Drug Database: Dolutegravir / Rilpivirine

What is Juluca?What is Juluca?

What is Juluca?

Juluca is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults who meet specific requirements, as determined by a health care provider.

Juluca is a complete HIV treatment regimen and should not be used with other HIV medicines. 

Juluca contains two different medicines: dolutegravir and rilpivirine.

For more information on the use of Juluca in adults with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV.

Although Juluca is not FDA-approved for use in adolescents, it may be appropriate for use in certain adolescents. For more information on the use Juluca in adolescents and children with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.

HIV medicines cannot cure HIV/AIDS, but taking HIV medicines every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission. If you are taking HIV medicines, do not cut down on, skip, or stop taking them unless your health care provider tells you to.

What should I tell my health care provider before taking Juluca?What should I tell my health care provider before taking Juluca?

What should I tell my health care provider before taking Juluca?

Before taking Juluca, tell your health care provider:

• If you are allergic to any of the HIV medicines in Juluca (dolutegravir or rilpivirine) or any other medicines.
• If you have or have ever had liver problems, including hepatitis B virus infection (HBV) or hepatitis C virus infection (HCV).
• If you have ever had a mental health problem.
• If you have any other medical conditions.
• If you are pregnant or plan to become pregnant. Talk to your health care provider about the risks and benefits of taking Juluca during pregnancy. For more information on the use of Juluca during pregnancy, please refer to the Recommendations for the Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States.
• If you are breast/chestfeeding or plan to breast/chestfeed. For people with HIV in the United States, the Guideline recommends speaking with your health care provider to discuss options for feeding your baby. People with suppressed viral load have a less than 1% chance of transmitting HIV to their baby via their own milk.
• If you are using hormone-based birth control (such as pills, implants, or vaginal rings). For more information about using birth control and HIV medicines at the same time, view the HIVinfo HIV and Birth Control infographic.
• About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products (particularly St. John’s wort) you are taking or plan to take. Juluca may affect the way other medicines or products work, and other medicines or products may affect how Juluca works. Taking Juluca together with certain medicines or products may cause serious, life-threatening side effects.

How should I take Juluca?How should I take Juluca?

How should I take Juluca?

Juluca comes in tablet form. Each tablet contains:

• 50 mg dolutegravir
• 25 mg rilpivirine

Take Juluca according to your health care provider’s instructions. Do not miss a dose of Juluca, and do not change your dose or stop taking Juluca without first talking with your health care provider.

Always take Juluca by mouth and with a meal. (A protein drink is not a substitute for a meal.)

If you are taking H2 blockers or antacids (medicines for reducing stomach acid); laxatives; other products containing aluminum, calcium carbonate, magnesium; or buffered medicines (such as buffered aspirin), carefully follow instructions on how to take them with Juluca.

Proton pump inhibitors (medicines for reducing stomach acid) should NOT be taken with Juluca.

If you have taken too much Juluca, contact your health care provider or local poison control center (1-800-222-1222 or online) right away, or go to the nearest hospital emergency room. 

For more information on how to take Juluca, see the FDA drug label.

What should I do if I forget a dose?What should I do if I forget a dose?

What should I do if I forget a dose?

If you miss a dose of Juluca, take the missed dose as soon as you remember it. (Take the missed dose with a meal.) But if it is almost time for your next dose, skip the missed dose and just take your next dose at the regular time. Do not take two doses at the same time to make up for a missed dose.

What side effects can Juluca cause?What side effects can Juluca cause?

What side effects can Juluca cause?

Juluca may cause side effects. Some side effects of Juluca can be serious as noted above. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the HIVinfo fact sheet on HIV Medicines and Side Effects for more information.

Other possible side effects of Juluca include diarrhea and headache.

Tell your health care provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Juluca. To learn more about possible side effects of Juluca, read the drug label or package insert or talk to your health care provider or pharmacist.

You can report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online.

How should Juluca be stored?How should Juluca be stored?

How should Juluca be stored?

• Store Juluca at room temperature, 68°F to 77°F (20°C to 25°C).
• Keep Juluca in the container that it came in. Keep the container tightly closed and away from moisture. If the container has a small packet of drying agent (called a desiccant), do not remove it. The desiccant protects the medicine from moisture.
• Do not use Juluca if the original seal over the container opening is broken or missing.
• Throw away Juluca that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
• Keep Juluca and all medicines out of reach of children.

Where can I find more information about Juluca?Where can I find more information about Juluca?

Where can I find more information about Juluca?

• For more information on the use of Juluca in people with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection. 
• This Patient Version drug summary is based on the following FDA label(s): Tablet, film-coated. The Patient Package Insert includes information for people taking Juluca.
• Juluca-related research studies, from ClinicalTrials.gov. (The ClinicalTrials.gov search can be modified so that you can get results that better match your interests.)
• A list of FDA-approved HIV medicines, from HIVinfo.