Semaglutide — Important Safety Information (ISI)

This information is required by the FDA for semaglutide-containing medications including Ozempic®, Wegovy®, and compounded semaglutide. Read this information carefully before starting treatment. Discuss any questions with your provider.

What Is Semaglutide?

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist used for chronic weight management and type 2 diabetes management. It is available under the brand names Ozempic® (for type 2 diabetes) and Wegovy® (for chronic weight management) and as compounded formulations prepared by FDA-registered pharmacies.

Boxed Warning — Thyroid C-Cell Tumors

WARNING: RISK OF THYROID C-CELL TUMORS. In animal studies, semaglutide caused dose-dependent and treatment-duration-dependent thyroid C-cell tumors in both sexes of rats and mice. It is unknown whether semaglutide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans. Semaglutide is 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 (a lump in the neck, hoarseness, dysphagia, or dyspnea).

Contraindications

Semaglutide is contraindicated in patients with:

• Personal or family history of medullary thyroid carcinoma (MTC)
• Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• Known serious hypersensitivity reaction to semaglutide or any excipients
• Pregnancy (see Pregnancy section below)

Warnings and Precautions

• Pancreatitis: Acute pancreatitis has been reported. Discontinue semaglutide and do not restart if pancreatitis is suspected. Use with caution in patients with a history of pancreatitis.
• Diabetic Retinopathy Complications (in T2D patients): Worsening of diabetic retinopathy has been reported. Monitor patients with history of diabetic retinopathy.
• Hypoglycemia: Risk of hypoglycemia when used with insulin or insulin secretagogues. Dose reduction of insulin or secretagogue may be required.
• Acute Kidney Injury: Cases of acute kidney injury and worsening chronic renal failure, sometimes requiring dialysis, have been reported, usually in association with nausea, vomiting, diarrhea, or dehydration. Monitor renal function in patients reporting severe GI reactions.
• Hypersensitivity Reactions: Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported. Discontinue immediately if suspected.
• Suicidal Behavior and Ideation: Monitor for depression and suicidal ideation. Discontinue if symptoms develop.
• Gallbladder Disease: Cholelithiasis and cholecystitis have been reported. Patients reporting symptoms of gallbladder disease should be evaluated.
• Heart Rate Increase: Semaglutide causes a mean increase in resting heart rate. Monitor periodically.

Most Common Adverse Reactions

The most common adverse reactions (5% or more incidence) in clinical trials were:

• Nausea (44%)
• Diarrhea (30%)
• Vomiting (24%)
• Constipation (24%)
• Abdominal pain (20%)
• Headache (14%)
• Fatigue (11%)
• Dyspepsia (9%)
• Dizziness (8%)
• Abdominal distension (7%)

Most GI side effects are mild to moderate and transient, occurring primarily during dose escalation. Slow dose titration significantly reduces their incidence and severity.

Drug Interactions

Semaglutide slows gastric emptying, which may impact absorption of oral medications. Monitor patients taking oral medications that require consistent absorption (e.g., oral contraceptives, levothyroxine). Semaglutide may augment hypoglycemic effects of insulin and insulin secretagogues.

Use in Specific Populations

• Pregnancy: May cause fetal harm. Discontinue semaglutide at least 2 months before a planned pregnancy. If a patient becomes pregnant, semaglutide should be discontinued. Advise patients of the potential risk.
• Lactation: There is no information on the presence of semaglutide in human milk or its effects on the breastfed infant. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need.
• Renal Impairment: No dose adjustment required for mild to moderate renal impairment. Limited data for severe impairment; use with caution.
• Hepatic Impairment: No clinically meaningful differences in semaglutide pharmacokinetics.
• Geriatric Use: No overall differences in safety or effectiveness in patients 65 years of age or older, but greater sensitivity cannot be ruled out.

Dosage and Administration Summary

Administer semaglutide once weekly via subcutaneous injection, on the same day each week. Inject into the abdomen, thigh, or upper arm. Rotate injection sites. The dose escalation schedule used at Tactus Health is designed to minimize GI side effects. Do not accelerate the schedule without consulting your provider.

Full Prescribing Information

This ISI is a summary. Full prescribing information is available on the FDA website and in the medication package insert included with your prescription. Discuss any questions or concerns with Dr. Ashar before starting or continuing treatment.

References: Wegovy® (semaglutide) Prescribing Information. Novo Nordisk Inc. Ozempic® (semaglutide) Prescribing Information. Novo Nordisk Inc. FDA Drug Safety Communications. Information current as of March 2026.