Drug information

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Brand Name:
Dovato
Other Names:
DTG / 3TC, dolutegravir sodium / lamivudine
Drug Class:
Combination Drugs
Integrase Strand Transfer Inhibitor (dolutegravir)
Nucleoside Reverse Transcriptase Inhibitor (lamivudine)
Drug Image(s): (Click to enlarge)
 
What are the most important things to know about Dovato?What are the most important things to know about Dovato?

What are the most important things to know about Dovato?

Dovato can cause serious, life-threatening side effects. These include severe skin rash and allergic reactions, liver problems, a buildup of lactic acid in the blood (lactic acidosis), and drug interactions.

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

  • General ill feeling
  • Extreme tiredness
  • Muscle or joint aches
  • Fever
  • Blisters 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

People with a history of hepatitis B virus infection (HBV) or hepatitis C virus infection (HCV) may have an increased risk of developing new or worsening liver problems while taking Dovato. Liver problems have also occurred in people taking Dovato who have no history of liver disease.

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

If you have both HIV and HBV infection and take Dovato, your HBV infection may get much worse (flare up) if you stop taking Dovato. Do not stop taking Dovato without first talking to your health care provider.

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

  • Weakness or tiredness
  • Unusual muscle pain
  • Shortness of breath or fast breathing
  • Stomach pain with nausea and vomiting
  • Cold or blue hands and feet
  • Dizziness or lightheadedness
  • Fast or abnormal heartbeat

Taking Dovato with certain other medicines may cause serious, life-threatening side effects. Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

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

What is Dovato? What is Dovato?

What is Dovato?

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

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

Dovato contains two different medicines: dolutegravir and lamivudine.

For more information on the use of Dovato 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 Dovato?What should I tell my health care provider before taking Dovato?

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

Before taking Dovato, tell your health care provider:

  • If you are allergic to any of the HIV medicines in Dovato (dolutegravir or lamivudine) or any other medicines.
  • If you have or have had liver problems, including HBV infection or HCV infection.
  • If you have kidney problems.
  • 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 Dovato during pregnancy. For more information on the use of Dovato 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. Dovato may affect the way other medicines or products work, and other medicines or products may affect how Dovato works. Taking Dovato together with certain medicines or products may cause serious, life-threatening side effects.
How should I take Dovato?How should I take Dovato?

How should I take Dovato?

Dovato comes in tablet form. Each tablet contains:

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

Take Dovato by mouth with or without food. 

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

What side effects can Dovato cause?

Dovato may cause side effects. Some side effects of Dovato 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 Dovato include:

  • Changes 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.
  • Headache, diarrhea, trouble sleeping, tiredness, and anxiety.

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

How should Dovato be stored?

  • Store Dovato below 86°F (30°C).
  • Keep Dovato in the container that it came in and keep the container tightly closed.
  • Do not use Dovato if the original seal over the container opening is broken or missing.
  • Throw away Dovato that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
  • Keep Dovato and all medicines out of reach of children.
Where can I find more information about Dovato?Where can I find more information about Dovato?

Where can I find more information about Dovato?

Manufacturer Information

ViiV Healthcare

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

 

Last Reviewed: April 19, 2021