Dolutegravir

Class
Antiretroviral agents
Subclass
Integrase inhibitors
Substance name
Dolutegravir sodium
Brand names
Tivicay PD®
Common formulations
Tablet for oral suspension
Contained in
Abacavir / dolutegravir / lamivudine (Triumeq®)
Dolutegravir / lamivudine (Dovato®)
Dolutegravir / rilpivirine (Juluca®)
Indications for use
Off-label indications
Adults
•
Prevention of HIV infection (occupational post-exposure prophylaxis)
Safety risks
Contraindications
A history of dolutegravir hypersensitivity
Warnings and precautions
Depression
•
Use caution with a pre-existing history of depression or other psychiatric illness.
Opportunistic infections
•
Use caution with combination antiretroviral therapy.
Reactivation of hepatitis
•
Use caution with a history of liver problems or hepatitis B or C infection.
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required.
Renal replacement therapy
Any modality
•
Use acceptable. No dose adjustment required.
Hepatic impairment
Child-Pugh A (mild)
•
Use acceptable. No dose adjustment required. Monitor for toxicity.
Child-Pugh B (moderate)
•
Use acceptable. No dose adjustment required. Monitor for toxicity.
Child-Pugh C (severe)
•
Do not use.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: B1
•
Use only if benefits outweigh potential risks. Monitor CD4 counts. Monitor plasma HIV RNA. Viral load should be assessed. Perform standard glucose screening. First trimestar ultrasound for gestational age. A second trimester ultrasound can be used for both anatomical survey and determination of gestational age. Antiretroviral therapy should be provided to all patients during pregnancy, regardless of HIV RNA concentrations or CD4 cell count.
•
Using highly active antiretroviral combination therapy (HAART) to maximally suppress viral replication is the most effective strategy to prevent the development of resistance and to minimize the risk of perinatal transmission.
Breastfeeding
Do not use during breastfeeding.
Low excretion in breastmilk (5-25%).
Very low levels in breastfed infants (< 5%).
No overt adverse effects reported in breastfed infants.
Adverse reactions
Very common > 10%
•
↑ blood glucose, ↑ liver enzymes
Common 1-10%
•
↓ blood neutrophil count, hepatitis, ↑ serum TBIL, maculopapular rash, abdominal pain, depression, diarrhea, dizziness, fatigue, flatulence, headache, insomnia, itching, nausea, suicidal ideation, vomiting
Uncommon < 1%
•
Lactic acidosis
Unknown frequency
•
Acute liver failure, anemia, ↑ serum potassium, anxiety, arthralgia, myalgia, weight gain, teratogenesis
Interactions
Drug(s)
Check Interactions
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