Clinical Information
Gen. Code and Des.
83389 tirzepatide SUBCUT PEN INJCTR 12.5MG/0.5
GCN and Des.
52334 tirzepatide SUBCUT PEN INJCTR 12.5MG/0.5
Strength
12.5MG
Dose Form
PEN INJECTOR (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
68200600 INCRETIN MIMETICS
Active Ingredients
19067 tirzepatide
These highlights do not include all the information needed to use MOUNJARO safely and effectively. See full prescribing information for MOUNJARO.
MOUNJARO® (tirzepatide) Injection, for subcutaneous use
Initial U.S. Approval: 2022
WARNING: RISK OF THYROID C-CELL TUMORS
See full prescribing information for complete boxed warning.
Tirzepatide causes thyroid C-cell tumors in rats. It is unknown whether MOUNJARO causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined (5.1, 13.1).
MOUNJARO is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors (4, 5.1).
RECENT MAJOR CHANGES
Contraindications (4) 04/2023
Warnings and Precautions
Hypersensitivity Reactions (5.4) 04/2023
INDICATIONS AND USAGE
MOUNJARO® is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1)
Limitations of Use:
Has not been studied in patients with a history of pancreatitis (1, 5.2)
Is not indicated for use in patients with type 1 diabetes mellitus (1)
DOSAGE AND ADMINISTRATION
The recommended starting dosage is 2.5 mg injected subcutaneously once weekly (2.1)
After 4 weeks, increase to 5 mg injected subcutaneously once weekly (2.1)
If additional glycemic control is needed, increase the dosage in 2.5 mg increments after at least 4 weeks on the current dose.
The maximum dosage is 15 mg subcutaneously once weekly (2.1).
Administer once weekly at any time of day, with or without meals. (2.2)
Inject subcutaneously in the abdomen, thigh, or upper arm. (2.2)
Rotate injection sites with each dose.
DOSAGE FORMS AND STRENGTHS
Injection: 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg per 0.5 mL in single-dose pen (3)
CONTRAINDICATIONS
Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2 (4, 5.1)
Known serious hypersensitivity to tirzepatide or any of the excipients in MOUNJARO (4, 5.4)
WARNINGS AND PRECAUTIONS
Pancreatitis: Has been reported in clinical trials. Discontinue promptly if pancreatitis is suspected. (5.2)
Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin: Concomitant use with an insulin secretagogue or insulin may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing dose of insulin secretagogue or insulin may be necessary. (5.3)
Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported. Discontinue MOUNJARO if suspected and promptly seek medical advice. (5.4)
Acute Kidney Injury: Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions. (5.5)
Severe Gastrointestinal Disease: Use may be associated with gastrointestinal adverse reactions, sometimes severe. Has not been studied in patients with severe gastrointestinal disease and is not recommended in these patients. (5.6)
Diabetic Retinopathy Complications in Patients with a History of Diabetic Retinopathy: Has not been studied in patients with non-proliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy, or diabetic macular edema. Monitor patients with a history of diabetic retinopathy for progression. (5.7)
Acute Gallbladder Disease: Has occurred in clinical trials. If cholelithiasis is suspected, gallbladder studies and clinical follow-up are indicated. (5.8)
ADVERSE REACTIONS
The most common adverse reactions, reported in =5% of patients treated with MOUNJARO are: nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
MOUNJARO delays gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications. (7.2)
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal study, may cause fetal harm. (8.1)
Females of Reproductive Potential: Advise females using oral 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. (7.2, 8.3, 12.3)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 5/2023
