Tirzepatide
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alen Antony Pathil, M.D.[2]
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Black Box Warning
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Overview
Tirzepatide is a glucagon-like peptide-1 (GLP-1) receptor agonist that is FDA approved for the treatment of type 2 diabetes mellitus in adults in adjunct to diet and exercise.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include pancreatitis,hypoglycemia with concomitant use of insulin or insulin secretagogues, acute kidney injury, severe gastrointestinal disease, acute gallbladder disease, diabetic retinopathy complication, risk of thyroid C-cell tumor and hypersensitivity reaction..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Tirzepatide FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Tirzepatide FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
There is limited information regarding Tirzepatide Contraindications in the drug label.
Warnings
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There is limited information regarding Tirzepatide Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Tirzepatide Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Tirzepatide Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Tirzepatide Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Tirzepatide in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Tirzepatide in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Tirzepatide during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Tirzepatide in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Tirzepatide in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Tirzepatide in geriatric settings.
Gender
There is no FDA guidance on the use of Tirzepatide with respect to specific gender populations.
Race
There is no FDA guidance on the use of Tirzepatide with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Tirzepatide in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Tirzepatide in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Tirzepatide in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Tirzepatide in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Tirzepatide Administration in the drug label.
Monitoring
There is limited information regarding Tirzepatide Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Tirzepatide and IV administrations.
Overdosage
There is limited information regarding Tirzepatide overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Tirzepatide Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Tirzepatide Mechanism of Action in the drug label.
Structure
There is limited information regarding Tirzepatide Structure in the drug label.
Pharmacodynamics
There is limited information regarding Tirzepatide Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Tirzepatide Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Tirzepatide Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Tirzepatide Clinical Studies in the drug label.
How Supplied
There is limited information regarding Tirzepatide How Supplied in the drug label.
Storage
There is limited information regarding Tirzepatide 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 Tirzepatide Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Tirzepatide interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Tirzepatide Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Tirzepatide Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.