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 who may or may not have used an integrase strand transfer inhibitor, as well as children who have not used an integrase strand transfer inhibitor previously, weigh at least 3 kg, and are 4 weeks of age or older. 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.

The dose for dolutegravir tablets and dolutegravir dispersible tablets is not the same. Do not switch one for the other without talking to your doctor as the dose will be different.

The recommended dose of dolutegravir tablets for adults and children who weigh at least 20 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.

The recommended dose of dolutegravir dispersible tablets for adults and children who weigh at least 20 kg is 30 mg (6 tablets) 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 30 mg twice a day.

The recommended dose of dolutegravir dispersible tablets for children who weigh between 3 kg and 20 kg is based on body weight and will be determined by your child's doctor.

Dispersible tablets may be swallowed whole with some liquid or mixed in some drinking water. When they are mixed with water, they break apart to become a liquid suspension that can be easily swallowed. The water containing the medication should be taken within 30 minutes. Do not crush or chew the tablets.

Dolutegravir tablets and dolutegravir dispersible tablets may be taken with food or on an empty stomach. 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.

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 less than 4 hours 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 dolutegravir tablets at room temperature, protected from light, and keep them out of the reach of children. Dolutegravir dispersible tablets should also be stored in the original package to protect from moisture. Do not remove the silica gel desiccant.

Tablet

10 mg
Each white, round, film-coated, biconvex tablet, debossed with "SV 572" on one side and "10" on the other side, contains 10 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 macrogol/PEG, polyvinyl alcohol – part hydrolyzed, talc, and titanium dioxide.

25 mg
Each pale yellow, round, film-coated, biconvex tablet, debossed with "SV 572" on one side and "25" on the other side. Each tablet contains 25 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.

50 mg
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.

Dispersible Tablet

5 mg
Each white, round, film-coated, biconvex tablet, debossed with "SV H7S" on one side and "5" on the other side, contains 5.26 mg of dolutegravir sodium which is equivalent to 5 mg dolutegravir free acid. Nonmedicinal ingredients: calcium sulfate dihydrate, crospovidone, mannitol, microcrystalline cellulose, povidone K29/32, silicified microcrystalline cellulose, sodium starch glycolate, strawberry cream flavor, sucralose, and sodium stearyl fumarate; film-coating: hypromellose, polyethylene glycol, and titanium dioxide.

Do not take dolutegravir if you:

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

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
• stomach pain
• trouble sleeping
• vomiting
• weight gain

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:

• signs of autoimmune disorder (e.g., high temperature, redness, rash, fatigue, numbness, tingling or weakness, rapid or pounding heartbeat, liver problems, muscle weakness)
• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• 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 or joint 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, swelling of the face and throat, muscle or joint aches)
• 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)
• thoughts of self-harm or suicide

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.

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.

Hepatitis: Dolutegravir may cause decreased liver function or liver failure. This may be more likely 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.

Hypersensitivity reactions: A severe allergic reaction called hypersensitivity syndrome has occurred for some people taking dolutegravir. This reaction involves a number of organs in the body and may be fatal if not treated quickly. Stop taking the medication and get immediate medical attention if you have symptoms of a severe allergic reaction, including fever, swollen glands, yellowing of the skin or eyes, or flu-like symptoms with skin rash or blistering.

Immune reconstitution inflammatory syndrome: This medication may cause immune reconstitution inflammatory 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.

Kidney function: If you have kidney problems, 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.

Liver function: Dolutegravir can cause liver problems, including liver failure. If you have liver disease or decreased liver function, 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.

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: Dolutegravir may cause birth defects in the baby if it is taken during pregnancy. When used during the first 12 weeks of pregnancy, dolutegravir may increase the risk of a defect in the spinal cord, such as spina bifida, in the unborn baby. People who could become pregnant should use effective birth control while taking this medication. If you are planning to become pregnant, discuss other options for medications with your doctor. If you become pregnant while taking this medication, contact your doctor immediately. This medication should not be used during pregnancy.

Breast-feeding: Dolutegravir passes into breast milk. People 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 4 weeks old who weigh less than 3 kg. This medication should not be given to children who have previously used integrase strand transfer inhibitors.

For a full list of interactions, use the Drug Interaction Checker available on the Drugs.com website.

If you are taking other 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.

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.