Generic Name: dolutegravir
Brand Names: Tivicay, Tivicay PD
Drug Class: HIV, Integrase Inhibitors
What is dolutegravir, and what is it used for?
Dolutegravir is an antiretroviral medication used to treat human immunodeficiency virus type-1 (HIV-1) infection in adults and children.
Dolutegravir is used as a component of antiretroviral therapy (ART) regimen, which combines several antiretroviral drugs that work in different ways to prevent viral replication at different stages in the viral life cycle. HIV infection has no cure, but ART can effectively control viral growth and keep the infection under control.
HIV infects the immune system and eventually weakens it to the extent that the body is unable to defend itself effectively against even common infections. Without treatment, HIV infection in its later stages can progress to acquired immune deficiency syndrome (AIDS), with severe impairment of immune function.
HIV-1 is a retrovirus, whose genetic material is composed of only a single strand of ribonucleic acid (RNA). The virus infects T-cell, a type of immune cell and secretes an enzyme known as reverse transcriptase, converting into a double-stranded deoxyribonucleic acid (DNA). The viral DNA then releases another enzyme known as integrase, which enables it to integrate with the T-cell’s DNA, and proceeds to use the host DNA to replicate itself and infect other T-cells.
Dolutegravir is an integrase strand transfer inhibitor (INSTI), the latest class of drugs to be added to antiretroviral therapy. Dolutegravir works by preventing the integrase enzyme from transferring the viral DNA strand into the T-cell DNA strand. Without integrating with the T-cell DNA, HIV-1 cannot replicate itself and gets degraded. Dolutegravir is a second generation Integrase strand transfer inhibitor (INSTI) and has a high barrier to resistance, particularly when used as a first line therapy.
Warnings
- Do not use in patients with previous hypersensitivity reactions to dolutegravir or any of its components
- Do not use concurrently with dofetilide, a drug used to treat irregular heart rhythms (arrhythmia). Dolutegravir can increase dofetilide effects which can cause life-threatening cardiac arrhythmia.
- Dolutegravir can cause injury to the liver including elevated liver enzymes, hepatitis and liver failure; patients with underlying hepatitis B or C are at higher risk for worsening of liver condition and reactivation of hepatitis B, particularly if anti-hepatitis therapy has been withdrawn; test patients before initiating dolutegravir therapy and monitor liver enzyme levels during therapy
- Dolutegravir can cause hypersensitivity reactions including skin reactions, fever, facial edema, difficulty breathing and organ dysfunction. Discontinue dolutegravir immediately if hypersensitivity reactions occur; delay may result in life-threatening reaction.
- Combination ART including dolutegravir can cause immune reconstitution syndrome; the immune system’s response to the drugs can reactivate indolent or residual opportunistic infections or trigger autoimmune disorders such as Graves’ disease, polymyositis, and Guillain-Barre syndrome
- Redistribution and accumulation of fat in the neck and abdominal regions, breast enlargement, facial wasting and peripheral wasting have been observed with ART; long-term consequences are not clear
- Dolutegravir use at conception and early pregnancy may increase the risk of neural tube defects in the fetus and may be associated with adverse pregnancy outcomes including preterm delivery, stillbirth and low birth weight:
- Perform pregnancy testing in women of child-bearing potential before initiating therapy
- Advise patients to use effective contraception during therapy
- If pregnancy occurs during therapy, inform the patient about the potential risk to the fetus
- Assess benefits and risks of continuing dolutegravir during pregnancy or switching to alternate HIV medicines
- Discontinuing ART can increase viral load and risk of transmission to the child
- Dolutegravir therapy may be considered during the second and third trimesters of pregnancy if the benefit outweighs the potential risk to the mother and the fetus
- Adult and pediatric formulations are not bioequivalent and not interchangeable on milligram-to-milligram basis. Dosage must be adjusted as per dosing recommendations when a pediatric patient is switched from one formulation to the other.

QUESTION
What is HIV? See AnswerWhat are the side effects of dolutegravir?
Common side effects of dolutegravir include:
- Increase in levels of serum lipase, the enzyme that breaks down lipids
- Increase in levels of triglycerides and cholesterol
- Increase in blood glucose levels (hyperglycemia)
- Elevation in liver enzymes ALT and AST
- Excessive bilirubin in blood (hyperbilirubinemia)
- Liver inflammation (hepatitis)
- Inflammation in muscles (myositis)
- Increase in serum creatinine phosphokinase
- Gastrointestinal symptoms including:
- Insomnia
- Fatigue
- Headache
- Depression
- Suicidal ideation and tendencies
- Itching (pruritus)
- Kidney impairment
- Low blood count of neutrophil immune cells (neutropenia)
Less common side effects of dolutegravir include:
- Skin rash
- Hypersensitivity reactions
- Dizziness
- Vertigo
- Abnormal dreams
- Weight gain
- Toxicity to liver (hepatotoxicity)
- Liver failure
- Anxiety
- Muscle pain (myalgia)
- Joint pain (arthralgia)
- Immune reconstitution syndrome
This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug.
Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.
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What are the dosages of dolutegravir?
Tablet (Tivicay)
- 10mg
- 25mg
- 50mg
Tablet for oral suspension (Tivicay PD)
- 5mg
Adult:
HIV Infection
- Indicated in combination with other ARTs
- INSTI indicated in patients who weigh 30 kg or more
- Treatment-naïve or treatment-experienced INSTI-naïve: 50 mg orally once a day
- INSTI-experienced with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistance: 50 mg orally twice a day
Indicated in combination with rilpivirine
- To replace the current ART regimen in virologically suppressed patients (HIV-1 RNA less than 50 copies/mL) on a stable ART regimen for 6 months or longer with no history of treatment failure or known substitutions associated with resistance to dolutegravir or rilpivirine
- 50 mg orally once a day
Dosage Modifications
Coadministration with potent UGT1A or CYP3A inducers
- Treatment-naïve or treatment-experienced INSTI-naïve
- Potent UGT1A/CYP3A inducers (e.g., efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, rifampin)
- Increase dose to 50 mg orally twice a day
Hepatic impairment
- Mild-to-moderate hepatic impairment (Child-Pugh A or B): No dosage adjustment required
- Severe hepatic impairment (Child-Pugh C): Not recommended
Renal impairment
- Plasma concentrations were decreased in subjects with severe renal impairment
- No dosage adjustment required for treatment-naïve or treatment-experienced and INSTI-naïve patients with mild, moderate, or severe renal impairment or for INSTI-experienced patients (with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistance) with mild or moderate renal impairment
- Severe renal impairment or for INSTI-experienced patients with resistance: Not recommended; decrease in dolutegravir concentrations may result in loss of therapeutic effect and development of resistance
Dosing Considerations
- Dosage forms (i.e., Tivicay, Tivicay PD) are not bioequivalent or interchangeable
- Poor virologic response was observed in subjects treated with TIVICAY 50 mg twice daily with an INSTI-resistance Q148 substitution plus 2 or more additional INSTI-resistance substitutions, including L74I/M, E138A/D/K/T, G140A/S, Y143H/R, E157Q, G163E/K/Q/R/S, or G193E/R
- In patients with underlying hepatitis B or C, measure hepatic enzymes before initiating therapy and periodically thereafter
- Perform pregnancy testing before initiation in females of childbearing potential
Pediatric:
HIV Infection
Indicated in combination with other ARTs for treatment-naïve or treatment-experienced, but INSTI-naïve children aged 4 weeks or older who weigh 3 kg or more
Weight 3 to 14 kg
Tablets for oral suspension
- 3 to 6 kg: 5 mg orally once a day
- 6 to 10 kg: 15 mg orally once a day
- 10 to 14 kg: 20 mg orally once a day
Weight 14 kg or more
Tablets for oral suspension
- 14 to 20 kg: 25 mg orally once a day
- 20 kg or more: 30 mg orally once a day
Tablets
- 14 to 20 kg: 40 mg orally once a day
- 20 kg or more: 50 mg orally once a day
Dosage Modifications
- Coadministration with potent UGT1A or CYP3A inducers (e.g., efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, rifampin): Increase weight-based dose to twice daily
Dosing Considerations
- Dosage forms (i.e., Tivicay, Tivicay PD) are not bioequivalent or interchangeable
- Perform pregnancy testing before initiation of dolutegravir in females of childbearing potential
Overdose
- There is no known specific treatment for dolutegravir overdose. Limited experience with single high doses of up to 250 mg in healthy individuals reveal no symptoms other than the listed side effects.
- Dolutegravir overdose is treated with symptomatic and supportive care.
- In case of overdose seek medical help immediately or contact Poison Control.
What drugs interact with dolutegravir?
Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.
- Severe interactions of dolutegravir include:
- dofetilide
- Serious interactions of dolutegravir include:
- aluminum hydroxide/magnesium carbonate
- cabotegravir
- carbamazepine
- efavirenz
- fosamprenavir
- fosphenytoin
- magnesium citrate
- magnesium oxide
- nevirapine
- oxcarbazepine
- phenobarbital
- phenytoin
- rifampin
- tipranavir
- Moderate interactions of dolutegravir include:
- aluminum hydroxide
- calcium acetate
- calcium carbonate
- calcium citrate
- dalfampridine
- eslicarbazepine acetate
- ferric maltol
- ferrous fumarate
- ferrous gluconate
- ferrous sulfate
- magnesium hydroxide
- magnesium supplement
- metformin
- multivitamins
- orlistat
- selenium
- sodium sulfate/magnesium sulfate/potassium chloride
- sodium sulfate/potassium sulfate/magnesium sulfate
- zinc
- Dolutegravir has no known mild interactions with other drugs.
The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.
It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.
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Pregnancy and breastfeeding
- There are no adequate and well-controlled studies of dolutegravir use in pregnant women; should be used only if clearly needed.
- Limited studies reveal an increase in neural tube defects in babies of women who became pregnant while taking dolutegravir, but not in women who started dolutegravir during pregnancy.
- Risk for neural tube defects is greatest in early stage of pregnancy; risk of neural tube defects may decrease with folic acid supplementation before conception and during pregnancy.
- Women on dolutegravir therapy should practice effective contraception.
- Pregnant women should not discontinue dolutegravir without consulting a healthcare professional; stopping treatment can cause the HIV infection to worsen and increase the risk of transmission to the fetus.
- Antiretroviral therapy is recommended for all pregnant women with HIV infection to improve health, keep the viral load low, and reduce the risk of transmission to the fetus. Therapy should be individualized after discussion with the patient, on the potential risks and benefits of treatment during pregnancy.
- It is not known whether dolutegravir is present in breast milk, affects milk production or has effects on the breastfed infant; animal studies show its presence in milk. Mothers with HIV infection should not breastfeed their infants to avoid the risk of transmission of HIV infection to the baby and the potential for adverse reactions in the infant from maternal dolutegravir therapy.
- A pregnancy exposure registry monitors pregnancy outcomes in women during pregnancy; healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263.
What else should I know about dolutegravir?
- Take dolutegravir exactly as prescribed
- Discontinue dolutegravir and seek medical help immediately if you develop:
- In some patients, initiation of dolutegravir therapy may reactivate symptoms of inflammation from previous infections because of the improved immune response, or trigger autoimmune disorders; notify your healthcare provider if you develop any infection or symptoms of autoimmune conditions
- Dolutegravir cannot cure HIV infection; continuous antiretroviral therapy is required to control HIV, decrease HIV-related illnesses and reduce the risk of progression to AIDS
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Summary
Dolutegravir is an antiretroviral medication used to treat human immunodeficiency virus type-1 (HIV-1) infection in adults and children, as a component of antiretroviral therapy (ART) regimen. Patients with underlying hepatitis B or C are at higher risk for worsening of liver condition and reactivation of hepatitis B. Common side effects of dolutegravir include increase in levels of serum lipase, increase in levels of triglycerides and cholesterol, increase in blood glucose levels (hyperglycemia), elevation in liver enzymes ALT and AST, excessive bilirubin in blood (hyperbilirubinemia), liver inflammation (hepatitis), inflammation in muscles (myositis), increase in serum creatinine phosphokinase, gastrointestinal symptoms, insomnia, and others.
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What Is the Difference Between HIV and AIDS?
HIV is a virus that causes immunosuppression. The difference between HIV and AIDS is that HIV is the first stage of the viral illness while AIDS represents the progression of the illness.
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Should I Take PrEP for HIV?
Pre-exposure prophylaxis (PrEP) is a course of prescribed medications that people who are at risk of human immunodeficiency virus (HIV) may take to prevent infection. This medication is administered to individuals who have tested negative for HIV but are at a high risk of HIV infection.
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STD Symptoms for Women
Many women may not show any symptoms of STDs and may be unaware of the need for treatment. Women experiencing problems must seek gynecological advice.
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How Is HIV Currently Being Treated?
Treatment for human immunodeficiency virus (HIV) is ongoing and consists of various antiviral medication combinations (antiretroviral therapy).
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What Is the Most Common STD 2020?
Human papillomavirus (HPV) is the most common sexually transmitted disease (STD) in the United States.
Treatment & Diagnosis
- STD FAQs
- HIV-AIDS FAQs
- HIV Treatment, Medications, and Prevention
- Circumcise Or Not? - The Matter of AIDS
- HIV: Two Patients Face The Diagnosis
- Antiretroviral Therapy - Guidelines
- HIV Treatment - To Interrupt or Not
- Unprotected Sex Between HIV-Infected Partners: What's the Harm?
- HIV Transmission and Progression to AIDS Continues
- Physical and Biochemical Changes in HIV Disease
- Babies On The Breast Of HIV Moms
- Generic AIDS Drug Effective - And Now?
- HIV Urine Test Approved
- Retrovirus & Opportunistic Infections Part II
- Can You Treat Hepatitis B With Aids Drug Lamivudine?
- Does Circumcision Prevent HIV and AIDS?
- Can HIV Cause Kaposi's Sarcoma?
- Do You Need Antiretroviral Therapy for HIV with No Symptoms?
- Does HIV Cause Colorectal Cancer?
- Does Anti-Retroviral Therapy for HIV Cause Diabetes?
- How Long Should You Wait to Get an HIV Test?
- What Liver Problems Does HIV Cause?
- HIV Infection Facts, History, Causes, and Risk Factors
- HIV Tests, Symptoms, Signs, and Stages of Infection
- Baby "Cured" of HIV Infection
Medications & Supplements
- How Do Protease Inhibitors Work in Antiretroviral Therapy for HIV Infection?
- What Are NNRTIs In Antiretroviral Therapy for HIV Infection?
- How Do Integrase Strand-Transfer Inhibitors Work in Antiretroviral Therapy for HIV Infection?
- What Are NRTIs in Antiretroviral Therapy For HIV Infection?
- Dovato (dolutegravir and lamivudine)
- Triumeq (abacavir, dolutegravir, and lamivudine)
Health Solutions From Our Sponsors

Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
https://reference.medscape.com/drug/tivicay-tivicay-pd-dolutegravir-999861#0
https://www.uptodate.com/contents/dolutegravir-drug-information#F21273346
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204790lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213983s000lbl.pdf
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4413831/