Janssen CarePath

Savings Program

Express Enrollment

SYMTUZA™ darunavir/cobicistat/emtricitabine/tenofovir alafenamide tablets 800mg/150mg/200mg/10mg

Janssen CarePath Provider Portal

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  • Benefits investigations & prior authorizations
  • Enroll eligible patients in Savings Program
  • View Savings Program transactions

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.

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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 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 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 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™. Closely 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), 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

  • Severe Acute Exacerbation of Hepatitis B in Patients Coinfected with HIV-1 and HBV: Patients with HIV-1 should be tested for the presence of chronic HBV before initiating antiretroviral therapy. Severe acute exacerbations of hepatitis B (e.g., liver decompensation and liver failure) have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine and/or tenofovir disoproxil fumarate, and may occur with discontinuation of SYMTUZA™.

    Patients coinfected with HIV-1 and HBV who discontinue SYMTUZA™ should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment. If appropriate, anti-hepatitis B therapy may be warranted, especially in patients with advanced liver disease or cirrhosis, since post-treatment exacerbation of hepatitis may lead to hepatic decompensation and liver failure.

  • Hepatotoxicity: Drug-induced 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.

    Appropriate laboratory testing should be conducted prior to initiating and during therapy with SYMTUZA™. 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, and hepatomegaly) should prompt consideration of interruption or discontinuation of SYMTUZA™.

  • Severe Skin Reactions: In patients receiving darunavir, a component of SYMTUZA™, severe skin reactions may occur. Stevens-Johnson syndrome was reported with darunavir coadministered with cobicistat in clinical trials at a rate of 0.1%. During darunavir postmarketing experience, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis have been reported.

    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: The concomitant use of SYMTUZA™ and other drugs may result in known or potentially significant drug interactions, some of which may lead to the loss of therapeutic effect of SYMTUZA™ and possible development of resistance or possible clinically significant adverse reactions from greater exposures of concomitant drugs.

    Consult the full Prescribing Information for potential drug interactions prior to and during SYMTUZA™ therapy, review concomitant medications during SYMTUZA™ therapy, and monitor for the adverse reactions associated with concomitant medications.

  • Immune Reconstitution Syndrome, including the occurrence of autoimmune disorders with variable time to onset, had been reported in patients treated with combination antiretroviral therapy.
  • 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. 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.

    In all patients, monitor serum creatinine, creatinine clearance, urine glucose, and urine protein prior to or when initiating SYMTUZA™ and during therapy. 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.

  • Sulfa Allergy: Monitor patients with a known sulfonamide allergy after initiating SYMTUZA™.
  • 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. 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. 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: Increased bleeding in hemophiliacs has been reported in patients receiving protease inhibitors.

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

DRUG INTERACTIONS

  • Consult the full Prescribing Information for SYMTUZA™ for information on significant drug interactions, including clinical comments.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: SYMTUZA™ is not recommended for use during pregnancy because of substantially lower exposures of darunavir and cobicistat during pregnancy.

    SYMTUZA™ should not be initiated in pregnant individuals. An alternative regimen is recommended for individuals who become pregnant during therapy with SYMTUZA™.

  • Renal Impairment: SYMTUZA™ is not recommended in patients with severe renal impairment (creatinine clearance below 30 mL per minute).
  • Hepatic Impairment: SYMTUZA™ is not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C).
  • 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™.

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