Dulaglutide
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];
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Black Box Warning
WARNING
See full prescribing information for complete Boxed Warning.
RISK OF THYROID C-CELL TUMORS:
|
Overview
Dulaglutide is a that is FDA approved for the {{{indicationType}}} of . There is a Black Box Warning for this drug as shown here. Common adverse reactions include .
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Condition1
- TRULICITY™ is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use
- TRULICITY is not recommended as a first-line therapy for patients who have inadequate glycemic control on diet and exercise because of the uncertain relevance of rodent C-cell tumor findings to humans. Prescribe *TRULICITY only to patients for whom the potential benefits outweigh the potential risk .
- TRULICITY has not been studied in patients with a history of pancreatitis . Consider other antidiabetic therapies in patients with a history of pancreatitis.
- TRULICITY should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. TRULICITY is not a substitute for insulin.
- TRULICITY has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis. The use of TRULICITY is not recommended in patients with pre-existing severe gastrointestinal disease
- The concurrent use of TRULICITY and basal insulin has not been studied.
- Dosing Information
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Dulaglutide in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Dulaglutide in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Dulaglutide in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Dulaglutide in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Dulaglutide in pediatric patients.
Contraindications
Medullary Thyroid Carcinoma
- TRULICITY is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) .
Hypersensitivity
- TRULICITY is contraindicated in patients with a prior serious hypersensitivity reaction to dulaglutide or to any of the product components
Warnings
WARNING
See full prescribing information for complete Boxed Warning.
RISK OF THYROID C-CELL TUMORS:
|
Risk of Thyroid C-cell Tumors
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 Glucagon-like peptide (GLP-1) receptor agonists have induced thyroid C-cell adenomas and carcinomas in mice and rats at clinically relevant exposures. It is unknown whether TRULICITY will cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined.
- One case of MTC was reported in a patient treated with TRULICITY. This patient had pretreatment calcitonin levels approximately 8 times the upper limit of normal (ULN). Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist, have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and GLP-1 receptor agonist use in humans.
- TRULICITY is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the potential risk for MTC with the use of TRULICITY and inform them of symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea, persistent hoarseness).
- Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with TRULICITY. Such monitoring may increase the risk of unnecessary procedures, due to the low test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin value may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.
=====Pancreatitis
=
- In Phase 2 and Phase 3 clinical studies, 12 (3.4 cases per 1000 patient years) pancreatitis related adverse reactions were reported in patients exposed to TRULICITY versus 3 in non-incretin comparators (2.7 cases per 1000 patient years). An analyses of adjudicated events revealed 5 cases of confirmed pancreatitis in patients exposed to TRULICITY (1.4 cases per 1000 patient years) versus 1 case in non-incretin comparators (0.88 cases per 1000 patient years).
- After initiation of TRULICITY, observe patients carefully for signs and symptoms of pancreatitis, including persistent severe abdominal pain. If pancreatitis is suspected, promptly discontinue TRULICITY. If pancreatitis is confirmed, TRULICITY should not be restarted. TRULICITY has not been evaluated in patients with a prior history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis.
=====Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin
=
- The risk of hypoglycemia is increased when TRULICITY is used in combination with insulin secretagogues (e.g., sulfonylureas) or insulin. Patients may require a lower dose of sulfonylurea or insulin to reduce the risk of hypoglycemia in this setting .
=====Hypersensitivity Reactions
=
- Systemic hypersensitivity reactions were observed in patients receiving TRULICITY in clinical trials. If a hypersensitivity reaction occurs, the patient should discontinue TRULICITY and promptly seek medical advice.
=====Renal Impairment
=
- In patients treated with GLP-1 receptor agonists, there have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis. Some of these events were reported in patients without known underlying renal disease. A majority of reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Because these reactions may worsen renal function, use caution when initiating or escalating doses of TRULICITY in patients with renal impairment. Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions.
=====Severe Gas
trointestinal Disease=====
- Use of TRULICITY may be associated with gastrointestinal adverse reactions, sometimes severe . TRULICITY has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients.
Macrovascular Outcomes
- There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with TRULICITY or any other antidiabetic drug.
Precautions
- Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Dulaglutide in the drug label.
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Dulaglutide in the drug label.
Drug Interactions
- Drug
- Description
Use in Specific Populations
Pregnancy
- Pregnancy Category
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Dulaglutide in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Dulaglutide during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Dulaglutide with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Dulaglutide with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Dulaglutide with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Dulaglutide with respect to specific gender populations.
Race
There is no FDA guidance on the use of Dulaglutide with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Dulaglutide in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Dulaglutide in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Dulaglutide in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Dulaglutide in patients who are immunocompromised.
Administration and Monitoring
Administration
- Oral
- Intravenous
Monitoring
There is limited information regarding Monitoring of Dulaglutide in the drug label.
- Description
IV Compatibility
There is limited information regarding IV Compatibility of Dulaglutide in the drug label.
Overdosage
There is limited information regarding Chronic Overdose of Dulaglutide in the drug label.
Pharmacology
There is limited information regarding Dulaglutide Pharmacology in the drug label.
Mechanism of Action
Structure
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Dulaglutide in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Dulaglutide in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Dulaglutide in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Dulaglutide in the drug label.
How Supplied
Storage
There is limited information regarding Dulaglutide Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Patient Counseling Information of Dulaglutide in the drug label.
Precautions with Alcohol
- Alcohol-Dulaglutide interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- ®[1]
Look-Alike Drug Names
- A® — B®[2]
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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- ↑ "http://www.ismp.org". External link in
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