Indications (and usage): #Zepbound™ is indicated as an adjunct to a #reduced-caloriediet and increased physical activity for chronic #weightmanagement in adults with an initial body mass index (BMI) of:
30 kg/m2 or greater (obesity) or
27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea, or cardiovascular disease).
Limitations of use:
#Zepbound contains tirzepatide. Coadministration with other tirzepatide-containing products or with any #glucagon-likepeptide-1 (GLP-1) receptor agonist is not recommended.
The safety and efficacy of #Zepbound in combination with other products intended for #weightmanagement, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.
#Zepbound has not been studied in patients with a history of pancreatitis
IMPORTANT SAFETY CONCERNS
Thyroid Cancer: In rats, tirzepatide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether #Zepbound causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined. #Zepbound is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). #Zepbound is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2, and in patients with known serious hypersensitivity to tirzepatide or any of the excipients in #Zepbound. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with tirzepatide.
Severe Gastrointestinal Disease: Use of #Zepbound has been associated with gastrointestinal adverse reactions, sometimes severe. In clinical trials, severe gastrointestinal adverse reactions were reported more frequently among patients receiving #Zepbound (5 mg 1.7%, 10 mg 2.5%, 15 mg 3.1%) than placebo (1.0%). #Zepbound has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients.
Acute Kidney Injury: Use of #Zepbound has been associated with acute kidney injury, which can result from dehydration due to gastrointestinal adverse reactions to #Zepbound, including nausea, vomiting, and diarrhea. In patients treated with GLP-1 receptor agonists, there have been post marketing reports of acute kidney injury and worsening of chronic renal failure, which may sometimes require hemodialysis. Some of these events have been reported in patients without known underlying renal disease. A majority of the reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration.
Acute Gallbladder Disease: Treatment with #Zepbound and GLP-1 receptor agonists is associated with an increased occurrence of acute gallbladder disease. In clinical trials of #Zepbound, cholelithiasis was reported in 1.1% of #Zepbound-treated patients and 1.0% of placebo-treated patients, cholecystitis was reported in 0.7% of #Zepbound-treated patients and 0.2% of placebo-treated patients, and cholecystectomy was reported in 0.2% of #Zepbound-treated patients and no placebo-treated patients. Acute gallbladder events were associated with weight reduction.
Acute Pancreatitis: Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists, or tirzepatide. In clinical trials of tirzepatide for a different indication, 14 events of acute pancreatitis were confirmed by adjudication in 13 tirzepatide-treated patients (0.23 patients per 100 years of exposure) versus 3 events in 3 comparator-treated patients (0.11 patients per 100 years of exposure). In #Zepbound clinical trials, 0.2% of #Zepbound-treated patients had acute pancreatitis confirmed by adjudication (0.14 patients per 100 years of exposure) versus 0.2% of placebo-treated patients (0.15 patients per 100 years of exposure). #Zepbound has not been studied in patients with a prior history of pancreatitis. It is unknown if patients with a history of pancreatitis are at higher risk for development of pancreatitis on #Zepbound.
Hypersensitivity Reactions: There have been postmarketing reports of serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) in patients treated with tirzepatide. In Zepbound clinical trials, 0.1% of Zepbound-treated patients had severe hypersensitivity reactions compared to no placebo-treated patients.
Hypoglycemia: Zepbound lowers blood glucose and can cause hypoglycemia. In a trial of patients with type 2 diabetes mellitus and BMI ≥27 kg/m2, hypoglycemia (plasma glucose <54mg/dL) was reported in 4.2% of Zepbound-treated patients versus 1.3% of placebo-treated patients. In this trial, patients taking Zepbound in combination with an insulin secretagogue (e.g., sulfonylurea) had increased risk of hypoglycemia (10.3%) compared to Zepbound-treated patients not taking a sulfonylurea (2.1%). Hypoglycemia has also been associated with Zepbound and GLP-1 receptor agonists in adults without type 2 diabetes mellitus. There is also increased risk of hypoglycemia in patients treated with tirzepatide in combination with insulin. Inform patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.
Diabetic Retinopathy Complications in Patients with Type 2 Diabetes Mellitus: Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. Tirzepatide has not been studied in patients with non-proliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy, or diabetic macular edema.
Suicidal Behavior and Ideation: Suicidal behavior and ideation have been reported in clinical trials with other chronic weight management products.
Common adverse reactions: nausea, diarrhea, vomiting, constipation, abdominal pain, dyspepsia, injection site reactions, fatigue, hypersensitivity reactions, eructation, hair loss, and gastroesophageal reflux disease.
Drug Interactions: Zepbound lowers blood glucose. Zepbound delays gastric emptying and thereby has the potential to impact the absorption of concomitantly administered oral medications. Caution should be exercised when oral medications are concomitantly administered with Zepbound.
Pregnancy: Available data with tirzepatide in pregnant patients are insufficient to evaluate for a drug-related risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Zepbound is not recommended to take during pregnancy. Based on animal reproduction studies, there may be risks to the fetus from exposure to tirzepatide during pregnancy.
Lactation: There are no data on the presence of tirzepatide or its metabolites in animal or human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Zepbound and any potential adverse effects on the breastfed infant from Zepbound or from the underlying maternal condition.
Females and Males of Reproductive Potential: Use of Zepbound may reduce the efficacy of oral hormonal contraceptives due to delayed gastric emptying. This delay is largest after the first dose and diminishes over time.
Pediatric Use: The safety and effectiveness of Zepbound have not been established in pediatric patients less than 18 years of age.
*Information adapted from Lilly USA
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