ERLEADA® (apalutamide) HCP

Janssen CarePath is your one source for access, affordability, and treatment support for your patients

Access support to help navigate payer processes

Janssen CarePath helps verify insurance coverage for your patients taking ERLEADA^® and provides reimbursement information. Our offerings include:

Benefits investigation support
Prior authorization support and status monitoring
Information on the exceptions and appeals process
Coding and billing information, if needed
Triage to specialty pharmacy providers, if needed
Provider Portal at JanssenCarePathPortal.com for online benefits investigation, prior authorization support, and other resources
- Online Secure Messaging to ask a question, request a status update, or send missing information related to an existing case

Affordability support to help your patients start and stay on treatment you prescribe

Janssen CarePath can help you find out what affordability assistance may be available for your patients taking ERLEADA^®:

Support for patients using commercial or private insurance:

Janssen CarePath Savings Program for ERLEADA^® allows eligible patients to save on their out-of-pocket medication costs. Depending on the patient's health insurance plan, savings may apply toward co-pay, co-insurance, or deductible.

Janssen Carepath savings program co pay card

Eligible patients pay $0 per month with a $15,000 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. There is no income requirement. See full eligibility requirements at Erleada.JanssenCarePathSavings.com

Online enrollment and tracking of patient Savings Program benefits by you, the pharmacy, or the patient

Comprehensive Provider Portal at JanssenCarePathPortal.com allows you to enroll eligible patients in Savings Programs, view patients' available benefit and transactions as requested by the patient, and receive timely alerts and program updates
If you just want to check eligibility and enroll patients in the Janssen CarePath Savings Program for ERLEADA^®, visit the Express Enrollment site at JanssenCarePathPortal.com/express. You will not have a Janssen CarePath account and you will not be able to view patients’ Savings Program benefits at this site
Patients can manage Savings Program benefits and more on their Janssen CarePath Account at MyJanssenCarePath.com

Support for patients using government-funded healthcare programs or patients without insurance coverage:

Janssen CarePath can provide information about other resources that may be able to help your patients with their out-of-pocket medication costs, including:
- State Pharmaceutical Assistance Programs (SPAPs)
- State Health Insurance Programs (SHIPs)
- Medicare Savings Program
- Medicare Part D Extra Help—Low-Income Subsidy
- Independent Foundations*
Call a Janssen CarePath Care Coordinator 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.

Treatment support to help your patients get informed and stay on prescribed treatment

Janssen CarePath provides additional support to your patients taking ERLEADA^®, including:

Education tools

Patient education brochures
Web-based resources
Information about Advocacy Connector, a Janssen-sponsored resource that connects patients and caregivers to national and state-specific advocacy groups that offer resources relevant to oncology

Adherence tools

Appointment reminders
Prescription refill reminders for ERLEADA^®

Call a Janssen CarePath Care Coordinator at

877-CarePath (877-227-3728),

Monday-Friday, 8:00 _AM to 8:00 _PM ET.

Multilingual phone support available.

JanssenCarePathPortal.com

Visit

JanssenCarePath.com

Other Resources

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.

Patient insurance benefits investigation and other Janssen CarePath program offerings are provided by third-party service providers for Janssen CarePath, under contract with Johnson & Johnson Health Care Systems Inc. on behalf of Janssen Pharmaceuticals, Inc., Janssen Biotech, Inc., and Janssen Products, LP (Janssen). Janssen CarePath is not available to patients participating in the Patient Assistance Program offered by Johnson & Johnson Patient Assistance Foundation. The availability of information and assistance may vary based on the Janssen medication, geography and other program differences. Janssen CarePath assists healthcare providers (HCPs) in the determination of whether treatment could be covered by the applicable third-party payer based on coverage guidelines provided by the payer, and patient information provided by the healthcare provider under appropriate authorization following the provider’s exclusive determination of medical necessity. This information and assistance are made available as a convenience to patients, and there is no requirement that patients or HCPs use any Janssen product in exchange for this information or assistance. Janssen assumes no responsibility for and does not guarantee the quality, scope, or availability of the information and assistance provided. The third-party service providers, not Janssen, are responsible for the information and assistance provided under this program. Each HCP and patient is responsible for verifying or confirming any information provided. All claims and other submissions to payers should be in compliance with all applicable requirements.

Download a list of specialty pharmacies that distribute ERLEADA^®.

WARNINGS AND PRECAUTIONS

Cerebrovascular and Ischemic Cardiovascular Events — In a randomized study (SPARTAN) of patients with nmCRPC, ischemic cardiovascular events occurred in 4% of patients treated with ERLEADA^® and 3% of patients treated with placebo. In a randomized study (TITAN) in patients with mCSPC, ischemic cardiovascular events occurred in 4% of patients treated with ERLEADA^® and 2% of patients treated with placebo. Across the SPARTAN and TITAN studies, 5 patients (0.5%) treated with ERLEADA^® and 2 patients (0.2%) treated with placebo died from an ischemic cardiovascular event. Patients with history of unstable angina, myocardial infarction, congestive heart failure, stroke, or transient ischemic attack within 6 months of randomization were excluded from the SPARTAN and TITAN studies.

In the SPARTAN study, cerebrovascular events occurred in 4.7% of patients treated with ERLEADA^® and 0.8% of patients treated with placebo. In the TITAN study, cerebrovascular events occurred in 1.9% of patients treated with ERLEADA^® and 2.1% of patients treated with placebo. Across the SPARTAN and TITAN studies, 3 patients (0.2%) treated with ERLEADA^®, and 2 patients (0.2%) treated with placebo died from a cerebrovascular event.

Cerebrovascular and ischemic cardiovascular events, including events leading to death, occurred in patients receiving ERLEADA^®. Monitor for signs and symptoms of ischemic heart disease and cerebrovascular disorders. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Consider discontinuation of ERLEADA^® for Grade 3 and 4 events.

Fractures — In a randomized study (SPARTAN) of patients with nmCRPC, fractures occurred in 12% of patients treated with ERLEADA^® and in 7% of patients treated with placebo. In a randomized study (TITAN) of patients with mCSPC, fractures occurred in 9% of patients treated with ERLEADA^® and in 6% of patients treated with placebo. Evaluate patients for fracture risk. Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone-targeted agents.

Falls — In a randomized study (SPARTAN), falls occurred in 16% of patients treated with ERLEADA^® compared with 9% of patients treated with placebo. Falls were not associated with loss of consciousness or seizure. Falls occurred in patients receiving ERLEADA^® with increased frequency in the elderly. Evaluate patients for fall risk.

Seizure — In two randomized studies (SPARTAN and TITAN), 5 patients (0.4%) treated with ERLEADA^® and 1 patient treated with placebo (0.1%) experienced a seizure. Permanently discontinue ERLEADA^® in patients who develop a seizure during treatment. It is unknown whether anti-epileptic medications will prevent seizures with ERLEADA^®. Advise patients of the risk of developing a seizure while receiving ERLEADA^® and of engaging in any activity where sudden loss of consciousness could cause harm to themselves or others.

Embryo-Fetal Toxicity — The safety and efficacy of ERLEADA^® have not been established in females. Based on its mechanism of action, ERLEADA^® 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 and for 3 months after the last dose of ERLEADA^®[see Use in Specific Populations (8.1, 8.3)].

ADVERSE REACTIONS

Adverse Reactions — The most common adverse reactions (≥10%) that occurred more frequently in the ERLEADA^®-treated patients (≥2% over placebo) from the randomized placebo-controlled clinical trials (TITAN and SPARTAN) were fatigue, arthralgia, rash, decreased appetite, fall, weight decreased, hypertension, hot flush, diarrhea, and fracture.

Laboratory Abnormalities — All Grades (Grade 3-4)

Hematology — In the TITAN study: white blood cell decreased ERLEADA^® 27% (0.4%), placebo 19% (0.6%). In the SPARTAN study: anemia ERLEADA^® 70% (0.4%), placebo 64% (0.5%); leukopenia ERLEADA^® 47% (0.3%), placebo 29% (0%); lymphopenia ERLEADA^® 41% (2%), placebo 21% (2%)
Chemistry — In the TITAN study: hypertriglyceridemia ERLEADA^® 17% (3%), placebo 12% (2%). In the SPARTAN study: hypercholesterolemia ERLEADA^® 76% (0.1%), placebo 46% (0%); hyperglycemia ERLEADA^® 70% (2%), placebo 59% (1%); hypertriglyceridemia ERLEADA^® 67% (2%), placebo 49% (0.8%); hyperkalemia ERLEADA^® 32% (2%), placebo 22% (0.5%)

Rash — In 2 randomized studies (SPARTAN and TITAN), rash was most commonly described as macular or maculopapular. Adverse reactions of rash were 26% with ERLEADA^® vs 8% with placebo. Grade 3 rashes (defined as covering >30% body surface area [BSA]) were reported with ERLEADA^® treatment (6%) vs placebo (0.5%).

The onset of rash occurred at a median of 83 days. Rash resolved in 78% of patients within a median of 78 days from onset of rash. Rash was commonly managed with oral antihistamines, topical corticosteroids, and 19% of patients received systemic corticosteroids. Dose reduction or dose interruption occurred in 14% and 28% of patients, respectively. Of the patients who had dose interruption, 59% experienced recurrence of rash upon reintroduction of ERLEADA^®.

Hypothyroidism — In 2 randomized studies (SPARTAN and TITAN), hypothyroidism was reported for 8% of patients treated with ERLEADA^® and 2% of patients treated with placebo based on assessments of thyroid-stimulating hormone (TSH) every 4 months. Elevated TSH occurred in 25% of patients treated with ERLEADA^® and 7% of patients treated with placebo. The median onset was at the first scheduled assessment. There were no Grade 3 or 4 adverse reactions. Thyroid replacement therapy, when clinically indicated, should be initiated or dose-adjusted.

DRUG INTERACTIONS

Effect of Other Drugs on ERLEADA^® — Co-administration of a strong CYP2C8 or CYP3A4 inhibitor is predicted to increase the steady-state exposure of the active moieties. No initial dose adjustment is necessary; however, reduce the ERLEADA^® dose based on tolerability [see Dosage and Administration (2.2)].

Effect of ERLEADA^® on Other Drugs

CYP3A4, CYP2C9, CYP2C19, and UGT Substrates — ERLEADA^® is a strong inducer of CYP3A4 and CYP2C19, and a weak inducer of CYP2C9 in humans. Concomitant use of ERLEADA^® with medications that are primarily metabolized by CYP3A4, CYP2C19, or CYP2C9 can result in lower exposure to these medications. Substitution for these medications is recommended when possible or evaluate for loss of activity if medication is continued. Concomitant administration of ERLEADA^® with medications that are substrates of UDP-glucuronosyl transferase (UGT) can result in decreased exposure. Use caution if substrates of UGT must be co-administered with ERLEADA^® and evaluate for loss of activity.

P-gp, BCRP, or OATP1B1 Substrates — Apalutamide is a weak inducer of P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), and organic anion transporting polypeptide 1B1 (OATP1B1) clinically. Concomitant use of ERLEADA^® with medications that are substrates of P-gp, BCRP, or OATP1B1 can result in lower exposure of these medications. Use caution if substrates of P-gp, BCRP, or OATP1B1 must be co-administered with ERLEADA^® and evaluate for loss of activity if medication is continued.

Please see the full Prescribing Information for ERLEADA^®.

cp-50507v3

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Access and Affordability

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Janssen CarePath

Janssen CarePath is your one source for access, affordability, and treatment support for your patients

Support for patients using commercial or private insurance:

Support for patients using government-funded healthcare programs or patients without insurance coverage:

DOSING

PATIENT RESOURCES

PRACTICE RESOURCES

You are leaving the HCP website

Locate a Representative

Request Samples

Register for Updates

Frequently Asked Questions

Access and Affordability

Patient Resources

Useful Tools & Info

Janssen CarePath

Janssen CarePath is your one source for access, affordability, and treatment support for your patients

Support for patients using commercial or private insurance:

Support for patients using government-funded healthcare programs or patients without insurance coverage:

DOSING

PATIENT RESOURCES

PRACTICE RESOURCES

You are leaving the HCP website

Useful Tools & Info