Patient Assistance & Support

Patient Assistance Program

Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF) is an independent, private, nonprofit organization that assists patients who do not have financial resources or prescription drug coverage to obtain free prescription products that are donated by Johnson & Johnson operating companies. These companies have a long-standing commitment to helping patients access medicines. Janssen Therapeutics donates medicines to JJPAF.

JJPAF is participating in a unique industry public-private partnership aimed at streamlining access to HIV medicines through the use of a Common Patient Assistance Program Application developed in partnership with the Department of Health and Human Services (HHS) and 6 industry partners. This form will allow you to apply to multiple HIV manufacturer patient assistance programs through a single application. You can access the common application form here: common application form. All of the information you need to apply for assistance for HIV medicines offered by the 7 participating patient assistance programs is included in this one application.

For additional information regarding JJPAF, please visit the JJPAF website at www.jjpaf.org or call and speak to a patient assistance program specialist at 1-800-652-6227.

Patient Savings Program

For eligible patients with prescription coverage that may require significant out-of-pocket (co-pay or co-insurance) expenses for their HIV medications, the Patient Savings Program (PSP) is a simple and easy way to reduce out-of-pocket costs for up to 1 year. Patients should refer to the Q&A below for Eligibility Rules and Regulations to determine whether they qualify. For more information, call 1-866-961-7169.

To enroll in the Janssen Therapeutics Patient Savings Program, print out the Instant Savings Card or complete the application form and call 1-866-961-7169 to activate your enrollment:

Printable Instant
Savings Card

Patient Savings Program application form

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OR

Patient Savings Program Application Form

Patient Savings Program application form

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Patient Savings Program Q&A

Patient Savings Program Q&A
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Reimbursement form for patients who use mail order or a nonparticipating pharmacy

Reimbursement form for patients who use mail order or a nonparticipating pharmacy
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The forms above require Adobe® Reader® for viewing and printing.

JanssenTherapeuticsLine

JanssenTherapeuticsLine is a convenient, toll-free hotline that provides support for patients seeking guidance about insurance coverage or financial assistance. Reach them by phone at 1-866-836-0114 or by fax at 1-866-836-0567, Monday through Friday from 8 am to 8 pm ET.

JanssenTherapeuticsLine offers helpful services including insurance benefit verification to help you understand your insurance coverage, assistance with prior authorizations, process and procedures relating to appeals or exceptions, alternate sources of payment, and additional information about patient assistance.

Insurance benefit verification form

Insurance benefit verification form
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The form above requires Adobe® Reader® for viewing and printing.

This information is provided for informational purposes only and represents no statement, promise, or guarantee by Janssen Therapeutics concerning levels of reimbursement, payment, or charge. We strongly suggest that you consult your payer organization about local reimbursement policies.


Important Safety Information

Drug Interactions

  • Coadministration of 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 (eg, alfuzosin, dihydroergotamine, ergotamine, methylergonovine, cisapride, pimozide, oral midazolam, triazolam, lovastatin, simvastatin, or sildenafil for the treatment of pulmonary arterial hypertension)
  • Coadministration of PREZISTA®/r is also contraindicated with rifampin and products containing St. John’s wort (Hypericum perforatum) because this may cause significant decrease in plasma concentrations of darunavir, resulting in loss of therapeutic effect and development of resistance
  • Coadministration is not recommended with indinavir, lopinavir/ritonavir, saquinavir, salmeterol, boceprevir, telaprevir, and colchicine in patients with hepatic or renal impairment
  • Caution should be used when prescribing agents such as sildenafil, vardenafil, tadalafil, or other substrates, inhibitors, or inducers of CYP3A in patients receiving PREZISTA®/r

Indication: Adults

PREZISTA® (darunavir), coadministered with ritonavir (PREZISTA®/r), and with other antiretroviral agents (ARVs), is indicated for the treatment of human immunodeficiency virus (HIV-1) infection.

This indication is based on analyses of plasma HIV-1 RNA levels and CD4+ cell counts from 2 controlled Phase 3 trials of 48 weeks duration in ARV treatment-naïve and treatment-experienced patients and 2 controlled Phase 2 trials of 96 weeks duration in clinically advanced, treatment-experienced adult patients.

In treatment-experienced adult patients, the following points should be considered when initiating therapy with PREZISTA®/r:

  • Treatment history and, when available, genotypic or phenotypic testing should guide the use of PREZISTA®/r
  • The use of other active agents with PREZISTA®/r is associated with a greater likelihood of treatment response

This list of potential drug interactions is not complete.

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. Please refer to ritonavir prescribing information for additional information on precautionary measures
  • Drug-induced hepatitis (eg, acute hepatitis, cytolytic 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 events
  • 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
  • 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 has been reported in patients treated with combination ARV therapy, including PREZISTA®
  • 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 of onset is more variable and can occur many months after the initiation of treatment

  • Resistance/Cross-Resistance: The potential for HIV cross-resistance among protease inhibitors has not been fully explored in PREZISTA®/r-treated patients

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
  • Pregnancy: PREZISTA® 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

  • 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.

Please see full Prescribing Information for more details.