Drug Database: Dolutegravir

What is dolutegravir?What is dolutegravir?

What is dolutegravir?

Dolutegravir (brand names: Tivicay and Tivicay PD) 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 meet specific requirements, as determined by a health care provider; 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.

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 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 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 ever 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 dolutegravir during pregnancy. For more information on the use of dolutegravir 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. 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, life-threatening side effects. 

How should I take dolutegravir?How should I take dolutegravir?

How should I take dolutegravir?

Dolutegravir comes in the following forms and strengths:

• Tablets (brand name: Tivicay): 50 mg
• Tablets for oral suspension (brand name: Tivicay PD): 5 mg

Take dolutegravir according to your health care provider’s instructions. Do not miss a dose of dolutegravir, and do not change your dose or stop taking dolutegravir without first talking with your health care provider.

Take dolutegravir by mouth, with or without food. If you are taking any other medicines, supplements, antacids, or laxatives that contain magnesium, aluminum, calcium, or iron, carefully follow instructions on how to take them with dolutegravir.

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

Dolutegravir tablets (Tivicay) are not the same as dolutegravir tablets for oral suspension (Tivicay PD) and cannot be substituted for each other. Check to make sure you receive the correct form each time you or your child’s prescription is filled.

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 or online) 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 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?

• 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 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), tablet (for suspension). The Patient Package Insert includes information for people taking dolutegravir.
• The American Hospital Formulary Service (AHFS) Patient Medication Information for dolutegravir available from MedlinePlus.
• Dolutegravir-related research studies, from ClinicalTrials.gov. (The ClinicalTrials.gov search can be modified so that you can get results that better match your interests.)
• A list of FDA-approved HIV medicines, from HIVinfo.