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Juluca: Uses, Side Effects and Dosage

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Facts
Status:
Prescription (Rx)
Strength:
50 mg, 25 mg
Drug class:
Active ingredients:
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Juluca

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 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.

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 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. Talk to your healthcare provider about the benefits and risks of treatment with JULUCA during pregnancy.

Pregnancy Registry. There is a pregnancy registry for those who take 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. One of the medicines in JULUCA passes to your baby in your breast milk. Talk with your healthcare provider about the following risks to your baby from breastfeeding during treatment with JULUCA:

    • the HIV-1 virus may pass to your baby if your baby does not have HIV-1 infection.
    • the HIV-1 virus may become harder to treat if your baby has HIV-1 infection.
    • your baby may get side effects from JULUCA.

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:

    1. 1. You may take these supplements at the same time that you take JULUCA with food.
    2. 2. 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.

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
  • nausea
  • 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.

How should I store JULUCA?

  • Store JULUCA at room temperature between 68°F to 77°F (20°C to 25°C).
  • Store JULUCA tablets in the original bottle. Keep the bottle tightly closed and protected from moisture.
  • The bottle of JULUCA 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 JULUCA and all medicines out of the reach of children.

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 JULUCA for a condition for which it was not prescribed. Do not give JULUCA 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 about JULUCA 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.

Manufactured for:

ViiV Healthcare

Durham, NC 27701

Trademarks are owned by or licensed to the ViiV Healthcare group of companies.

©2025 ViiV Healthcare group of companies or its licensor.

JLC:10PIL

For more information go to www.JULUCA.com or call 1-877-844-8872.

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 11/2025

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 210192 · View the label on DailyMed

Revision date stated in the text: November 2025

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Juluca

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor, Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor
Active ingredients Dolutegravir sodium 50 mg, Rilpivirine hydrochloride 25 mg
Dosage form Tablet, film coated
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) VIIV HLTHCARE
FDA approval NDA 210192New Drug Application (NDA) Approved November 21, 2017
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
50 mg, 25 mg – 30 in 1 bottle NDC 49702-242-13

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.