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
- 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
Some people taking dolutegravir, a component of Dovato, may develop 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 Dovato. Liver problems have also occurred in people who have no history of liver problems or other risk factors.
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/abdominal area
If you have both HIV and HBV infection and take Dovato, the hepatitis B virus can change (mutate) during your treatment with Dovato and become harder to treat (resistant). If you use Dovato and have both HIV and HBV infection, you will need to take additional treatment for HBV infection. Also, 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?
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 with HIV and 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 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 hepatitis B virus infection (HBV) or hepatitis C virus infection (HCV).
- 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 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. 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?
Dovato comes in tablet form. Each tablet contains:
- 50 mg dolutegravir
- 300 mg lamivudine
Take Dovato according to your health care provider’s instructions. Do not miss a dose of Dovato, and do not change your dose or stop taking Dovato without first talking with your health care provider.
Take Dovato by mouth with or without food. If you are taking any other medicines or supplements, including antacids; laxatives; other products containing aluminum or magnesium; buffered medicines; iron; or calcium, carefully follow instructions on how to take them with Dovato.
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?
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?
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?
- 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?
- 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 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 Dovato.
- The American Hospital Formulary Service (AHFS) Patient Medication Information for dolutegravir and lamivudine available from MedlinePlus.
- Dovato-related research studies, from ClinicalTrials.gov. (The ClinicalTrials.gov search can be modified so that you can get results that better match your interests. To learn more about the ClinicalTrials.gov search features, please see How to Search.)
- A list of FDA-approved HIV medicines, from HIVinfo.
Main number: 877-844-8872
Patient assistance (ViiV Connect): 844-588-3288
Last Reviewed: April 10, 2023