Important Regulatory Note:
Compounded semaglutide is not approved by the U.S. Food and Drug Administration (FDA). It is prepared by licensed U.S. compounding pharmacies under a healthcare provider’s prescription when FDA-approved alternatives are unavailable or clinically inappropriate. Compounded medications do not undergo the same safety, efficacy, or quality reviews as FDA-approved drugs.

Formulation Note:
 This medication may be compounded with vitamin B12 or glycine based on your individual needs and provider recommendations.

• Vitamin B12 may be added to support energy metabolism and optimize nutrient balance during weight loss.
• Glycine may be included to promote gut health, reduce nausea, and support liver detoxification.

These enhancements are selected by your prescribing provider based on your medical intake questionnaire and clinical judgment to help improve tolerability and support long-term success.

Intended Use:
Compounded semaglutide may be prescribed as part of a chronic weight management plan for adults with:

• A body mass index (BMI) ≥30 kg/m² (obesity), or
• A BMI ≥27 kg/m² (overweight) with at least one weight-related comorbidity (e.g., hypertension, type 2 diabetes, or dyslipidemia).
  It should be used alongside a reduced-calorie diet and increased physical activity.
  
  

Contraindications:
Do not use compounded semaglutide if:

• You or a family member has a history of medullary thyroid carcinoma (MTC)
• You have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• You are allergic to semaglutide or any of the excipients used in the compounded formulation
  
  

Warnings & Serious Risks:

• Thyroid tumors: Risk of thyroid C-cell tumors observed in animal studies; relevance to humans is not confirmed.
• Pancreatitis: Seek immediate care for persistent or severe abdominal pain.
• Gallbladder complications: May include gallstones or inflammation.
• Kidney impairment: Dehydration from vomiting or diarrhea can worsen kidney function.
• Hypoglycemia: Particularly if used with insulin or sulfonylureas.
• Vision changes: May worsen diabetic retinopathy in individuals with a history of the condition.
• Mental health changes: Monitor for signs of depression or suicidal thoughts.
• Severe gastrointestinal disorders: Use caution in individuals with a history of gastroparesis or related conditions.
  
  

Common Side Effects:

• Nausea
• Vomiting
• Diarrhea
• Constipation
• Stomach discomfort
• Headache
• Fatigue
• Decreased appetite
• Injection site irritation

Most effects are temporary and resolve as your body adapts to the medication.

Drug Interactions:

• Slowed gastric emptying may affect absorption of oral medications.
• Caution is advised when combined with:
  • Insulin or sulfonylureas
  • Oral contraceptives (alternative birth control may be necessary)
  • Drugs with a narrow therapeutic index

Pregnancy & Breastfeeding:

• Not recommended during pregnancy. Discontinue at least 2 months before attempting conception.
• It is unknown whether semaglutide is excreted in breast milk. Avoid use while nursing unless explicitly approved by your healthcare provider.
  
  

Administration:
Inject subcutaneously once weekly into the abdomen, thigh, or upper arm. Administer on the same day each week. Rotate injection sites to minimize irritation. Follow your provider’s instructions regarding titration and dosing schedule.

Storage:
Store in a refrigerator between 36°F and 46°F (2°C and 8°C). Do not freeze. Protect from light. Some compounded formulations may have shorter shelf lives; follow your pharmacy’s guidance.

Emergency Situations:
Seek medical attention immediately if you experience signs of allergic reaction, severe abdominal pain, or low blood sugar. For emergencies, call 911 or go to the nearest hospital.

Disclaimer:
This information is for educational purposes and does not replace medical advice. Compounded semaglutide is prescribed off-label and not evaluated by the FDA for safety, quality, or effectiveness. Speak with your provider before making changes to your medication regimen. Report side effects to your provider or to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.