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.

You should always talk to your doctor about any side effect.

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.
    • You should not take JULUCA at the time of becoming pregnant or during the first 12 weeks of pregnancy. Your healthcare provider may change your medicine during this time in your pregnancy
    • If you can become pregnant, your healthcare provider will perform a pregnancy test before you start treatment with JULUCA, and you should consistently use 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

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

Get more information about taking JULUCA.

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.