What is symtuza ®?
WHAT IS SYMTUZA ®? SYMTUZA ® is a prescription medicine that is used without other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) infection in adults and in children who weigh at least 88 pounds (40 kg) who: when their healthcare provider determines that they meet certain requirements.
What should I do if I stop taking symtuza®?
Refill your prescription or talk to your healthcare provider before your SYMTUZA® is all gone. If you stop taking SYMTUZA®, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your HBV infection or give you a medicine to treat your HBV infection.
Is symtuza ® safe for children with AIDS?
HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). It is not known if SYMTUZA ® is safe and effective in children weighing less than 88 pounds (40 kg). WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT SYMTUZA ®? Worsening of hepatitis B virus infection.
How do I get a free trial of symtuza?
SYMply Start® Trial Offer from Janssen CarePath offers eligible patients a free 30-day trial supply of SYMTUZA ® to determine if SYMTUZA ® is right for them. Patients must be 12 years of age or older and have a valid, signed 30-day prescription.
What is the cost of Symtuza?
The cost for Symtuza oral tablet (150 mg-800 mg-200 mg-10 mg) is around $4,529 for a supply of 30 tablets, depending on the pharmacy you visit. Prices are for cash paying customers only and are not valid with insurance plans.
What is Janssen CarePath savings program?
If you use commercial or private health insurance, Janssen CarePath Savings Program may help you save on your out-of-pocket costs. Patients using Medicare, Medicaid, or any other federally funded programs to pay for their Janssen medication are not eligible to participate. No income requirements.
Who makes Symtuza?
TITUSVILLE, N.J, JULY 17, 2018 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved SYMTUZATM, the first and only complete, darunavir-based single-tablet regimen (STR) for the treatment of human immunodeficiency virus type 1 (HIV-1) in ...
What does Symtuza contain?
Symtuza is a single-tablet regimen for HIV. It contains a protease inhibitor (darunavir), a boosting agent (cobicistat) and two nucleoside/nucleotide reverse transcriptase inhibitors (tenofovir alafenamide +emtricitabine).
Does Janssen have a patient assistance program?
Janssen is committed to helping patients obtain appropriate access to our medicines. We partner with private and public payers and healthcare systems to support availability of our products and we offer and support a variety of programs and services to assist with access to and appropriate use of new treatment options.
What is Jansen care path?
Janssen CarePath is your one source for resources focused on access, affordability, and treatment support for your patients. Our Care Coordinator team supports all the Janssen products you prescribe. We can help make it easier for you and your patients to get the resources you both may need.
Does Symtuza cause weight gain?
Is weight gain a concern? *Across 2 clinical trials, one patient taking SYMTUZA® experienced treatment-related weight gain. The average weight gain over 48 weeks was between 3.13 lbs (1.42 kg) and 3.84 lbs (1.75 kg) in 1,125 patients in the SYMTUZA® group, and ~1 lb (. 45 kg) for 741 patients in the control group.
Can you take Symtuza on an empty stomach?
How do I take Symtuza? You should take Symtuza once a day with food – you should take it within half an hour of having a meal or snack. The tablet should be swallowed whole – don't chew, crush or split it. HIV treatment works best if you take it every day, ideally at the same time each day.
What is the generic name for Symtuza?
SYMTUZA (darunavir, cobicistat, emtricitabine, and tenofovir alafenamide) is a fixed-dose combination tablet. Darunavir is an inhibitor of the HIV-1 protease. Cobicistat is a mechanism-based inhibitor of cytochrome P450 (CYP) enzymes of the CYP3A family.
How long does Symtuza stay in your system?
If you're currently undetectable, you could stay that way while switching. In a clinical trial, 95% of patients who switched to SYMTUZA® stayed undetectable (viral load <50 copies/mL) after 48 weeks.
How fast does Symtuza work?
After initiating treatment with Symtuza within 2 weeks of HIV diagnosis, 84% of patients achieved undetectable viral loads at 48 weeks.
How good is Symtuza?
Overall, 75% of patients taking Symtuza (77 patients out of 103) achieved this reduction after 24 weeks of treatment, which was similar to the 74% (37 of 50) of patients who achieved it with the comparator.
Does Janssen CarePath expire?
You must meet the program requirements every time you use the card. Program terms will expire at the end of each calendar year. The program may change or end without notice, including in specific states.
Is Janssen part of Johnson and Johnson?
Janssen Pharmaceuticals is a pharmaceutical company headquartered in Beerse, Belgium, and wholly-owned by Johnson & Johnson. It was founded in 1953 by Paul Janssen.
What drugs does Janssen make?
Janssen United States > ProductsB. BALVERSA™ (erdafitinib) Full Prescribing Information. ... C. CARVYKTI™ (ciltacabtagene autoleucel; cilta-cel) ... D. DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) ... E. EDURANT® (rilpivirine) ... H. HALDOL® (haloperidol) ... I. IMBRUVICA® (ibrutinib) ... O. OPSUMIT® (macitentan) ... P. PONVORY™ (Ponesimod)More items...
Does Janssen make REMICADE?
Janssen CarePath Savings Program can help eligible patients save on their out-of-pocket medication costs for REMICADE®. Your eligible patients will pay $5 per infusion with a $20,000 maximum program benefit per calendar year.
What is Symtuza used for?
SYMTUZA ® is a prescription medicine that is used without other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) infection in adults and in children who weigh at least 88 pounds (40 kg) who:
What are the side effects of Symtuza?
The most common side effects of SYMTUZA® are: Diarrhea, rash, nausea, fatigue, headache, stomach problems, and gas. These are not all of the possible side effects of SYMTUZA ® . Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA.
What happens if you stop taking Symtuza?
If you stop taking SYMTUZA®, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your HBV infection or give you a medicine to treat your HBV infection.
What to tell your doctor before taking Symtuza?
Before taking SYMTUZA®, tell your healthcare provider about all of your medical conditions, including if you: have liver problems (including hepatitis B or hepatitis C), have kidney problems, are allergic to sulfa (sulfonamide), have diabetes, have hemophilia, or have any other medical condition.
How to report side effects of Janssen?
Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Janssen Products, LP at 1-800-JANSSEN (1-800-526-7736).
Can you breastfeed with Symtuza?
Do not breastfeed if you take SYMTUZA®. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with SYMTUZA ®. Keep a list of your medicines to show your healthcare provider and pharmacist.
Can Symtuza cause bleeding?
Increased bleeding can occur in people with hemophilia who are taking SYMTUZA®.
What is Symtuza used for?
SYMTUZA ® is a prescription medicine that is used without other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) infection in adults and in children who weigh at least 88 pounds (40 kg) who: when their healthcare provider determines that they meet certain requirements.
What to tell your doctor before taking Symtuza?
Before taking SYMTUZA ®, tell your healthcare provider about all of your medical conditions, including if you: have liver problems (including hepatitis B or hepatitis C), have kidney problems, are allergic to sulfa (sulfonamide), have diabetes, have hemophilia, or have any other medical condition.
What happens if you stop taking Symtuza?
If you stop taking SYMTUZA®, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your HBV infection or give you a medicine to treat your HBV infection.
How to report side effects of Janssen?
Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Janssen Products, LP at 1-800-JANSSEN (1-800-526-7736).
Can you take Symtuza with a med?
Do not take SYMTUZA® with any of the following medicines: alfuzosin, carbamazepine, colchicine (if you have liver or kidney problems), dronedarone, elbasvir and grazoprevir, ergot-containing medicines (such as: dihydroergotamine, ergotamine tartrate, methylergonovine), ivabradine, lomitapide, lovastatin or a product that contains lovastatin, lurasidone, midazolam (when taken by mouth), naloxegol, phenobarbital, phenytoin, pimozide, ranolazine, rifampin, St. John's wort (Hypericum perforatum) or a product that contains St. John's wort, sildenafil when used for pulmonary arterial hypertension (PAH), simvastatin or a product that contains simvastatin, or triazolam.
Does Symtuza cause HBV?
SYMTUZA® can cause serious side effects including: Worsening of hepatitis B virus infection. Your healthcare provider will test you for hepatitis B virus (HBV) before starting treatment with SYMTUZA®. If you have HBV infection and take SYMTUZA®, your HBV may get worse (flare-up) if you stop taking SYMTUZA®.
Can Symtuza cause high blood sugar?
Diabetes and high blood sugar (hyperglycemia). Some people who take protease inhibitors including SYMTUZA® can get high blood sugar, develop diabetes, or your diabetes can get worse. Tell your healthcare provider if you notice an increase in thirst or if you start urinating more often while taking SYMTUZA®.
What is Symtuza used for?
SYMTUZA ® is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 40 kg:
What are the lab results for Symtuza?
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.
How long is the Symtuza trial?
Patients must be 12 years of age or older and have a valid, signed 30-day prescription. At the conclusion of the program, you and your patient decide if it is appropriate to continue treatment. Terms expire at the end of each calendar year and may change. This Trial Offer is open to patients who have commercial insurance, government coverage, or no insurance coverage; however, there is no guarantee of continuous accessibility after the program ends. Please refer to the SYMply Start ® Trial Offer brochure for program requirements or call Janssen CarePath at 877-CarePath (877-227-3728) to get a Trial Offer card for your patient.
Can Symtuza be discontinued?
Action: Discontinue SYMTUZA ® in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity.
What are the actions of antiretroviral therapy?
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.
What is Janssen Carepath?
Janssen CarePath provides additional support that your patients may need to get started with their treatment. A personally assigned Janssen CarePath Care Coordinator will work closely with you and your patients to provide the support you direct.
Can Symtuza cause a rash?
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.
What is Symtuza used for?
Symtuza (cobicistat/darunavir/emtricitabine/tenofovir alafenamide) is a member of the antiviral combinations drug class and is commonly used for HIV Infection.
How much does Symtuza Janssen CarePath save?
Symtuza Janssen CarePath Savings Program: Most eligible commercially insured patients may pay $0 per fill on out-of-pocket costs with savings of up to $12,500 per calendar year; for additional assistance contact the program at 866-836-0114.
How to contact the hospital access program?
This program allows eligible hospitals to receive free medications to give to qualified outpatients directly. Contact the program for more details (1-800-652-6227) . The hospital access application is only available via the online portal.
Does Symtuza Janssen accept savings cards?
Symtuza Janssen CarePath Savings Program Rebate: Eligible commercially insured patients may submit a rebate request if the pharmacy does not accept the Savings Card; for additional assistance contact the program at 866-836-0114.
Do you have to be a US resident to be a patient?
The patient must also be a US resident.
Do you have to have a Social Security number to be a patient?
The patient must also be a US resident with a Social Security Number.
Is Symtuza a generic?
Symtuza is available as a brand name drug only, a generic version is not yet available. For more information, read about generic Symtuza availability . This Symtuza price guide is based on using the Drugs.com discount card which is accepted at most U.S. pharmacies.
What is Symtuza used for?
SYMTUZA ® is a prescription medicine that is used without other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) infection in adults and in children who weigh at least 88 pounds (40 kg) who: when their healthcare provider determines that they meet certain requirements.
What to tell your doctor before taking Symtuza?
Before taking SYMTUZA®, tell your healthcare provider about all of your medical conditions, including if you: have liver problems (including hepatitis B or hepatitis C), have kidney problems, are allergic to sulfa (sulfonamide), have diabetes, have hemophilia, or have any other medical condition.
What happens if you stop taking Symtuza?
If you stop taking SYMTUZA®, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your HBV infection or give you a medicine to treat your HBV infection.
How to report side effects of Janssen?
Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Janssen Products, LP at 1-800-JANSSEN (1-800-526-7736).
Can you take Symtuza with a med?
Do not take SYMTUZA® with any of the following medicines: alfuzosin, carbamazepine, colchicine (if you have liver or kidney problems), dronedarone, elbasvir and grazoprevir, ergot-containing medicines (such as: dihydroergotamine, ergotamine tartrate, methylergonovine), ivabradine, lomitapide, lovastatin or a product that contains lovastatin, lurasidone, midazolam (when taken by mouth), naloxegol, phenobarbital, phenytoin, pimozide, ranolazine, rifampin, St. John's wort (Hypericum perforatum) or a product that contains St. John's wort, sildenafil when used for pulmonary arterial hypertension (PAH), simvastatin or a product that contains simvastatin, or triazolam.
Does Symtuza cause HBV?
SYMTUZA® can cause serious side effects including: Worsening of hepatitis B virus infection. Your healthcare provider will test you for hepatitis B virus (HBV) before starting treatment with SYMTUZA®. If you have HBV infection and take SYMTUZA®, your HBV may get worse (flare-up) if you stop taking SYMTUZA®.
Can you breastfeed with Symtuza?
Do not breastfeed if you take SYMTUZA®. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with SYMTUZA ®. Keep a list of your medicines to show your healthcare provider and pharmacist.
What are the side effects of Symtuza?
The most common side effects of SYMTUZA®are:Diarrhea, rash, nausea, fatigue, headache, stomach problems, and gas. These are not all of the possible side effects of SYMTUZA®. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA.
What to tell your doctor before taking Symtuza?
Before taking SYMTUZA®, tell your healthcare provider about all of your medical conditions, including if you: have liver problems (including hepatitis B or hepatitis C), have kidney problems, are allergic to sulfa (sulfonamide), have diabetes, have hemophilia, or have any other medical condition.
What is a patient authorization form?
Patient Authorization Form [PDF]- Allows you to authorize the use of your personal information for Janssen CarePathsupport programs.
What is LIS in Medicare?
Medicare Low-Income Subsidy (LIS) Brochure [PDF]- Offers information about extra help with prescription drug costs that is available to low-income residents of the United States enrolled in Medicare Prescription Drug Plans.
What is Medicare Resource Guide?
Medicare Resource Guide [PDF]- Provides information on sources for cost support that may be available to patients enrolled in Medicare.
Does Symtuza cause HBV?
SYMTUZA®can cause serious side effects including: Worsening of hepatitis B virus infection. Your healthcare provider will test you for hepatitis B virus (HBV) before starting treatment with SYMTUZA®. If you have HBV infection and take SYMTUZA®, your HBV may get worse (flare-up) if you stop taking SYMTUZA®.
Is Symtuza safe for children?
HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). It is not known if SYMTUZA® is safe and effective in children weighing less than 88 pounds (40 kg).
What is Symtuza used for?
SYMTUZA ® is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 40 kg:
What are the lab results for Symtuza?
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.
What is Janssen CarePath Savings Program?
Janssen CarePath Savings Program may provide instant savings on your eligible patients' out-of-pocket costs for SY MTUZA ®. Depending on their health insurance plan, savings may apply toward co-pay, co-insurance, or deductible. For SYMTUZA ®, your eligible patients will pay $0 per prescription fill, with a $12,500 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 .
What are the actions of antiretroviral therapy?
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.
How to contact JJPAF?
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, 9:00 AM to 6:00 PM ET ).
What is JJPAF?
The Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF) is an independent, nonprofit organization. JJPAF gives eligible patients free prescription medicines donated by Johnson & Johnson. 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.
How to contact Janssen CarePath?
Call Janssen CarePath at 877-CarePath (877-227-3728) to speak with a Care Coordinator about affordability programs that may be available.
What is The Patient Assistance Program?
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.
Program Update
Patients may now choose the option of electronic income verification. Instead of submitting a copy of their Federal tax return, they can simply check a box on the updated application form.
