Dulaglutide
Dosing in kidney impairment
Renal Impairment TRULICITY has been studied in patients with varying degrees of renal function, including a dedicated clinical trial in patients with moderate to severe chronic kidney disease. No overall differences in safety or effectiveness were observed in these studies according to renal function [see Clinical Studies ( 14.2 , 14.3 , 14.4 )] .
In a clinical pharmacology study in patients with renal impairment, including end-stage renal disease (ESRD), no clinically relevant change in dulaglutide pharmacokinetics (PK) was observed. In the 52-week trial in patients with type 2 diabetes and moderate to severe renal impairment, the PK behavior of TRULICITY 0.75 mg and 1.5 mg once weekly was similar to that demonstrated in previous clinical studies [see Clinical Pharmacology] .
No dose adjustment is recommended in patients with renal impairment including end-stage renal disease (ESRD). Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions. Use TRULICITY with caution in patients with ESRD [see Warning and Precautions, Clinical Pharmacology] .
Dosing in liver impairment
Hepatic Impairment In a clinical pharmacology study in patients with varying degrees of hepatic impairment, no clinically relevant change in dulaglutide PK was observed [see Clinical Pharmacology] . However, there is limited clinical experience in patients with mild, moderate, or severe hepatic impairment; therefore, use TRULICITY with caution in these patient populations.
Preparation and administration
Important Administration Instructions Prior to initiation, train patients and caregivers on proper injection technique [see Instructions for Use] . Administer TRULICITY once weekly, any time of day, with or without food. Inject TRULICITY subcutaneously in the abdomen, thigh, or upper arm. Rotate injection sites with each dose.
Inspect TRULICITY visually before use. It should appear clear and colorless. Do not use TRULICITY if particulate matter or coloration is seen. When using TRULICITY with insulin, administer as separate injections and never mix. It is acceptable to inject TRULICITY and insulin in the same body region, but the injections should not be adjacent to each other.