Dulaglutide 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
- Thyroid C-cell tumors
- Approved uses
- 2
- Warnings
- 9
- First approved
- 2014
Trulicity in brief
Its half-life is about 5 days: after 5 d, half remains, and after five half-lives (25 d), about 3% is left.
This comes from the FDA DailyMed label.
The Trulicity boxed warning
Boxed warning: In rodents, it caused thyroid C-cell tumors. Whether the same happens in people is unknown. You must not use this medicine with a history of medullary thyroid cancer (MTC) in you or your family, or with MEN 2.
The label words
“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 children 10 and older with type 2 diabetes when used with diet and exercise.
The label words
“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).
For adults with type 2 diabetes, this applies when heart disease or several heart risk factors are present.
The label words
“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
A personal or family history of medullary thyroid cancer (MTC), or MEN 2.
The label words
“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 past severe allergic reaction to dulaglutide or any product ingredient.
The label words
“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 precautions
Thyroid C-cell tumors. In rodents, it caused thyroid C-cell tumors; whether it causes the same in people is not known. It is not for people who have had medullary thyroid cancer (MTC) themselves or in their family, and not for anyone with MEN 2.
The label words
“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 can cause pancreas inflammation. If severe stomach pain continues and sometimes spreads to your back, stop taking it and seek care.
The label words
“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).
Low blood sugar. Taking it with insulin or a sulfonylurea makes low blood sugar more likely, so those doses may need to be lowered.
The label words
“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).
Serious allergic reactions. Reported serious allergic reactions have included swelling of the face, lips, or throat. If this reaction occurs, stop taking the medicine and get help right away.
The label words
“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).
Kidney injury due to fluid loss. Fluid loss from vomiting or diarrhea can lead to kidney injury. If you lose a lot of fluid, report it and drink fluids.
The label words
“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).
Reactions in the gut and stomach can be severe. Stomach and gut side effects are common. They can also be severe. Severe gastroparesis is a condition for which this drug is not recommended.
The label words
“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. With type 2 diabetes, your diabetic eye disease can worsen, particularly when blood sugar drops quickly. Eye checks are important if you already have it.
The label words
“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).
Gallbladder disease. Gallstones and inflammation of the gallbladder may occur. Report fever, yellow skin or eyes, or upper right belly pain.
The label words
“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 entering the lungs during anesthesia or sedation. Food can remain in the stomach longer, which matters under anesthesia or deep sedation. Tell your care team before any procedure.
The label words
“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).
The table of Adverse reactions
Most common side effects reported in label trials are grouped by dose and compared 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).
Drug interactions
Low blood sugar is more likely when you use this drug with insulin or a sulfonylurea, such as glimepiride or glipizide. Your doctor may lower those doses.
The label words
“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).
The medicine slows stomach emptying, which can affect the absorption of other pills.
The label words
“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).
Drugs such as warfarin need closer monitoring because even small changes in their levels matter.
The label words
“Monitor drug levels of oral medications with a narrow therapeutic index (e.g., warfarin) when concomitantly administered with TRULICITY.”
Source: FDA label (DailyMed).
While pregnant and breastfeeding
Before trying to conceive, talk with your doctor because the pregnancy data are too limited to assess the risk.
The label words
“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).
It is not known whether the drug enters human breast milk.
The label words
“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 instructions and patient counseling
Refrigerate it. For up to 14 days total, each pen may stay at room temperature, with a maximum of 86°F. Do not freeze it.
The label words
“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).
Other GLP-1 labels compared with this one
| 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, Birth control pills, Simvastatin, and Strong CYP3A4 inducers |
 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 | Antibiotics and Birth control pills; Warfarin and narrow-range medicines |
Sources: 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 this complete Trulicity label
The complete prescribing information is available on DailyMed, the National Library of Medicine label site.