August 24, 2016
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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 pediatric patients weighing at least 30 kg.

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].

DOSAGE AND ADMINISTRATION

Adults

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] 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].

Pediatric Patients

TIVICAY tablets may be taken with or without food.

Treatment-Na´ve Or Treatment-Experienced INSTI-Na´ve

The recommended dose of TIVICAY in pediatric patients weighing at least 30 kg is provided in Table 2.

Table 2: Dosing Recommendations for TIVICAY in Pediatric Patients Weighing at Least 30 kg

Body Weight (kg) Daily Dosea (Number of Tablets per Dose when Different Strength(s) are Required)
30 to less than 40 35 mg once daily (One 25-mg tablet and one 10-mg tablet)
40 or greater 50 mg once daily
a If certain UGT1A or CYP3A inducers are coadministered, then increase the weight-based dose of TIVICAY to twice daily [see DRUG INTERACTIONS for relevant inducers].

Safety and efficacy of TIVICAY have not been established in pediatric patients who are INSTI-experienced with documented or clinically suspected resistance to other INSTIs (raltegravir, elvitegravir).

HOW SUPPLIED

Dosage Forms And Strengths

Tablets:

10 mg: Each tablet contains 10 mg of dolutegravir (as dolutegravir sodium). Tablets are white, round, film-coated, biconvex tablets debossed with “SV 572” on one side and “10” on the other side.

25 mg: Each tablet contains 25 mg of dolutegravir (as dolutegravir sodium). Tablets are pale yellow, round, film-coated, biconvex tablets debossed with “SV 572” on one side and “25” on the other side.

50 mg: Each tablet contains 50 mg of dolutegravir (as dolutegravir sodium). Tablets are yellow, round, film-coated, biconvex tablets debossed with “SV 572” on one side and “50” on the other side.

Storage And Handling

TIVICAY tablets, 10 mg, are white, round, film-coated, biconvex tablets debossed with “SV 572” on one side and “10” on the other side. Bottle of 30 tablets with child-resistant closure and containing a desiccant. NDC 49702-226-13.

Store and dispense the 10-mg tablets in the original package, protect from moisture, and keep the bottle tightly closed. Do not remove desiccant.

TIVICAY tablets, 25 mg, are pale yellow, round, film-coated, biconvex tablets debossed with “SV 572” on one side and “25” on the other side. Bottle of 30 tablets with child-resistant closure. NDC 49702-227-13.

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: Jun 2016

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

Last reviewed on RxList: 6/17/2016

Indications
Dosage
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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