Please read this information carefully before starting any treatment. Discuss all questions and concerns with your healthcare provider.
GLP-1 (glucagon-like peptide-1) receptor agonists are a class of prescription medications used for the management of type 2 diabetes and, in certain formulations, for chronic weight management in adults. These medications work by mimicking the GLP-1 hormone, which helps regulate blood sugar, appetite, and food intake. GLP-1 medications are available only by prescription and require evaluation by a licensed healthcare provider.
FDA-approved GLP-1 receptor agonists for weight management are indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management 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, type 2 diabetes, dyslipidemia).
In rodent studies, GLP-1 receptor agonists caused dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether GLP-1 receptor agonists cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans. GLP-1 receptor agonists are 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.
GLP-1 receptor agonists are contraindicated in patients with:
Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed.
Cholelithiasis and cholecystitis have been reported. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated.
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. Use caution in patients with renal impairment. Monitor renal function in patients who report severe gastrointestinal adverse reactions.
The risk of hypoglycemia is increased when GLP-1 receptor agonists are used in combination with insulin secretagogues (e.g., sulfonylureas) or insulin. Consider reducing the dose of the concomitant insulin secretagogue or insulin to reduce the risk of hypoglycemia.
Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported. If a hypersensitivity reaction occurs, discontinue use and treat promptly per standard of care.
In patients with type 2 diabetes, rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. Monitor patients with a history of diabetic retinopathy.
Mean increases in resting heart rate have been observed. Monitor heart rate at regular intervals. Discontinue if patients experience a sustained increase in resting heart rate.
Monitor patients for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Discontinue if patients experience suicidal thoughts or behaviors.
The most commonly reported side effects include:
Most side effects are mild to moderate and tend to improve over time. Your healthcare provider can help manage side effects through dosage adjustments and supportive care.
GLP-1 receptor agonists may affect the absorption of concomitantly administered oral medications due to delayed gastric emptying. Use caution when oral medications are concomitantly administered. Inform your healthcare provider of all medications you are currently taking, including prescription medications, over-the-counter drugs, vitamins, and herbal supplements.
Pregnancy: GLP-1 receptor agonists are not recommended during pregnancy. Discontinue use at least 2 months before a planned pregnancy due to the long washout period.
Lactation: It is not known whether GLP-1 receptor agonists are excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue the drug.
Pediatric Use: Safety and effectiveness have not been established in pediatric patients under 18 years of age for weight management.
Geriatric Use: No overall differences in safety or effectiveness have been observed between older and younger patients. Greater sensitivity of some older individuals cannot be ruled out.
Renal Impairment: Use caution in patients with renal impairment. Monitor renal function.
Hepatic Impairment: Use caution in patients with hepatic impairment.
When clinically appropriate, your healthcare provider may prescribe compounded GLP-1 medication dispensed by a licensed pharmacy. Compounded medications are not reviewed or approved by the U.S. Food and Drug Administration (FDA) for safety, effectiveness, or quality. The FDA does not verify the safety or effectiveness of compounded drugs. Compounded drugs are made based on a provider's prescription to meet a patient's individual medical needs.
If you experience any side effects or adverse reactions, contact your healthcare provider immediately. You may also report side effects to the FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
This safety information is provided for educational purposes and does not replace the advice of a licensed healthcare provider. Always consult your physician before starting, stopping, or changing any medication. For the most current prescribing information, refer to the FDA-approved labeling for the specific medication prescribed to you.