like Medicare, we can identify programs that may help them afford their medications. Here are some independent programs that may be right for them.

State-Sponsored Programs
Some states have financial assistance programs, each with its own eligibility requirements. Find out if your state has a program that can help your patients.
Medicare Savings Program
Many states have programs that offer support for people with limited income and resources. They may help with Medicare premiums, deductibles, and co-insurance.
Medicare Part D Extra Help — Low-Income Subsidy
This program gives "extra help" to patients with limited income and resources. It can help them:
  • Pay their monthly premiums
  • Reduce or eliminate their deductible
  • Reduce or eliminate their co-insurance and co-payments
  • Have no gap in coverage
Medicaid
Some of your patients may qualify for free or low-cost health coverage. Certain states have even expanded their Medicaid programs to cover all people with incomes below a certain level.
Independent Co-Pay Assistance Foundations
Learn about foundations that may be able to help your patients. We have listed programs that give support to patients with a condition treated by this medication. There may be others that can help that are not listed here. These foundations are independent and have their own rules for eligibility, which are subject to change. We have no control over these foundations. We do not endorse any particular foundation.

For Patients with No Insurance Coverage

If your patients need help with drug costs, we can identify programs that may help them afford their medications.

Here are some programs that are not offered by Janssen. Each program has its own eligibility rules.

Take a look and see which ones may be right for your patients.

State-Sponsored Programs
Some states have financial assistance programs, each with its own eligibility requirements. Find out if your state has a program that can help your patients.
Medicaid
Some of your patients may qualify for free or low-cost health coverage. Certain states have even expanded their Medicaid programs to cover all people with incomes below a certain level.
Patients Looking for Coverage?
The Health Insurance Marketplace may have a plan that is right for your patient. Some patients may qualify for savings on premiums.
Janssen CarePath Savings Program for ZYTIGA®
Eligible patients pay as little as
$10
per month
Your eligible patients with commercial or private insurance pay as little as $10 per month for their ZYTIGA® medication

There is a limit to savings each year. Savings may apply to co-pay, co-insurance, or deductible. 

Patients may participate without sharing their income information. Offer not valid in CA or MA or for prescriptions filled in CA or MA.

We provide cost support directly to patients through the Janssen CarePath Savings Program. This benefit is intended to help eligible patients afford their out-of-pocket obligations as set by their health plans. The cost support is meant solely for patients—not health plans and/or their partners.

If your patients are having any difficulty accessing cost support through the Janssen CarePath Savings Program, please have them contact us at 877-CarePath (877-227-3728).

Sign your patients up for the Janssen CarePath Savings Program only or create a Provider Portal account.
Janssen CarePath Savings Program Savings Program Only
Janssen CarePath Provider Portal Provider Portal
Sign Patients Up for the Janssen CarePath Savings Program and Get a Savings Card
 
 
View Savings Program Transactions
 
 
Requires Business Associate Agreement / Patient Authorizations
 
 
Get Benefits Investigations
 
 
Get Prior Authorization Support
 
 
Create Medical Necessity Letters
 
 
Request Exceptions and Appeals Information
 
 
View Patient Dashboard
 
 
Get Timely Notifications
 
 
24-hour Online Access to Your Account
 
 
Get Started with the Option That Works Best for You and Your Patients
Sign your patients up for the Janssen CarePath Savings Program only or create a Provider Portal account.
Janssen CarePath Savings Program
  • Sign Patients Up for the Janssen CarePath Savings Program and Get a Savings Card

Sign Up for the Savings Program Only

Janssen CarePath Provider Portal
  • Sign Patients Up for the Janssen CarePath Savings Program and Get a Savings Card
  • View Savings Program Transactions
  • Requires Business Associate Agreement / Patient Authorizations
  • Get Benefits Investigations
  • Get Prior Authorization Support
  • Create Medical Necessity Letters
  • Request Exceptions and Appeals Information
  • View Patient Dashboard
  • Get Timely Notifications
  • 24-hour Online Access to Your Account

Create a Provider Portal Account

In addition to the Janssen CarePath Savings Program, here are some independent programs that may be right for your patients.

State-Sponsored Programs
Some states have financial assistance programs, each with its own eligibility requirements. Find out if your state has a program that can help your patients.
Medicare Savings Program
Many states have programs that offer support for people with limited income and resources. They may help with Medicare premiums, deductibles, and co-insurance.
Medicare Part D Extra Help — Low-Income Subsidy
This program gives "extra help" to patients with limited income and resources. It can help them:
  • Pay their monthly premiums
  • Reduce or eliminate their deductible
  • Reduce or eliminate their co-insurance and co-payments
  • Have no gap in coverage
Medicaid
Some of your patients may qualify for free or low-cost health coverage. Certain states have even expanded their Medicaid programs to cover all people with incomes below a certain level.
Patients Looking for Coverage?
The Health Insurance Marketplace may have a plan that is right for your patient. Some patients may qualify for savings on premiums.
Independent Co-Pay Assistance Foundations
Learn about foundations that may be able to help your patients. We have listed programs that give support to patients with a condition treated by this medication. There may be others that can help that are not listed here. These foundations are independent and have their own rules for eligibility, which are subject to change. We have no control over these foundations. We do not endorse any particular foundation.

Important Safety Information For

  • ZYTIGA®

    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) 

    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-54013v5

    INDICATION

IMPORTANT SAFETY INFORMATION

INDICATIONS

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INDICATIONS

IMPORTANT SAFETY INFORMATION