Tipranavir / EMEA

FICHA FARMACOLÓGICA de TipranavirContiene la Monografía en distintos idiomas (de la Comunidad Económica Europea), así como la discusión científica que sustenta su aprobación terapéutica. Para acceder a la monografía en idioma español, hacer doble clik en la sigla (es) en la fila que se sitúa más abajo del centro de la página oficial. Se recuerda que todas las informaciones científico-clínicas, así como técnicas propias de la producción, sólo se publican en idioma inglés. Cerasale. SEPTIEMBRE 22, 2009.

abrir aquí para acceder al documento EMEA completo:
http://www.emea.europa.eu/humandocs/Humans/EPAR/aptivus/aptivus.htm

Active Substance
Tipranavir
International Nonproprietary Name or Common Name
Tipranavir
Pharmaco-therapeutic Group
Protease inhibitors
ATC Code
J05A E09

Therapeutic Indication:
APTIVUS, co-administered with low dose ritonavir, is indicated for combination antiretroviral treatment of HIV-1 infection in highly pre-treated adults and adolescents 12 years of age or older with virus resistant to multiple protease inhibitors. APTIVUS should only be used as part of an active combination antiretroviral regimen in patients with no other therapeutic options.

This indication is based on the results of two phase III studies, performed in highly pre-treated adult patients (median number of 12 prior antiretroviral agents) with virus resistant to protease inhibitors and of one phase II study investigating pharmacokinetics, safety and efficacy of APTIVUS in mostly treatment-experienced adolescent patients aged 12 to 18 years.

APTIVUS 100mg/ml oral solution, co-administered with low dose ritonavir, is indicated for combination antiretroviral treatment of HIV-1 infection in highly pre-treated children from 2 to 12 years of age with virus resistant to multiple protease inhibitors. APTIVUS should only be used as part of an active combination antiretroviral regimen in patients with no other therapeutic options.

This indication is based on the results of one phase II study investigating pharmacokinetics, safety and efficacy of APTIVUS oral solution in mostly treatment-experienced children aged 2 to 12 years.

In deciding to initiate treatment with APTIVUS, co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of APTIVUS. Initiation of treatment should take into account the combinations of mutations which may negatively impact the virological response to APTIVUS, co-administered with low dose ritonavir.

Date of issue of Marketing Authorisation valid throughout the European Union
25 October 2005

Orphan medicinal product designation date
Not applicable