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Information

An Overview of Dolutegravir

May 7, 2015

Dolutegravir

Brand Name: Tivicay
Other Names: DTG
Drug Class: Integrase Inhibitors
Approved Use: Treatment of HIV Infection

Chemical Image:

Dolutegravir chemical image

dolutegravir sodium
Molecular Weight: 441.3642

WARNING:

Dolutegravir can cause serious, life-threatening side effects. These include allergic 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 have a rash with any of the following symptoms:

  • Fever.
  • General ill feeling.
  • Extreme tiredness.
  • 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.

Stop taking dolutegravir and get medical help 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 or tea-colored urine.
  • Pale-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. 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 adults and children 12 years of age and older and weighing at least 88 pounds (40 kilograms). 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?

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Before taking dolutegravir, tell your health care provider:

  • If you are allergic to dolutegravir or any other medicines.
  • If you have had or currently have liver problems, including hepatitis B virus (HBV) or hepatitis C virus (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 benefit justifies the potential risk. 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 are infected with HIV or are taking dolutegravir.
  • If you are using hormone-based birth control (such as pills, injections, or implants). 
  • 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 can cause side effects that may be life threatening.


How Should I Take Dolutegravir?

Dolutegravir comes in tablet form. Each tablet contains 50 mg dolutegravir (brand name: Tivicay).

Take dolutegravir according to your health care provider's instructions.

Take dolutegravir by mouth, with or without food.

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 within 4 hours of 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 can cause serious, life-threatening side effects. These include allergic reactions and liver problems. (See the WARNING above.)

Other possible side effects of dolutegravir include:

  • Changes in liver test results. People with a history of HBV or HCV may have an increased risk of developing new or worsening changes in certain liver test results during treatment with dolutegravir.
  • Changes in body fat (lipodystrophy).
  • Immune reconstitution inflammatory syndrome (IRIS), 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 start having new symptoms after starting your HIV medicine.
  • Trouble sleeping.
  • Tiredness.
  • Headache.

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.

The AIDSinfo fact sheet on HIV Medicines and Side Effects also includes information that may apply to dolutegravir.

You can also 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 bottle 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:


Manufacturer Information

ViiV Healthcare
877-844-8872

The above Patient Version drug summary is based on the following FDA label(s): Tablet (film coated).


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More on Tivicay (Dolutegravir, DTG)


  
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This article was provided by AIDSinfo. Visit the AIDSinfo website to find out more about their activities and publications.
 

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