Mounjaro®

Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of use: Has not been studied in patients with a history of pancreatitis. Use in patients with type 1 diabetes mellitus is not recommended.

Do not use if you have a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Do not use if you have a known serious hypersensitivity reaction to the medication or any of its components.

Risk of thyroid C-cell tumors: See Boxed Warning. Monitor for signs of thyroid tumors. Mounjaro® is contraindicated in patients with a personal or family history of MTC or MEN 2.

Pancreatitis: Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed. If pancreatitis is suspected, discontinue promptly. Do not resume if pancreatitis is confirmed.

Acute gallbladder disease: Cholelithiasis and cholecystitis have been reported. Evaluate for gallbladder disease in patients who develop suggestive symptoms.

Hypoglycemia with concomitant use of insulin or insulin secretagogues: When combined, lower doses of the secretagogue or insulin may be needed.

Acute kidney injury: There have been reports of acute kidney injury and worsening of chronic renal failure, sometimes requiring hemodialysis, in patients treated with GLP-1 receptor agonists. Most events occurred in patients with nausea, vomiting, diarrhea, or dehydration. Monitor renal function in patients with renal impairment.

Severe hypersensitivity reactions: Anaphylaxis and angioedema have been reported. Discontinue and seek medical advice if a severe reaction is suspected.

Diabetic retinopathy complications (in patients with type 2 diabetes): Rapid improvement in glucose control has been associated with temporary worsening of diabetic retinopathy. Monitor patients with a history of diabetic retinopathy for progression.

Suicidal behavior and ideation: Monitor patients for the emergence or worsening of depression, suicidal thoughts, or any unusual changes in mood or behavior. Discontinue if symptoms develop.

The most common adverse reactions, reported in ≥5% of patients treated, are nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distension, eructation, hypoglycemia in patients with type 2 diabetes, flatulence, gastroenteritis, and gastroesophageal reflux disease.

Gastrointestinal side effects are typically dose-dependent and tend to occur during dose initiation and dose escalation, decreasing over time as treatment continues.

Pregnancy: May cause fetal harm. Advise females of reproductive potential to use effective contraception during treatment and for the recommended period after the last dose. Discontinue at least 2 months before a planned pregnancy due to the long washout period.

Lactation: There are no data on the presence of this medication in human milk or its effects on the breastfed infant or on milk production. Weigh developmental and health benefits of breastfeeding against the mother's clinical need.

Pediatric use: Safety and effectiveness in pediatric patients have not been established (refer to product-specific labeling for any approved pediatric indications).

Geriatric use: Greater sensitivity in older patients cannot be ruled out. In clinical trials, no overall differences in safety or efficacy were observed between elderly and younger patients.

Hepatic / renal impairment: No dose adjustment is recommended; however, monitoring is advised in patients with severe renal impairment, given the increased risk of acute kidney injury when dehydration occurs.