From: "U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>
Date: Tue, 01 Mar 2016 16:15:38 -0600
Title: STRIBILD label updated
Informationabout FDA HIV product approvals, safety warnings, medical product labeling changes, notices of upcoming public meetings, and notices about proposed regulatory guidances.
Recently the STRIBILD® (elvitegravir, cobicistat,
emtricitabine, tenofovir disoproxil fumarate) tablet label was updated to
include drug-drug interaction information with quetiapine and
ledipasvir/sofosbuvir and to update section 12.2 with information on the
effects on serum creatinine. The changes to the label are summarized below.
Initiation of STRIBILD in patients taking quetiapine:
Consider alternative antiretroviral
therapy to avoid increases in quetiapine exposure.If coadministration is necessary, reduce the
quetiapine dose to 1/6 of the current dose and monitor for
quetiapine-associated adverse reactions.Refer to the quetiapine prescribing information for recommendations on
adverse reaction monitoring.
Initiation of quetiapine in patients taking STRIBILD:
Refer to the quetiapine prescribing
information for initial dosing and titration of quetiapine.
The safety of increased
tenofovir concentrations in the setting of HARVONI®
(ledipasivir/sofosbuvir) and STRIBILD has not been established.Coadministration is not recommended.
12.2Pharmacodynamics
Effects on Serum Creatinine
The effect of cobicistat on serum creatinine was
investigated in a Phase 1 study in subjects with an eGFR of at least 80 mL per
minute (N=18) and with an eGFR of 50 to 79 mL per minute (N=12). A
statistically significant change of eGFRCG from baseline was observed after 7
days of treatment with cobicistat 150 mg among subjects with an eGFR of at
least 80 mL per minute (-9.9 ± 13.1 mL/min) and subjects with an eGFR of 50 to
79 mL per minute (-11.9 ± 7.0 mL per minute). These decreases in eGFRCG were
reversible after cobicistat was discontinued. The actual glomerular filtration
rate, as determined by the clearance of probe drug iohexol, was not altered
from baseline following treatment of cobicistat among subjects with an eGFR of
at least 50 mL per minute, indicating cobicistat inhibits tubular secretion of
creatinine, reflected as a reduction in eGFRCG, without affecting the actual
glomerular filtration rate.
You will be able to view the complete label at drugs@fda or 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
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