Important Safety Information for Semaglutide

Indications:
Semaglutide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
 It is not approved by the U.S. Food and Drug Administration (FDA) for weight loss. Licensed clinicians may, at their discretion, prescribe Semaglutide off-label for metabolic or weight-related care when clinically appropriate.

Limitations of Use:
Semaglutide has not been studied in patients with a history of pancreatitis and is not recommended for use in this population.

Contraindications:
Semaglutide is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
 It should not be used in patients with a history of severe gastrointestinal disease, including gastroparesis.

Do not use Semaglutide in patients with a known hypersensitivity to the medication or any of its components.

Warnings and Precautions:

Risk of Thyroid C-Cell Tumors:
Cases of MTC have been reported in patients treated with GLP-1 receptor agonists, including Semaglutide. The relevance of these findings to humans has not been determined. Patients should be evaluated for risk factors before starting therapy and monitored for signs or symptoms of thyroid tumors (such as a neck mass, difficulty swallowing, or persistent hoarseness).

Pancreatitis:
Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been reported with GLP-1 receptor agonists. Patients should be informed of the possible symptoms of pancreatitis (such as severe abdominal pain that may radiate to the back, with or without vomiting) and instructed to stop using Semaglutide and seek immediate medical attention if they occur. If pancreatitis is confirmed, Semaglutide should not be restarted.

Gallbladder Disease:
Acute gallbladder events, including cholelithiasis or cholecystitis, have been reported in patients treated with Semaglutide. Patients should be advised to contact their provider if they experience persistent upper-abdominal pain, fever, or jaundice.

Hypoglycemia with Concomitant Use of Insulin or Insulin Secretagogues:
The risk of hypoglycemia is increased when Semaglutide is used in combination with insulin or insulin secretagogues (for example, sulfonylureas). A reduction in the dose of these agents may be required to lower the risk of low blood sugar.

Diabetic Retinopathy Complications:
Rapid improvement in glucose control has been associated with temporary worsening of diabetic retinopathy. Patients with a history of diabetic eye disease should be monitored accordingly.

Acute Kidney Injury:
Cases of acute renal failure and worsening of chronic renal failure have been reported with GLP-1 receptor agonists. Renal function should be monitored in patients who experience nausea, vomiting, or dehydration, particularly those with pre-existing kidney disease.

Hypersensitivity Reactions:
 Serious hypersensitivity reactions — including anaphylaxis (severe allergic reaction), angioedema (swelling of the face, lips, or throat), and urticaria (hives) — have been reported in patients using Semaglutide. If a hypersensitivity reaction occurs, discontinue Semaglutide immediately and initiate appropriate medical treatment.

Gastrointestinal Adverse Reactions:
Nausea, vomiting, diarrhea, and constipation are among the most common side effects of Semaglutide. These reactions are generally mild to moderate, tend to decrease over time, and may be managed by adjusting the dosage. Caution is advised in patients with severe gastrointestinal disease.

Adverse Reactions:
 The most commonly reported adverse reactions (≥5%) associated with Semaglutide include nausea, vomiting, diarrhea, abdominal pain, and constipation. Other adverse events observed with GLP-1 receptor agonists include fatigue, dyspepsia, dizziness, and injection-site reactions.

Pregnancy and Lactation:
Semaglutide should not be used during pregnancy, as it may cause fetal harm. It is recommended to discontinue Semaglutide at least two months before a planned pregnancy.
 It is unknown whether Semaglutide is excreted in human milk. Use caution when administering Semaglutide to breastfeeding individuals, and discuss potential risks and benefits with a qualified healthcare provider.

Drug Interactions:
Caution should be exercised when Semaglutide is co-administered with medications that affect gastrointestinal motility or absorption, or those that may increase the risk of hypoglycemia. Patients should be closely monitored when starting or adjusting such therapies.

Patient Counseling Information:
Patients should be advised on the potential risks and benefits of Semaglutide therapy, including possible gastrointestinal reactions, risk of hypoglycemia (particularly when combined with insulin or insulin secretagogues), and the importance of maintaining a balanced diet and regular exercise routine.

Patients should be instructed to recognize and promptly report symptoms of thyroid tumors, pancreatitis, gallbladder disease, visual changes, or allergic reactions. Regular follow-up with a healthcare provider is recommended to monitor progress and manage side effects.
 Patients should be advised to administer Semaglutide exactly as prescribed and to follow storage and handling instructions provided by their pharmacy or healthcare provider to ensure product stability and safety.

Note:
This information is provided for educational purposes only and does not replace professional medical advice. Patients should consult a licensed healthcare provider to determine whether Semaglutide therapy is appropriate for their individual circumstances.

Compounded Semaglutide is not FDA-approved, and the FDA has not evaluated compounded medications for safety, effectiveness, or quality.