Getting Started

Who should not take EDURANT^®?

Do not take EDURANT^® if you also take:

• anti-seizure medicines:
  • carbamazepine
  • oxcarbazepine
  • phenobarbital
  • phenytoin
• anti-tuberculosis (anti-TB) medicines:
  • rifampin
  • rifapentine
• proton pump inhibitor (PPI) medicine for certain stomach or intestinal problems:
  • esomeprazole
  • lansoprazole
  • omeprazole
  • pantoprazole sodium
  • rabeprazole
• 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 provider before taking EDURANT^®?

Before taking EDURANT^®, tell your healthcare provider 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 provider 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 provider about the best way to feed your baby during EDURANT^® treatment.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider 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 provider 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 provider. Stay under the care of your healthcare provider 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 provider or go to the nearest hospital emergency room right away.

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 provider 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:
  • fever
  • 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 provider may need to do tests to check your liver enzymes before and during treatment with EDURANT^®.
• Depression or mood changes. Tell your healthcare provider 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 provider 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 provider right away. Do not stop taking EDURANT^® or any other medications without first talking to your healthcare provider.

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 see accompanying full Product Information for more details.

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