Helping Patients Afford PREZCOBIX®
Helping Patients Afford PREZCOBIX®
Janssen CarePath can help you find out what affordability assistance may be available for your patients taking PREZCOBIX®. You may download the Affordability Options 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 PREZCOBIX®
Janssen CarePath Savings Program may provide instant savings on your eligible patients' out-of-pocket costs for PREZCOBIX®. Depending on their health insurance plan, savings may apply toward co-pay, co-insurance, or deductible. For PREZCOBIX® (darunavir 800 mg/cobicistat 150 mg), 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.
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 PREZCOBIX®, 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.
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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 PREZCOBIX®, 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
- JanssenPrescriptionAssistance.com provides 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.
The Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF) is an independent, nonprofit organization that is committed to helping eligible patients without insurance coverage receive prescription products donated by Johnson & Johnson operating companies. To see if they might qualify for assistance, please have your patient contact a JJPAF program specialist at 800-652-6227 (Monday–Friday, 9:00 AM to 6:00 PM ET) or visit the foundation website at JJPAF.org.
PREZCOBIX® is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in treatment-naïve and treatment-experienced adults and pediatric patients weighing at least 40 kg with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V).
- Do not coadminister PREZCOBIX® and the following drugs due to the potential for serious and/or life-threatening events or loss of therapeutic effect: alfuzosin, carbamazepine, cisapride, colchicine (in patients with renal and/or hepatic impairment), dihydroergotamine, dronedarone, elbasvir/grazoprevir, ergotamine, ivabradine, lomitapide, lovastatin, lurasidone, methylergonovine, oral midazolam, naloxegol, phenobarbital, phenytoin, pimozide, ranolazine, rifampin, St. John’s wort (Hypericum perforatum), sildenafil for pulmonary arterial hypertension, simvastatin, and triazolam.
Warnings and Precautions
Hepatotoxicity: Patients with pre-existing liver dysfunction, including chronic active hepatitis B or C, have an increased risk for liver function abnormalities, including severe hepatic adverse reactions. Drug-induced hepatitis and cases of liver injury, including some fatalities, have been reported.
Appropriate laboratory testing should be conducted prior to initiating and during therapy with PREZCOBIX®. Evidence of new or worsening liver dysfunction in patients on PREZCOBIX® should prompt consideration of interruption or discontinuation of treatment.
Severe Skin Reactions: Severe skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms, and acute generalized exanthematous pustulosis have been reported in patients receiving darunavir coadministered with ritonavir. Mild-to-moderate rash was also reported and often occurred and resolved with continued dosing. Discontinue PREZCOBIX® immediately if signs or symptoms of severe skin reaction develop.
Sulfa Allergy: Monitor patients with a known sulfonamide allergy after initiating PREZCOBIX®.
Effects on Serum Creatinine: Cobicistat decreases estimated creatinine clearance (CrCl) due to inhibition of tubular secretion of creatinine without affecting actual renal glomerular function. Prior to starting PREZCOBIX®, assess estimated CrCl. Patients who experience a confirmed increase in serum creatinine of greater than 0.4 mg/dL from baseline should be closely monitored for renal safety. Consider alternative medications that do not require dosage adjustments in patients with renal impairment.
Renal Impairment When Used With Tenofovir Disoproxil Fumarate: Renal impairment, including cases of acute renal failure and Fanconi syndrome, has been reported with the use of tenofovir DF and cobicistat. Coadministration with tenofovir DF is not recommended in patients who have an estimated CrCl <70 mL/min. In all patients, monitor estimated CrCl, urine glucose, and urine protein prior to initiating and during therapy. Measure serum phosphorus in patients at risk of renal impairment. Coadministration of PREZCOBIX® and tenofovir DF in combination with concomitant or recent use of a nephrotoxic agent is not recommended.
Risk of Serious Adverse Reactions or Loss of Virologic Response Due to Drug Interactions: Initiation of PREZCOBIX®, which inhibits CYP3A, in patients receiving medications metabolized by CYP3A or initiation of medications metabolized by CYP3A in patients already receiving PREZCOBIX® 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 respectively increase or decrease concentrations of PREZCOBIX®. These interactions may lead to clinically significant adverse reactions, potentially leading to severe, life threatening, or fatal events from higher exposures of concomitant medications; clinically significant adverse reactions from higher exposures of PREZCOBIX®; loss of therapeutic effect of concomitant medications from lower exposures of active metabolite(s); or loss of therapeutic effect of PREZCOBIX® and possible development of resistance from lower exposures of PREZCOBIX®.
Antiretrovirals Not Recommended: Do not use PREZCOBIX® in combination with other antiretroviral drugs that require pharmacokinetic boosting or which contain the individual components of PREZCOBIX® (darunavir and cobicistat) or with ritonavir.
Diabetes Mellitus/Hyperglycemia and Hemophilia: New onset or exacerbation of pre-existing diabetes mellitus and hyperglycemia have been reported in patients receiving protease inhibitors. Initiation or dose adjustments of insulin or oral hypoglycemic agents may be required. Increased bleeding in hemophiliacs has been reported in patients receiving protease inhibitors.
Fat Redistribution: Redistribution and/or accumulation of body fat have been observed in patients receiving antiretroviral therapy.
Immune Reconstitution Syndrome including the occurrence of autoimmune disorders with variable time to onset has been reported.
- The most common clinical adverse reactions (incidence ≥5%) of at least moderate intensity (≥Grade 2) were diarrhea, nausea, rash, headache, abdominal pain, and vomiting during the darunavir clinical development program, where darunavir was coadministered with ritonavir.
This is not a complete list of all adverse drug reactions reported with the use of PREZCOBIX®. Please refer to the full Prescribing Information for a complete list of adverse drug reactions.
- Consult the full Prescribing Information for PREZCOBIX® for information on potentially significant drug interactions, including clinical comments.
Use in Specific Populations
- PREZCOBIX® is not recommended for use during pregnancy because of substantially lower exposures of darunavir and cobicistat during pregnancy.
PREZCOBIX® should not be initiated in pregnant individuals. An alternative regimen is recommended for those who become pregnant during therapy with PREZCOBIX®.
Lactation: The Centers for Disease Control and Prevention recommends that HIV-infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection.
The safety and effectiveness of PREZCOBIX® have not been established and is not recommended in pediatric patients weighing less than 40 kg.
- Consult the full Prescribing Information for PREZCOBIX® for additional information on the Uses in Specific Populations.
Please see full Prescribing Information for more details.