Diabetes:

Indications for: MOUNJARO

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.

Adult Dosage:

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 Dosage:

<18yrs: not established.

MOUNJARO Contraindications:

History (personal or family) of medullary thyroid carcinoma. Multiple endocrine neoplasia syndrome type 2.

Boxed Warning:

Risk of thyroid C-cell tumors.

MOUNJARO 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 Classification:

Glucose-dependent insulinotropic polypeptide (GIP) receptor + glucagon-like peptide-1 (GLP-1) receptor agonist.

MOUNJARO 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.

Adverse Reactions:

Nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, abdominal pain; acute pancreatitis, hypersensitivity reactions, inj site reactions, acute kidney injury, acute gallbladder disease.

Generic Drug Availability:

NO

How Supplied:

Single-dose pens—4