DolutegravirBrand Name: Tivicay Other Names: DTG, dolutegravir sodium Drug Class: Integrase Inhibitors
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What are the most important things to know about dolutegravir?
Dolutegravir can cause serious, life-threatening side effects. These include allergic () reactions and 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 hypersensitivity reaction:
- General ill feeling
- Muscle or joint aches
- Blisters or sores in your mouth
- Blisters or peeling skin
- Redness or swelling of your eyes
- Swelling of your mouth, face, lips, or tongue
- Trouble breathing
Some people taking dolutegravir have had serious liver problems. People with a history of(HBV) or (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 whites of your eyes ( )
- Dark-colored urine
- Light-colored bowel movements
- Nausea or vomiting
- Loss of appetite
- Pain, aching, or tenderness on your right side below your ribs
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?
Dolutegravir is a prescription medicine approved by the U.S.(FDA) for the treatment of HIV in combination with:
- Other HIV medicines in adults and children who weigh at least 66 lb (30 kg), or
- 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.
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. 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?
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 B infection (HBV) or hepatitis C virus infection (HCV).
- If you have any other medical conditions.
- If you are pregnant or plan to become pregnant. Dolutegravir may harm your unborn baby. You should not take dolutegravir at the time of becoming pregnant or during the first 12 weeks of pregnancy. Your health care provider may change your medicine during this time in your pregnancy. If you can become pregnant, your health care provider will perform a pregnancy test before you start treatment with dolutegravir. You should also consistently use effective birth control (contraception) during treatment with dolutegravir. 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 dolutegravir.
- If you are breastfeeding or plan to breastfeed. Do not breastfeed if you have HIV or are taking dolutegravir.
- If you are using HIV and Birth Control infographic. -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
- About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products 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 serious or life threatening.
How should I take dolutegravir?
Dolutegravir (brand name: Tivicay) comes in tablet form in the following strengths:
- 10 mg
- 25 mg
- 50 mg
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.
Always take dolutegravir in combination with other HIV medicines.
If you take 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?
If you miss aof 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?
Dolutegravir 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 dolutegravir can be serious. Serious side effects of dolutegravir include allergic reactions and liver problems. (See section above: What are the most important things to know about dolutegravir?)
Other possible side effects of dolutegravir include:
- Changes in liver test results. People with a history of HBV or HCV infection may have an increased risk of developing new or worsening changes in certain liver test results during treatment with dolutegravir.
- Changes in your (called 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.
- Trouble sleeping, tiredness, and headache, which are among the most common side effects of dolutegravir.
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 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?
- Store dolutegravir at room temperature, 68°F to 77°F (20°C to 25°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?
More information about dolutegravir is available:
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: March 9, 2020