Compounded medications, including compounded tirzepatide, are legally prescribed under federal law but are not FDA-approved and do not undergo FDA review for safety, effectiveness, or manufacturing standards. Based on your medical evaluation, our healthcare providers at Boynton Pain Relief & Wellness may recommend specific doses of compounded tirzepatide.

Indications and Use

Compounded tirzepatide is an injectable prescription medication that can assist adults with obesity or excess weight (overweight) accompanied by weight-related medical issues in losing weight and maintaining that weight loss. This treatment should be combined with a reduced-calorie diet and increased physical activity.

As a synthetic, dual-acting glucagon-like peptide-1 (GLP-1) and GIP receptor agonist, compounded tirzepatide aids in chronic weight management when paired with a reduced-calorie diet and increased physical activity. It is suitable for individuals with an initial body mass index (BMI) of:

• 30 kg/m² or greater (obesity)

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

Note: Compounded tirzepatide should not be used with other tirzepatide-containing products or any GLP-1 receptor agonist medications. Its safety and efficacy when combined with other prescription, over-the-counter, or herbal weight loss products are unknown. Additionally, its use in individuals with a history of pancreatitis or those under 18 years of age has not been established.

Important Safety Information

Warning: Risk of Thyroid C-Cell Tumors

In animal studies, tirzepatide caused thyroid tumors, including thyroid cancer. It is unknown whether compounded tirzepatide will cause thyroid tumors or medullary thyroid carcinoma (MTC) in humans. Inform your provider if you notice a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath, as these could be symptoms of thyroid cancer.

Do not use compounded tirzepatide if you or any of your family members have had medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

FDA Approval Status

Compounded tirzepatide is not FDA-approved and does not undergo the same rigorous efficacy and safety checks as FDA-approved medications. It may be used for chronic weight management in adults with an initial BMI of:

• 30 kg/m² or greater (obesity)

• 27 kg/m² or greater (overweight) with at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea, or cardiovascular disease)

Limitations of Use:

• Compounded tirzepatide should not be used in combination with other tirzepatide-containing products or any other GLP-1 receptor agonist.

• The safety and efficacy of co-administration with other products for weight management have not been established.

• Compounded tirzepatide has not been studied in patients with a history of pancreatitis.

Who Should Not Use Compounded Tirzepatide?

Do not use compounded tirzepatide if:

• You or any family members have had medullary thyroid carcinoma (MTC) or an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

• You have a known allergic reaction to tirzepatide.

Administration Instructions

You can take compounded tirzepatide 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 every week. Your provider at Boynton Pain Relief & Wellness will guide you on a treatment regimen that may include an increase in dose every four weeks.

Important Considerations

Before starting compounded tirzepatide, inform your provider about all medications you are taking, including prescription, over-the-counter drugs, vitamins, and herbal supplements, especially if you are using medications for diabetes, oral contraceptives, or other GLP-1 medications.

Potential Serious Side Effects

• Thyroid C-Cell Tumors: Watch for symptoms such as neck lumps, hoarseness, or trouble swallowing.

• Severe Gastrointestinal Disease: Monitor for severe gastrointestinal symptoms like nausea and diarrhea.

• Acute Kidney Injury: Ensure proper hydration to avoid kidney issues due to dehydration.

• Acute Gallbladder Disease: Be alert for upper stomach pain or jaundice.

• Pancreatitis: Watch for severe, persistent abdominal pain.

• Allergic Reactions: Seek immediate medical attention for serious allergic reactions.

• Low Blood Sugar: Monitor blood sugar levels, especially if you have type 2 diabetes.

• Diabetic Retinopathy Complications: Notify your provider of any vision changes.

• Suicidal Behavior and Ideation: Report any mental health changes immediately.

Common Side Effects

Common side effects include nausea, diarrhea, vomiting, constipation, stomach pain, indigestion, injection site reactions, tiredness, allergic reactions, belching, hair loss, and heartburn.

Conclusion

For more detailed information on compounded tirzepatide, including instructions for use and potential drug interactions, please consult your healthcare provider at Boynton Pain Relief & Wellness. We are committed to helping you achieve your health and wellness goals safely and effectively.