Raltegravir indications and usage: Difference between revisions
(Created page with "__NOTOC__ {{Raltegravir}} {{CMG}}; {{AE}} {{chetan}} ==Indications And Usage== ===Adults=== ISENTRESS® is indicated in combination with other antiretroviral agents for th...") |
|||
| Line 16: | Line 16: | ||
===Pediatrics=== | ===Pediatrics=== | ||
ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in children and adolescents 2 years of age and older and weighing at least 10 kg [see Use in Specific Populations | ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in children and adolescents 2 years of age and older and weighing at least 10 kg [see Use in Specific Populations]. | ||
This indication is based on the evaluation of safety, tolerability, pharmacokinetic parameters and efficacy of ISENTRESS through at least 24-weeks in a multi-center, open-label, noncomparative study in HIV-1 infected children and adolescents 2 to 18 years of age [see Clinical Studies]. | This indication is based on the evaluation of safety, tolerability, pharmacokinetic parameters and efficacy of ISENTRESS through at least 24-weeks in a multi-center, open-label, noncomparative study in HIV-1 infected children and adolescents 2 to 18 years of age [see Clinical Studies]. | ||
The safety and efficacy of ISENTRESS have not been established in children less than 2 years of age.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE [MERCK SHARP & DOHME CORP.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=89a5ec53-d956-4329-8004-0f40f51c88a3 | publisher = | date = | accessdate = }}</ref> | The safety and efficacy of ISENTRESS have not been established in children less than 2 years of age.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE [MERCK SHARP & DOHME CORP.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=89a5ec53-d956-4329-8004-0f40f51c88a3 | publisher = | date = | accessdate = }}</ref> | ||
==References== | ==References== | ||
Latest revision as of 00:26, 10 January 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]
Indications And Usage
Adults
ISENTRESS® is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection.
This indication is based on analyses of plasma HIV-1 RNA levels in three double-blind controlled studies of ISENTRESS. Two of these studies were conducted in clinically advanced, 3-class antiretroviral (NNRTI, NRTI, PI) treatment-experienced adults through 96 weeks and one was conducted in treatment-naïve adults through 240 weeks.
The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response [see Clinical Studies].
Pediatrics
ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in children and adolescents 2 years of age and older and weighing at least 10 kg [see Use in Specific Populations].
This indication is based on the evaluation of safety, tolerability, pharmacokinetic parameters and efficacy of ISENTRESS through at least 24-weeks in a multi-center, open-label, noncomparative study in HIV-1 infected children and adolescents 2 to 18 years of age [see Clinical Studies].
The safety and efficacy of ISENTRESS have not been established in children less than 2 years of age.[1]
References
Adapted from the FDA Package Insert.