Drugs

Dolutegravir / Rilpivirine

Dolutegravir / Rilpivirine

Brand Name: Juluca Other Names: DTG/RPV, dolutegravir sodium / rilpivirine hydrochloride Drug Class: Combination Drugs

Drug Image(s):

(Click to enlarge)
What are the most important things to know about Juluca?

What are the most important things to know about Juluca?

Juluca can cause serious, life-threatening side effects. These include severe skin rash and allergic reactions, liver problems, and depression.

Contact your health care provider right away if you develop a rash while taking Juluca. Stop taking Juluca and get medical help right away if you develop a rash with any of the following signs or symptoms:

  • Fever
  • General ill feeling
  • Extreme tiredness
  • Muscle or joint aches
  • Blisters or peeling skin
  • Blisters or sores in your mouth
  • Redness or swelling of your eyes
  • Swelling of your mouth, face, lips, or tongue
  • Trouble breathing

Some people taking Juluca have had liver problems. People with a history of hepatitis B virus infection (HBV) or hepatitis C virus infection (HCV) or who have elevated results on liver function tests may have an increased risk of developing new or worsening liver problems while taking Juluca. Liver problems have also occurred in people taking Juluca who have no history of liver disease. Liver function tests may be done before and during treatment with Juluca. 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-colored urine
  • Light-colored bowel movements
  • Nausea or vomiting
  • Loss of appetite
  • Pain, aching, or tenderness on the right side of your stomach area

Contact your health care provider right away or get medical help if you have any of the following symptoms that could be signs of depression or mood changes:

  • Feeling sad or hopeless
  • Feeling anxious or restless
  • Harming yourself or having thoughts about harming yourself (including suicidal thoughts)

While taking Juluca, it is important to keep all of your appointments with your health care provider.

What is Juluca?

What is Juluca?

Juluca is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) to treat HIV infection in adults and to replace the current HIV regimen in people who:

  • have a viral load (the amount of HIV in a sample of blood) that is less than 50 copies/mL, and
  • have been on the same HIV regimen for at least 6 months, and
  • have never had treatment failure (treatment failure is when an HIV regimen is unable to control HIV infection), and 
  • have no drug resistance mutations associated with any of the HIV medicines in Juluca (drug resistance mutations are changes in the genetic material of HIV that cause the virus to become insensitive to certain HIV medicines).

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

Juluca contains the following two different medicines combined in one pill:

Integrase inhibitors block an HIV enzyme called integrase and NNRTIs block an HIV enzyme called reverse transcriptase. (An enzyme is a protein that starts or increases the speed of a chemical reaction.) By blocking integrase and reverse transcriptase, these two drugs work in combination to prevent HIV from multiplying and can reduce the amount of HIV in the body. 

HIV medicines can’t cure HIV/AIDS, but taking a combination of HIV medicines (called an HIV regimen) every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission.

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, rilpivirine) or any other medicines.
  • If you have ever had a severe skin rash or allergic reaction to medicines that contain dolutegravir or rilpivirine.
  • 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 possible risks with taking Juluca when pregnant.
  • If you are breastfeeding or plan to breastfeed. Do not breastfeed if you have HIV or are taking Juluca.
  • 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 AIDSinfo HIV and Birth Control infographic.
  • About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products 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 side effects.

How should I take Juluca?

How should I take Juluca?

Juluca comes in tablet form. Each tablet contains:

Take Juluca according to your health care provider’s instructions.

Take Juluca with food (a protein drink is not a substitute for food). If you are taking any other medicines, carefully follow instructions on how to take them with Juluca.

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

For more information on how to take Juluca, see the FDA drug label from DailyMed. (DailyMed is a federal website that includes the most recent drug labels submitted to FDA.)

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. 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?

Juluca may cause side effects. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the AIDSinfo fact sheet on HIV Medicines and Side Effects for more information.

Some side effects of Juluca can be serious. Serious side effects of Juluca include severe skin rash and allergic reactions, liver problems, and depression or mood changes. (See the WARNING box above.)

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 at https://www.accessdata.fda.gov/scripts/medwatch/.

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?

More information about Juluca is available:

Manufacturer Information

ViiV Healthcare

Main number: 877-844-8872
Patient assistance (ViiV Connect): 844-588-3288

The above Patient Version drug summary is based on the following FDA label(s): Tablet, film-coated.

Last Reviewed: November 27, 2017