How does this medication work? What will it do for me?

Dolutegravir belongs to the class of medications called human immunodeficiency virus (HIV) integrase strand transfer inhibitors. It is used in combination with other medications to treat HIV infection for adults and adolescents who weigh at least 40 kg. Dolutegravir works by blocking an enzyme called integrase that is necessary for the HIV virus to reproduce. In doing so, it reduces the amount of HIV in the blood.

This medication does not cure AIDS and does not reduce the risk of passing HIV to others through sexual contact or blood contamination.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each yellow, round, film-coated, biconvex tablet, debossed with "SV 572" on one side and "50" on the other, contains 50 mg of dolutegravir as dolutegravir sodium. Nonmedicinal ingredients: D-mannitol, microcrystalline cellulose, povidone K29/32, sodium starch glycolate, and sodium stearyl fumarate. The tablet film-coating contains the inactive ingredients iron oxide yellow, macrogol/PEG, polyvinyl alcohol – part hydrolyzed, talc, and titanium dioxide.

How should I use this medication?

The recommended dose of dolutegravir for adults and adolescents ages 12 to 18 years and who weigh at least 40 kg is 50 mg (1 tablet) taken once a day. Depending on other medications you may be using or may have used in the past to treat HIV infection, you may be advised to take 50 mg (1 tablet) twice a day.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Dolutegravir may be taken with food or on an empty stomach. It should be swallowed with some liquid.

It is important that this medication be taken exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is 4 hours or less before your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take dolutegravir if you:

  • are allergic to dolutegravir or any ingredients of the medication
  • are taking the medication "dofetilide"

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal discomfort
  • abnormal dreams
  • diarrhea
  • dizziness
  • fatigue
  • gas
  • headache
  • itching, rash
  • nausea
  • trouble sleeping
  • vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • increased fat on the upper back, neck, breasts, and around the trunk and loss of fat from the legs, arms, and face
  • signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
  • unusual muscle pain

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
  • signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Fat redistribution: Over time, this medication may change how fat is distributed in your body and may change your body shape. You may notice increased fat in the upper back and neck, breasts, and around the back, chest, and stomach area; or loss of fat from the legs, arms, and face. The long-term effects of this are not known.

Hepatitis: Dolutegravir may cause liver function to worsen, particularly for people who also have hepatitis B or hepatitis C. If you have hepatitis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms of liver problems (e.g., abdominal pain, persistent vomiting, feeling unwell, fever, itching, yellowing of the skin and eyes, dark urine), contact your doctor immediately.

Immune reconstitution syndrome: This medication may cause immune reconstitution syndrome, where signs and symptoms of inflammation from previous infections appear. These symptoms occur soon after starting anti-HIV medication and can vary. They are thought to occur as a result of the immune system improving and being able to fight infections that have been present without symptoms (such as pneumonia, herpes, or tuberculosis). Report any new symptoms to your doctor as soon as possible.

Stopping the medication: If you stop taking this medication, your HIV infection could get worse. Take the medication exactly as prescribed by your doctor, and do not stop taking the medication without checking with your doctor first.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if dolutegravir passes into breast milk. Women who have HIV infection are cautioned against breast-feeding because this increases the risk of passing HIV to a baby who does not have the infection.

Children: The safety and effectiveness of using this medication have not been established for children less than 12 years old and adolescents who weigh less than 40 kg.

What other drugs could interact with this medication?

There may be an interaction between dolutegravir and any of the following:

  • aluminum hydroxide
  • calcium supplements (e.g., calcium carbonate, calcium citrate)
  • carbamazepine
  • dofetilide
  • efavirenz
  • etravirine
  • fosamprenavir
  • fosphenytoin
  • iron (e.g., ferrous fumarate, ferrous gluconate, ferrous sulfate)
  • magnesium (e.g., magnesium hydroxide, magnesium oxide)
  • metformin
  • multiple vitamins and minerals with vitamins A, E
  • nevirapine
  • oxcarbazepine
  • phenobarbital
  • phenytoin
  • primidone
  • rifampin
  • selenium
  • St. John’s wort
  • sucralfate
  • tipranavir
  • zinc

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.