Il 18 febbraio 2015, la FDA ha approvato le modifiche al foglio illustrativo di Isentress (raltegravir) per includere informazioni aggiornate per quanto riguarda la somministrazione concomitante di raltegravir e antiacidi contenenti alluminio e/o magnesio.
Nuovi dati mostrano che la sommonistrazione di antiacido contenente alluminio e/o magnesio entro 6 ore dalla somministrazione di Isentress riducono significativamente i livelli plasmatici di raltegravir.
Di seguito il comunicato originale FDA
On February 18, 2015, FDA approved changes to the Isentress (raltegravir) label to include updated information regarding the coadministration of raltegravir and aluminum and/or magnesium containing antacid.
New data show taking an aluminum and magnesium antacid within 6 hours of Isentress administration significantly decreased raltegravir plasma levels. The previously approved Isentress label recommended against coadministration or staggered administration by 2 hours with aluminum and magnesium antacids. The new label recommendations state coadministration or staggered administration of aluminum and/or magnesium hydroxide-containing antacids and Isentress is not recommended.
Isentress, indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in patients 4 weeks of age and older, is a product of Merck & Co.
The updated label will be posted soon on DailyMed.
Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration
Kimberly Struble
Division of Antiviral Products
Food and Drug Administration
Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration
Fonte: FDA
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