Helping Patients Afford SYMTUZA®

Support for Patients using Commercial or Private Insurance

Janssen CarePath Savings Program for SYMTUZA®

Janssen CarePath Savings Program may provide instant savings on your eligible patients' out-of-pocket costs for SYMTUZA®. Depending on the health insurance plan, savings may apply toward co-pay, co-insurance, or deductible. Eligible patients pay $0 per prescription fill, with a $10,500 maximum program benefit per calendar year. Not valid for patients using Medicare, Medicaid, or any 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 SYMTUZA®, click here for the Express Enrollment Site. There is a "Print a Card" feature to provide the patient with a Savings card.

OR

In the Janssen CarePath Provider Portal, you can enroll your patients in the Janssen CarePath Savings Program, print a Savings card, review your patients' available benefits, review their Savings Program transactions with the patient's permission, and receive timely alerts and program updates. You can also request and review benefits investigations, and request prior authorization or appeals support.

Sign Up

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 SYMTUZA®, 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 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 Health Coverage

Janssen CarePath can provide information about other resources that may be able to help your patients with their out-of-pocket medication costs, including State-Sponsored Programs, Medicare Savings Program, Medicare Part D Extra Help — Low-Income Subsidy, and independent foundations*. Call Janssen CarePath at 877-CarePath (877-227-3728) to speak with a Care Coordinator about affordability programs that may be available.

Janssen Prescription Assistance for SYMTUZA®

JanssenPrescriptionAssistance.com provides information on affordability programs and information about independent foundations* that may have funding available to help with your patients' medication costs for SYMTUZA®.

*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.

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

Other Resources

The Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF) is an independent, non-profit 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 1-800-652-6227 (9 AM to 6 PM ET) or visit the foundation website at www.JJPAF.org.

INDICATION

SYMTUZA® is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults:

  • who have no prior antiretroviral treatment history or
  • who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months and have no known substitutions associated with resistance to darunavir or tenofovir.
IMPORTANT SAFETY INFORMATION

BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

  • Severe acute exacerbations of hepatitis B (HBV) have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine and/or tenofovir disoproxil fumarate (TDF) and may occur with discontinuation of SYMTUZA®.
    Action: Monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue SYMTUZA®. If appropriate, anti-hepatitis B therapy may be warranted.


CONTRAINDICATIONS

  • Do not coadminister SYMTUZA® 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), dronedarone, elbasvir/grazoprevir, ergot derivatives (such as: dihydroergotamine, ergotamine, methylergonovine), lomitapide, lovastatin, lurasidone, oral midazolam, phenobarbital, phenytoin, pimozide, ranolazine, rifampin, St. John’s wort (Hypericum perforatum), sildenafil for pulmonary arterial hypertension, simvastatin, and triazolam.


WARNINGS AND PRECAUTIONS

  • Hepatotoxicity: Drug-induced hepatitis (e.g., acute hepatitis, cytolytic hepatitis) and cases of liver injury, including some fatalities, have been reported in patients receiving darunavir, a component of SYMTUZA®. 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.

    Action: Monitor liver function prior to initiating and during therapy, especially in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pretreatment elevations of transaminases. Patients with evidence of new or worsening liver function should consider discontinuing SYMTUZA®. SYMTUZA® is not recommended in patients with severe hepatic impairment (Child-Pugh Class C).

  • Severe Skin Reactions: In patients receiving darunavir, a component of SYMTUZA®, severe skin reactions may occur, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis. These include conditions accompanied by fever and/or elevations of transaminases.

    Action: Discontinue SYMTUZA® immediately if signs or symptoms of severe skin reactions develop. These can include but are 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.

  • Risk of Serious Adverse Reactions or Loss of Virologic Response Due to Drug Interactions: Consult the full Prescribing Information prior to and during treatment for potential drug interactions.

  • Immune Reconstitution Syndrome: Patients receiving SYMTUZA® may develop new onset or exacerbations of immune reconstitution syndrome.

  • New Onset or Worsening Renal Impairment: Renal impairment, including cases of acute renal failure and Fanconi syndrome, has been reported with the use of tenofovir prodrugs. In clinical trials of SYMTUZA®, there were no cases of proximal renal tubulopathy, including Fanconi syndrome, reported in the SYMTUZA® group through Week 48. SYMTUZA® is not recommended in patients with creatinine clearance below 30 mL per minute. Patients taking tenofovir prodrugs who have impaired renal function and those taking nephrotoxic agents including nonsteroidal anti-inflammatory drugs are at increased risk of developing renal-related adverse reactions.

    Action: Prior to initiating or during treatment, on a clinically appropriate schedule, monitor serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus. Discontinue SYMTUZA® in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Patients who experience a confirmed increase in serum creatinine of greater than 0.4 mg/dL should be closely monitored for renal safety.

  • Sulfa Allergy: Darunavir contains a sulfonamide moiety. The incidence and severity of rash were similar in subjects with or without a history of sulfonamide allergy.

    Action: Monitor patients with a known sulfonamide allergy.

  • Lactic Acidosis/Severe Hepatomegaly With Steatosis: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including emtricitabine, a component of SYMTUZA®, and tenofovir disoproxil fumarate (TDF), another prodrug of tenofovir, alone or in combination with other antiretrovirals.

    Action: Discontinue SYMTUZA® in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity.

  • Diabetes Mellitus/Hyperglycemia: New-onset or exacerbations of pre-existing diabetes mellitus and hyperglycemia have been reported in patients receiving protease inhibitors.

    Action: Initiation or dose adjustments of insulin or oral hypoglycemic agents may be required.

  • Fat Redistribution: Redistribution and/or accumulation of body fat have been observed in patients receiving antiretroviral therapy.

  • Hemophilia: Patients with hemophilia may develop an increase in bleeding events.


ADVERSE REACTIONS

  • The most common clinical adverse reactions (all grades) occurring in at least 2% of treatment-naïve patients were diarrhea, rash,* nausea, fatigue, headache, abdominal discomfort, and flatulence.

    *Includes pooled reported terms: dermatitis, dermatitis allergic, erythema, photosensitivity reaction, rash, rash generalized, rash macular, rash maculopapular, rash morbilliform, rash pruritic, toxic skin eruption, and urticaria.

    Grade 2-4 laboratory abnormalities have been reported in patients receiving SYMTUZA®, including elevations in serum creatinine, liver function tests, triglycerides, total cholesterol, low-density lipoproteins, and glucose levels.

    This is not a complete list of all adverse reactions reported with the use of SYMTUZA®. Please refer to the full Prescribing Information for a complete list of adverse drug reactions.


USE IN SPECIFIC POPULATIONS

  • Pregnancy: SYMTUZA® is not recommended for use during pregnancy and should not be initiated in pregnant individuals because of substantially lower exposures of darunavir and cobicistat during pregnancy.

    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.

  • Consult the full Prescribing Information for SYMTUZA® for additional information on the Uses in Specific Populations.

Please see the full Prescribing Information, including Boxed WARNING for SYMTUZA®.

cp-62076v3