Risks & side effects.

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IMPORTANT SAFETY INFORMATION

Do not take JULUCA if you:

• have ever had an allergic reaction to a medicine that contains dolutegravir or rilpivirine.
• are taking any of the following medicines:
  • dofetilide
  • carbamazepine
  • oxcarbazepine
  • phenobarbital
  • phenytoin
  • rifampin
  • rifapentine
  • proton pump inhibitors (including esomeprazole, lansoprazole, omeprazole, pantoprazole sodium, rabeprazole)
  • St. John’s wort (Hypericum perforatum)
  • more than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium phosphate

What are the possible side effects of JULUCA?

JULUCA can cause serious side effects, including:

• Severe skin rash and allergic reactions. Call your healthcare provider right away if you develop a rash with JULUCA. Stop taking JULUCA and get medical help right away if you develop a rash with any of the following signs or symptoms:
  • fever
  • generally ill feeling
  • tiredness
  • muscle or joint aches
  • blisters or sores in mouth

  • blisters or peeling of the skin
  • redness or swelling of the eyes
  • swelling of the mouth, face, lips, or tongue
  • problems breathing
• Liver problems. People with a history of hepatitis B or C virus who have certain liver function test changes may have an increased risk of developing new or worsening changes in certain liver tests during treatment with JULUCA. Liver problems, including liver failure, have also happened in people without history of liver disease or other risk factors. Your healthcare provider may do blood tests to check your liver function. Call your healthcare provider right away if you develop any of the following signs or symptoms of liver problems:
  • your skin or the white part of your eyes turns yellow (jaundice)
  • dark or “tea-colored” urine
  • light-colored stools (bowel movements)

  • nausea or vomiting
  • loss of appetite
  • pain, aching, or tenderness on the right side of your stomach area
• Depression or mood changes. Tell your healthcare provider right away or get medical help 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
• The most common side effects of JULUCA include:
  • diarrhea
  • headache
  • nausea

These are not all the possible side effects of JULUCA. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my healthcare provider before taking JULUCA?

Before you take JULUCA, tell your healthcare provider about all of your medical conditions, including if you:

• have ever had a severe skin rash or an allergic reaction to medicines that contain dolutegravir or rilpivirine.
• have or have had liver problems, including hepatitis B or C infection.
• have ever had a mental health problem.
• are pregnant or plan to become pregnant. One of the medicines in JULUCA, called dolutegravir, may harm your unborn baby.
  • Your healthcare provider may prescribe a different medicine than JULUCA if you are planning to become pregnant or if pregnancy is confirmed during the first 12 weeks of pregnancy.
  • If you can become pregnant, your healthcare provider may perform a pregnancy test before you start treatment with JULUCA.
  • If you can become pregnant, you and your healthcare provider should talk about the use of effective birth control (contraception) during treatment with JULUCA.
  • Tell your healthcare provider right away if you are planning to become pregnant, you become pregnant, or think you may be pregnant during treatment with JULUCA.
• are breastfeeding or plan to breastfeed. Do not breastfeed if you take JULUCA.
  • You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
  • One of the medicines in JULUCA passes to your baby in your breast milk.

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 JULUCA. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

• You can ask your healthcare provider or pharmacist for a list of medicines that interact with JULUCA.
• Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take JULUCA with other medicines.

How should I take JULUCA?

• Take JULUCA 1 time a day exactly as your healthcare provider tells you.
• Always take JULUCA with a meal. A protein drink alone does not replace a meal.

What is JULUCA?

JULUCA is a prescription medicine that is used without other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) infection in adults to replace their current anti-HIV-1 medicines when their healthcare provider determines that they meet certain requirements.
HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).
It is not known if JULUCA is safe and effective in children.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please read the Patient Information for JULUCA and discuss it with your healthcare provider.