Important Safety Information for Compounded Semaglutide
Compounded drugs are permitted to be prescribed under federal law, but are not FDA-approved and do not undergo safety, effectiveness, or manufacturing review. Your Bluebiotech Team may recommend certain doses of compounded semaglutide based on your medical evaluation.
Warning: Risk of Thyroid C-Cell Tumors
In studies with mice and rats, semaglutide (the active ingredient in Wegovy and Ozempic) caused thyroid tumors, including thyroid cancer. It is not known if semaglutide will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. Tell the Bluebiotech Team if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.
Do not use semaglutide if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
What is semaglutide used for?
Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist for chronic weight management, along with a reduced-calorie diet and increased physical activity, for people with an initial body mass index (BMI) of:
- 30 kg/m² or greater (obesity), or
- 27 kg/m² or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia).
Limitations of Use:
- Semaglutide should not be used in combination with other semaglutide-containing products or any other GLP-1 receptor agonist.
- The safety and efficacy of coadministration with other products for weight loss have not been established.
- Semaglutide has not been studied in patients with a history of pancreatitis.
- Semaglutide should not be used in patients with type 1 diabetes mellitus.
Who should not use semaglutide?
Do not use semaglutide if:
- You or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- You have a known allergic reaction to semaglutide (the active ingredient in Wegovy or Ozempic).
How should semaglutide be administered?
You can take semaglutide with or without food. The medication is self-administered as a subcutaneous injection in the stomach, thigh, or upper arm once a week on the same day every week. For detailed instructions on how to administer your dose, refer to your treatment plan or reach out to the Bluebiotech Team. They will guide you on a treatment regimen that may include an increase in dose every four weeks.
You should not change your dosing regimen or stop taking semaglutide as prescribed without discussing with the Bluebiotech Team first.
What should I tell the Bluebiotech Team before using semaglutide?
Semaglutide has certain drug interactions. It’s important to tell the Bluebiotech Team all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements.
Medications to watch out for include:
- Medications used to treat type 1 or type 2 diabetes, including insulin or sulfonylureas (such as Amaryl or Glucotrol XL).
- Medications taken by mouth at the same time as semaglutide, as it causes a delay in gastric emptying, potentially impacting absorption.
- Other medications in the same drug class, including Wegovy, Ozempic, Saxenda, Victoza, Trulicity, Byetta, or Bydureon.
- Other products for weight loss, including dietary supplements.
Share your medical history, including:
- Type 1 or type 2 diabetes.
- Thyroid cancer.
- Pancreatitis.
- Kidney disease.
- Diabetic retinopathy.
- Depression or suicidal thoughts.
- Ileus.
If you are pregnant, planning to become pregnant, or breastfeeding, inform the Bluebiotech Team as semaglutide should not be used during these periods.
Most Serious Side Effects to Monitor:
- Thyroid C-Cell Tumors
- Inflammation of Pancreas (Acute Pancreatitis)
- Acute Gallbladder Disease
- Low Blood Sugar (Hypoglycemia)
- Acute Kidney Injury
- Serious Allergic Reactions
- Diabetic Retinopathy Complications
- Increase in Heart Rate
- Suicidal Behavior and Ideation
Most Common Side Effects:
Nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, and more.
For negative side effects, contact FDA MedWatch at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
This information is not comprehensive. Please consult the Bluebiotech Team for complete safety details.