EFFECTIVE AS OF 04/01 2025

Important Safety Information for Medications

Table of Content

Ozempic®Wegovy®Zepbound®Mounjaro®Compounded SemaglutideCompounded Tirzepatide
Ozempic® - Important Safety Information

What is Ozempic®?
Ozempic® (semaglutide) injection 0.5 mg, 1 mg, or 2 mg is an injectable prescription medicine used:
Along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes. To reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes with known heart disease. To reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease

It is not known if Ozempic® is safe and effective for use in children.

Do not share your Ozempic® pen with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.

What is the most important information I should know about Ozempic®?
Ozempic® may cause serious side effects, including:
Possible thyroid tumors, including cancer. Tell your health care 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. In studies with rodents, Ozempic® and medicines that work like Ozempic® caused thyroid tumors, including thyroid cancer. It is not known if Ozempic® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people

Do not use Ozempic® if you or any of your family have ever had MTC, or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

Do not use Ozempic® if:

you or any of your family have ever had MTC or if you have MEN 2
you are allergic to semaglutide or any of the ingredients in Ozempic®. See symptoms of serious allergic reaction in “What are the possible side effects of Ozempic®?”

Before using Ozempic®, tell your health care provider if you have any other medical conditions, including if you:

- have or have had problems with your pancreas
- have a history of diabetic retinopathy
- have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food
- are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)
- are pregnant or breastfeeding or plan to become pregnant or breastfeed. It is not known if Ozempic®® will harm your unborn baby or pass into your breast milk. You should stop using Ozempic®® at least 2 months before you plan to become pregnant.

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and other medicines to treat diabetes, including insulin or sulfonylureas.

What are the possible side effects of Ozempic®?
Ozempic® may cause serious side effects, including:

- inflammation of your pancreas (pancreatitis). Stop using Ozempic®® and call your health care provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.

- changes in vision. Tell your health care provider if you have changes in vision during treatment with Ozempic®®
-
low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Ozempic®® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include: dizziness or lightheadedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, and feeling jittery
- dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your health care provider right away if you have nausea, vomiting, or diarrhea that does not go away.
- severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Ozempic®®. Tell your health care provider if you have stomach problems that are severe or will not go away.
- serious allergic reactions. Stop using Ozempic®® and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat.
- gallbladder problems. Gallbladder problems have happened in some people who take Ozempic®®. Tell your health care provider right away if you get symptoms which may include: pain in your upper stomach (abdomen), fever, yellowing of the skin or eyes (jaundice), or clay-colored stools.
- food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Ozempic®® may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your health care providers that you are taking Ozempic®® before you are scheduled to have surgery or other procedures.

The most common side effects of Ozempic® may include nausea, vomiting, diarrhea, stomach (abdominal) pain, and constipation.
Wegovy® - Important Safety Information

WEGOVY® (semaglutide) injection 2.4 mg is an injectable prescription medicine used with a reduced calorie diet and increased physical activity:
- to reduce the risk of major cardiovascular events such as death, heart attack, or stroke in adults with known heart disease and with either obesity or overweight.
- that may help adults and children aged 12 years and older with obesity, or some adults with overweight who also have weight-related medical problems, to help them lose excess body weight and keep the weight off.

Wegovy® contains semaglutide and should not be used with other semaglutide-containing products or other GLP-1 receptor agonist medicines.

It is not known if Wegovy® is safe and effective for use in children under 12 years of age.

Important Safety Information

What is the most important information I should know about Wegovy®?
Wegovy® may cause serious side effects, including:

- Possible thyroid tumors, including cancer. Tell your healthcare 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. In studies with rodents, Wegovy®® and medicines that work like Wegovy®® caused thyroid tumors, including thyroid cancer. It is not known if Wegovy®® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people
- Do not use Wegovy®® 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).

Do not use Wegovy® 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 had a serious allergic reaction to semaglutide or any of the ingredients in Wegovy®

Before using Wegovy®, tell your healthcare provider if you have any other medical conditions, including if you:
- have or have had problems with your pancreas or kidneys
- have type 2 diabetes and a history of diabetic retinopathy
- have or have had depression, suicidal thoughts, or mental health issues
- are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)
- are pregnant or plan to become pregnant. Wegovy®® may harm your unborn baby. You should stop using Wegovy®® 2 months before you plan to become pregnant
- are breastfeeding or plan to breastfeed. It is not known if Wegovy®® passes into your breast milk

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Wegovy® may affect the way some medicines work and some medicines may affect the way Wegovy® works. Tell your healthcare provider if you are taking other medicines to treat diabetes, including sulfonylureas or insulin. Wegovy® slows stomach emptying and can affect medicines that need to pass through the stomach quickly.

What are the possible side effects of Wegovy®?
Wegovy® may cause serious side effects, including:

- inflammation of your pancreas (pancreatitis). Stop using Wegovy®® and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back
- gallbladder problems. Wegovy®® may cause gallbladder problems, including gallstones. Some gallstones may need surgery. Call your healthcare provider if you have symptoms, such as pain in your upper stomach (abdomen), fever, yellowing of the skin or eyes (jaundice), or clay-colored stools
- increased risk of low blood sugar (hypoglycemia), especially those who also take medicines for diabetes such as insulin or sulfonylureas. This can be a serious side effect. Talk to your healthcare provider about how to recognize and treat low blood sugar and check your blood sugar before you start and while you take Wegovy®®. Signs and symptoms of low blood sugar may include dizziness or light-headedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, or feeling jittery
- kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration
- severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Wegovy®®. Tell your healthcare provider if you have stomach problems that are severe or will not go away
- serious allergic reactions. Stop using Wegovy®® and get medical help right away, if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat
- change in vision in people with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Wegovy®®
-
increased heart rate. Wegovy®® can increase your heart rate while you are at rest. Tell your healthcare provider if you feel your heart racing or pounding in your chest and it lasts for several minutes
- depression or thoughts of suicide. You should pay attention to any mental 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
- food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Wegovy®® may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Wegovy®® before you are scheduled to have surgery or other procedures.

The most common side effects of Wegovy® may include: nausea, diarrhea, vomiting, constipation, stomach (abdomen) pain, headache, tiredness (fatigue), upset stomach, dizziness, feeling bloated, belching, low blood sugar in people with type 2 diabetes, gas, stomach flu, heartburn, and runny nose or sore throat.

Zepbound®  - Important Safety Information

Zepbound® is an injectable prescription medicine that may help adults with:
obesity, or some adults with overweight who also have weight-related medical problems to lose excess body weight and keep the weight off.

moderate-to-severe obstructive sleep apnea (OSA) and obesity to improve their OSA.

It should be used with a reduced-calorie diet and increased physical activity.

Zepbound contains tirzepatide and should not be used with other tirzepatide-containing products or any GLP-1 receptor agonist medicines. It is not known if Zepbound is safe and effective for use in children.

SAFETY SUMMARY WITH WARNINGS

Warnings - Zepbound may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.

- Do not use Zepbound if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).
- Do not use Zepbound if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- Do not use Zepbound if you have had a serious allergic reaction to tirzepatide or any of the ingredients in Zepbound.

Zepbound may cause serious side effects, including:

- Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Zepbound®. Tell your healthcare provider if you have stomach problems that are severe or will not go away.
- Kidney problems (kidney failure). Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration.
- Gallbladder problems. Gallbladder problems have happened in some people who use Zepbound®. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools.
- Inflammation of the pancreas (pancreatitis). Stop using Zepbound® and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.
- Serious allergic reactions. Stop using Zepbound® and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat.
- Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Zepbound® with medicines that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness or feeling jittery.
- Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Zepbound®.
- Depression or thoughts of suicide. You should pay attention to changes in your mood, behaviors, feelings or thoughts. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.
- Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Zepbound® may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Zepbound® before you are scheduled to have surgery or other procedures.

Common side effects

The most common side effects of Zepbound include nausea, diarrhea, vomiting, constipation, stomach (abdominal) pain, indigestion, injection site reactions, feeling tired, allergic reactions, belching, hair loss, and heartburn. These are not all the possible side effects of Zepbound. Talk to your healthcare provider about any side effect that bothers you or doesn’t go away.

Tell your doctor if you have any side effects. You can report side effects at or.

Before using Zepbound
Your healthcare provider should show you how to use Zepbound before you use it for the first time. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea 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 Zepbound. Birth control pills may not work as well while using Zepbound. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Zepbound and for 4 weeks after each increase in your dose of Zepbound.

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? Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)? 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? Zepbound may harm your unborn baby. Tell your healthcare provider if you become pregnant while using Zepbound. It is not known if Zepbound passes into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using Zepbound.

How to take -
- Read the Instructions for Use that come with Zepbound. Use Zepbound exactly as your healthcare provider says. Use Zepbound with a reduced-calorie diet and increased physical activity. Zepbound is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm. Use Zepbound 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 Zepbound, call your healthcare provider, seek medical advice promptly, or contact a Poison Center expert right away at 1-800-222-1222.

Zepbound injection is approved as a 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg per 0.5 mL in single-dose pen or single-dose vial.

This summary provides basic information about Zepbound 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 Zepbound and how to take it. Your healthcare provider is the best person to help you decide if Zepbound is right for you.

Zepbound® and its delivery device base are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.
Mounjaro®  - Important Safety Information

Mounjaro® (mown-JAHR-OH) is an injectable medicine for adults with type 2 diabetes used along with diet and exercise to improve blood sugar (glucose).

It is not known if Mounjaro can be used in people who have had inflammation of the pancreas (pancreatitis). Mounjaro is not for use in people with type 1 diabetes. It is not known if Mounjaro is safe and effective for use in children under 18 years of age.

Warnings - Mounjaro may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.

- Do not use Mounjaro if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).
- Do not use Mounjaro if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- Do not use Mounjaro if you are allergic to it or any of the ingredients in Mounjaro.

Mounjaro may cause serious side effects, including:

- Inflammation of the pancreas (pancreatitis).
Stop using Mounjaro® and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.
- Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Mounjaro® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, or mood changes, hunger, weakness and feeling jittery.
- Serious allergic reactions. Stop using Mounjaro® and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, and very rapid heartbeat.
- Kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration.
- Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Mounjaro®. Tell your healthcare provider if you have stomach problems that are severe or will not go away.
- Changes in vision. Tell your healthcare provider if you have changes in vision during treatment with Mounjaro®.
- Gallbladder problems. Gallbladder problems have happened in some people who use Mounjaro®. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), and clay-colored stools.
- Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Mounjaro® may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Mounjaro® before you are scheduled to have surgery or other procedures.

Common side effects-
The most common side effects of Mounjaro include nausea, diarrhea, decreased appetite, vomiting, constipation, indigestion, and stomach (abdominal) pain. These are not all the possible side effects of Mounjaro. Talk to your healthcare provider about any side effect that bothers you or doesn't go away.

Tell your healthcare provider if you have any side effects. You can report side effects at 1-800-FDA-1088 or .

Before using Mounjaro

Your healthcare provider should show you how to use Mounjaro before you use it for the first time. Talk to your healthcare provider about low blood sugar and how to manage it. If you take birth control pills by mouth, talk to your healthcare provider before you use Mounjaro. Birth control pills may not work as well while using Mounjaro. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Mounjaro and for 4 weeks after each increase in your dose of Mounjaro.

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 other diabetes medicines, such as insulin or sulfonylureas?
- Do you have a history of diabetic retinopathy?
- Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?
- Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? It is not known if Mounjaro will harm your unborn baby or pass into your breast milk.
- Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements?

How to take -
- Read the Instructions for Use that come with Mounjaro.
- Use Mounjaro exactly as your healthcare provider says.
- Mounjaro is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm.
- Use Mounjaro 1 time each week, at any time of the day.
- Do not mix insulin and Mounjaro together in the same injection.
- You may give an injection of Mounjaro and insulin in the same body area (such as your stomach area), but not right next to each other.
- Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection.If you take too much Mounjaro, call your healthcare provider or seek medical advice promptly.

Mounjaro is a prescription medicine available as a pre-filled single-dose pen in 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg per 0.5 mL injection. For more information, call 1-833-807-MJRO (833-807-6576) or go to

This summary provides basic information about Mounjaro 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 Mounjaro and how to take it. Your healthcare provider is the best person to help you decide if Mounjaro is right for you.

Mounjaro® and its delivery device base are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.


Important Safety Information for Compounded Semaglutide

Your medical provider may recommend personalized dosages of compounded semaglutide based on a medical review. Compounded drugs are not FDA approved and are not evaluated by the FDA for safety, effectiveness, or quality standards.

This document is a summary of product information and does NOT have all possible information and potential side effects of the product. This is not medical advice and does not substitute advice from your health care provider.

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 provider may recommend certain doses of compounded semaglutide based on your medical evaluation.

Indications and Use:

Compounded semaglutide is an injectable prescription medicine that may help adults and adolescents with obesity and excess weight (overweight) - who may 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 semaglutide is a synthetic glucagon-like peptide-1 (GLP-1) 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 27 kg/m2 or higher.

Compounded semaglutide should not be used with other semaglutide-containing products or any other GLP-1/GIP receptor agonist medicines. It is not known if compounded semaglutide is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products. It is not known if compounded semaglutide can be used in people who have had pancreatitis. It is not known if compounded semaglutide is safe and effective for use in children under 18 years of age.

At lower (micro) doses, compounded semaglutide may also be beneficial for patients who:

- Have side effects at higher doses
- Would like to reduce cardiovascular disease risk
- Would like to reduce inflammation
- Would like to improve gastrointestinal conditions such as inflammatory bowel disease (IBD) or irritable bowel syndrome (IBS)
- Would like to protect against Alzheimer’s or Parkinson’s disease
- Would like to reduce the use of alcohol or tobacco

Important Safety Information for Compounded Semaglutide injection
Warning: Risk of Thyroid C-Cell Tumors
In studies with mice and rats, semaglutide caused thyroid tumors, including thyroid cancer. It is not known if compounded semaglutide 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 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).

Is Compounded Semaglutide FDA-approved?
Compounded semaglutide is not FDA approved and does not undergo the same rigorous efficacy and safety checks as do FDA-approved medications. Compounded semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist which may be 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 of 27 kg/m2 or higher.
Limitations of Use:
Compounded semaglutide should not be used in combination with other semaglutide-containing products or any other GLP-1/GIP receptor agonist medicines.The safety and efficacy of coadministration with other products for weight loss have not been established.Compounded semaglutide 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.
Who should not use compounded semaglutide?
Do not use compounded 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 compounded semaglutide.
How should compounded semaglutide be administered?
You can take compounded semaglutide with or without food. The pre-filled vial is self-administered with a needle and syringe as a subcutaneous injection in the stomach, thigh, or upper arm once a week on the same day every week. Your 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 semaglutide as prescribed without discussing with your provider first.
What should I tell my provider before using compounded semaglutide?
Compounded semaglutide has certain drug interactions. It’s important to tell your 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 used to treat type 1 or type 2 diabetes, including insulin or sulfonylureas (such as Amaryl or Glucotrol XL).Compounded semaglutide 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.Other GLP-/GIP medications, including Wegovy® (semaglutide), Ozempic® (semaglutide), Saxenda® (liraglutide), Zepbound® (tirzepatide), Mounjaro® (tirzepatide), Victoza® (liraglutide), Byetta® (exenatide), or Bydureon® (exenatide).If you’re using 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
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 semaglutide should not be used during pregnancy. Based on animal studies, there may be potential risks to an unborn baby from exposure to compounded semaglutide 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 or male of reproductive potential: Discontinue compounded semaglutide at least 2 months before a planned pregnancy since the drug can stay in the bloodstream for a long time.If you are breastfeeding: Compounded semaglutide was found in the milk of lactating rats. Tell your provider if you are breastfeeding before you start compounded semaglutide. At this time, we do not recommend taking compounded semaglutide if you are breastfeeding or bottle-feeding with breastmilk.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 semaglutide?

The most common side effects are typically mild and usually resolve after the first several weeks of treatment. These can include nausea, vomiting, diarrhea, constipation, abdominal pain, upset stomach, abdominal distension, reflux, headache, fatigue, and dizziness. Swelling, redness, and itchiness at the injection site may occur. The FDA has issued its most serious warning (called a BOXED WARNING) that GLP-1s may be associated with a type of thyroid cancer called medullary thyroid carcinoma. So far, this side effect has primarily been seen in laboratory studies using rodents, so the risk to humans has not been determined.

SIDE EFFECTS:

Nausea, vomiting, stomach upset, diarrhea, tiredness, dizziness, or constipation may occur. Nausea usually lessens as you continue to use semaglutide. If any of these effects last or get worse, tell your provider or pharmacist promptly. Remember that this medication has been prescribed because your provider has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Vomiting/diarrhea that doesn’t stop may result in dehydration. Contact your provider promptly if you notice any symptoms of dehydration, such as unusual dry mouth/thirst or dizziness/ lightheadedness. Tell your provider right away if you have any serious side effects, including: signs of kidney problems (such as change in the amount of urine), vision changes (such as decreased/blurred vision), fast heartbeat, mental/mood changes (such as depression, thoughts of suicide), signs of low blood sugar (sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, tingling hands/feet).

Get medical help right away if you have any very serious side effects, including: signs of pancreas or gallbladder disease (such as nausea/vomiting that doesn’t stop, severe stomach/abdominal pain). A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your provider or pharmacist.

In the US - Call your provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch

WARNING:

This medication has been found to cause a certain type of thyroid tumor (thyroid C-cell tumors) in rats and mice. It is unknown if this medication can cause similar tumors in humans. Talk with your provider about the benefits and risks of treatment with this medication. This medication should not be used by people with a personal/family history of a certain type of cancer (medullary thyroid carcinoma) or by people with a certain inherited disease (Multiple Endocrine Neoplasia syndrome type 2 or MEN 2). While using this medication, tell your provider right away if you notice any signs or symptoms of thyroid tumors, including unusual growth or lump in the neck, difficulty swallowing, shortness of breath, or unusual/lasting hoarseness

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

These serious side effects can occur with compounded semaglutide. 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 mice and rats, semaglutide caused an increase in thyroid C-cell tumors, including medullary thyroid carcinoma (MTC). It is unknown whether compounded semaglutide causes thyroid C-cell tumors in humans. There were cases of MTC reported in patients who took liraglutide (the active ingredient in Victoza® and Saxenda®) after the drug was put on the market. Compounded semaglutide is contraindicated in patients with a family history of 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.

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.
Acute Gallbladder Disease:
Compounded semaglutide may cause gallbladder problems, including gallstones. Some gallbladder problems require surgery. Tell your provider right away if you have pain in your upper stomach, yellowing of skin or eyes (jaundice), fever, or clay-colored stools.
Low Blood Sugar (Hypoglycemia):
Compounded semaglutide lowers blood glucose. It can cause 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.
Acute Kidney Injury:
In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse. It is important for you to drink plenty of water to help reduce your chance of dehydration.
Serious Allergic Reactions:
Stop using compounded semaglutide 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.
Diabetic Retinopathy Complications in Patients with Type 2 Diabetes:
If you have type 2 diabetes, tell your provider right away if you experience changes in vision.
Increase in Heart Rate:
Tell your provider right away if you have a racing heartbeat while at rest.
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 Vial/Needle/Syringe:
Sharing poses a risk of infection.
Current/Recent Prescriptions
If you have any current/recent prescriptions for either compounded or brand name weight loss medications, do not take both medications. You will be asked to provide evidence of the current/recent prescription including dose specifics. Taking two or more GLP-1/GIP medications at the same time increases the risk of potentially serious side effects. Notify your provider immediately if you have any current or previous prescriptions for compounded or brand name weight loss medications.
Medical History
Failure to fully disclose your medical history to your provider may result in serious side effects, including death.
Before using Compounded Semaglutide
Your healthcare provider will direct you to instructions on how to administer your GLP-1 therapy.

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 semaglutide. Birth control pills may not work as well while using compounded semaglutide. Your healthcare provider may recommend another type of birth control for 4 weeks after you start compounded semaglutide and for 4 weeks after each increase in your dose of compounded semaglutide.

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 semaglutide may harm your unborn baby. Tell your healthcare provider if you become pregnant while using compounded semaglutide. It is not known if compounded semaglutide passes into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using compounded semaglutide.

How to take-
- Read the instructions that come with compounded semaglutide.
- Use compounded semaglutide exactly as your healthcare provider says.
- Compounded semaglutide is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm.
- Use compounded semaglutide 1 time each week on the same day every week.
- Change (rotate) your injection site with each weekly injection.

Do not
use the same site for each injection.

If you take too much compounded semaglutide, call your healthcare provider, seek medical advice promptly, or contact a Poison Center expert right away at 1-800-222-1222.

HOW IS COMPOUNDED SEMAGLUTIDE PRESCRIBED?
Compounded semaglutide typically starts at a low dose that is gradually increased overtime.
The typical dosing schedule of compounded semaglutide is:
Weeks 1–4: 0.25 mg once a week
Weeks 5–8: 0.5 mg once a week
Weeks 9–12: 1 mg once a week
Weeks 13–16: 1.7 mg once a week
Weeks 17–20:2.4 mg once a week

Depending on your specific situation, your maintenance dose could be lower than 2.4 mg once a week.
Oral forms of compounded semaglutide are typically dosed between 5-10 mg daily.
Follow the dosing instructions from your provider, as they may personalize your plan for your individual needs.

Legal Disclaimers:
Compounded semaglutide is not approved by the FDA. The FDA does not evaluate compounded products for safety, effectiveness, or quality.Zepbound and Mounjaro is a registered trademark of Eli Lilly and Company. Ozempic, Wegovy, Saxenda, and Victoza are registered trademarks of Novo Nordisk A/S. Byetta and Bydureon are registered trademarks of Amylin Pharmaceuticals, Inc..

Important Safety Information for Compounded Tirzepatide
Your medical provider may recommend personalized dosages of compounded tirzepatide based on a medical review. Compounded drugs are not FDA approved and are not evaluated by the FDA for safety, effectiveness, or quality standards.This document is a summary of product information and does NOT have all possible information and potential side effects of the product. This is not medical advice and does not substitute advice from your health care provider.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 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 and adolescents with obesity and excess weight (overweight) - who may 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 glucagon-like peptide-1 (GLP-1) 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 27 kg/m2 or higher.Compounded tirzepatide should not be used with other tirzepatide-containing products or any other GLP-1/GIP receptor agonist medicines. It is not known if compounded tirzepatide is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products. It is not known if compounded tirzepatide can be used in people who have had pancreatitis. It is not known if compounded tirzepatide is safe and effective for use in children under 18 years of age.

At lower (micro) doses, compounded tirzepatide may also be beneficial for patients who:

Have side effects at higher doses
-Would like to reduce cardiovascular disease risk
-Would like to reduce inflammation
-Would like to improve gastrointestinal conditions such as inflammatory bowel disease (IBD) or irritable bowel syndrome (IBS)
-Would like to protect against Alzheimer’s or Parkinson’s disease
-Would like to reduce the use of alcohol or tobacco



Important Safety Information for Compounded Tirzepatide

Your medical provider may recommend personalized dosages of compounded tirzepatide based on a medical review. Compounded drugs are not FDA approved and are not evaluated by the FDA for safety, effectiveness, or quality standards.

This document is a summary of product information and does NOT have all possible information and potential side effects of the product. This is not medical advice and does not substitute advice from your health care provider.

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 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 and adolescents with obesity and excess weight (overweight) - who may 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 glucagon-like peptide-1 (GLP-1) 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 27 kg/m2 or higher.

Compounded tirzepatide should not be used with other tirzepatide-containing products or any other GLP-1/GIP receptor agonist medicines. It is not known if compounded tirzepatide is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products. It is not known if compounded tirzepatide can be used in people who have had pancreatitis. It is not known if compounded tirzepatide is safe and effective for use in children under 18 years of age.

At lower (micro) doses, compounded tirzepatide may also be beneficial for patients who:
-Have side effects at higher doses
-Would like to reduce cardiovascular disease risk
-Would like to reduce inflammation
-Would like to improve gastrointestinal conditions such as inflammatory bowel disease (IBD) or irritable bowel syndrome (IBS)
-Would like to protect against Alzheimer’s or Parkinson’s disease
-Would like to reduce the use of alcohol or tobacco

Important Safety Information for Compounded Tirzepatide injection
Warning: Risk of Thyroid C-Cell Tumors

In studies with mice and 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 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).

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 is a glucagon-like peptide-1 (GLP-1) receptor agonist which may be 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 of 27 kg/m2 or higher.

Limitations of Use:
Compounded tirzepatide should not be used in combination with other tirzepatide-containing products or any other GLP-1/GIP receptor agonist medicines.The safety and efficacy of coadministration with other products for weight loss 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.

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 compounded tirzepatide.

How should compounded tirzepatide be administered?
You can take compounded tirzepatide with or without food. The pre-filled vial is self-administered with a needle and syringe as a subcutaneous injection in the stomach, thigh, or upper arm once a week on the same day every week. Your 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 provider before using compounded tirzepatide?
Compounded tirzepatide has certain drug interactions. It’s important to tell your 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 used to treat type 1 or type 2 diabetes, including insulin or sulfonylureas (such as Amaryl or Glucotrol XL).
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.

Other GLP-/GIP medications, including Wegovy® (tirzepatide), Ozempic® (tirzepatide), Saxenda® (liraglutide), Zepbound® (tirzepatide), Mounjaro® (tirzepatide), Victoza® (liraglutide), Byetta® (exenatide), or Bydureon® (exenatide).

If you’re using other products for weight loss, including dietary supplements.

It’s important to share your entire medical history with your provider.

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 or male of reproductive potential: Discontinue compounded tirzepatide at least 2 months before a planned pregnancy since the drug can stay in the bloodstream for a long time.If you are breastfeeding: Compounded tirzepatide was found in the milk of lactating rats. Tell your provider if you are breastfeeding before you start compounded tirzepatide. At this time, we do not recommend taking compounded tirzepatide if you are breastfeeding or bottle-feeding with breastmilk.
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?

The most common side effects are typically mild and usually resolve after the first several weeks of treatment. These can include nausea, vomiting, diarrhea, constipation, abdominal pain, upset stomach, abdominal distension, reflux, headache, fatigue, and dizziness. Swelling, redness, and itchiness at the injection site may occur. The FDA has issued its most serious warning (called a BOXED WARNING) that GLP-1s may be associated with a type of thyroid cancer called medullary thyroid carcinoma. So far, this side effect has primarily been seen in laboratory studies using rodents, so the risk to humans has not been determined.

SIDE EFFECTS:

Nausea, vomiting, stomach upset, diarrhea, tiredness, dizziness, or constipation may occur. Nausea usually lessens as you continue to use tirzepatide. If any of these effects last or get worse, tell your provider or pharmacist promptly. Remember that this medication has been prescribed because your provider has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Vomiting/diarrhea that doesn’t stop may result in dehydration. Contact your provider promptly if you notice any symptoms of dehydration, such as unusual dry mouth/thirst or dizziness/ lightheadedness. Tell your provider right away if you have any serious side effects, including: signs of kidney problems (such as change in the amount of urine), vision changes (such as decreased/blurred vision), fast heartbeat, mental/mood changes (such as depression, thoughts of suicide), signs of low blood sugar (sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, tingling hands/feet).Get medical help right away if you have any very serious side effects, including: signs of pancreas or gallbladder disease (such as nausea/vomiting that doesn’t stop, severe stomach/abdominal pain). A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your provider or pharmacist.

In the US - Call your provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch

WARNING:

This medication has been found to cause a certain type of thyroid tumor (thyroid C-cell tumors) in rats and mice. It is unknown if this medication can cause similar tumors in humans. Talk with your provider about the benefits and risks of treatment with this medication. This medication should not be used by people with a personal/family history of a certain type of cancer (medullary thyroid carcinoma) or by people with a certain inherited disease (Multiple Endocrine Neoplasia syndrome type 2 or MEN 2). While using this medication, tell your provider right away if you notice any signs or symptoms of thyroid tumors, including unusual growth or lump in the neck, difficulty swallowing, shortness of breath, or unusual/lasting hoarseness
If you are experiencing a medical emergency, call 911 or seek immediate medical attention.
These serious side effects 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 mice and rats, tirzepatide caused an increase in thyroid C-cell tumors, including medullary thyroid carcinoma (MTC). It is unknown whether compounded tirzepatide causes thyroid C-cell tumors in humans. There were cases of MTC reported in patients who took liraglutide (the active ingredient in Victoza® and Saxenda®) after the drug was put on the market. Compounded tirzepatide is contraindicated in patients with a family history of 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.

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.

Acute Gallbladder Disease: Compounded tirzepatide may cause gallbladder problems, including gallstones. Some gallbladder problems require surgery. Tell your provider right away if you have pain in your upper stomach, yellowing of skin or eyes (jaundice), fever, or clay-colored stools.

Low Blood Sugar (Hypoglycemia): Compounded tirzepatide lowers blood glucose. It can cause 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

.Acute Kidney Injury: In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse. It is important for you to drink plenty of water to help reduce your chance of dehydration.

Serious 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.

Diabetic Retinopathy Complications in Patients with Type 2 Diabetes: If you have type 2 diabetes, tell your provider right away if you experience changes in vision.

Increase in Heart Rate: Tell your provider right away if you have a racing heartbeat while at rest.

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 Vial/Needle/Syringe: Sharing poses a risk of infection.

Current/Recent PrescriptionsIf you have any current/recent prescriptions for either compounded or brand name weight loss medications, do not take both medications. You will be asked to provide evidence of the current/recent prescription including dose specifics. Taking two or more GLP-1/GIP medications at the same time increases the risk of potentially serious side effects. Notify your provider immediately if you have any current or previous prescriptions for compounded or brand name weight loss medications.

Medical HistoryFailure to fully disclose your medical history to your provider may result in serious side effects, including death.

Before using Compounded Tirzepatide

Your healthcare provider will direct you to instructions on how to administer your GLP-1 therapy.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 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 on the same day every week.
-
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.

HOW IS COMPOUNDED TIRZEPATIDE PRESCRIBED?
Compounded tirzepatide typically starts at a low dose that is gradually increased overtime. The typical dosing schedule of compounded tirzepatide is:
Weeks 1–4:2.5 mg once a week
Weeks 5–8:5 mg once a week
Weeks 9–12:7.5 mg once a week
Weeks 13–16:10 mg once a week
Weeks 17–20:12.5 mg once a week
Weeks 21-2415 mg once a week

Depending on your specific situation, your maintenance dose could be lower than 15 mg once a week.Follow the dosing instructions from your provider, as they may personalize your plan for your individual needs.Oral forms of compounded tirzepatide are typically dosed between 3-6 mg daily.For micro-dosing purposes, compounded tirzepatide dosing starts at 1.25 mg once or twice weekly. Orally micro-dosed tirzepatide is typically at 1.5 mg daily.

Legal Disclaimers:

Compounded tirzepatide is not approved by the FDA. The FDA does not evaluate compounded products for safety, effectiveness, or quality.Zepbound and Mounjaro is a registered trademark of Eli Lilly and Company. Ozempic, Wegovy, Saxenda, and Victoza are registered trademarks of Novo Nordisk A/S. Byetta and Bydureon are registered trademarks of Amylin Pharmaceuticals, Inc..