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These highlights do not include all the information needed to use TIVICAY safely and effectively. See full prescribing information for TIVICAY.TIVICAY (dolutegravir) tablets, for oral use TIVICAY PD (dolutegravir) tablets for oral suspensionInitial U.S. Approval: 2013
Medication labelWhy this: Advisory · dailymed-prescription
TIVICAY and TIVICAY PD are indicated in combination with other antiretroviral agents for the treatment of HIV‑1 infection in adults (treatment-naïve or -experienced) and in pediatric patients (treatment-naïve or -experienced but integrase strand transfer inhibitor [INSTI]-naïve) aged at least 4 weeks and weighing at least 3 kg [see Microbiology (12.4)]. TIVICAY is indicated in combination with rilpivirine as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure or known substitutions associated with resistance to either antiretroviral agent.
- generic_name
- dolutegravir sodium
- product_names
- dolutegravir sodium
- ndc
- 53002-1810, 49702-228, 53002-1810-6
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en