Comprehensive Safety Information for Compound Semaglutide

Compounded medications are allowed by federal law but aren't FDA-approved and don't undergo the same safety, effectiveness, or manufacturing reviews. Our Boynton Pain Relief & Wellness providers may recommend specific doses of Compound Semaglutide based on your medical evaluation.

Indications and Use:

Compounded Semaglutide is an injectable prescription medicine designed to assist adults with obesity or excess weight (overweight) who also face weight-related medical issues. It aids in weight loss and maintaining it. This treatment should be combined with a reduced-calorie diet and increased physical activity.

Compounded Semaglutide, a synthetic glucagon-like peptide-1 (GLP-1) receptor agonist, is used for chronic weight management alongside a reduced-calorie diet and increased physical activity for individuals with:

  • A body mass index (BMI) of 30 kg/m² or higher (obesity) or

  • A BMI of 27 kg/m² or higher (overweight) with at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes, or dyslipidemia).

Avoid using Compounded Semaglutide with other semaglutide-containing products or any GLP-1 receptor agonist medications. Its safety and effectiveness when combined with other prescription, over-the-counter, or herbal weight loss products are unknown. It is also unclear if it is safe for individuals with a history of pancreatitis or for children under 18 years.

Important Safety Information for Compounded Semaglutide Injections

Warning: Risk of Thyroid C-Cell Tumors

In animal studies, semaglutide caused thyroid tumors, including thyroid cancer. It’s not known if Compounded Semaglutide will cause similar tumors or medullary thyroid carcinoma (MTC) in humans. Inform your provider if you experience a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath, as these may be signs of thyroid cancer.

Do not use Compounded Semaglutide if you or your family have a history of medullary thyroid carcinoma (MTC) or an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Is Compounded Semaglutide FDA-Approved?

Compounded Semaglutide is not FDA-approved and does not undergo the same rigorous efficacy and safety checks as FDA-approved medications. It is a GLP-1 receptor agonist used for chronic weight management, combined with a reduced-calorie diet and increased physical activity for individuals with:

  • A BMI of 30 kg/m² or higher (obesity) or

  • A BMI of 27 kg/m² or higher (overweight) with at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes, or dyslipidemia).

Limitations of Use:

  • 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 weight loss products have not been established.

  • Has not been studied in patients with a history of pancreatitis.

Who Should Not Use Compounded Semaglutide?

Do not use Compounded Semaglutide if:

  • You or your family have a history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

  • You have a known allergic reaction to Compounded Semaglutide.

Administration:

Compounded Semaglutide can be taken with or without food. The pre-filled injector pen is self-administered as a subcutaneous injection in the stomach, thigh, or upper arm once a week on the same day each week. Our providers will guide your treatment regimen, potentially increasing the dose every four weeks.

Do not alter your dosing regimen or stop taking Compounded Semaglutide without consulting your provider first.

Important Considerations:

Compounded Semaglutide may interact with other medications. It is crucial to inform your provider of all medications you are taking, including prescription, over-the-counter, vitamins, and herbal supplements. Specific medications to monitor include those used for type 1 or type 2 diabetes, as Compounded Semaglutide may impact the absorption of orally taken medications.

Pregnancy and Breastfeeding:

  • Compounded Semaglutide should not be used during pregnancy. It may pose risks to an unborn baby.

  • If planning to become pregnant, discontinue use at least two months before.

  • Inform your provider if you are breastfeeding.

Serious Side Effects to Monitor:

  • Thyroid C-Cell Tumors: Monitor for lumps or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath.

  • Pancreatitis: Watch for severe abdominal pain that does not go away, sometimes radiating to the back.

  • Gallbladder Disease: Look for upper stomach pain, yellowing of the skin or eyes, fever, or clay-colored stools.

  • Low Blood Sugar: Be aware of dizziness, blurred vision, mood changes, sweating, or fast heartbeat.

  • Kidney Injury: Stay hydrated to reduce the risk of dehydration-related kidney problems.

  • Allergic Reactions: Discontinue use if you experience swelling of the face, lips, tongue, or throat, severe rash, rapid heartbeat, breathing issues, or dizziness.

  • Diabetic Retinopathy: Report any vision changes if you have type 2 diabetes.

  • Increased Heart Rate: Notify your provider of a racing heartbeat while at rest.

  • Suicidal Thoughts: Pay attention to any mental health changes and seek immediate help if necessary.

Common Side Effects:

  • Nausea

  • Diarrhea

  • Vomiting

  • Constipation

  • Stomach pain

  • Indigestion

  • Injection site reactions

  • Fatigue

  • Allergic reactions

  • Belching

  • Hair loss

  • Heartburn

Reporting Side Effects:

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

Before Using Compounded Semaglutide:

  • Ensure you receive proper instructions on how to use it.

  • Discuss all your medications, including diabetes treatments, with your provider.

  • Inform your provider if you are pregnant, planning to become pregnant, or breastfeeding.

How to Take:

  • Follow the Instructions for Use.

  • Inject under the skin (subcutaneously) of the stomach, thigh, or upper arm.

  • Use once a week, at any time of the day, rotating the injection site each week.

  • In case of overdose, seek medical advice promptly or contact a Poison Center expert at 1-800-222-1222.

Learn More:

For more information on Semaglutide-containing products, contact us at Boynton Pain Relief & Wellness or call 877-581-2210.

This summary provides essential information about Compounded Semaglutide. It does not replace discussions with your healthcare provider. Always consult your provider to determine if Compounded Semaglutide is right for you.

Disclaimer:

Ozempic®, WeGovy®, Saxenda®, and Victoza® are trademarks of Novo Nordisk. Zepbound® and Mounjaro® are trademarks of Eli Lilly. Byetta® and Bydureon® are trademarks of Amylin Pharmaceuticals. Boynton Pain Relief & Wellness has no affiliation with Novo Nordisk, Eli Lilly, or Amylin Pharmaceuticals. Our compounded products are not manufactured by these companies.