Helping Patients Afford ZYTIGA®
Helping Patients Afford ZYTIGA®
Janssen CarePath can help you find out what affordability assistance may be available for your patients taking ZYTIGA®. You may download the Affordability Options for ZYTIGA® resource for your patients to help them learn about cost support options.
Support for Patients Using Commercial or Private Insurance to Pay for Medication
Janssen CarePath Savings Program for ZYTIGA® can help eligible patients receive instant savings on their out-of-pocket medication costs for ZYTIGA®. Depending on the patient's health insurance plan, savings may apply toward co-pay, co-insurance, or deductible. Your eligible patients will pay $10 per month with a $12,000 maximum program benefit per calendar year or one-year supply, whichever comes first. Not valid for patients using Medicare, Medicaid, or other government-funded programs to pay for their medications. Terms expire at the end of each calendar year and may change. Offer not valid in CA or MA or for MA residents. There is no income requirement. See full eligibility requirements.
Two ways to help get your patients started:
In the Janssen CarePath Provider Portal, you can enroll your eligible patients in the Janssen CarePath Savings Program, print a card, review your patients' available benefits, view patient transactions, and receive timely alerts and program updates. You can also request and review benefits investigations, and request prior authorization or appeals support.
Already registered? Log In
If you just want to check your patients' eligibility and enroll them in the Janssen CarePath Savings Program for ZYTIGA®, visit JanssenCarePathPortal.com/express. There is a "Print a Card" feature to provide the patient with a Savings Program card.
If your patient's pharmacy is unable to process their Savings Program card, your patient can complete, sign and return the rebate form, with the required proof of purchase, to receive a rebate check from the Janssen CarePath Savings Program. Click here to get the rebate form for your patient. Your patient can also request a rebate online in their Janssen CarePath Account.
By using the Janssen CarePath Provider Portal, you agree that you are receiving access to information about your patient's Savings Program account to assist in program administration as requested by the patient. You further agree that access to this information will not influence your clinical decisions.
Patients can also create their own Janssen CarePath Account where they can enroll in the Janssen CarePath Savings Program, learn about their insurance coverage for ZYTIGA®, and sign up for personalized treatment reminders. Encourage your patient to sign up today at MyJanssenCarePath.com.
Support for Patients Using Government-Funded Healthcare Programs or Patients Without Health Coverage
Janssen CarePath can provide information about other resources that may be able to help your patients with their out-of-pocket medication costs:
- State Pharmaceutical Assistance Programs (SPAPs)
- State Health Insurance Programs (SHIPs)
- Medicare Savings Program
- Medicare Part D Extra Help—Low-Income Subsidy
- Independent Foundations*
Call Janssen CarePath at 877-CarePath (877-227-3728) or visit JanssenPrescriptionAssistance.com for more information on affordability programs that may be available.
*Independent co-pay assistance foundations have their own rules for eligibility. We have no control over these independent foundations and can only refer your patients to a foundation that supports their disease state. We do not endorse any particular foundation.
The Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF) is an independent, nonprofit organization that is committed to helping eligible patients without insurance coverage receive prescription products donated by Johnson & Johnson operating companies. To see if they might qualify for assistance, please have your patient contact a JJPAF program specialist at 800-652-6227 (Monday–Friday, 9:00 AM to 6:00 PM ET) or visit the foundation website at JJPAF.org.
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 2.5X ULN and total bilirubin less than or equal to 1.5X ULN [see Dosage and Administration (2.4)].
Permanently discontinue ZYTIGA® for patients who develop a concurrent elevation of ALT greater than 3X ULN and total bilirubin greater than 2X 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 20X ULN and/or bilirubin greater than or equal to 10X 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 - 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.
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 (2.3)]. 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 >5X ULN or total bilirubin >3X 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)].