Dolutegravir
TIVICAY
Pronunciation: doe-loo-TEG-ra-veer (TIV-e-kay)
“Gravy Diluter, T.V. decay”
What it isHIV integrase strand-transfer inhibitor; a preferred anchor for initial and treatment-experienced regimens.
Why this oneIts unusually high barrier to resistance distinguishes it from earlier integrase inhibitors.
What limits itPolyvalent cations block absorption—separate antacids and supplements. It raises creatinine by blocking tubular secretion without lowering GFR; weight gain.
FDA-approved for
- HIV infection (2013)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| HIV-1 (INSTI-naive or virologically suppressed) | Adults | 50 mg QD | 50 mg QD | 50 mg QD |
| HIV-1 with UGT1A/CYP3A inducers or INSTI resistance | Adults | 50 mg BID | 50 mg BID | 50 mg BID |
| HIV-1 (weight-based, Tivicay PD) | Peds ≥4 wk & ≥3 kg | 5 mg QD (3–<6 kg) | weight-based QD | 30 mg QD (≥20 kg) |
Renal No adjustment for INSTI-naive (mild–severe); caution in INSTI-experienced with severe impairment (reduced levels)
Hepatic No adjustment mild–moderate (Child-Pugh A/B); not recommended in severe (C)
Instructions
- May be taken with or without food.
- Tivicay and Tivicay PD are not bioequivalent and not substitutable on a mg-per-mg basis.
Available strengths
- tab 5, 50 mg
Contraindications
- Coadministration with dofetilide
Cautions
- Hypersensitivity reactions (rash, constitutional findings, organ/liver injury) — discontinue immediately
- Hepatotoxicity, esp. with underlying hepatitis B/C
- Immune reconstitution syndrome
Adverse reactions
- Insomnia
- Fatigue
- Headache
Pregnancy Pregnancy exposure registry; surveillance data do not show increased neural tube defects vs comparators; human data insufficient for definitive assessment
Lactation Undefined
Cost
| Strength | #/mo | generic $/mo | brand $/mo | CostPlus | |
|---|---|---|---|---|---|
| 5 mg | tab | 30 qd | — | not offered | |
| 50 mg | tab | 30 qd | — | $2,329.07 | not offered |
Available combined with: dolutegravir / lamivudine
Generic entry2030 est.
NO BOXED WARNINGS
Principal riskCations block absorption; weight gain
Classes and tags
Clinical profile
Legacy pregnancy categoryUnknown / historical label unavailable
Defining liabilityAgent-specific renal, hepatic, hematologic, metabolic and drug-interaction toxicity.
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