Compounded Semaglutide - Safety Information
Overview
Compounded semaglutide is used as an injectable medication to help manage weight in adults who are either obese or overweight with weight-related medical conditions. It functions as a glucagon-like peptide-1 (GLP-1) receptor agonist, helping regulate blood sugar levels and reduce appetite. However, it is important to understand that compounded semaglutide is not FDA-approved, and its safety, efficacy, and manufacturing standards have not been evaluated in the same way as FDA-approved medications.
Indications for Use
Compounded semaglutide may be used for chronic weight management in adults with:
- Obesity: Body mass index (BMI) ≥ 30 kg/m².
- Overweight: BMI ≥ 27 kg/m² with at least one weight-related comorbidity such as hypertension, type 2 diabetes, or dyslipidemia.
Important Safety Information
Warning: Risk of Thyroid C-Cell Tumors
In animal studies, semaglutide caused thyroid C-cell tumors. It is not known if this risk is present in humans, but the use of semaglutide is contraindicated in individuals with a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Signs to watch for:
- Lump or swelling in the neck.
- Hoarseness, trouble swallowing.
- Shortness of breath.
Contraindications
Do not use compounded semaglutide if you:
- Have a history of medullary thyroid carcinoma or MEN 2.
- Are allergic to semaglutide or any other ingredients in the formulation.
- Are pregnant or planning to become pregnant. Compounded semaglutide should not be used during pregnancy.
Common Side Effects
- Gastrointestinal Issues: Nausea, vomiting, diarrhea, constipation, abdominal pain, and indigestion.
- Injection Site Reactions: Redness, pain, or swelling at the site of injection.
- Fatigue: Feeling unusually tired or lethargic.
- Dizziness: Lightheadedness or a spinning sensation.
- Increased Heart Rate: Noticeable racing of the heart even while at rest.
Serious Side Effects
- Acute Pancreatitis: Severe abdominal pain that may radiate to the back, with or without vomiting.
- Acute Kidney Injury: Nausea, vomiting, or diarrhea leading to dehydration and worsening kidney function.
- Gallbladder Disease: Gallstones or inflammation, marked by upper abdominal pain, jaundice, or clay-colored stools.
- Diabetic Retinopathy: Worsening of eye disease in individuals with type 2 diabetes.
- Hypoglycemia: Severe low blood sugar, particularly when used with other glucose-lowering medications.
- Serious Allergic Reactions: Swelling of the face, lips, tongue, or throat, rash, rapid heartbeat, or trouble breathing.
Drug Interactions
Compounded semaglutide may interact with other medications, especially:
- **Diabetes Medications**: Insulin or sulfonylureas, which could increase the risk of hypoglycemia.
- **Oral Medications**: Delayed gastric emptying caused by semaglutide can affect the absorption of oral medications.
Usage Guidelines
- Administration: Compounded semaglutide is injected subcutaneously (under the skin) once weekly, in the abdomen, thigh, or upper arm.
- Missed Dose: If a dose is missed, administer it as soon as possible within 5 days after the missed dose. If more than 5 days have passed, skip the missed dose and resume the regular dosing schedule.
Special Precautions
- Renal Function: Monitor kidney function, especially in patients with a history of kidney disease.
- Mental Health: Be vigilant for changes in mood, behavior, or thoughts, especially concerning depression or suicidal thoughts.
Monitoring and Follow-up
- Regular monitoring of blood glucose, kidney function, and mental health is recommended during treatment.
- Report any new or worsening symptoms to your healthcare provider immediately.
Note on FDA Approval
Compounded semaglutide is not FDA-approved and lacks the rigorous testing and quality control associated with FDA-approved medications. It should be used under the guidance of a healthcare provider, and patients should be fully informed of its risks and benefits.
Disclaimer
Always consult your healthcare provider to ensure the information displayed here applies to your specific circumstances. Report any adverse reactions or concerns to your healthcare provider and consider reviewing additional resources or seeking a second opinion if needed.
Ozempic®, WeGovy®, Saxenda®, and Victoza® are registered trademarks of Novo Nordisk. Zepbound® and Mounjaro® are registered trademarks of Eli Lilly. Byetta® and Bydureon® are registered trademarks of Amylin Pharmaceuticals. Dharma Nutrition Clinic has no affiliation with Novo Nordisk, Eli Lilly, or Amylin Pharmaceuticals. The compounded products available as part of Dharma Nutrition Clinic’s Weight Loss Program are not made by Novo Nordisk, Eli Lilly, Amylin Pharmaceuticals, or any company affiliated with these entities.
For more detailed information, consult your healthcare provider or refer to the medication guide provided with your prescription.
