Helping Patients Afford EDURANT®

Helping Patients Afford EDURANT®

Janssen CarePath can help you find out what affordability assistance may be available for your patients taking EDURANT®. You may download the Affordability Options for EDURANT® resource for your patients to help them learn about cost support options.

Support for Patients Using Commercial or Private Insurance

Janssen CarePath Savings Program for EDURANT®

Janssen CarePath Savings Program may provide instant savings on your eligible patients' out-of-pocket costs for EDURANT®. Depending on their health insurance plan, savings may apply toward co-pay, co-insurance, or deductible. For EDURANT® (rilpivirine), your eligible patients will pay $0 per prescription fill, with a $7,500 maximum program benefit per calendar year. 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.

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 866-836-0114.

Two ways to help get your patients started:

If you only want to check your patients' eligibility and enroll them in the Janssen CarePath Savings Program for EDURANT®, click here for the Express Enrollment Site. There is a "Print a Card" feature to provide the patient with a Savings Program card. Your patients will not have a Janssen CarePath account and will not be able to view their Savings Program benefits.

OR

In the Janssen CarePath Provider Portal, you can enroll your eligible patients in the Janssen CarePath Savings Program, print a Savings Program 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.

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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 EDURANT®, and sign up for personalized treatment reminders. Encourage your patient to sign up today at MyJanssenCarePath.com.

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.

Support for Patients Using Government-Funded Healthcare Programs or Patients without Insurance Coverage

  • Click here for information on affordability programs and information about independent foundations* that may have funding available to help your patients with medication costs for Janssen medications.
  • Call Janssen CarePath at 877-CarePath (877-227-3728) to speak with a Care Coordinator about 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.

Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF)

The Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF) is an independent, nonprofit organization. JJPAF gives eligible patients free prescription medicines donated by Johnson & Johnson companies. Patients may be eligible if they don't have insurance, if their medicine is not covered by insurance, or if they have Medicare coverage and can't pay for their medicine.

Do you have patients who may need help? They can see if they are eligible and get an application at JJPAF.org or call 800-652-6227 (Monday through Friday, 8:00 AM to 8:00 PM ET).

Indication

Treatment of HIV-1 in Treatment-Naïve Patients

EDURANT® (rilpivirine), a non-nucleoside reverse transcriptase inhibitor (NNRTI), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve patients 12 years of age and older and weighing at least 35 kg with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy.

Limitations of Use:

  • More EDURANT®-treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure (HIV-1 RNA ≥50 copies/mL) compared to EDURANT®-treated subjects with HIV-1 RNA less than or equal to 100,000 copies/mL

Treatment of HIV-1 in Combination With Cabotegravir

EDURANT® is indicated in combination with VOCABRIA (oral cabotegravir) for short-term treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine, for use as:

  • Oral lead-in to assess the tolerability of rilpivirine prior to administration of rilpivirine extended-release injectable suspension, a component of CABENUVA (cabotegravir, rilpivirine) extended-release injectable suspensions
  • Oral therapy for patients who will miss planned injection dosing with CABENUVA (cabotegravir; rilpivirine) extended-release injectable suspensions
Important Safety Information

Contraindications

  • Coadministration of EDURANT® with the following drugs is contraindicated because significant decreases in rilpivirine plasma concentrations may occur due to CYP3A enzyme induction or gastric pH increase, which may result in loss of virologic response and possible resistance and cross-resistance: carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine, proton pump inhibitors such as esomeprazole, lansoprazole, omeprazole, pantoprazole, and rabeprazole, systemic dexamethasone (more than single dose), and products containing St. John’s wort (Hypericum perforatum)
  • Coadministration of rifabutin with cabotegravir [VOCABRIA (cabotegravir) tablets, CABENUVA (cabotegravir extended-release injectable suspension; rilpivirine extended-release injectable suspension), co-packaged for intramuscular use] is contraindicated. Consult the Prescribing Information for CABENUVA and VOCABRIA

Warnings and Precautions

  • Skin and Hypersensitivity Reactions: Severe skin and hypersensitivity reactions have been reported during the postmarketing experience, including cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), with rilpivirine-containing regimens. While some skin reactions were accompanied by constitutional symptoms such as fever, other skin reactions were associated with organ dysfunctions, including elevations in hepatic serum biochemistries. EDURANT® should be discontinued immediately if signs or symptoms of severe skin or hypersensitivity reactions develop, including but not limited to, severe rash or rash accompanied by fever, blisters, mucosal involvement, conjunctivitis, facial edema, angioedema, hepatitis or eosinophilia. Clinical status including laboratory parameters should be monitored and appropriate therapy should be initiated
  • Hepatotoxicity: Hepatic adverse events were reported. Patients with underlying hepatic disease, including hepatitis B or C, or marked elevations in transaminases before treatment may be at increased risk for worsening or development of transaminase elevations. Monitor liver function tests (LFTs) before and during treatment. A few hepatotoxicity cases occurred in patients with no pre-existing hepatic disease or other identifiable risk factors; therefore, monitoring of LFTs should be considered in all patients
  • Depressive Disorders: Severe depressive disorders, defined as depressed mood, depression, dysphoria, major depression, mood altered, negative thoughts, suicide attempt, and suicidal ideation, have been reported with EDURANT®. Immediate medical evaluation is recommended for severe depressive symptoms
  • Fat Redistribution: Redistribution and/or accumulation of body fat have been observed in patients receiving antiretroviral (ARV) therapy. The causal relationship, mechanism, and long-term consequences of these events have not been established
  • Immune Reconstitution Syndrome has been reported in patients treated with combination ARV therapy, including EDURANT®. Autoimmune disorders (such as Graves disease, polymyositis, Guillain-Barré syndrome and autoimmune hepatitis) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable and can occur many months after initiation of treatment

Drug Interactions

  • EDURANT® is primarily metabolized by cytochrome P450 (CYP)3A.
    • Coadministration of EDURANT® and drugs that induce CYP3A may result in decreased plasma concentrations, loss of virologic response and possible resistance to EDURANT® or to the class of NNRTIs
    • Coadministration of EDURANT® and drugs that inhibit CYP3A may result in increased plasma concentrations of rilpivirine
  • Coadministration of EDURANT® with drugs that increase gastric pH may result in decreased plasma concentrations, loss of virologic response and possible resistance to rilpivirine or to the class of NNRTIs
  • EDURANT® should be used with caution when coadministered with a drug with a known risk of Torsade de Pointes
  • EDURANT® should not be used in combination with NNRTIs

This is not a complete list of potential drug interactions.

Please see full Prescribing Information for more details.

Use in Specific Populations

  • Hepatic Impairment: No dosage adjustment of EDURANT® is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. EDURANT® has not been studied in patients with severe hepatic impairment (Child‑Pugh Class C)
  • Pregnancy: In a clinical trial, total rilpivirine exposures were generally lower during pregnancy compared to the postpartum period
  • Lactation: Women infected with HIV should be instructed not to breastfeed due to the potential for HIV transmission
  • Pediatric Use: Safety and effectiveness in pediatric patients less than 12 years of age or weighing less than 35 kg have not been established
  • Renal Impairment: Use with caution and with increased monitoring for adverse effects in patients with severe renal impairment or end-stage renal disease. EDURANT® concentrations may be increased due to alteration of drug absorption, distribution, and metabolism secondary to renal dysfunction. EDURANT® is highly bound to plasma proteins; it is unlikely that it will be significantly removed by hemodialysis or peritoneal dialysis
  • Geriatric Use: Clinical studies of EDURANT® did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, caution should be exercised in the administration and monitoring of EDURANT® in elderly patients reflecting the greater frequency of decreased renal and hepatic function, and of concomitant disease or other drug therapy

Adverse Reactions

  • The most common adverse drug reactions reported (incidence >2%) of at least moderate intensity (≥ Grade 2) in patients taking EDURANT® through 96 weeks were depressive disorders (5%), headache (3%), insomnia (3%), and rash (3%)

Please read the full Prescribing Information for EDURANT®.

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