Drug information

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Pronounce:
Brand Name:
Tivicay, Tivicay PD
Other Names:
DTG, dolutegravir sodium
Drug Class:
Integrase Strand Transfer Inhibitor (INSTIs)
Drug Image(s): (Click to enlarge)
 
What are the most important things to know about dolutegravir? What are the most important things to know about dolutegravir?

What are the most important things to know about dolutegravir?

Dolutegravir can cause serious, life-threatening side effects. These include allergic reactions and liver problems.

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

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

Some people taking dolutegravir have had serious 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 dolutegravir. Liver problems have also occurred in people taking dolutegravir who have no history of liver disease. Liver function tests may be done before and during treatment with dolutegravir.

Contact your health care provider right away if you have any of the following symptoms that could be signs of liver problems:

  • Yellowing of your skin or the whites of your eyes (jaundice)
  • Dark-colored urine
  • Light-colored bowel movements
  • Loss of appetite for several days or longer
  • Nausea or vomiting
  • Pain, aching, or tenderness on the right side of your stomach area
  • Itching

Do not take dolutegravir if you take dofetilide (a medicine used to treat an irregular heartbeat). Taking dolutegravir and dofetilide can cause side effects that may be life threatening.

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

What is dolutegravir?What is dolutegravir?

What is dolutegravir?

Dolutegravir is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in combination with:

  • Other HIV medicines in adults;
  • Other HIV medicines in children at least 4 weeks of age and older who weigh at least 6.6 lb (3 kg) and who have never received an integrase strand transfer inhibitoror
  • Rilpivirine (brand name: Edurant) in adults to replace their current HIV medicines when their health care provider determines that they meet certain requirements.

Dolutegravir is always used in combination with other HIV medicines.

For more information on the use of dolutegravir in people with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV  and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.

HIV medicines can’t 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, don't 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 dolutegravir?What should I tell my health care provider before taking dolutegravir?

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

Before taking dolutegravir, tell your health care provider:

  • If you are allergic to dolutegravir or any other medicines.
  • If you have or have had liver problems, including hepatitis B virus infection (HBV) or hepatitis C virus infection (HCV).
  • 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 dolutegravir during pregnancy. For more information on the use of dolutegravir during pregnancy, please refer to the Recommendations for the Use of Antiretroviral Drugs in Pregnant Women with HIV Infection and Interventions to Reduce Perinatal HIV Transmission in the United States.
  • If you are breastfeeding or plan to breastfeed. For women with HIV in the United States, the Guideline does not recommend breastfeeding. Before your baby is born, or if you are already breastfeeding, talk to your health care provider to discuss alternative options for feeding your baby.
  • 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. Dolutegravir may affect the way other medicines or products work, and other medicines or products may affect how dolutegravir works. Taking dolutegravir together with certain medicines or products may cause serious side effects. Do not take dolutegravir if you take dofetilide. Taking dolutegravir and dofetilide together can cause side effects that may be life threatening.
How should I take dolutegravir?How should I take dolutegravir?

How should I take dolutegravir?

Dolutegravir comes in tablet form in the following strengths:

  • 5-mg tablet for oral suspension (brand name: Tivicay PD)
  • 10-mg, 25-mg, and 50-mg tablets (brand name: Tivicay)

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

Take dolutegravir by mouth, with or without food. If you are taking any other medicines, carefully follow instructions on how to take them with dolutegravir.

The 5-mg dolutegravir tablets for oral suspension may be swallowed whole or dispersed in drinking water and should not be chewed, cut, or crushed. Read the dolutegravir drug label for detailed instructions on how to prepare these tablets for oral suspension.

Always take dolutegravir in combination with other HIV medicines.

If you have taken too much dolutegravir, 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 dolutegravir, 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 dolutegravir, 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 dolutegravir cause?What side effects can dolutegravir cause?

What side effects can dolutegravir cause?

Dolutegravir may cause side effects. Some side effects of dolutegravir 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.

Another possible side effect of dolutegravir is a change in your immune system (called immune reconstitution inflammatory syndrome or IRIS). IRIS is a condition that sometimes occurs when the immune system begins to recover after treatment with an HIV medicine. As the immune system gets stronger, it may have an increased response to a previously hidden infection.

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 dolutegravir. To learn more about possible side effects of dolutegravir, 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 dolutegravir be stored?How should dolutegravir be stored?

How should dolutegravir be stored?

  • Store dolutegravir 10-mg, 25-mg, and 50-mg tablets at room temperature, 68°F to 77°F (20°C to 25°C). Store dolutegravir 5-mg tablets for oral suspension at room temperature, below 86°F (30°C).
  • Keep dolutegravir in the container that it came in and keep the container tightly closed. 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 dolutegravir if the original seal over the container opening is broken or missing.
  • Throw away dolutegravir that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
  • Keep dolutegravir and all medicines out of reach of children.
Where can I find more information about dolutegravir?Where can I find more information about dolutegravir?

Where can I find more information about dolutegravir?

More information about dolutegravir 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), tablet (for suspension).

 

Last Reviewed: March 25, 2021