Dolutegravir
Dolutegravir is an HIV-1 integrase strand transfer inhibitor (INSTI) used as part of combination antiretroviral therapy for the treatment of HIV-1 infection in adults and children. It works by blocking the integration of viral DNA into host cell chromosomes, preventing viral replication. It is available as a single-agent tablet (Tivicay) and in fixed-dose combinations with other antiretrovirals.
Dolutegravir is an HIV integrase inhibitor used in combination antiretroviral therapy to suppress HIV replication.
This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.
Key facts at a glance
- ATC
- J05AJ03
- RxNorm
- 1433868
- Generic
- Dolutegravir
- Class
- atc-j05
- Brands
- Tivicay, Triumeq, Juluca, Dovato
- Availability
- rx
- Lactation
- unknown
- Routes
- oral
- Forms
- tablet
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 50mg once daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 50mg once daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 50mg once daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
9 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks; neural tube defect risk reported in some studies
regular fetal monitoring, genetic counseling recommended
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
second third trimesterstandard dosing may continue
use only if benefits outweigh risks; consider alternative antiretroviral therapy
routine prenatal monitoring
Use with caution and monitor for adverse effects.
lactation
breastfeedingnot recommended
HIV-positive mothers should not breastfeed to prevent HIV transmission to infant; dolutegravir is excreted in breast milk
infant HIV testing if breastfeeding occurs
Use of this medication in this population requires careful consideration of risks and benefits.
pediatric_age
children 40kg and abovestandard adult dose
approved for use in pediatric patients weighing 40 kg or more
regular monitoring of weight and growth
pediatric_age
children under 40kgweight-based dosing required
use oral solution or appropriate pediatric formulation; dose based on weight
close monitoring of weight, growth and developmental milestones
Use with caution and monitor for adverse effects.
geriatric
elderly 65 years and olderno specific dose adjustment required
use with caution due to potential comorbidities and concomitant medications
monitor renal and hepatic function regularly
Use with caution and monitor for adverse effects.
renal_impairment
severe renal impairmentno dose adjustment required
no dosage adjustment needed for any degree of renal impairment; dolutegravir is not renally excreted
routine renal function monitoring
hepatic_impairment
mild hepatic impairmentno dose adjustment required
no dosage adjustment needed for mild hepatic impairment
routine hepatic function monitoring
hepatic_impairment
moderate severe hepatic impairmentuse with caution
use with caution in moderate to severe hepatic impairment; limited data available
close hepatic function monitoring recommended
Use with caution and monitor for adverse effects.
Statistics and clinical data
FDA approval year
FDA approval date for Dolutegravir (Tivicay)
Drug class
Antiretroviral drug class information
Common uses
Primary therapeutic indication
WHO essential medicines list
WHO recommendation status
Treatment of HIV-1 infection in adults and children weighing at least 10 kg, in combination with other antiretroviral agents. Used regardless of viral load or CD4 count as part of initial therapy or as a switch regimen.
Dolutegravir inhibits HIV integrase, an enzyme required for viral DNA integration into the host cell genome. By blocking this step, it prevents viral replication and reduces viral load in the blood.
Should be taken with or without food. Not recommended for patients with known integrase inhibitor resistance. May cause sleep disturbances or mood changes in some patients. Always used in combination with other antiretrovirals, never as monotherapy. Perform HLA-B*5701 testing before starting abacavir-containing products.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy