• INTELENCE® (etravirine)

    INTELENCE® (etravirine), in combination with other antiretroviral (ARV) agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in ARV treatment-experienced adults and pediatric patients ages 2 years and older.

    WARNINGS & PRECAUTIONS

    • Severe Skin and Hypersensitivity Reactions:
      • Severe, potentially life-threatening, and fatal skin reactions have been reported in patients taking INTELENCE®. In clinical trials, these include cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme.
      • Stevens-Johnson syndrome was reported in 1.1% (2/177) of pediatric patients less than 18 years of age receiving INTELENCE® in combination with other HIV-1 ARV agents in an observational study.
      • Hypersensitivity reactions including Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) have also been reported and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including hepatic failure.

      Discontinue INTELENCE® immediately if signs or symptoms of severe skin reactions or hypersensitivity reactions develop (including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, hepatitis, eosinophilia, or angioedema).

      • Monitor clinical status including liver transaminases, and initiate appropriate therapy.
      • Delay in stopping INTELENCE® treatment after the onset of severe rash may result in a life-threatening reaction.
    • Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions:
      • The concomitant use of INTELENCE® and other drugs may result in potentially significant drug interactions, some of which may lead to the loss of therapeutic effect of INTELENCE® and possible development of resistance or possible clinically significant adverse reactions from greater exposures of INTELENCE® or concomitant drugs.
      • Consult the full Prescribing Information for potential drug interactions prior to and during INTELENCE® therapy; review concomitant medications during INTELENCE® therapy.
    • Immune Reconstitution Syndrome has been reported in patients treated with ARV therapy, including INTELENCE®. 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.
    • Fat Redistribution: Redistribution and/or accumulation of body fat have been observed in patients receiving ARV therapy. The causal relationship, mechanism, and long-term consequences of these events have not been established.

    ADVERSE REACTIONS

    • The most common adverse drug reactions (≥2%) of at least moderate intensity (≥Grade 2) reported in adult patients taking INTELENCE® and that occurred at a higher rate compared with placebo were rash (10% vs 3%) and peripheral neuropathy (4% vs 2%). The most common adverse drug reactions in at least 2% of pediatric subjects were rash and diarrhea.

    DRUG INTERACTIONS

    • Consult the full Prescribing Information for INTELENCE® for more information on significant drug interactions, including clinical comments.
    • Etravirine is an inducer of CYP3A and inhibitor of CYP2C9, CYP2C19 and P‑glycoprotein (P-gp). Therefore, co‑administration of INTELENCE® and drugs that are substrates of CYP3A, CYP2C9 and CYP2C19 or are transported by P-gp may alter the therapeutic effect or adverse reaction profile of the co‑administered drug(s).

    USE IN SPECIFIC POPULATIONS

    • Lactation: Breastfeeding is not recommended due to the potential for HIV-1 transmission. Patients should not breastfeed if they are receiving INTELENCE®.
    • Hepatic Impairment: INTELENCE® should be used with caution in patients with severe hepatic impairment (Child-Pugh Class C) as pharmacokinetics of INTELENCE® have not been evaluated in these patients.
    • Pediatric Use: In clinical trials, the safety, pharmacokinetics, and efficacy were comparable to that observed in adults except for rash (greater than or equal to Grade 2) which was observed more frequently in pediatric subjects. Postmarketing reports of Stevens-Johnson syndrome in pediatric patients receiving INTELENCE® have been reported (see Warnings & Precautions).

    Please see full Prescribing Information for INTELENCE®.

    cp-63695v3

    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/INTELENCE-pi.pdf
    https://www.janssenlabels.com/package-insert/product-patient-information/INTELENCE-ppi.pdf

Helping Patients Afford INTELENCE®

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

Helping Patients Afford INTELENCE®

Janssen CarePath can help you find out what affordability assistance may be available for your patients taking INTELENCE®. 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 INTELENCE®
Eligible patients pay as little as
$0
per fill
Your eligible patients with commercial or private insurance pay as little as $0 per fill for their INTELENCE® 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.

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.
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.

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.

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).

Janssen CarePath Savings Program for INTELENCE®
Eligible patients pay as little as
$0
per fill
Your eligible patients with commercial or private insurance pay as little as $0 per fill for their INTELENCE® 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.

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.

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.

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).

Important Safety Information For

  • INTELENCE®

    INTELENCE® (etravirine), in combination with other antiretroviral (ARV) agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in ARV treatment-experienced adults and pediatric patients ages 2 years and older.

    WARNINGS & PRECAUTIONS

    • Severe Skin and Hypersensitivity Reactions:
      • Severe, potentially life-threatening, and fatal skin reactions have been reported in patients taking INTELENCE®. In clinical trials, these include cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme.
      • Stevens-Johnson syndrome was reported in 1.1% (2/177) of pediatric patients less than 18 years of age receiving INTELENCE® in combination with other HIV-1 ARV agents in an observational study.
      • Hypersensitivity reactions including Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) have also been reported and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including hepatic failure.

      Discontinue INTELENCE® immediately if signs or symptoms of severe skin reactions or hypersensitivity reactions develop (including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, hepatitis, eosinophilia, or angioedema).

      • Monitor clinical status including liver transaminases, and initiate appropriate therapy.
      • Delay in stopping INTELENCE® treatment after the onset of severe rash may result in a life-threatening reaction.
    • Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions:
      • The concomitant use of INTELENCE® and other drugs may result in potentially significant drug interactions, some of which may lead to the loss of therapeutic effect of INTELENCE® and possible development of resistance or possible clinically significant adverse reactions from greater exposures of INTELENCE® or concomitant drugs.
      • Consult the full Prescribing Information for potential drug interactions prior to and during INTELENCE® therapy; review concomitant medications during INTELENCE® therapy.
    • Immune Reconstitution Syndrome has been reported in patients treated with ARV therapy, including INTELENCE®. 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.
    • Fat Redistribution: Redistribution and/or accumulation of body fat have been observed in patients receiving ARV therapy. The causal relationship, mechanism, and long-term consequences of these events have not been established.

    ADVERSE REACTIONS

    • The most common adverse drug reactions (≥2%) of at least moderate intensity (≥Grade 2) reported in adult patients taking INTELENCE® and that occurred at a higher rate compared with placebo were rash (10% vs 3%) and peripheral neuropathy (4% vs 2%). The most common adverse drug reactions in at least 2% of pediatric subjects were rash and diarrhea.

    DRUG INTERACTIONS

    • Consult the full Prescribing Information for INTELENCE® for more information on significant drug interactions, including clinical comments.
    • Etravirine is an inducer of CYP3A and inhibitor of CYP2C9, CYP2C19 and P‑glycoprotein (P-gp). Therefore, co‑administration of INTELENCE® and drugs that are substrates of CYP3A, CYP2C9 and CYP2C19 or are transported by P-gp may alter the therapeutic effect or adverse reaction profile of the co‑administered drug(s).

    USE IN SPECIFIC POPULATIONS

    • Lactation: Breastfeeding is not recommended due to the potential for HIV-1 transmission. Patients should not breastfeed if they are receiving INTELENCE®.
    • Hepatic Impairment: INTELENCE® should be used with caution in patients with severe hepatic impairment (Child-Pugh Class C) as pharmacokinetics of INTELENCE® have not been evaluated in these patients.
    • Pediatric Use: In clinical trials, the safety, pharmacokinetics, and efficacy were comparable to that observed in adults except for rash (greater than or equal to Grade 2) which was observed more frequently in pediatric subjects. Postmarketing reports of Stevens-Johnson syndrome in pediatric patients receiving INTELENCE® have been reported (see Warnings & Precautions).

    Please see full Prescribing Information for INTELENCE®.

    cp-63695v3

    INDICATION

IMPORTANT SAFETY INFORMATION

INDICATIONS

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INDICATIONS

IMPORTANT SAFETY INFORMATION