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Tivicay

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Tivicay

Indications
Dosage
How Supplied

INDICATIONS

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.

Adults

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 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
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 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).

HOW SUPPLIED

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 Healthcare, Research Triangle Park, NC 27709. By: GlaxoSmithKline, Research Triangle Park, NC 27709. Revised: May 2014

Last reviewed on RxList: 6/2/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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