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dolutegravir

Generic Name: dolutegravir (DOE loo TEG ra vir)
Brand Name: Tivicay

What is dolutegravir?

Dolutegravir is an antiviral medicine that prevents human immunodeficiency virus (HIV) from multiplying in your body.

Dolutegravir is used with other antiviral medications to treat HIV, the virus that can cause the acquired immunodeficiency syndrome (AIDS). Dolutegravir is not a cure for HIV or AIDS.

This medicine is for use in adults and children who weigh at least 66 pounds.

Dolutegravir may also be used for purposes not listed in this medication guide.

Important Information

You should not use dolutegravir if you are also taking dofetilide (Tikosyn).

Before taking this medicine

You should not use this medication if you are allergic to dolutegravir or if you are also taking dofetilide (Tikosyn).

To make sure dolutegravir is safe for you, tell your doctor if you have:

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of dolutegravir on the baby.

Women with HIV or AIDS should not breast feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

How should I take dolutegravir?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take dolutegravir with or without food.

If a child is using this medicine, tell your doctor if the child has any changes in weight. Dolutegravir doses are based on weight in children, and any changes may affect your child's dose.

While using dolutegravir, you may need frequent blood tests.

If you have ever had hepatitis B, dolutegravir can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function during treatment and for several months after you stop using this medicine.

HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with any packet or canister of moisture-absorbing preservative.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking dolutegravir?

Taking this medication will not prevent you from passing HIV to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Dolutegravir side effects

Stop taking this medicine and get emergency medical help if you have signs of an allergic reaction: fever, general ill feeling, trouble breathing, extreme tiredness; mouth sores, redness or swelling in your eyes; blistering or peeling skin; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • the first sign of any skin rash, no matter how mild; or

  • liver problems--nausea, vomiting, loss of appetite, upper stomach pain, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Dolutegravir may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with dolutegravir. Tell your doctor if you have:

  • signs of a new infection--fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss;

  • chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;

  • cold sores, sores on your genital or anal area;

  • rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;

  • trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or

  • swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.

Common side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Dolutegravir dosing information

Usual Adult Dose for HIV Infection:

Therapy-naive or therapy-experienced integrase strand transfer inhibitor (INSTI)-naive patients or virologically-suppressed patients switching to this drug plus rilpivirine: 50 mg orally once a day

Therapy-naive or therapy-experienced INSTI-naive patients when coadministered with certain UGT1A or CYP450 3A inducers: 50 mg orally twice a day

INSTI-experienced patients with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistance: 50 mg orally twice a day

Comments:
-Rilpivirine dose is 25 mg orally once a day for patients switching to this drug plus rilpivirine.
-The manufacturer product information should be consulted for relevant UGT1A or CYP450 3A inducers.
-In INSTI-experienced patients, alternative combinations that do not include metabolic inducers should be considered where possible.

Uses:
-In combination with other antiretroviral agents, for the treatment of HIV-1 infection
-In combination with rilpivirine, as a complete regimen for the treatment of HIV-1 infection to replace a stable antiretroviral regimen in patients who are virologically-suppressed (HIV-1 RNA less than 50 copies/mL) for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to either drug

Usual Pediatric Dose for HIV Infection:

30 to less than 40 kg: 35 mg orally once a day
At least 40 kg: 50 mg orally once a day

Comments:
-Recommended for therapy-naive or therapy-experienced INSTI-naive patients
-If certain UGT1A or CYP450 3A inducers are coadministered, the weight-based dose should be increased to twice a day; the manufacturer product information should be consulted for relevant inducers.
-Safety and efficacy not established in INSTI-experienced patients with documented or clinically suspected resistance to other INSTIs (raltegravir, elvitegravir).

Use: In combination with other antiretroviral agents, for the treatment of HIV-1 infection

What other drugs will affect dolutegravir?

Some medicines can make dolutegravir much less effective when taken at the same time. If you take any of the following medicines, take your dolutegravir dose 2 hours before or 6 hours after you take the other medicine.

Tell your doctor about all your current medicines and any you start or stop using, especially:

This list is not complete. Other drugs may interact with dolutegravir, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your pharmacist can provide more information about dolutegravir.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 3.01.

Date modified: February 01, 2018
Last reviewed: December 26, 2017

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