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TIVICAY® is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and children aged 12 years and older and weighing at least 40 kg.
The following should be considered prior to initiating treatment with TIVICAY:
- Poor virologic response was observed in subjects treated with TIVICAY 50 mg twice daily with an integrase strand transfer inhibitor (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 [see Microbiology].
DOSAGE AND ADMINISTRATION
TIVICAY tablets may be taken with or without food.
Table 1: Dosing Recommendations for TIVICAY in Adult
|Treatment-naive or treatment-experienced INSTI-naive||50 mg once daily|
|Treatment-naive or treatment-experienced INSTI-naive when coadministered with the following potent UGT1A/CYP3A inducers: efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, or rifampin||50 mg twice daily|
|INSTI-experienced with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistancea [see Microbiology]||50 mg twice daily|
|a Alternative combinations that do not include metabolic inducers should be considered where possible [see DRUG INTERACTIONS].|
The safety and efficacy of doses above 50 mg twice daily have not been evaluated.
Treatment-Na´ve or Treatment-Experienced INSTI-Na´ve
The recommended dose of TIVICAY in pediatric patients aged 12 years and older and weighing at least 40 kg is 50 mg administered orally once daily.
If efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, or rifampin are coadministered, the recommended dose of TIVICAY is 50 mg twice daily.
Safety and efficacy of TIVICAY have not been established in pediatric patients younger than 12 years or weighing less than 40 kg, or in pediatric patients who are INSTI-experienced with documented or clinically suspected resistance to other INSTIs (raltegravir, elvitegravir).
Dosage Forms And Strengths
TIVICAY 50-mg tablets are yellow, round, film-coated, biconvex tablets debossed with SV 572 on one side and 50 on the other side. Each tablet contains 50 mg of dolutegravir (as dolutegravir sodium) [seeDESCRIPTION].
Storage And Handling
TIVICAY Tablets, 50 mg, are yellow, round, film-coated, biconvex tablets debossed with SV 572 on one side and 50 on the other side.
Bottle of 30 tablets with child-resistant closure NDC 49702-228-13.
Store at 25°C (77°F); excursions permitted 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Manufactured for: ViiV Healthcare, Research Triangle Park, NC 27709. by: GlaxoSmithKline, Research Triangle Park, NC 27709. Revised: August 2013
Last reviewed on RxList: 8/26/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Tivicay Information
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