TRULICITY
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TRULICITY (TRULICITY).
Glucagon-like peptide-1 (GLP-1) receptor agonist. Increases glucose-dependent insulin secretion, decreases glucagon secretion, slows gastric emptying, and promotes satiety.
| Metabolism | Metabolized via proteolytic degradation to small peptides and amino acids. Not metabolized by cytochrome P450 enzymes. |
| Excretion | Renal: negligible (intact peptide not excreted in urine); Biliary/fecal: peptide backbone catabolized via proteolysis, with amino acids recycled; no biliary excretion of intact drug. |
| Half-life | Terminal elimination half-life approximately 5 days (112–120 hours) after subcutaneous administration, supporting once-weekly dosing. |
| Protein binding | Albumin: >99% bound (primarily to albumin, with moderate affinity). |
| Volume of Distribution | Approximately 0.6–1.0 L/kg; limited extravascular distribution consistent with large peptide. |
| Bioavailability | Subcutaneous: ~80–90% relative to intravenous administration; absolute bioavailability not established due to lack of IV formulation. |
| Onset of Action | Subcutaneous: improvement in glycemic parameters observed within 2–4 weeks; maximal effect on HbA1c reduction seen at 12–16 weeks. |
| Duration of Action | Subcutaneous: 7 days (once-weekly dosing); trough concentrations maintain glucose control throughout the dosing interval. |
1.5 mg subcutaneously once weekly, with or without food.
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment required for mild to moderate renal impairment (eGFR ≥30 mL/min/1.73 m²). For severe renal impairment (eGFR <30 mL/min/1.73 m²) or end-stage renal disease, limited data; use with caution. |
| Liver impairment | No dose adjustment required for mild to moderate hepatic impairment (Child-Pugh class A or B). Not studied in severe hepatic impairment (Child-Pugh class C); use with caution. |
| Pediatric use | Not indicated for pediatric patients; safety and effectiveness not established in patients under 18 years. |
| Geriatric use | No specific dose adjustment based on age alone. However, consider renal function due to age-related decline in GFR; monitor renal function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for TRULICITY (TRULICITY).
| Breastfeeding | No data on presence in human milk; present in rat milk. Consider benefits of breastfeeding and importance of drug to mother. M/P ratio unknown. |
| Teratogenic Risk | Limited human data; in animal studies, no evidence of fetal harm at exposures up to 132 times the human exposure at the maximum recommended human dose. Caution in pregnancy, especially first trimester. |
| Fetal Monitoring |
■ FDA Black Box Warning
No FDA boxed warning.
| Common Effects | Nausea Diarrhea Vomiting Abdominal pain Loss of appetite |
| Serious Effects |
Personal or family history of medullary thyroid carcinoma, patients with Multiple Endocrine Neoplasia syndrome type 2, severe gastrointestinal disease (e.g., gastroparesis), and known hypersensitivity to dulaglutide or any product component.
| Precautions | Risk of thyroid C-cell tumors (medullary thyroid carcinoma), acute pancreatitis, hypoglycemia when used with insulin secretagogues or insulin, renal impairment, gastrointestinal effects (nausea, vomiting, diarrhea), increased heart rate, hypersensitivity reactions, and acute gallbladder disease. |
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| Monitor maternal blood glucose, HbA1c, and fetal growth via ultrasound if diabetes management is critical. |
| Fertility Effects | No evidence of impaired fertility in animal studies. Not expected to affect human fertility. |