Intelence®

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JanssenCarePathPortal.com

Provider Portal for online access to:

  • Benefits investigations
  • Prior authorizations
  • Enroll patients in Savings Program

Helping Patients Afford INTELENCE®

Support for Patients using Commercial or Private Insurance

Janssen CarePath Savings Program for INTELENCE®

The Janssen CarePath Savings Program may provide instant savings on your patients' out-of-pocket medication costs for INTELENCE®. Eligible patients will pay $0 each time they fill their prescription for a covered Janssen Therapeutics product. Program pays deductible, co-pay, and/or co-insurance up to a $7,500 maximum benefit per calendar year. Not valid for Medicaid, Medicare, or similar state or federal programs. Learn more about the Janssen CarePath Savings Program, including full eligibility requirements.

Get your patients started today:

In the Janssen CarePath Provider Portal, you can enroll your patients in the Janssen CarePath Savings Program. There is also a "Print a Card" feature on the Provider Portal if the patient needs a card.

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 INTELENCE®, 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 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 insurance or patients without insurance coverage

Janssen Prescription Assistance for INTELENCE®

JanssenPrescriptionAssistance.com provides information on affordability programs and up-to-date information about independent foundations that may have funding available to help you with medication costs for INTELENCE®.

Questions? Call a Janssen CarePath Care Coordinator at 877-CarePath (877-227-3728).

Other Resources

Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF) provides free prescription medications to eligible individuals without insurance coverage for their medications and those who do not have adequate financial resources to pay for them. To see if they might qualify for assistance, please have your patient contact a JJPAF program specialist at 1-800-652-6227 (9 AM to 6 PM ET) or visit the foundation Web site at www.JJPAF.org.

Indication Statement

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 patients ages 6 years and older, who have evidence of viral replication and HIV-1 strains resistant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) and other ARV agents.

The indication for adult use is based on Week 48 analyses from 2 randomized, double-blind, placebo-controlled trials of INTELENCE®. Both studies were conducted in clinically advanced, 3-class ARV (NNRTI, N[t]RTI, PI) treatment-experienced adults. The indication for pediatric use is based on 24-week analyses of a single arm, Phase 2 trial in ARV treatment-experienced pediatric subjects 6 years to less than 18 years of age.

In treatment-experienced adult and pediatric patients, the following points should be considered when initiating therapy with INTELENCE®:

  • Treatment history and resistance testing should guide the use of INTELENCE® due to concerns for potential cross-resistance
  • In patients who have experienced virologic failure on an NNRTI-containing regimen, do not use INTELENCE® in combination with only N[t]RTIs
  • The use of other active ARV agents with INTELENCE® is associated with an increased likelihood of treatment response
  • The safety and efficacy of INTELENCE® have not been established in pediatric patients less than 6 years of age or in treatment-naïve adult or pediatric patients
Important Safety Information For INTELENCE®

Warnings & Precautions

  • Severe Skin and Hypersensitivity Reactions:
    • Severe, potentially life-threatening, and fatal skin reactions have been reported in patients taking INTELENCE®. These include cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme
    • 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

    In the DUET studies, Grade 3 and 4 rashes were reported in 1.3% of patients receiving INTELENCE® compared to 0.2% of patients in the placebo arm. Discontinuation rate due to rash was 2.2% in patients taking INTELENCE®. In clinical trials of patients on INTELENCE®, the incidence of rash was higher in women compared to men. Rash occurred most commonly during the first 6 weeks of therapy. In the PIANO study of children ages 6 to ≤17 years of age, rash was seen more commonly than in adults and occurred in 15% (≥Grade 2) of pediatric subjects

    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
  • 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
  • Immune Reconstitution Syndrome has been reported in patients treated with ARV therapy, including INTELENCE®. Autoimmune disorders (such as Graves' disease, polymyositis, and Guillain-Barré syndrome) 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

Use in Specific Populations

  • 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
  • Pregnancy Category B: INTELENCE® should be used during pregnancy only if the potential benefit justifies the potential risk. No adequate and well-controlled studies have been conducted in pregnant women

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

  • INTELENCE® should not be coadministered with the following ARVs: fosamprenavir/ritonavir, tipranavir/ritonavir, full-dose ritonavir (600 mg bid), PIs administered without low-dose ritonavir, and other NNRTIs
  • INTELENCE® should only be used with dolutegravir when coadministered with atazanavir/ritonavir, darunavir/ritonavir, or lopinavir/ritonavir. INTELENCE® should not be coadministered with dolutegravir in the absence of a boosted PI. INTELENCE® significantly reduces plasma concentrations of dolutegravir
  • INTELENCE® should not be coadministered with carbamazepine, phenobarbital, phenytoin, rifampin, rifapentine, rifabutin (when part of a regimen containing PI/ritonavir), or products containing St. John’s wort (Hypericum perforatum)
  • Caution should be used when prescribing agents such as substrates, inhibitors, or inducers of CYP3A, CYP2C9, CYP2C19, and/or P-glycoprotein in patients receiving INTELENCE® as it may alter the therapeutic effect or adverse reaction profile of INTELENCE® or the coadministered drug(s)

This is not a complete list of potential drug interactions.

Please see full Prescribing Information for more details.

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