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Mounjaro Generic Name & Formulations
Legal Class
Rx
General Description
Tirzepatide 2.5mg, 5mg, 7.5mg, 10mg, 12.5mg, 15mg; per 0.5mL; soln for SC inj; preservative-free.
Pharmacological Class
Glucose-dependent insulinotropic polypeptide (GIP) receptor + glucagon-like peptide-1 (GLP-1) receptor agonist.
How Supplied
Single-dose pens—4
Manufacturer
Generic Availability
NO
Mechanism of Action
Tirzepatide, a GIP receptor and GLP-1 receptor agonist, is a 39-amino-acid modified peptide with a C20 fatty diacid moiety that enables albumin binding and prolongs the half-life. Tirzepatide selectively binds to and activates both the GIP and GLP-1 receptors, the targets for native GIP and GLP-1. Tirzepatide enhances first- and second-phase insulin secretion, and reduces glucagon levels, both in a glucose-dependent manner.
Mounjaro Indications
Indications
As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use
Not studied in those with a history of pancreatitis. Not for treating type 1 diabetes mellitus.
Mounjaro Dosage and Administration
Adult
Give by SC inj in abdomen, thigh, or upper arm; rotate inj sites. Initially 2.5mg once weekly; after 4 weeks, increase to 5mg once weekly. If additional control is needed, increase in 2.5mg increments after ≥4 weeks on the current dose; max 15mg once weekly.
Children
<18yrs: not established.
Mounjaro Contraindications
Contraindications
History (personal or family) of medullary thyroid carcinoma. Multiple endocrine neoplasia syndrome type 2.
Mounjaro Boxed Warnings
Boxed Warning
Risk of thyroid C-cell tumors.
Mounjaro Warnings/Precautions
Warnings/Precautions
Risk of thyroid C-cell tumors (including medullary thyroid carcinoma); inform patients of potential risk and symptoms. History of pancreatitis: not studied. Monitor for pancreatitis; discontinue if suspected. Severe GI disease, including severe gastroparesis: not recommended. History of diabetic retinopathy; monitor for progression. History of anaphylaxis or angioedema with other GLP-1 receptor agonist. Discontinue if hypersensitivity reactions occur. Perform gallbladder studies and clinical follow-up if cholelithiasis or cholecystitis are suspected. Monitor renal function when initiating or escalating dose, and in renally-impaired patients reporting severe GI reactions. Pregnancy. Nursing mothers.
Mounjaro Pharmacokinetics
Absorption
Time to maximum plasma concentration ranges from 8 to 72 hours. Mean absolute bioavailability: 80%.
Distribution
Mean apparent steady-state volume of distribution: ~10.3 L. Highly bound to plasma albumin (99%).
Elimination
Renal, fecal. Half-life: ~5 days.
Mounjaro Interactions
Interactions
Concomitant insulin: administer as separate injections not adjacent to each other. Increased risk of hypoglycemia with concomitant insulin secretagogues (eg, sulfonylureas) or insulin; consider reducing dose of these. May affect absorption of concomitant oral drugs (delayed gastric emptying); caution. Monitor drugs with narrow therapeutic index (eg, warfarin). Advise patients using oral hormonal contraceptives to switch to a non-oral contraceptive method or add a barrier method of contraception for 4 weeks after initiation and for 4 weeks after each dose escalation.
Mounjaro Adverse Reactions
Adverse Reactions
Nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, abdominal pain; acute pancreatitis, hypersensitivity reactions, inj site reactions, acute kidney injury, acute gallbladder disease.
Mounjaro Clinical Trials
See Literature
Mounjaro Note
Not Applicable
Mounjaro Patient Counseling
See Literature
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