Important Safety Information for Compounded Semaglutide

What is Compounded Semaglutide?

Compounded Semaglutide is a prescription GLP-1 receptor agonist medication used in combination with diet and exercise for chronic weight management in adults with obesity (BMI ≥30) or overweight (BMI ≥27) with at least one weight-related medical condition. Semaglutide works by mimicking a natural hormone that targets areas of the brain involved in regulating appetite and food intake, helping you feel full sooner and reducing hunger between meals.

Boxed Warning: Thyroid C-Cell Tumor Risk

Semaglutide has been shown to cause thyroid C-cell tumors in rodents. The relevance of these findings to humans has not been established. Do not use semaglutide if you have a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Monitor for and report any of the following symptoms to your healthcare provider:

• Swelling or a lump in your neck
• Hoarseness that persists
• Trouble swallowing
• Shortness of breath

Who Should Not Use Compounded Semaglutide?

This medication is not appropriate for individuals who:

• Have a personal or family history of medullary thyroid carcinoma (MTC)
• Have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• Have experienced a previous serious allergic reaction to semaglutide
• Have a history of pancreatitis
• Are pregnant, planning pregnancy, or breastfeeding
• Have severe kidney or liver disease (use with caution under medical supervision)
• Have diabetic retinopathy complications (use with caution)

Warnings and Precautions

1. Pancreatitis (Inflammation of the Pancreas)Cases of acute pancreatitis, some severe, have been reported with semaglutide use. Symptoms include severe pain in your upper stomach spreading to your back, vomiting, and tenderness when touching your abdomen. If you experience these symptoms, stop taking semaglutide immediately and contact your healthcare provider.

2. Diabetic Eye Disease (Retinopathy)Patients with a history of diabetic retinopathy should be monitored carefully. Rapid improvements in blood sugar control have been associated with temporary worsening of diabetic eye disease. Report any vision changes to your healthcare provider.

3. Hypoglycemia (Low Blood Sugar)The risk of low blood sugar increases when semaglutide is used with insulin or sulfonylureas. Symptoms include dizziness, blurred vision, anxiety, irritability, sweating, trembling, rapid heartbeat, and confusion. Your provider may need to adjust doses of other diabetes medications.

4. Acute Kidney InjuryKidney problems, including kidney failure requiring dialysis, have been reported in patients taking semaglutide, particularly those experiencing dehydration from gastrointestinal side effects. Stay well-hydrated, especially if you experience nausea, vomiting, or diarrhea.

5. Gallbladder DiseaseSemaglutide may increase the risk of gallstones and gallbladder inflammation. Symptoms include severe upper abdominal pain, fever, jaundice (yellowing of skin or eyes), and clay-colored stools. Contact your provider if you experience these symptoms.

6. Serious Allergic ReactionsAnaphylaxis and angioedema have been reported. Signs include swelling of face, lips, tongue, or throat; difficulty breathing or swallowing; severe rash or itching; rapid heartbeat; and dizziness. Seek emergency care immediately if these occur.

7. Heart Rate IncreaseSemaglutide may cause a slight increase in resting heart rate. Patients with pre-existing heart conditions should discuss this with their healthcare provider. Report sustained rapid heartbeat or palpitations.

8. Suicidal Thoughts and BehaviorsAlthough rare, reports of suicidal ideation have been associated with weight loss medications. Contact your healthcare provider immediately if you experience new or worsening depression, anxiety, mood changes, or thoughts of self-harm.

9. Anesthesia and Surgical ProceduresBecause semaglutide slows gastric emptying, there may be food remaining in your stomach even after fasting. This increases the risk of aspiration during sedation or anesthesia. Notify your healthcare team about semaglutide use before any procedure.

Common Side Effects

Most frequently reported side effects include:

• Nausea
• Diarrhea
• Vomiting
• Constipation
• Abdominal pain
• Headache
• Fatigue
• Indigestion or heartburn
• Dizziness
• Bloating
• Gas
• Gastroesophageal reflux (acid reflux)
• Injection site reactions

Side effects are typically most pronounced during dose escalation and often improve as treatment continues.

Pregnancy and Breastfeeding

Pregnancy: Semaglutide should not be used during pregnancy. Weight loss provides no benefit during pregnancy and may cause fetal harm. Based on animal studies, semaglutide may cause birth defects or pregnancy loss. Stop semaglutide at least 2 months before planning to become pregnant, as the medication remains in your body for an extended period after your last dose.

Breastfeeding: It is unknown whether semaglutide is excreted in human breast milk. Given the potential risks to nursing infants, a decision should be made whether to discontinue nursing or discontinue the medication, considering the importance of treatment to the mother.

Drug Interactions

Tell your healthcare provider about all medications, supplements, and herbal products you use, including:

• Insulin and sulfonylureas – hypoglycemia risk increases; dose adjustments may be necessary
• Oral contraceptives – effectiveness may be reduced due to delayed absorption
• Warfarin and other anticoagulants – monitoring of clotting parameters may be needed
• Medications requiring precise timing – absorption may be affected

Do not use semaglutide with other GLP-1 receptor agonists or with tirzepatide.

Important Patient Information

• Inject semaglutide subcutaneously once weekly, on the same day each week
• You may inject at any time of day, with or without food
• Rotate injection sites (abdomen, thigh, or upper arm) to reduce injection site reactions
• Never share injection devices with others
• Follow the prescribed dose escalation schedule; starting doses are lower to minimize side effects
• Store in refrigerator before first use; after first use, may be kept at room temperature for up to 56 days
• Keep all follow-up appointments for safety monitoring
• Maintain a reduced-calorie diet and physical activity program as directed

When to Seek Emergency Medical Care

Get emergency help immediately for:

• Severe, persistent stomach pain with or without vomiting
• Signs of severe allergic reaction (throat swelling, difficulty breathing, collapse)
• Severe diarrhea or vomiting leading to dehydration
• Vision changes or vision loss
• Signs of kidney problems (decreased urination, swelling in legs/ankles, fatigue)
• Chest pain, shortness of breath, or irregular heartbeat
• Suicidal thoughts or intentions to harm yourself

Reporting Side Effects

Report negative side effects to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.

This safety information is not comprehensive. Consult your healthcare provider or pharmacist for complete information about semaglutide.

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