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Generic Name: dolutegravir and rilpivirine
Dosage Form: Tablets
Date of Approval: November 21, 2017
Company: ViiV Healthcare

Treatment for: HIV Infection

FDA Approves Juluca

The U.S. Food and Drug Administration (FDA) has approved Juluca (dolutegravir and rilpivirine) is a HIV-1 integrase strand transfer inhibitor (INSTI) and a HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) combination indicated as a complete regimen for the maintenance treatment of HIV-1 infection in adults who are virologically suppressed.

Patient Information

Read this Patient Information before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

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.

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.
  • 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

Before taking Juluca

Before you start treatment, 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. It is not known if this medicine will harm your unborn baby.
    Pregnancy Registry. There is a pregnancy registry for women who take antiretroviral medications, including Juluca during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to 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 this medicine 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 one time a day exactly as your healthcare provider tells you.
  • Always take the tablets with a meal. A protein drink alone does not replace a meal.
  • Do not change your dose or stop treatment 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:
    • 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 these supplements at least 4 hours before or 6 hours after you take Juluca.
  • Do not miss a dose.
  • If you miss a dose, take it as soon as you remember with a meal. Do not take two doses at the same time.
  • Stay under the care of a healthcare provider during treatment.
  • Do not run out of your prescription. 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 or overdose, call your healthcare provider or go to the nearest hospital emergency room right away.

Juluca side effects

Juluca can cause serious side effects, including:

  • Severe skin rash and allergic reactions. Call your healthcare provider right away if you develop a rash during treatment. Stop taking the tablets 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
    • welling 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. 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 include diarrhea and headache.

These are not all the possible side effects. 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.

See also: Side effects (in more detail)

How should I store Juluca?

  • Store the tablets at room temperature between 68°F to 77°F (20°C to 25°C).
  • Store the tablets in the original bottle. Keep the bottle tightly closed and protected from moisture.
  • The tablet bottle contains a desiccant to help keep your medicine dry (protect it from moisture). Keep the desiccant in the bottle. Do not remove the desiccant.

Keep all medicines out of the reach of children and pets.

General information about the safe and effective use of Juluca.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information that is written for health professionals.

What are the ingredients in Juluca?

Active ingredients: dolutegravir and rilpivirine.

Inactive ingredients: croscarmellose sodium, D-mannitol, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 20, povidone K29/32 and K30, silicified microcrystalline cellulose, sodium starch glycolate, and sodium stearyl fumarate.

The tablet film-coating contains: iron oxide red, iron oxide yellow, macrogol/PEG, polyvinyl alcohol-part hydrolyzed, talc, and titanium dioxide.