Compounded Semiglutide: Important Considerations
The Considerations
Compounded drugs are legally permissible for prescription under federal law, yet they do not receive FDA approval, nor are they subjected to reviews for safety, efficacy, or manufacturing processes. Your healthcare provider affiliated with AK Twisted Wellness may suggest specific dosages of compounded semiglutide based on a thorough medical assessment.
Caution: Potential Risk of Thyroid C-Cell Tumors
Research involving rodents has indicated that semiglutide, the active compound in medications such as Wegovy and Ozempic, could lead to the formation of thyroid tumors, including thyroid cancer. It remains uncertain whether semiglutide poses a similar risk to humans. Patients should inform their healthcare provider if they experience any symptoms, such as a lump or swelling in the neck, hoarseness, difficulty swallowing, or shortness of breath, as these may indicate thyroid cancer.
Semiglutide is contraindicated for individuals with a personal or family history of medullary thyroid carcinoma (MTC) or those diagnosed with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Applications of Semiglutide:
Semiglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist recommended for chronic weight management alongside a reduced-calorie diet and increased physical activity. It is suitable for adults with:
- A body mass index (BMI) of 30 kg/m^2 or higher (obesity), or
- A BMI of 27 kg/m^2 or higher (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia).
Restrictions on Use:
Semiglutide should not be combined with other semiglutide-containing products or GLP-1 receptor agonists.
Its safety and efficacy with other weight loss products have not been confirmed.
It has not been evaluated in patients with a history of pancreatitis.
It is not advised for patients with type 1 diabetes mellitus.
Contraindications:
Avoid semiglutide if:
- You or any family member have been diagnosed with MTC, or if you suffer from MEN 2.
- You have had allergic reactions to semiglutide or any of its components.
Administration Guidelines:
Semiglutide can be administered with or without food through subcutaneous injection in the stomach, thigh, or upper arm once a week, consistently on the same day each week. Your AK Twisted Wellness-affiliated healthcare provider will offer detailed administration instructions and may adjust your dosage every four weeks.
Before Using Semiglutide:
It’s crucial to disclose all medications you are currently taking to your healthcare provider, including prescription and over-the-counter drugs, as well as any vitamins, herbal, and dietary supplements, due to potential drug interactions.
Particularly Note: Diabetes medications, including insulin and sulfonylureas.
Semiglutide may delay gastric emptying, affecting the absorption of concurrently administered oral medications.
Other GLP-1 receptor agonists or weight loss products.
Medical History:
Inform your healthcare provider if you have or have had:
- Diabetes (type 1 or 2),
- Thyroid cancer,
- Pancreatitis,
- Kidney disease,
- Diabetic retinopathy,
- Depression,
- Suicidal thoughts or behaviors,
Pregnancy and Breastfeeding:
– Semiglutide is not recommended during pregnancy or breastfeeding due to potential risks to the baby.
Monitoring for Serious Side Effects:
Be vigilant for serious side effects such as thyroid C-Cell tumors, acute pancreatitis, gallbladder disease, hypoglycemia, acute kidney injury, severe allergic reactions, complications of diabetic retinopathy, increased heart rate, and suicidal behaviors or ideation.
Common Side Effects:
These may include nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distension, eructation, hypoglycemia in patients with type 2 diabetes, flatulence, gastroenteritis, and gastroesophageal reflux disease.
To report adverse effects, contact FDA MedWatch at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
This summary only encompasses some safety information.
Refer to the complete Consumer Medical Information for a comprehensive overview.