Helping Patients Afford PREZISTA®
Helping Patients Afford PREZISTA®
Janssen CarePath can help you find out what affordability assistance may be available for your patients taking PREZISTA®. You may download the Affordability Options for PREZISTA® 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 PREZISTA®
Janssen CarePath Savings Program may provide instant savings on your eligible patients' out-of-pocket costs for PREZISTA®. Depending on their health insurance plan, savings may apply toward co-pay, co-insurance, or deductible. For PREZISTA® (darunavir), 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 PREZISTA®, 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.
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.
Already registered? Log In
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 PREZISTA®, 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.
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).
PREZISTA® (darunavir), coadministered with ritonavir (PREZISTA®/r), in combination with other antiretroviral agents (ARVs), is indicated for the treatment of Human Immunodeficiency Virus (HIV-1) infection in adult patients.
Co-administration of PREZISTA®/ritonavir (PREZISTA®/r) is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. Examples of these drugs and other contraindicated drugs (which may lead to reduced efficacy of darunavir) are listed below. Due to the need for co-administration of PREZISTA® with ritonavir, please refer to ritonavir Prescribing Information for a description of ritonavir contraindications.
- alfuzosin, colchicine (in patients with renal and/or hepatic impairment), dihydroergotamine, dronedarone, elbasvir/grazoprevir, ergotamine, ivabradine, lomitapide, lovastatin, lurasidone, methylergonovine, oral midazolam, naloxegol, pimozide, ranolazine, rifampin, St. John’s wort (Hypericum perforatum), sildenafil (for the treatment of pulmonary arterial hypertension), simvastatin, and triazolam.
Warnings & Precautions
- PREZISTA® must be coadministered with ritonavir and food to achieve the desired antiviral effect. Failure to administer PREZISTA® with ritonavir and food may result in a loss of efficacy of darunavir.
Hepatotoxicity: Drug-induced hepatitis has been reported with PREZISTA®/r. During the clinical development program (N=3063), hepatitis has been reported in 0.5% of patients receiving combination therapy with PREZISTA®/r. Patients with preexisting liver dysfunction, including chronic active hepatitis B or C, have an increased risk for liver function abnormalities, including severe hepatic adverse reactions.
Post-marketing cases of liver injury, including some fatalities, have been reported. A causal relationship with PREZISTA®/r therapy has not been established.
Appropriate laboratory testing should be conducted prior to initiating therapy with PREZISTA®/r and patients should be monitored during treatment. Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pretreatment elevations of transaminases, especially during the first several months of PREZISTA®/r treatment. Evidence of new or worsening liver dysfunction (including clinically significant elevation of liver enzymes and/or symptoms such as fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, hepatomegaly) in patients on PREZISTA®/r should prompt consideration of interruption or discontinuation of treatment.
Severe Skin Reactions: Severe skin reactions (0.4%), accompanied by fever and/or elevations of transaminases in some cases, and Stevens-Johnson Syndrome (<0.1%) have been reported in patients receiving PREZISTA®/r. During post-marketing experience, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms, and acute generalized exanthematous pustulosis have been reported in patients receiving PREZISTA®/r. Discontinue PREZISTA®/r immediately if signs or symptoms of severe skin reactions develop (including, but not limited to, severe rash or rash accompanied with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis, and/or eosinophilia).
In clinical trials (N=3063), rash (all grades, generally mild to moderate, regardless of causality) occurred in 10.3% of patients receiving PREZISTA®/r. Discontinuation due to rash was 0.5%.
Rash occurred more commonly in treatment-experienced subjects receiving regimens containing PREZISTA®/r + raltegravir compared to subjects receiving either drug regimen alone. However, rash that was considered drug-related occurred at similar rates. These rashes were mild to moderate in severity and did not limit therapy; there were no discontinuations due to rash.
- Sulfa Allergy: PREZISTA® should be used with caution in patients with known sulfonamide allergy.
Risk of Serious Adverse Reactions Due to Drug Interactions: Initiation of PREZISTA®/r, a CYP3A inhibitor, in patients receiving medications metabolized by CYP3A or initiation of medications metabolized by CYP3A in patients already receiving PREZISTA®/r, may increase plasma concentrations of medications metabolized by CYP3A and reduce plasma concentrations of active metabolite(s) formed by CYP3A. Initiation of medications that inhibit or induce CYP3A may increase or decrease concentrations of PREZISTA®/r, respectively. These interactions may lead to:
- Clinically significant adverse reactions, potentially leading to severe, life-threatening, or fatal events from greater exposures of concomitant medications.
- Clinically significant adverse reactions from greater exposures of PREZISTA®/r.
- Loss of therapeutic effect of the concomitant medications from lower exposures of active metabolite(s).
- Loss of therapeutic effect of PREZISTA®/r and possible development of resistance from lower exposures of PREZISTA®/r.
Consider the potential for drug interactions prior to and during PREZISTA®/r therapy, review concomitant medications during PREZISTA®/r therapy, and monitor for the adverse reactions associated with the concomitant drugs.
- Diabetes Mellitus/Hyperglycemia and Hemophilia: New-onset or exacerbations of preexisting diabetes mellitus, hyperglycemia, and increased bleeding in hemophiliacs have been reported in patients receiving protease inhibitors. Initiation or dose adjustments of insulin or oral hypoglycemic agents may be required. A causal relationship between protease inhibitors and these events has not been established.
- 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: Patients receiving PREZISTA®/r may develop new onset or exacerbations of immune reconstitution syndrome.
- In treatment-naïve adult patients, the most common adverse drug reactions (≥5%) reported of at least moderate intensity (≥Grade 2) in the PREZISTA®/r arm through 192 weeks were diarrhea (9%), headache (7%), abdominal pain (6%), and rash (6%).
- In treatment-experienced adult patients, the most common adverse drug reactions (≥5%) reported of at least moderate intensity (≥Grade 2) in the PREZISTA®/r arm through 96 weeks were diarrhea (14%), nausea (7%), rash (7%), abdominal pain (6%), and vomiting (5%).
This is not a complete list of all adverse drug reactions reported with the use of PREZISTA®/r.
- Consult the full Prescribing Information for PREZISTA® for information on potentially significant drug interactions, including clinical comments.
Use in Specific Populations
- Hepatic Impairment: PREZISTA®/r is not recommended for use in patients with severe hepatic impairment. There are no pharmacokinetic or safety data available in patients with severe hepatic impairment.
This list of uses in specific populations is not complete.
Please refer to the ritonavir Prescribing Information for additional safety information.
Please see full Prescribing Information for more details.