Brand Name: Tivicay
Other Names: DTG, dolutegravir sodium
Drug Class: Integrase Inhibitors
Dolutegravir can cause serious, life-threatening side effects. These include allergic (hypersensitivity) reactions and liver 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 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 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 (jaundice)
- Dark-colored urine
- Pale-colored bowel movements
- Nausea or vomiting
- Loss of appetite for several days or longer
- 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. Food and Drug Administration (FDA) for the treatment of HIV infection in combination with:
- Other HIV medicines in adults and children who weigh at least 66 pounds (30 kilograms), or
- Rilpivirine (brand name: Edurant) as a complete regimen in adults who:
- have a viral load (the amount of HIV in a sample of blood) that is less than 50 copies/mL, and
- have been on the same HIV regimen for at least 6 months, and
- have never had treatment failure (treatment failure is when an HIV regimen is unable to control HIV infection), and
- have no drug resistance mutations associated with either dolutegravir or rilpivirine (drug resistance mutations are changes in the genetic material of HIV that cause the virus to become insensitive to certain HIV medicines).
Dolutegravir is always used in combination with other HIV medicines.
Dolutegravir belongs to a class (group) of HIV drugs called integrase inhibitors. Integrase inhibitors block an HIV enzyme called integrase. (An enzyme is a protein that starts or increases the speed of a chemical reaction.) By blocking integrase, integrase inhibitors 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 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 Dolutegravir?
Before taking dolutegravir, tell your health care provider:
- If you have ever had an allergic reaction to dolutegravir or are allergic to any other medicines.
- If you have or have ever had liver problems, including HBV infection or HCV infection.
- If you have any other medical conditions.
- If you are pregnant or plan to become pregnant. Whether dolutegravir can harm an unborn baby is unknown. Dolutegravir should be used during pregnancy only if the potential benefits outweigh the risks. Talk to your health care provider about possible risks with taking dolutegravir when pregnant.
- If you are breastfeeding or plan to breastfeed. Do not breastfeed if you have HIV or are taking dolutegravir.
- 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 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 from DailyMed. (DailyMed is a federal website that includes the most recent drug labels submitted to FDA.)
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?
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 the WARNING box above.)
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 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.
- 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 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 at www.accessdata.fda.gov/scripts/medwatch/.
How Should Dolutegravir Be Stored?
- Store dolutegravir at room temperature, 68°F to 77°F (20°C to 25°C).
- Do not use dolutegravir if the original seal over the container opening is broken or missing. If the container has a small packet of drying agent (called a desiccant), do not remove it. The desiccant protects the medicine from moisture.
- 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:
- The dolutegravir drug label, from DailyMed. The Patient Counseling Information section of the label includes information for people taking dolutegravir.
- Dolutegravir-related research studies, from the AIDSinfo database of ClinicalTrials.gov study summaries.
- A list of FDA-approved HIV medicines, from AIDSinfo.
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).
[Note from TheBody: This article was created by AIDSinfo, who last updated it on March 23, 2018. We have cross-posted it with their permission.]