What are the side effects of dtg?

Medically reviewed by Drugs.com. Last updated on Dec 5, 2022.

Applies to dolutegravir: oral tablet, oral tablet for suspension.

Along with its needed effects, dolutegravir may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking dolutegravir:

Some side effects of dolutegravir may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Applies to dolutegravir: oral tablet, oral tablet dispersible.

The most common side effects were diarrhea, nausea, and headache. The most common side effects of moderate to severe intensity were insomnia, fatigue, and headache.

Very common (10% or more): Diarrhea (up to 18%), nausea (up to 13%), elevated lipase

Common (1% to 10%): Abdominal pain, abdominal discomfort, flatulence, upper abdominal pain, vomiting

Grade 2 and grade 3 to 4 elevations in lipase were reported in up to 11% and up to 5% of therapy-naive patients, respectively. Elevated lipase was reported in 10% of therapy-experienced integrase strand transfer inhibitor (INSTI)-experienced patients.

Very common (10% or more): Headache (up to 13%)

Common (1% to 10%): Dizziness

Grade 2 and grade 3 to 4 elevations in AST were reported in up to 5% and up to 3% of therapy-naive patients, respectively. Grade 2 and grade 3 to 4 elevations in ALT were reported in 4% and up to 2% of therapy-naive patients, respectively. Grade 2 and grade 3 to 4 elevations in total bilirubin were reported in up to 3% and less than 1% of therapy-naive patients, respectively. Elevated ALT and AST were reported in 9% and 8% of therapy-experienced INSTI-experienced patients, respectively.

The rates of AST and ALT abnormalities were higher patients coinfected with hepatitis B and/or C virus. ALT abnormalities (grade 2 to 4) in hepatitis B and/or C coinfected patients compared with HIV monoinfected patients were reported in 18% versus 3% with 50 mg once a day and 13% versus 8% with 50 mg twice a day.

Liver chemistry elevations consistent with immune reconstitution syndrome were reported in some patients with hepatitis B and/or C at the start of therapy, especially when antihepatitis therapy was stopped.

Acute liver failure has been reported in a regimen containing this drug; contribution of this drug was unclear.

Common (1% to 10%): Elevated AST, elevated ALT, elevated total bilirubin

Uncommon (0.1% to 1%): Hepatitis

Rare (0.01% to 0.1%): Increased bilirubin (in combination with increased transaminases)

Frequency not reported: Liver chemistry elevations consistent with immune reconstitution syndrome

Postmarketing reports: Acute liver failure, hepatotoxicity

Common (1% to 10%): Hyperglycemia

Frequency not reported: Fasted lipid values increased (including cholesterol, HDL cholesterol, LDL cholesterol, triglycerides)

Antiretroviral therapy:

-Frequency not reported: Increased glucose levels

Grade 2 and grade 3 hyperglycemia were reported in up to 9% and up to 2% of therapy-naive patients, respectively. Hyperglycemia and elevated cholesterol were reported in 14% and 10% of therapy-experienced INSTI-experienced patients, respectively.

Suicidal ideation, attempt, behavior, or completion were observed primarily in patients with history of depression or other psychiatric illness.

Common (1% to 10%): Insomnia, abnormal dreams, depression

Uncommon (0.1% to 1%): Suicidal ideation, suicide attempt

Frequency not reported: Suicidal behavior, suicide completion

Postmarketing reports: Anxiety

Grade 2 and grade 3 to 4 elevations in CPK were reported in up to 5% and up to 7% of therapy-naive patients, respectively. Elevated CPK was reported in 6% of therapy-experienced INSTI-experienced patients.

Arthralgia and myalgia have also been reported during postmarketing experience.

Common (1% to 10%): Elevated creatine phosphokinase (CPK)

Uncommon (0.1% to 1%): Arthralgia, myalgia

Frequency not reported: Myositis

Grade 2 and grade 3 to 4 reductions in total neutrophils were reported in up to 4% and up to 3% of therapy-naive patients, respectively. Hematology laboratory abnormality (grade 3 to 4) was reported in 2% of therapy-experienced INSTI-experienced patients, with neutropenia (2%) reported most often.

Common (1% to 10%): Decreased total neutrophils, hematology laboratory abnormality

Frequency not reported: Decreased neutrophil count, decreased hemoglobin

Common (1% to 10%): Pruritus, rash (includes rash, generalized rash, macular rash, maculopapular rash, pruritic rash, drug eruption)

Frequency not reported: Renal impairment, increased serum creatinine (due to inhibition of tubular secretion of creatinine), changes in median serum creatinine

Increased serum creatinine occurred due to inhibition of tubular secretion of creatinine without affecting renal glomerular function. Increased serum creatinine was reported within the first week of therapy and remained stable through 48 weeks; a mean change of 9.96 mcmol/L (range of -53 to 54.8 mcmol/L) was reported after 48 weeks of therapy in therapy-naive patients. Increased serum creatinine was reported within the first 4 weeks of therapy and remained stable through 96 weeks; a mean change of 0.15 mg/dL (range of -0.32 to 0.65 mg/dL) was reported after 96 weeks of therapy in therapy-naive patients.

Common (1% to 10%): Fatigue

Frequency not reported: Decreased blood bicarbonate, increased blood potassium

Postmarketing reports: Increased weight

Antiretroviral therapy:

-Frequency not reported: Increased weight, increased blood lipid levels

Uncommon (0.1% to 1%): Hypersensitivity reactions (characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury)

Uncommon (0.1% to 1%): Immune reconstitution/reactivation syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome, autoimmune hepatitis)

Frequency not reported: Immune reconstitution inflammatory syndrome

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Dolutegravir is a medication used to treat HIV, marketed under the brand name Tivicay. It is taken in combination with other antiretroviral drugs.

The usual adult dose of dolutegravir is one 50mg tablet once a day. If you are taking certain other medications, you may be prescribed a dose of one 50mg tablet twice a day.

Dolutegravir is also available in combination pills with lamivudine and abacavir (marketed as Triumeq), with lamivudine (marketed as Dovato) and with rilpivirine (marketed as Juluca).

Dolutegravir is from a class of drugs known as integrase inhibitors. Your doctor will prescribe dolutegravir as part of your HIV treatment, along with antiretrovirals from another class of drugs. It is important to take all the drugs as prescribed, every day. Each drug class works against HIV in a different way.

The aim of HIV treatment is to reduce the level of HIV in your body (viral load). Ideally, your viral load should become so low that it is undetectable – usually less than 50 copies of virus per ml of blood. Taking HIV treatment and having an undetectable viral load protects your immune system and stops HIV being passed on to someone else during sex.

You can usually take dolutegravir with or without food. If you are prescribed dolutegravir to be taken twice a day, your doctor will advise you to take it with food.

HIV treatment works best if you take it every day. When would be a good time for you to plan to take your treatment? Think about your daily routine and when you will find it easiest to take your treatment.

If you forget to take a dose of dolutegravir, take it as soon as you remember. If your next dose is due within four hours, then don’t take a double dose, just skip the dose you’ve forgotten and carry on.

If you regularly forget to take your treatment, or you aren’t taking it for another reason, it’s important to talk to your doctor about this.

All drugs have possible side effects. It’s a good idea to talk to your doctor about possible side effects before you start taking a drug. If you experience something that might be a side effect, talk to your doctor about what can be done. A full list of side effects, including less common side effects, should be included in the leaflet that comes in the packaging with dolutegravir.

We generally divide side effects into two types:

Common – a side effect that occurs in at least one in a hundred people (more than 1%) who take this drug.

Rare – a side effect that occurs in fewer than one in a hundred people (less than 1%) who take this drug.

Common side effects of dolutegravir include (most common in bold):

Rarely, dolutegravir can cause a hypersensitivity (allergic) reaction. If you develop a rash with other symptoms, such as a fever, seek medical advice.

People with HIV may gain weight after starting antiretroviral treatment. Clinical trials of new HIV drugs introduced since 2003 show that people taking dolutegravir are at higher risk of substantial weight gain than people taking other antiretroviral drugs.

You should always tell your doctor and pharmacist about any other drugs or medication you are taking. That includes anything prescribed by another doctor, medicines you have bought from a high-street chemist, herbal and alternative treatments, and recreational or party drugs (‘chems’).

Some medicines or drugs are not safe if taken together – the interaction could cause increased, dangerous levels, or it could stop one or both of the drugs from working. Other drug interactions are less dangerous but still need to be taken seriously. If levels of one drug are affected, you may need to change the dose you take. This must only be done on the advice of your HIV doctor.

A list of drugs, known to have interactions with dolutegravir, should be included in the leaflet that comes in the packaging with dolutegravir. Tell your doctor if you are taking any of these drugs, and other drugs that are not on the list.

If you are taking dolutegravir, it is particularly important to check with your HIV doctor or pharmacist before taking any of the following medicines:

Taking calcium, iron, magnesium or aluminium can stop you from absorbing dolutegravir properly – all multivitamins, mineral supplements and antacids (used to treat heartburn or indigestion) must be taken at least six hours before or two hours after dolutegravir.

If you are considering having a baby, or think you might be pregnant, talk to your doctor as soon as possible about which combination of anti-HIV medications would be right for you. It is important to take antiretroviral treatment during pregnancy to prevent passing HIV from mother to baby.

Initial studies found that dolutegravir was associated with a slight increase in neural tube defects. Neural tube defects affect the development of your baby’s brain and spine. It’s important to know that this increase was small and that more recent studies suggest that there is no increased risk.

Whether you continue to take dolutegravir or switch medication is your decision.

The World Health Organization has recommended that all adults and adolescents with HIV, including pregnant people, should start treatment with a dolutegravir-containing regimen.

The British HIV Association currently lists dolutegravir (in combination with other medications) as an option that may be considered if you begin HIV treatment later on in pregnancy, depending on your individual circumstances.

A dispersible tablet is approved for use by infants and children. Tablets of 10mg, 25mg or 50mg can be used by children aged 6 years and over.

If you have any concerns about your treatment or other aspects of your health, it’s important to talk to your doctor about them.

• Anxiety.
• difficulty in moving.
• joint pain or swelling.
• muscle cramp or stiffness.

Tablet

Pediatric Dosage Forms and Strengths

Tablet

HIV Infection

Indicated in combination with other ARTs in adults

Indicated in combination with other ARTs for treatment-naïve or treatment-experienced INSTI-naïve children who weigh 30 kg or greater.

Indicated in combination with rilpivirine for adults

Dosage Modifications

Administration with potent UGT1A/CYP3A inducers

Hepatic impairment

Renal impairment