Important Safety Information for Compound Tirzepatide Injection

Last updated October 18, 2024

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 OrderlyMeds 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 with 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 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).

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 rats, 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 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  compounded tirzepatide f 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).

Is Compounded Tirzepatide FDA Approved?

Compounded tirzepatide is not FDA approved and does not undergo the same rigorous efficacy and safety checks as do FDA-approved medications.  Compounded tirzepatide may be used along with a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:

• 30 kg/m^2 or greater (obesity) or
• 27 kg/m^2 or greater (overweight) in the presence of 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.

Note: Compounded medications are not FDA approved and do not have indications for treatment as an FDA approved medication would. The above are suggestions for use of compounded tirzepatide while the FDA approved therapies remain on shortage.

Who should not use Compounded Tirzepatide?

Do not use Compounded tirzepatide 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  tirzepatide.

How should I take Compounded Tirzepatide?

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 OrderlyMeds provider 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 compounded tirzepatide as prescribed without discussing with your provider first.

What should I tell my OrderlyMeds provider before using Compounded Tirzepatide?

• Compounded tirzepatide has certain drug interactions. It’s important to tell your OrderlyMeds provider all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements.

Some medications to watch out for include:

• Medications for diabetes: Medications used to treat type 1 or type 2 diabetes, including insulin or sulfonylureas (such as Amaryl or Glucotrol XL)
• Other oral medications: compounded tirzepatide causes a delay in gastric emptying, so it has the potential to impact the absorption of medications that are taken by mouth at the same time. Your provider can guide you on how to schedule your medications.
  • Hormonal birth control: If you are using an oral hormonal contraceptive (birth control), compounded tirzepatide may decrease its efficacy, especially after the first dose. Switch to a non-oral contraceptive method or use a barrier method of contraception for 4 weeks after starting compounded tirzepatide and for 4 weeks after each dose escalation, until you reach a maintenance dose.
• Other GLP-1 medications, including WeGovy® (semaglutide), Ozempic® (semaglutide), Saxenda® (liraglutide), Zepbound® (tirzepatide), Mounjaro® (tirzepatide), Victoza® (liraglutide), Byetta® (exenatide), or Bydureon® (exenatide).
• Other products for weight loss: Including dietary supplements

• It’s important to share your entire medical history with your provider. In particular, tell your provider if you have a past history of:

  • Type 1 or type 2 diabetes
  • Thyroid cancer
  • Gastrointestinal disease
  • Pancreatitis
  • Kidney disease
  • Diabetic retinopathy
  • Depression
  • Suicidal thoughts or behavior

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

  • If you are pregnant: Compounded tirzepatide should not be used during pregnancy. Based on animal studies, there may be potential risks to an unborn baby from exposure to Compounded tirzepatide during pregnancy. There is no benefit to weight loss during pregnancy and it may cause harm to the unborn baby.
  • If you are a female reproductive potential: Compounded tirzepatide may reduce the efficacy of oral hormonal contraceptives. Switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after starting medication and for 4 weeks after each dose escalation until you reach a maintenance dose.
  • If you are breastfeeding: It is not known if Compounded tirzepatide passes into breast milk. Talk to your provider first about the benefits and risks of using compounded tirzepatide while breastfeeding.

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

What are the most serious side effects that I or a caregiver should monitor for when taking  compounded tirzepatide?

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

These serious side effects are rare, but can occur with  compounded tirzepatide. You or a caregiver should carefully monitor for these side effects, especially in the beginning of treatment and with dose changes.

• Thyroid C-Cell Tumors: In rats, tirzepatide caused a dose-dependent and treatment-duration-dependent increase in thyroid C-cell tumors. It is unknown whether compounded tirzepatide causes thyroid C-cell tumors in humans. Compounded tirzepatide is contraindicated in patients with a family history of medullary thyroid cancer (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.
• Severe Gastrointestinal Disease: Compounded tirzepatide is associated with gastrointestinal side effects, such as nausea, diarrhea, vomiting, constipation, and stomach pain, and can sometimes be severe. It hasn’t been studied in patients with severe gastrointestinal disease and isn’t recommended in these patients. The majority of nausea, vomiting, and/or diarrhea events occurred during a dose increase and decreased over time.
• Acute Kidney Injury: Gastrointestinal side effects of compounded tirzepatide like diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems if dehydration is severe. It is important for you to drink plenty of water to help reduce your chance of dehydration.
• Acute Gallbladder Disease: Compounded tirzepatide, other GLP-1 receptor agonists, and weight loss are associated with an increased chance of acute gallbladder disease. Tell your provider right away if you have pain in your upper stomach, yellowing of skin or eyes (jaundice), fever, or clay-colored stools.
• Inflammation of Pancreas (Acute Pancreatitis): Monitor for signs of acute pancreatitis, including severe abdominal pain that does not go away, sometimes radiating to the back, with or without vomiting.
• Allergic Reactions: Stop using compounded tirzepatide right away if you experience symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, severe rash or itching, very rapid heartbeat, problems breathing or swallowing, or fainting or feeling dizzy.
• Low Blood Sugar (Hypoglycemia): Compounded tirzepatide lowers blood glucose. It can cause too low blood sugar in patients with type 2 diabetes who also take another glucose control medication. Monitor your blood sugar and watch out for signs of too low blood sugar such as dizziness, blurred vision, mood changes, sweating, or fast heartbeat.
• Diabetic Retinopathy Complications in Patients with a History of Diabetic Retinopathy: Rapid improvement of glucose control has been associated with temporary worsening of diabetic retinopathy. Tell your provider right away if you experience changes in vision.
• Suicidal Behavior and Ideation: You should pay attention to any mental health changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.
• Never Share a Pen: Pen-sharing poses a risk of infection.

What are the most common side effects of compounded tirzepatide?

• Nausea
• Diarrhea
• Vomiting
• Constipation
• Stomach pain
• Indigestion
• Injection site reactions
• Feeling tired
• Allergic reactions
• Belching
• Hair loss
• Gastroesophageal reflux disease (heartburn)

You are encouraged to report negative side effects of prescription products to the FDA. Visit <u>www.fda.gov/medwatch</u> or call 1-800-FDA-1088.

Before using Compounded Tirzepatide

• Your healthcare provider should show you how to use compounded tirzepatide before you use it for the first time.
• Tell your healthcare provider if you are taking medicines to treat diabetes including insulin or sulfonylureas which could increase your risk of low blood sugar. Talk to your healthcare provider about low blood sugar levels and how to manage them.
• If you take birth control pills by mouth, talk to your healthcare provider before you use compounded tirzepatide. Birth control pills may not work as well while using  compounded tirzepatide. Your healthcare provider may recommend another type of birth control for 4 weeks after you start compounded tirzepatide and for 4 weeks after each increase in your dose of  compounded tirzepatide.

Review these questions with your healthcare provider:

• Do you have other medical conditions, including problems with your pancreas or kidneys, or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?
• Do you take diabetes medicines, such as insulin or sulfonylureas?
• Do you have a history of diabetic retinopathy?
• Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements?
• Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? compounded tirzepatide may harm your unborn baby. Tell your healthcare provider if you become pregnant while using compounded tirzepatide. It is not known if compounded tirzepatide passes into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using  compounded tirzepatide.

How to take

• Read the Instructions for Use that come with  compounded tirzepatide.
• Use compounded tirzepatide exactly as your healthcare provider says.
• Compounded tirzepatide is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm.
• Use compounded tirzepatide 1 time each week, at any time of the day.
• Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection.
• If you take too much  compounded tirzepatide, call your healthcare provider, seek medical advice promptly, or contact a Poison Center expert right away at 1-800-222-1222.

Learn more

Compounded tirzepatide is a prescription medicine. For more information on tirzepatide-containing products, please call 877-581-2210 to learn more or receive information regarding how to contact your pharmacy.

This summary provides basic information about compounded tirzepatide but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about compounded tirzepatide and how to take it. Your healthcare provider is the best person to help you decide if compounded tirzepatide is right for you.

Disclaimer: Ozempic®, WeGovy®,  Saxenda® and Victoza® are registered trademarks of Novo Nordisk.  Zepbound® and Mounjaro® are registered trademarks of Eli Lilly.    Byetta® and Bydureon® are registered trademarks of Amylin Pharmaceuticals.  OrderlyMeds has no affiliation with Novo Nordisk, Eli Lilly or Amylin Pharmaceuticals.  The compounded products available as part of OrderlyMeds Weight Loss Program are not made by Novo Nordisk, Eli Lilly or Amylin Pharmaceuticals or any company affiliated with Novo Nordisk, Eli Lilly or Amylin Pharmaceuticals.