COMPOUNDED TIRZEPATIDE IMPORTANT SAFETY INFORMATION

Last revised: February 19, 2025

Compounded drugs are permitted to be prescribed under federal law but are not FDA-approved and do not undergo the same safety, effectiveness, or manufacturing reviews as FDA-approved medications. Your medical provider may recommend certain doses of compounded tirzepatide based on your medical evaluation.

Indications and Use

Compounded tirzepatide is an injectable prescription medicine that may help adults with obesity or excess weight (overweight) who also have weight-related medical problems, lose weight and keep it off. It should be used with a reduced-calorie diet and increased physical activity.

Compounded tirzepatide is a synthetic dual-acting glucagon-like peptide-1 (GLP-1) and GIP receptor agonist used for chronic weight management, along with a reduced-calorie diet and increased physical activity, 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)

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

  • It is not known if tirzepatide is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products.

  • It is not known if tirzepatide can be used in people who have had pancreatitis.

  • It is not known if tirzepatide is safe and effective for use in children under 18 years of age.

Important Safety Information for Compounded Tirzepatide Injection

Warning: Risk of Thyroid C-Cell Tumors

In animal studies, tirzepatide caused thyroid tumors, including thyroid cancer. It is not known if compounded tirzepatide will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.

Tell your provider immediately if you experience:

  • A lump or swelling in your neck

  • Hoarseness

  • Trouble swallowing

  • Shortness of breath

These may be symptoms of thyroid cancer.

Do not use compounded tirzepatide if:

  • You or your family have ever had medullary thyroid carcinoma (MTC).

  • You have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Is Compounded Tirzepatide FDA-Approved?

Compounded tirzepatide is not FDA-approved and does not undergo the same rigorous efficacy and safety checks as FDA-approved medications.

Limitations of Use

  • Should not be used in combination with other tirzepatide-containing products or GLP-1 receptor agonists.

  • 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.

Compounded medications are not FDA-approved and do not have the same indications for treatment as FDA-approved medications. These recommendations for compounded tirzepatide apply while FDA-approved therapies remain on shortage.

Who Should Not Use Compounded Tirzepatide?

Do not use compounded tirzepatide if:

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

  • You have a known allergic reaction to compounded tirzepatide.

How Should Compounded Tirzepatide Be Administered?

  • Take compounded tirzepatide with or without food.

  • Self-administered as a subcutaneous injection in the stomach, thigh, or upper arm once a week on the same day each week.

  • Your medical provider will guide you on a treatment regimen, which may include dose increases every four weeks.

Do not change your dosing regimen or stop taking compounded tirzepatide without consulting your provider.

What Should I Tell My Medical Provider Before Using Compounded Tirzepatide?

Tell your provider about all the medications you are currently taking, including:

  • Diabetes medications, including insulin or sulfonylureas (e.g., Amaryl, Glucotrol XL)

  • Oral medications, as compounded tirzepatide delays gastric emptying, which may affect the absorption of medications taken at the same time

  • Hormonal birth control, as oral contraceptives may be less effective after starting compounded tirzepatide. Consider switching to a non-oral contraceptive method for at least four weeks after starting or increasing the dose

  • Other GLP-1 medications, including Wegovy, Ozempic, Saxenda, Zepbound, Mounjaro, Victoza, Byetta, or Bydureon

  • Any other weight-loss products, including dietary supplements

Medical history to discuss with your provider:

  • Type 1 or type 2 diabetes

  • Thyroid cancer

  • Gastrointestinal disease

  • Pancreatitis

  • Kidney disease

  • Diabetic retinopathy

  • Depression or suicidal thoughts

Pregnancy and Breastfeeding Considerations:

  • Compounded tirzepatide should not be used during pregnancy as it may harm the unborn baby.

  • If you are of reproductive potential, switch to a non-oral contraceptive method for four weeks after starting or increasing the dose.

  • It is not known if compounded tirzepatide passes into breast milk. Talk to your provider about the risks of using it while breastfeeding.

Withholding or providing inaccurate health information can result in serious harm, including death.

Serious Side Effects to Monitor

Seek immediate medical attention if you experience:

  • Thyroid C-Cell Tumors – Lump or swelling in the neck, hoarseness, trouble swallowing, shortness of breath

  • Severe Gastrointestinal Disease – Persistent nausea, vomiting, diarrhea, or stomach pain

  • Kidney Injury – Dehydration, nausea, vomiting

  • Gallbladder Disease – Upper stomach pain, jaundice, fever, clay-colored stools

  • Pancreatitis – Severe abdominal pain that does not go away, pain radiating to the back, vomiting

  • Serious Allergic Reactions – Swelling, rash, rapid heartbeat, breathing issues

  • Low Blood Sugar (Hypoglycemia) – Dizziness, blurred vision, mood changes, sweating, fast heartbeat

  • Diabetic Retinopathy Complications – Vision changes

  • Suicidal Behavior and Ideation – Sudden mood or behavior changes

Never share pens or needles, as sharing increases the risk of infection.

Most Common Side Effects of Compounded Tirzepatide

  • Nausea

  • Diarrhea

  • Vomiting

  • Constipation

  • Stomach pain

  • Indigestion

  • Injection site reactions

  • Fatigue

  • Hair loss

  • Heartburn (GERD)

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

Before Using Compounded Tirzepatide

Discuss with your provider if you have:

  • Problems with your pancreas or kidneys

  • Severe stomach problems, such as gastroparesis

  • Diabetes and take insulin or sulfonylureas

  • A history of diabetic retinopathy

If you take birth control pills, consult your provider before using compounded tirzepatide, as birth control pills may be less effective.

Legal Disclaimer

Ozempic® and Wegovy® are registered trademarks of Novo Nordisk. Zepbound® and Mounjaro® are registered trademarks of Eli Lilly. Lovely Meds has no affiliation with Novo Nordisk or Eli Lilly.

This document ensures full compliance with Lovely Meds’ branding while maintaining clarity and professionalism. Let me know if you need any further refinements.