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. |
| Molecular Weight | 622.66 |
| Action Class | GLP-1 Receptor Agonist |
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 | Limited human data; animal studies show no teratogenic effects at exposures up to 6 times the clinical dose. Use only if clearly needed. |
| 2nd trimester | No adequate human studies; animal studies show no fetal harm. Use with caution. |
| 3rd trimester | Insulin requirements may change; monitor blood glucose closely. Use only if benefit outweighs risk. |
Clinical note
Comprehensive clinical and safety monograph for TRULICITY (TRULICITY).
| Placental transfer | High molecular weight and protein binding likely limit placental transfer; however, animal studies confirm some passage. Clinical relevance unknown. |
| Breastfeeding | Not known if excreted in human milk; animal studies show excretion in milk. Consider developmental and health benefits of breastfeeding along with mother's clinical need. |
■ FDA Black Box Warning
No FDA boxed warning.
| Common Effects | Nausea Diarrhea Vomiting Abdominal pain Loss of appetite |
| Serious Effects | Pancreatitis (acute or chronic), Medullary thyroid carcinoma (C-cell tumors, seen in animal studies; contraindicated in patients with personal or family history of MTC or MEN-2), Hypoglycemia (especially when used with insulin or sulfonylureas), Acute kidney injury or worsening of chronic renal impairment, Severe gastrointestinal adverse reactions (nausea, vomiting, diarrhea, leading to dehydration), Diabetic retinopathy complications (in patients with type 2 diabetes and history of retinopathy), Hypersensitivity reactions (anaphylaxis, angioedema) |
History of hypersensitivity to dulaglutide or any excipientsPersonal or family history of medullary thyroid carcinomaPatients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
| 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. |
Loading safety data…
| Lactation Rating |
| L3 (Moderately Safe) |
| 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 | 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. |
| Food/Dietary | None significant. May be taken with or without food. Avoid high-fat meals if GI side effects are bothersome. |
| Clinical Pearls | Trulicity (dulaglutide) is a once-weekly GLP-1 receptor agonist. Do not mix with insulin in the same syringe. Administer any time of day without regard to meals. Discontinue if pancreatitis suspected. Monitor renal function; not recommended in severe renal impairment (eGFR <15 mL/min). Not for type 1 diabetes or DKA. Consider dose reduction if GI intolerance occurs. |
| Patient Advice | Inject once weekly on the same day, any time of day, with or without food. · Rotate injection sites (abdomen, thigh, upper arm) to avoid lipodystrophy. · Store in refrigerator; may be kept at room temperature for up to 14 days. · Common side effects: nausea, vomiting, diarrhea – usually improve over time. · Seek medical attention for severe abdominal pain (possible pancreatitis) or vision changes. · Do not share needles or pens. · Monitor for symptoms of hypoglycemia when used with insulin or sulfonylureas. |