Odefsey Labeling Updated with New Data, Monitoring Recommendations
The Food and Drug Administration (FDA) has approved labeling changes for Odefsey (emtricitabine/rilpivirine/
In Study 1216, the efficacy and safety of switching from emtricitabine/rilpivirine/
In Study 1160, the efficacy and safety of switching from efavirenz/emtricitabine/
(–0.05% lumbar spine, –0.13% total hip).
In addition, the labeling includes information regarding renal laboratory tests and serum lipid changes in patients involved in these two trials.
Section 2.1, related to Dosing and Administration, has also been revised to now state: It is recommended that serum creatinine, serum phosphorus, estimated creatinine clearance, urine glucose, and urine protein should be assessed before initiating Odefsey and during therapy in all patients as clinically appropriate.
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