Drugs

Dolutegravir / Lamivudine

Dolutegravir / Lamivudine

Brand Name: Dovato Other Names: DTG / 3TC, dolutegravir sodium / lamivudine Drug Class: Combination Drugs

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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 allergic reactions, liver problems, and a buildup of lactic acid in the blood (lactic acidosis).

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 of a serious allergic reaction (hypersensitivity reaction):

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

Some people taking Dovato have had serious liver problems. 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. Liver function tests may be done before and during treatment with Dovato.

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
  • Nausea or vomiting
  • Loss of appetite
  • Pain, aching, or tenderness on the right side of your stomach

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:

  • Feeling very weak or tired
  • Unusual muscle pain
  • Trouble breathing
  • Stomach pain with nausea and vomiting
  • Feeling cold, especially in your arms and legs
  • Feeling dizzy or light-headed
  • Fast or irregular heartbeat

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

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

Dovato contains the following two different medicines combined in one tablet:

Integrase inhibitors block an HIV enzyme called integrase. NRTIs block another HIV enzyme called reverse transcriptase. By blocking integrase and reverse transcriptase, the two drugs in combination 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 treatment 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 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 ever 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. One of the medicines in Dovato (dolutegravir) may harm your unborn baby. You should not take Dovato if you are planning to become pregnant or during the first 12 weeks of pregnancy. Your health care provider may prescribe a different medicine if you are planning to become pregnant or if you become pregnant during treatment with Dovato. Tell your health care provider right away if you are planning to become pregnant, you become pregnant, or think you may be pregnant during treatment with Dovato.
  • If you are breastfeeding or plan to breastfeed. Do not breastfeed if you have HIV or are taking Dovato.
  • 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 (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 side effects. Do not take Dovato if you take dofetilide. Taking Dovato and dofetilide together can cause side effects that may be serious or life-threatening.

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

If you take 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?

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?

Dovato 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 Dovato can be serious. Serious side effects of Dovato include allergic reactions, liver problems, and a buildup of lactic acid in the blood (lactic acidosis). (See section above: What are the most important things to know about Dovato?)

Dovato may cause 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.

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?

  • 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?

More information about Dovato 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: April 9, 2019