For the replacement of current HIV-1 medicines in adults who meet certain requirements. See Full Indication.

Risks & side effects.

These are not all the risks and side effects of JULUCA, and this information does not replace talking with your doctor about your medical conditions or treatment. For more information, talk to your doctor and refer to the Patient Information for JULUCA.

Who should not take JULUCA?

Do not take JULUCA if you have ever had an allergic reaction to a medicine that contains dolutegravir or rilpivirine.

Talk with your doctor about all medications you take.

Do not take JULUCA if you take:

Drug Examples of Brand Names 
Dofetilide Tikosyn®
Anti-seizure medicines  
carbamazepine Carbatrol®, Epitol®, Equetro®, Tegretol®, Tegretol®-XR
oxcarbazepine Oxtellar XR®, Trileptal®
phenobarbital Luminal®, Solfoton®
phenytoin Dilantin®, Dilantin-125®, Phenytek®
Anti-tuberculosis medicines  
rifampin Rifater®, Rifamate®, Rimactane®, Rifadin®
rifapentine Priftin®
Proton pump inhibitor (PPI) medicines for certain stomach or intestinal problems  
esomeprazole Nexium®, Vimovo®
lansoprazole Prevacid®
omeprazole Prilosec®, Zegerid®
pantoprazole sodium Protonix®
rabeprazole AcipHex®, AcipHex® Sprinkle™
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

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 doctor 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.
  • Pregnancy Registry. There is a pregnancy registry for individuals who take antiretroviral medicines, including JULUCA, during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry.
  • 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.
    • It is not known if JULUCA can pass to your baby in your breast milk.
  • Talk with your healthcare provider about the best way to feed your baby.
  • 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
  • Do not change your dose or stop taking JULUCA without talking with your healthcare provider.
  • If you take an H2-receptor antagonist (famotidine, cimetidine, nizatidine, or ranitidine), JULUCA should be taken at least 4 hours before or 12 hours after you take these medicines.
  • If you take antacids, laxatives, or other products that contain aluminum, calcium carbonate, magnesium, or buffered medicines, JULUCA should be taken at least 4 hours before or 6 hours after you take these medicines.
  • If you need to take iron or calcium supplements by mouth during treatment with JULUCA:
    • You may take these supplements at the same time that you take JULUCA with food.
    • If you do not take these supplements with JULUCA and food, take JULUCA at least 4 hours before or 6 hours after you take these supplements.
  • Do not miss a dose of JULUCA.
  • If you miss a dose of JULUCA, take it as soon as you remember with a meal. Do not take 2 doses at the same time.
  • Stay under the care of a healthcare provider during treatment with JULUCA.
  • Do not run out of JULUCA. The virus in your blood may increase and the virus may become harder to treat. When your supply starts to run low, get more from your healthcare provider or pharmacy.
  • If you take too much JULUCA, call your healthcare provider or go to the nearest hospital emergency room right away.

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.