Important Safety Information

Important Safety Information for Compounded Semaglutide Injection

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 for safety, effectiveness, or quality standards.

This page is a summary. It does not contain all information about compounded semaglutide, including all possible side effects, drug interactions and risks. It is not medical advice and does not replace the judgment of your health care provider. Talk with your provider or pharmacist before you start, change or stop this medication.

Indications and Use

Compounded semaglutide is an injectable prescription medicine that your provider may prescribe for adults, together with a reduced-calorie diet and increased physical activity as part of a weight-management plan. Its effect on body weight, on long-term health outcomes and on how long weight change lasts has not been established for the compounded semaglutide formulations.

Lower doses may be considered when your prescribing clinician determines it is clinically appropriate for your individual medical needs. The safety and effectiveness of lower-dose compounded semaglutide regimens have not been established.

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist. Your provider will decide whether this medication is appropriate for you based on your body mass index (BMI), your other medical conditions and your full medical history.

Do not use compounded semaglutide together 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 has not been studied in people who have had pancreatitis. It is not for use in anyone under 18 years of age or those 75 years of age or older.

Lower dose compounded semaglutide may be considered for certain patients when the prescribing clinician determines that a patient-specific dose is clinically appropriate. The safety and effectiveness of lower dosed of compounded semaglutide has not been established.

Compounded semaglutide is prescribed only for weight management in specific adult patients who meet the clinical criteria and have been evaluated by a provider. Compounded semaglutide is not FDA-approved, and the FDA has not evaluated this compounded formulation for dosing regimen safety, effectiveness or quality for any use. Certain FDA-approved semaglutide products have separate approved indications, including type 2 diabetes and reduction of cardiovascular risk in specified patient populations. Those approvals do not apply to compounded semaglutide.

Important Safety Information for Compounded Semaglutide injection

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

Your provider can only assess whether this medicine is safe for you if your medical history is complete and accurate. Leaving out or misstating information about your health can lead to serious harm. Please answer every question fully.

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. Unlike FDA-approved medicines, it has not been reviewed by the FDA for safety and effectiveness, and the pharmacy that prepares it is not required to follow the FDA manufacturing standards that apply to approved drug products.

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. The above are suggestions for use of compounded semaglutide while the FDA approved therapies remain on shortage.

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 had an allergic reaction to semaglutide or to any ingredient in this compounded product. Ask your pharmacy for a full list of ingredients.
• You are pregnant, trying to become pregnant, or breastfeeding.
• You are under 18 years of age.

How should compounded injectable semaglutide be administered?

Compounded semaglutide may be taken with or without food. It is supplied in a vial. You draw up the dose and self-administer it with a needle and syringe as an injection under the skin (subcutaneous) of the stomach, thigh, or upper arm, once a week on the same day each week. Your provider will guide you on a treatment plan that may include a dose increase over time.

You should not change your dosing regimen or stop taking compounded semaglutide as prescribed without discussing with your provider first.

Important: How your dose is measured

Compounded semaglutide does not come in the same strength or concentration as FDA-approved pens, and serious overdoses have been reported when patients calculated their own dose. Your dose is written on your prescription label in strength (mg) or units injected of a particular concentration, to draw up in a syringe. If your label, syringe and your provider's instruction do not match or if you have questions on how much medication to pull up, do not inject. Call your pharmacy 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-1/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.

Before using compounded semaglutide

• Your healthcare provider will direct you to instructions on how to administer your compounded 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 compounded injectable semaglutide

• 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 injectable semaglutide 1 time each week on the same day every week or as directed by your provider.
• 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?

Patient-specific compounded semaglutide typically starts at a low dose that is gradually increased over time. 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 is a registered trademark of Eli Lilly and Company. Ozempic and Wegovy are registered trademarks of Novo Nordisk A/S.

Compounded Injectable Tirzepatide Safety Information

Compounded tirzepatide is an injectable prescription medicine that acts as a synthetic glucagon-like peptide-1 (GLP-1) and gastric inhibitory polypeptide (GIP) receptor agonist. Your provider may prescribe compounded tirzepatide for adults, together with a reduced-calorie diet and increased physical activity, as part of a weight-management plan, if clinically appropriate based on a complete medical evaluation of your BMI and other medical conditions.

Compounded medications are not FDA-approved, and the FDA has not reviewed compounded tirzepatide for safety, effectiveness, or quality. FDA-approved tirzepatide products have their own approved uses. The effects of compounded tirzepatide on body weight and long-term health outcomes, and its safety and effectiveness, have not been established.

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 or those 75 years of age or older.

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 has no FDA-approved indications. The FDA has not reviewed the compounded formulation for its dosing for safety, effectiveness or quality.

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.

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.

Do not use this weight-management therapy during pregnancy.

You may take compounded tirzepatide with or without food. For a vial, draw up only the prescribed dose using the syringe supplied or specified by the pharmacy. Inject under the skin of the abdomen, thigh, or the back of your upper arm as directed by your provider. Follow your prescription label and your provider's dosing instructions. Your provider will guide you on a treatment regimen that may include increases in your dose. Do not increase your dose or change your dosing schedule on your own. Contact your provider before changing treatment, except when the emergency or stop-use instructions below apply.

Important dose measurement information

Concentrations may differ between compounded products and refills. Confirm your dose in milligrams (mg), the volume in milliliters (mL), and the correct syringe marking with your pharmacist. Syringe units are not milligrams. If the label, syringe, or instructions do not match, do not inject; call your pharmacy. Do not calculate a dose from another product or an online dosing chart.

Follow your pharmacy's storage instructions, beyond-use date, and instructions after first puncture. Ask your pharmacy about any temperature excursion or change in appearance before using the medicine. Use a new needle and syringe for each injection. Ask your pharmacist what to do if you miss a dose; do not double your dose.

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-1/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 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 planning a pregnancy, talk with your provider before trying to become pregnant about when to stop tirzepatide. If you become pregnant, stop using this medication and contact your provider promptly.
• 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: Discuss treatment with your provider before use. At this time, we do not recommend taking compounded tirzepatide if you are breastfeeding or bottle-feeding with breastmilk.

Your provider needs complete and accurate information to assess whether treatment is appropriate. Please answer all medical-history questions fully.

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

Possible side effects include nausea, vomiting, diarrhea, constipation, abdominal discomfort, reflux, fatigue, injection site reactions, belching, and hair loss. Contact your provider if symptoms persist or worsen. Serious reactions require the actions below. This is not a complete list of effects. Report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 extending to your back, with or without vomiting. Stop using tirzepatide and seek medical care immediately if this occurs.
• 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.
• Severe stomach problems: Tell your provider about severe or persistent digestive symptoms. Tirzepatide is not recommended for severe gastroparesis (very slow stomach emptying).
• Procedures and Anesthesia: Tell your surgical and anesthesia teams that you take tirzepatide. Delayed stomach emptying may increase the risk of stomach contents entering the lungs during anesthesia or deep sedation.
• 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.

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 compounded tirzepatide injection

• 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 as instructed by your provider.
• 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 over time, but your provider will determine your individualized treatment. Follow the dosing instructions from your provider, as they may personalize your plan for your individual needs.

Legal Disclaimers

Compounded tirzepatide is not approved by the FDA. The FDA does not evaluate compounded products for safety, effectiveness, or quality.

Zepbound is a registered trademark of Eli Lilly and Company. Mounjaro is a registered trademark of Eli Lilly and Company. Ozempic and Wegovy are registered trademarks of Novo Nordisk A/S. Victoza and Saxenda are registered trademarks of Novo Nordisk A/S. Byetta is a registered trademark of AstraZeneca AB.

Your safety is our first priority. Learn more about key medication details, side effects, and other important information about your treatment below.

• Prescribing information
• Black Box Warning
• Common side effects: nausea, diarrhea, vomiting

Indication

OZEMPIC® (semaglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as:

• an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of Use:

• Co-administration with other semaglutide-containing products or any GLP-1 receptor agonist is not recommended.
• OZEMPIC® has not been studied in patients with a history of pancreatitis.
• OZEMPIC® is not indicated for use in patients with type 1 diabetes mellitus.

Warning: Risk of Thyroid C-Cell Tumors

See full prescribing information for the complete boxed warning.

• In rodents, semaglutide causes thyroid C-cell tumors at clinically relevant exposures. It is unknown whether OZEMPIC® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined.
• OZEMPIC® is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and the symptoms of thyroid tumors.

Do not take OZEMPIC® if you:

• Have a personal or family history of medullary thyroid carcinoma (MTC), or have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• Have been diagnosed with Type 1 diabetes.
• Have been diagnosed with pancreatitis or have a history of pancreatitis.
• Have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.
• Have a known allergy to semaglutide, any other GLP-1 drug, or any of the inactive ingredients in OZEMPIC®.
  • Injectable OZEMPIC® inactive ingredients include: di-sodium phosphate dihydrate, propylene glycol, phenol, and water for injection; hydrochloric acid or sodium hydroxide may be added to adjust pH.
  • Oral OZEMPIC® inactive ingredients include: magnesium stearate and salcaprozate sodium.

Warnings and Precautions

• Acute Pancreatitis: Has occurred in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed.
• Acute Gallbladder Disease: Has occurred in clinical trials. If cholelithiasis is suspected, gallbladder studies and clinical follow-up are indicated.
• Hypoglycemia: Concomitant use with an insulin secretagogue or insulin may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing the dose of the insulin secretagogue or insulin may be necessary. Inform all patients of the risk of hypoglycemia and educate them on its signs and symptoms.
• Acute Kidney Injury: Has occurred. Monitor renal function when initiating or escalating doses of OZEMPIC® in patients reporting severe adverse gastrointestinal reactions, or in those with renal impairment reporting severe adverse gastrointestinal reactions.
• Hypersensitivity Reactions: Anaphylactic reactions and angioedema have been reported postmarketing. Discontinue OZEMPIC® if suspected and promptly seek medical advice.
• Females of Reproductive Potential: Discontinue OZEMPIC® at least 2 months before a planned pregnancy because of the long half-life of semaglutide.
• Pregnancy: May cause fetal harm. When pregnancy is recognized, discontinue OZEMPIC® immediately.
• Breastfeeding: Breastfeeding is not recommended during treatment with OZEMPIC®. Talk to your healthcare provider about the best way to feed your baby while using OZEMPIC®.
• Diabetic Retinopathy Complications in Patients with Type 2 Diabetes: Has been reported in trials with OZEMPIC®. Patients with a history of diabetic retinopathy should be monitored.
• Heart Rate Increase: Monitor heart rate at regular intervals.

Side Effects

The most common side effects (incidence ≥ 5%) in adults or pediatric patients aged 12 years and older are: nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distension, eructation, hypoglycemia in patients with type 2 diabetes, flatulence, gastroenteritis, gastroesophageal reflux disease, and nasopharyngitis.

To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

OZEMPIC® delays gastric emptying and may impact the absorption of concomitantly administered oral medications. Use with caution.

Use in Specific Populations

• Pregnancy: May cause fetal harm. When pregnancy is recognized, discontinue OZEMPIC®.
• Breastfeeding: Breastfeeding is not recommended during treatment with OZEMPIC®. Talk to your healthcare provider about the best way to feed your baby while using OZEMPIC®.
• Females of Reproductive Potential: Discontinue OZEMPIC® at least 2 months before a planned pregnancy because of the long half-life of semaglutide.

Your safety is our first priority. Learn more about key medication details, side effects, and other important information about your treatment below.

• Prescribing information
• Black Box Warning
• Common side effects: nausea, diarrhea, vomiting

Indication

WEGOVY® (semaglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced-calorie diet and increased physical activity:

• to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight.
• to reduce excess body weight and maintain weight reduction long term in:
  • Adults and pediatric patients aged 12 years and older with obesity.
  • Adults with overweight in the presence of at least one weight-related comorbid condition.

Limitations of Use:

• Co-administration with other semaglutide-containing products or any GLP-1 receptor agonist is not recommended.
• The safety and efficacy of coadministration with other products for weight management have not been established.
• There is limited experience from clinical trials with WEGOVY® in patients with a history of pancreatitis. It is unknown if patients with a history of pancreatitis are at a higher risk for development of pancreatitis on WEGOVY®.

Warning: Risk of Thyroid C-Cell Tumors

See full prescribing information for the complete boxed warning.

• In rodents, semaglutide causes thyroid C-cell tumors at clinically relevant exposures. It is unknown whether WEGOVY® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined.
• WEGOVY® is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and the symptoms of thyroid tumors.

Do not take WEGOVY® if you:

• Have a personal or family history of medullary thyroid carcinoma (MTC), or have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• Have been diagnosed with Type 1 diabetes.
• Have been diagnosed with pancreatitis or have a history of pancreatitis.
• Have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.
• Have a known allergy to semaglutide, any other GLP-1 drug, or any of the inactive ingredients in WEGOVY®.
  • Injectable WEGOVY® inactive ingredients include: di-sodium phosphate dihydrate, sodium chloride, and water for injection; hydrochloric acid or sodium hydroxide may be added to adjust pH.
  • Oral WEGOVY® inactive ingredients include: magnesium stearate and salcaprozate sodium.

Warnings and Precautions

• Acute Pancreatitis: Has occurred in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed.
• Acute Gallbladder Disease: Has occurred in clinical trials. If cholelithiasis is suspected, gallbladder studies and clinical follow-up are indicated.
• Hypoglycemia: Concomitant use with an insulin secretagogue or insulin may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing the dose of the insulin secretagogue or insulin may be necessary. Inform all patients of the risk of hypoglycemia and educate them on its signs and symptoms.
• Acute Kidney Injury: Has occurred. Monitor renal function when initiating or escalating doses of WEGOVY® in patients reporting severe adverse gastrointestinal reactions, or in those with renal impairment reporting severe adverse gastrointestinal reactions.
• Hypersensitivity Reactions: Anaphylactic reactions and angioedema have been reported postmarketing. Discontinue WEGOVY® if suspected and promptly seek medical advice.
• Females of Reproductive Potential: Discontinue WEGOVY® at least 2 months before a planned pregnancy because of the long half-life of semaglutide.
• Pregnancy: May cause fetal harm. When pregnancy is recognized, discontinue WEGOVY® immediately.
• Breastfeeding: Breastfeeding is not recommended during treatment with WEGOVY®. Talk to your healthcare provider about the best way to feed your baby while using WEGOVY®.
• Diabetic Retinopathy Complications in Patients with Type 2 Diabetes: Has been reported in trials with WEGOVY®. Patients with a history of diabetic retinopathy should be monitored.
• Heart Rate Increase: Monitor heart rate at regular intervals.
• For Wegovy® HD 7.2 mg only:
  • Dysesthesia: There may be an increased incidence of dysesthesia: this is often described as a "sunburn-like" feeling, tingling, crawling, or extreme sensitivity to the touch of clothing, even without a visible rash or redness. This is typically dose-related and self-limiting; please notify your medical provider if it becomes painful or interferes with sleep.
  • Higher incidence of GI side effects: If side effects become significant, please notify your medical provider.
  • Dehydration risk: Because this higher dose slows gastric emptying even further, the risk of "stealth" dehydration is greater. Please monitor for dark urine or lightheadedness. If side effects become significant, please notify your medical provider.

Side Effects

The most common side effects (incidence ≥ 5%) in adults or pediatric patients aged 12 years and older are: nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distension, eructation, hypoglycemia in patients with type 2 diabetes, flatulence, gastroenteritis, gastroesophageal reflux disease, and nasopharyngitis.

To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

WEGOVY® delays gastric emptying and may impact the absorption of concomitantly administered oral medications. Use with caution.

Use in Specific Populations

• Pregnancy: May cause fetal harm. When pregnancy is recognized, discontinue WEGOVY®.
• Breastfeeding: Breastfeeding is not recommended during treatment with WEGOVY®. Talk to your healthcare provider about the best way to feed your baby while using WEGOVY®.
• Females of Reproductive Potential: Discontinue WEGOVY® at least 2 months before a planned pregnancy because of the long half-life of semaglutide.

Your safety is our first priority. Learn more about key medication details, side effects, and other important information about your treatment.

• Prescribing information
• Black Box Warning
• Common side effects: nausea, diarrhea, vomiting, constipation, abdominal pain, dyspepsia, injection site reactions, fatigue, hypersensitivity reactions, eructation, hair loss, gastroesophageal reflux disease

Indication

ZEPBOUND® (tirzepatide) injection is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced-calorie diet and increased physical activity:

• to reduce excess body weight and maintain weight reduction long term in:
  • Adults with obesity.
  • Adults with 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).
• to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity.

Limitations of Use:

• Co-administration with other tirzepatide-containing products or any GLP-1 receptor agonist is not recommended.
• The safety and efficacy of coadministration with other products for weight management have not been established.
• ZEPBOUND® has not been studied in patients with a history of pancreatitis.

Warning: Risk of Thyroid C-Cell Tumors

See full prescribing information for the complete boxed warning.

• In rats, tirzepatide causes thyroid C-cell tumors. It is unknown whether ZEPBOUND® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined.
• ZEPBOUND® is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and the symptoms of thyroid tumors.

Do not use ZEPBOUND® if you:

• Have a personal or family history of medullary thyroid carcinoma (MTC), or have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• Have been diagnosed with Type 1 diabetes.
• Have been diagnosed with pancreatitis or have a history of pancreatitis.
• Have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.
• Have a known allergy to tirzepatide, any other GLP-1 drug, or any of the inactive ingredients in ZEPBOUND®.
  • Single-use injection pen inactive ingredients include: sodium chloride, sodium phosphate dibasic heptahydrate, and water for injection. Hydrochloric acid solution and/or sodium hydroxide solution may have been added to adjust the pH.
  • Single-use vials inactive ingredients include: sodium chloride, sodium phosphate dibasic heptahydrate, and water for injection.
  • Multi-use KwikPen inactive ingredients include: sodium chloride, sodium phosphate dibasic heptahydrate, hydrochloric acid solution, sodium hydroxide solution, water, phenol, benzyl alcohol, and glycerin.

Warnings and Precautions

• Pancreatitis: Has been reported in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed.
• Acute Gallbladder Disease: Has occurred in clinical trials. If cholelithiasis is suspected, gallbladder studies and clinical follow-up are indicated.
• Severe Gastrointestinal Disease: Use may be associated with gastrointestinal adverse reactions, sometimes severe. Has not been studied in patients with severe gastrointestinal disease and is not recommended in these patients.
• Hypoglycemia: Concomitant use with an insulin secretagogue or insulin may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing the dose of the insulin secretagogue or insulin may be necessary. Inform all patients of the risk of hypoglycemia and educate them on its signs and symptoms.
• Acute Kidney Injury: Monitor renal function in patients with renal impairment reporting adverse reactions that could lead to volume depletion.
• Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported postmarketing with tirzepatide. If suspected, advise patients to promptly seek medical attention and discontinue ZEPBOUND®.
• Females of Reproductive Potential: Advise females using oral contraceptives to switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after initiation and for 4 weeks after each dose escalation.
• Females of Reproductive Potential: Discontinue at least 2 months before a planned pregnancy because of the long half-life of ZEPBOUND®.
• Pregnancy: May cause fetal harm. When pregnancy is recognized, discontinue ZEPBOUND®.
• Breastfeeding: Breastfeeding is not recommended during treatment with ZEPBOUND®. Talk to your healthcare provider about the best way to feed your baby while using ZEPBOUND®.
• Diabetic Retinopathy Complications in Patients with Type 2 Diabetes: Has not been studied in patients with nonproliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy, or diabetic macular edema. Monitor patients with a history of diabetic retinopathy for progression.
• Pulmonary Aspiration During General Anesthesia or Deep Sedation: Has been reported in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures. Instruct patients to inform healthcare providers of any planned surgeries or procedures.

Side Effects

The most common side effects, reported in ≥ 5% of patients treated with ZEPBOUND®, are: nausea, diarrhea, vomiting, constipation, abdominal pain, dyspepsia, injection site reactions, fatigue, hypersensitivity reactions, eructation, hair loss, and gastroesophageal reflux disease.

To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

ZEPBOUND® delays gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications.

Use in Specific Populations

• Pregnancy: May cause fetal harm. When pregnancy is recognized, discontinue ZEPBOUND®.
• Breastfeeding: Breastfeeding is not recommended during treatment with ZEPBOUND®. Talk to your healthcare provider about the best way to feed your baby while using ZEPBOUND®.
• Females of Reproductive Potential: Advise females using oral contraceptives to switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after initiation and for 4 weeks after each dose escalation.
• Females of Reproductive Potential: Discontinue ZEPBOUND® at least 2 months before a planned pregnancy because of the long half-life of ZEPBOUND®.