Trulicity Prescribing Information, Explained Section by Section
The Trulicity label carries a boxed warning for thyroid c-cell tumors, 9 other warnings and 3 drug interaction lines. It is approved for 2 uses.
- Boxed warning
- C-cell tumors in the thyroid
- Approved uses
- 2
- Warnings
- 9
- First approved
- 2014
Trulicity overview
Its half-life is about 5 days. Half remains after 5 d, while about 3% remains after five half-lives (25 d).
Sources: FDA label (DailyMed).
Boxed warning for Trulicity
Boxed warning: It caused thyroid C-cell tumors in rodents, but it is not known whether it does so in people. Do not use it if your personal or family history includes medullary thyroid cancer (MTC), or if you have MEN 2.
What the label says
“In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure.”
Source: FDA label (DailyMed).
Indications
It lowers blood sugar in adults and in children age 10 and older who have type 2 diabetes, used along with diet and exercise.
What the label says
“As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2”
Source: FDA label (DailyMed).
Heart attack, stroke, and heart-related death become less likely for adults with type 2 diabetes who have heart disease or several risk factors for the heart.
What the label says
“To reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who”
Source: FDA label (DailyMed).
Contraindications
Medullary thyroid cancer (MTC) in your personal or family history, or MEN 2.
What the label says
“Personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)”
Source: FDA label (DailyMed).
A serious allergic reaction to dulaglutide or any product ingredient in the past.
What the label says
“Serious hypersensitivity reaction to dulaglutide or to any of the product components. Serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with TRULICITY”
Source: FDA label (DailyMed).
Warnings and cautions
C-cell tumors in the thyroid. It caused thyroid C-cell tumors in rodents, but it is not known whether it does so in people. Anyone with medullary thyroid cancer (MTC) in their personal or family history, or with MEN 2, must not use it.
What the label says
“In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure”
Source: FDA label (DailyMed).
Pancreatitis. It may cause inflammation of the pancreas. If severe stomach pain does not go away, stop taking it and get care. The pain sometimes spreads to the back.
What the label says
“Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists, including TRULICITY [see Adverse Reactions”
Source: FDA label (DailyMed).
Blood sugar that is too low Using it with insulin or a sulfonylurea makes low blood sugar more likely, and those doses may need lowering.
What the label says
“Patients receiving TRULICITY in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia [see Adverse”
Source: FDA label (DailyMed).
Allergic reactions that are serious. Serious allergic reactions have been reported, including swelling of your face, lips or throat. If any of these happen, stop the medicine and get help right away.
What the label says
“There have been postmarketing reports of serious hypersensitivity reactions including anaphylactic reactions and angioedema in patients treated with TRULICITY [see Adverse Reactions (6.2)]. If a”
Source: FDA label (DailyMed).
Fluid loss can cause kidney injury. Kidney injury can develop when vomiting or diarrhea causes fluid loss. Report heavy fluid loss and drink fluids.
What the label says
“There have been postmarketing reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with GLP-1 receptor agonists, including TRULICITY [see Adverse”
Source: FDA label (DailyMed).
Stomach and gut reactions that are severe. Stomach and gut side effects happen often, and they can be severe. It is not recommended for people with severe gastroparesis.
What the label says
“Use of TRULICITY has been associated with gastrointestinal adverse reactions, sometimes severe [see Adverse Reactions (6)]. In the pool of placebo-controlled trials, severe gastrointestinal adverse”
Source: FDA label (DailyMed).
Worsening of diabetic eye disease. Diabetic eye disease can get worse in people with type 2 diabetes, especially when blood sugar drops fast. If you already have diabetic eye disease, eye checks matter.
What the label says
“In a cardiovascular outcomes trial with a median follow up of 5.4 years involving patients with type 2 diabetes with established cardiovascular disease or multiple”
Source: FDA label (DailyMed).
Disease of the gallbladder. Gallstones and inflammation of the gallbladder can occur. Report belly pain in the upper right area, fever, or yellow skin or eyes.
What the label says
“Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing. In a cardiovascular outcomes trial”
Source: FDA label (DailyMed).
Food that gets into your lungs during anesthesia or sedation. This matters during anesthesia or deep sedation because food can stay in the stomach longer. Let your care team know before any procedure.
What the label says
“TRULICITY delays gastric emptying [see Clinical Pharmacology (12.2)]. There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective”
Source: FDA label (DailyMed).
Source: FDA label (DailyMed).
Adverse reactions in a table
Side effects that showed up most often in the label trials, listed by dose group with placebo.
| Side effect | Placebo | Trulicity 0.75 mg | Trulicity 1.5 mg | More than placebo, 1.5 mg |
|---|---|---|---|---|
| Nausea | 5.3% | 12.4% | 21.1% | +15.8 points |
| Vomiting | 2.3% | 6% | 12.7% | +10.4 points |
| Diarrhea | 6.7% | 8.9% | 12.6% | +5.9 points |
| Abdominal Pain | 4.9% | 6.5% | 9.4% | +4.5 points |
| Decreased Appetite | 1.6% | 4.9% | 8.6% | +7 points |
| Dyspepsia | 2.3% | 4.1% | 5.8% | +3.5 points |
| Fatigue | 2.6% | 4.2% | 5.6% | +3 points |
Source: Trulicity label (DailyMed).
Interactions with other drugs
When you take it with insulin or a sulfonylurea, including glipizide or glimepiride, the risk of low blood sugar rises. Your doctor may lower those doses.
What the label says
“When initiating TRULICITY, consider reducing the dose of concomitantly administered insulin secretagogues (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia [see Warnings”
Source: FDA label (DailyMed).
Because it slows stomach emptying, the way other pills are absorbed may change.
What the label says
“TRULICITY delays gastric emptying and thus has the potential to reduce the rate of absorption of concomitantly administered oral medications. The delay in gastric emptying”
Source: FDA label (DailyMed).
Medicines for which small changes in level matter (such as warfarin) require closer monitoring.
What the label says
“Monitor drug levels of oral medications with a narrow therapeutic index (e.g., warfarin) when concomitantly administered with TRULICITY.”
Source: FDA label (DailyMed).
Pregnancy and nursing
The risk cannot be judged from the limited pregnancy data. Talk to your doctor before you try to conceive.
What the label says
“Limited data with TRULICITY in pregnant women are not sufficient to determine a drug-associated risk for major birth defects and miscarriage. There are clinical considerations”
Source: FDA label (DailyMed).
Whether it passes into human breast milk is not known.
What the label says
“There are no data on the presence of dulaglutide in human milk, the effects on the breastfed infant, or the effects on milk production. The”
Source: FDA label (DailyMed).
Storage and counseling for patients
Store the pens in the fridge; each pen may stay at room temperature, never above 86°F, and for no more than 14 days in total. Never freeze it.
What the label says
“If needed, each single-dose pen can be kept at room temperature, not to exceed 86°F (30°C) for a total of 14 days. Do not freeze”
Source: FDA label (DailyMed).
Comparing the label with other GLP-1 labels
| Label | Boxed warning | Warnings | Interaction lines | Named beyond insulin and pills |
|---|---|---|---|---|
 Ozempic | Yes | 9 | 2 | Not listed |
 Wegovy | Yes | 10 | 3 | Levothyroxine |
 Rybelsus | Yes | 9 | 3 | Levothyroxine |
 Mounjaro | Yes | 9 | 4 | Birth control pills, Warfarin and narrow-range drugs |
 Zepbound | Yes | 9 | 4 | Birth control pills, Warfarin and narrow-range drugs |
 Foundayo | Yes | 9 | 6 | Strong CYP3A4 inhibitors and Strong CYP3A4 inducers, plus Simvastatin and Birth control pills |
| Trulicity | Yes | 9 | 3 | Warfarin and narrow-range drugs |
 Saxenda | Yes | 9 | 2 | Not listed |
 Victoza | Yes | 8 | 2 | Not listed |
| Byetta | No | 9 | 4 | Narrow-range drugs and Warfarin, Birth control pills and antibiotics |
Sources used: Ozempic label (DailyMed), Wegovy label (DailyMed), Rybelsus label (DailyMed), Mounjaro label (DailyMed), Zepbound label (DailyMed), Foundayo label (DailyMed), Trulicity label (DailyMed), Saxenda label (DailyMed), Victoza label (DailyMed), Byetta label (DailyMed).
Read the complete Trulicity label
You can find the complete prescribing information at DailyMed, the National Library of Medicine label site.