ERLEADA™ Patient Support

Supporting Treatment

Helping you help your patients get started with ERLEADA™ treatment as prescribed and supporting them along the way

Once you've determined that ERLEADA™ is right for your patients, we're committed to helping them get started on treatment and stay on track.

We understand how important it is for your patients to take their ERLEADA™ medication just as you've prescribed. Janssen CarePath provides ongoing support to help your patients stay on track with their ERLEADA™ treatment.

Janssen CarePath Account

Your patients can Sign Up or Log In to their personal Janssen CarePath Account so they can learn about support resources, get answers to questions about their insurance coverage, find affordability programs, and more.

Support

Janssen CarePath offers additional support to keep your patients informed about ERLEADA™ and provides ongoing resources and services to help them stay on track with their ERLEADA™ treatment as you've prescribed. We offer:

  • Access to nurses who can answer your patients' questions about ERLEADA™*
  • Personalized, live refill reminder calls
  • Resources and techniques to help your patients cope with stress
  • Tools to help them make healthy lifestyle choices

*The nurse program is limited to education for patients about their Janssen therapy, its administration, and/or their disease, and is not intended to provide medical advice, replace a treatment plan from the patient's doctor or nurse, or provide case management services.

Specialty Pharmacy and Specialty Distributor Options

ERLEADA™ is available through a limited distribution network of authorized specialty distributors and specialty pharmacy providers.

You can order ERLEADA™ for your office or hospital from an authorized specialty distributor, or Janssen CarePath can connect you to a specialty pharmacy provider who can ship EARLEADA™ directly to your patients.

Click here to identify specialty distributors authorized to sell ERLEADA™ and specialty pharmacy providers within ERLEADA™ limited distribution network.

Tools to help your patients track and meet their health and wellness goals

Care4Today® Connect is a helpful medication and appointment tracking and reminder tool designed to empower users to take an active role in their own health care. This application can enable users to track key health measures, providing support and motivation in between doctor visits in the following ways:

  • Delivers medication, medication refill, and appointment reminders
  • Enables users to record information such as exercise, etc.
  • Users can share self-reported data with healthcare professionals

Janssen Biotech, Inc., the maker of ERLEADA™, does not endorse and is not responsible for the content of the Web site listed below, or the services provided by this organization. Clicking on the link below will take you to a Web site to which our Privacy Policy does not apply. We encourage you to read the Privacy Policy of every Web site you visit.

Advocacy Connector

AdvocacyConnector.com
This Web site connects patients and caregivers to national and state-specific advocacy groups relevant to oncology.

Indication

ERLEADA™ (apalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer.

Important Safety Information For ERLEADA

CONTRAINDICATIONS

Pregnancy — ERLEADA™ (apalutamide) can cause fetal harm and potential loss of pregnancy.

WARNINGS AND PRECAUTIONS

Falls and Fractures In a randomized study (SPARTAN), falls and fractures occurred in 16% and 12% of patients treated with ERLEADA™ compared to 9% and 7% treated with placebo, respectively. Falls were not associated with loss of consciousness or seizure. Evaluate patients for fracture and fall risk. Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone targeted agents.

Seizure —  In a randomized study (SPARTAN), 2 patients (0.2%) treated with ERLEADA™ 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.

ADVERSE REACTIONS

Adverse Reactions —  The most common adverse reactions (≥10%) were fatigue, hypertension, rash, diarrhea, nausea, weight decreased, arthralgia, fall, hot flush, decreased appetite, fracture, and peripheral edema.

Laboratory Abnormalities — All Grades (Grade 3-4)

  • Hematology —  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 — 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 — Rash was most commonly described as macular or maculo-papular. Adverse reactions  were 24% with ERLEADA™ versus 6% with placebo. Grade 3 rashes (defined as covering > 30% body surface area [BSA]) were reported with ERLEADA™ treatment (5%) versus placebo (0.3%).

The onset of rash occurred at a median of 82 days. Rash resolved in 81% of patients within a median of 60 days (range: 2 to 709 days) from onset of rash. Four percent of patients treated with ERLEADA™ received systemic corticosteroids. Rash recurred in approximately half of patients who were re-challenged with ERLEADA™.

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 day 113. 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 — 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™.

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