Patient Authorization Form — Allows you to authorize the use of your personal information for Janssen CarePath support programs.
Janssen CarePath Savings Program Overview — Provides information on the Janssen CarePath Savings Program for EDURANT® and eligibility requirements for enrolling in the program.
Janssen CarePath Savings Program Rebate Form — Allows you to request a rebate for your medication cost if your pharmacy can't process your Janssen CarePath Savings Program card.
Patient Affordability Options — Gives information on options that can make your treatment more affordable.
Health Insurance Open Enrollment Guide — Even if you keep the same health plan, your benefits can change. This guide can help you review your coverage and make changes if needed during the open enrollment period so you can stay on treatment in the new benefit period.
Medicare Resource Guide — Provides information on sources for cost support that may be available to patients enrolled in Medicare.
Medicare Part D and Coverage Gap Guide — Helps you understand the 4 phases of coverage (Deductible, Initial Coverage, Coverage Gap, and Catastrophic Coverage), and when you will enter the Coverage Gap (formerly known as the Donut Hole).
Medicare Low-Income Subsidy (LIS) Brochure — 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.
Medicare Low-Income Subsidy (LIS) "Extra Help" Resource for Patients — Explains the level of "Extra Help" for low-income residents of the United States enrolled in Medicare Prescription Drug plans, the qualifications for each level, and how patients can apply.
Johnson & Johnson Patient Assistance Foundation (JJPAF) — An independent, nonprofit organization committed to helping eligible patients without insurance coverage receive prescription products donated by Johnson & Johnson operating companies.
EDURANT® is a prescription medicine that is used with:
other antiretroviral medicines to treat Human Immunodeficiency Virus (HIV-1) in people 12 years of age and older and who weigh at least 77 lbs (35 kg) who:
- have never taken HIV medicines before, and
- have an amount of HIV-1 in their blood (this is called ‘viral load’) that is no more than 100,000 copies/mL.
- oral VOCABRIA (cabotegravir) for short term treatment of HIV-1 infection in adults when their healthcare professional determines that they meet certain requirements.
HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
If you take EDURANT® in combination with oral VOCABRIA (cabotegravir), you should also read the Patient Information that comes with oral VOCABRIA (cabotegravir).
It is not known if EDURANT® is safe and effective in children less than 12 years of age or who weigh less than 77 lbs (35 kg).
Who should not take EDURANT®?
Do not take EDURANT® if you also take:
anti-tuberculosis (anti-TB) medicines:
proton pump inhibitor (PPI) medicine for certain stomach or intestinal problems:
- pantoprazole sodium
- more than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium phosphate
- St. John’s wort (Hypericum perforatum)
What should I tell my healthcare professional before taking EDURANT®?
Before taking EDURANT®, tell your healthcare professional about all your medical conditions, including if you:
- have or had liver problems, including hepatitis B or C virus infection
- have kidney problems
- have ever had a mental health problem
- are pregnant or plan to become pregnant. It is not known if EDURANT® will harm your unborn baby. Tell your healthcare professional if you become pregnant during treatment with EDURANT®
are breastfeeding or plan to breastfeed. Do not breastfeed if you take EDURANT®
- You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
- It is not known if EDURANT® passes into your breast milk. Talk with your healthcare professional about the best way to feed your baby during EDURANT® treatment.
Tell your healthcare professional about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Some medicines interact with EDURANT®. Keep a list of your medicines to show your healthcare professional and pharmacist when you get a new medicine. You can ask your healthcare professional or pharmacist for a list of medicines that interact with EDURANT®.
Do not start taking a new medicine without telling your healthcare professional. Your healthcare professional can tell you if it is safe to take EDURANT® with other medicines.
How should I take EDURANT®?
- Take EDURANT® every day exactly as your healthcare professional tells you to.
- Take EDURANT® 1 time each day with a meal. A protein drink alone does not replace a meal.
- Do not change your dose or stop taking EDURANT® without first talking with your healthcare professional. Stay under the care of your healthcare professional during treatment with EDURANT®.
- Do not miss a dose of EDURANT®.
- If you take an H2-receptor antagonist (famotidine, cimetidine, nizatidine, or ranitidine), you should take these medicines at least 12 hours before or at least 4 hours after you take EDURANT®.
- If you take antacids, or other products that contain aluminum, calcium carbonate, or magnesium hydroxide, you should take these medicines at least 2 hours before or at least 4 hours after you take EDURANT®.
- If you miss a dose of EDURANT® within 12 hours of the time you usually take it, take your dose of EDURANT® with a meal as soon as possible. Then, take your next dose of EDURANT® at the regularly scheduled time. If you miss a dose of EDURANT® by more than 12 hours of the time you usually take it, wait and then take the next dose of EDURANT® at the regularly scheduled time.
- Do not take more than your prescribed dose to make up for a missed dose.
- If you take too much EDURANT®, call your healthcare professional or go to the nearest hospital emergency room right away.
- When your supply of EDURANT® starts to run low, get more from your healthcare professional or pharmacy. It is important not to run out of EDURANT®. The amount of HIV in your blood may increase if the medicine is stopped even for a short time.
When your healthcare professional prescribes use of EDURANT® with oral VOCABRIA (cabotegravir):
- Take EDURANT® and oral VOCABRIA (cabotegravir) once a day at approximately the same time with a meal.
- You will receive treatment with EDURANT® tablets in combination with oral VOCABRIA (cabotegravir) tablets for one month (at least 28 days) before you receive the long-acting medicine called CABENUVA (cabotegravir; rilpivirine extended-release injectable suspensions) for the first time. This will allow your healthcare professional to assess how well you tolerate these medicines.
- Your final dose of EDURANT® and oral VOCABRIA should be taken on the same day you receive your first CABENUVA injections.
What are the possible side effects of EDURANT®?
EDURANT® can cause serious side effects including:
Severe skin rash and allergic reactions. Skin rash is a common side effect of EDURANT®. Skin rash can be serious. Call your healthcare professional right away if you get a rash. In some cases, rash and allergic reaction may need to be treated in a hospital.
If you get a rash with any of the following symptoms, stop taking EDURANT® and get medical help right away:
- skin blisters
- mouth sores
- redness or swelling of the eyes (conjunctivitis)
- swelling of the face, lips, mouth, tongue, or throat
- trouble breathing or swallowing
- pain on the right side of the stomach (abdominal) area
- dark-colored urine “tea colored”
- Change in liver enzymes. People with a history of hepatitis B or C virus infection or who have certain liver function test changes may have an increased risk of developing new or worsening liver problems during treatment with EDURANT®. Liver problems have also happened during treatment with EDURANT® in people without a history of liver disease. Your healthcare professional may need to do tests to check your liver enzymes before and during treatment with EDURANT®.
Depression or mood changes. Tell your healthcare professional right away if you have any of the following symptoms:
- feeling sad or hopeless
- feeling anxious or restless
- have thoughts of hurting yourself (suicide) or have tried to hurt yourself
- Changes in body fat can happen in people who take HIV medicine. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the middle of your body (trunk). Loss of fat from the legs, arms, and face may also happen. The exact cause and long-term health effects of these problems are not known.
- Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare professional right away if you start having any new symptoms after starting your HIV-1 medicine.
The most common side effects of EDURANT® include depression, headache, trouble sleeping (insomnia), and rash.
This is not a complete list of all side effects. If you experience these or other symptoms, contact your healthcare professional right away.
You are encouraged to report side effects of prescription drugs to the FDA. Visit 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).
Please read accompanying full Product Information for more details.