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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
TIVICAY tablets may be taken with or without food.
Table 1: Dosing Recommendations for TIVICAY in Adult
|Treatment-naive or treatment-experienced INSTI-nai've||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.
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) [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: 12/2014.
Last reviewed on RxList: 1/21/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Tivicay Information
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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