May 27, 2016
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How Supplied


TIVICAY® is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.

Limitations of Use

  • Use of TIVICAY in integrase strand transfer inhibitor (INSTI)-experienced patients should be guided by the number and type of baseline INSTI substitutions. The efficacy of TIVICAY 50 mg twice daily is reduced in patients with an INSTI-resistance Q148 substitution plus 2 or more additional INSTI-resistance substitutions, including T66A, L74I/M, E138A/K/T, G140S/A/C, Y143R/C/H, E157Q, G163S/E/K/Q, or G193E/R [see Microbiology].


TIVICAY tablets may be taken with or without food.


Table 1: Dosing Recommendations for TIVICAY in Adult Patients

Population Recommended Dose
Treatment-naive or treatment-experienced INSTI-naive 50 mg once daily
Treatment-naive or treatment-experienced INSTI-naive when coadministered with certain UGT1A or CYP3A inducers [see DRUG INTERACTIONS for relevant inducers] 50 mg twice daily
INSTI-experienced with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistancea [see Microbiology] 50 mg twice daily
aAlternative 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.

Pediatric Patients

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 certain UGT1A or CYP3A inducers are coadministered, then the recommended dose of TIVICAY is 50 mg twice daily [see DRUG INTERACTIONS for relevant inducers].

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) [see DESCRIPTION].

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 Healthcate Research Triangle Park, NC 27709. By: GlaxoSmithKline, Research Triangle Park, NC 27709. Revised: Aug 2015

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 9/30/2015

How Supplied

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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