Important Safety Information

Wegovy® (semaglutide) injection

What is the FDA-approved use of Wegovy?

Wegovy is a glucagon-like peptide-1 (GLP-1) receptor agonist for chronic weight management, along with a reduced calorie diet and increased physical activity, for people with an initial body mass index (BMI) of:

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

Limitations of Use:

• Wegovy should not be used in combination with other semaglutide-containing products or any other GLP-1 receptor agonist.
• The safety and efficacy of coadministration with other products for weight loss have not been established.
• Wegovy has not been studied in patients with a history of pancreatitis.

Who should not use Wegovy?

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 a known allergic reaction to semaglutide (the active ingredient in Wegovy or Ozempic).

How should Wegovy be administered?

You can take Wegovy with or without food. The pre-filled injector pen is self-administered as a subcutaneous injection in the stomach, thigh, or upper arm once a week on the same day every week. Your AmberHealth-affiliated 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 Wegovy as prescribed without discussing with your provider first.

What should I tell my AmberHealth-affiliated provider before using Wegovy?

Wegovy has certain drug interactions. It's important to tell your AmberHealth-affiliated provider all of the medications you are currently taking, including:

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)
• Wegovy 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 medications, including Ozempic, Saxenda, Victoza, Byetta, or Bydureon
• If you're using other products for weight loss, including dietary supplements
• If you're taking any other medications, including prescription and over-the-counter medications, vitamins, and herbal supplements.

Tell your provider if you have a past history of:

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

What are the most serious side effects to monitor for?

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

• Thyroid C-Cell Tumors: Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath.
• Inflammation of Pancreas (Acute Pancreatitis): Monitor for severe abdominal pain that does not go away, sometimes radiating to the back, with or without vomiting.
• Acute Gallbladder Disease: Tell your provider right away if you have pain in your upper stomach, yellowing of skin or eyes (jaundice), fever, or clay-colored stools.
• Low Blood Sugar (hypoglycemia): Monitor your blood sugar and watch for signs such as dizziness, blurred vision, mood changes, sweating, or fast heartbeat.
• Acute Kidney Injury: Drink plenty of water to help reduce your chance of dehydration.
• Serious Allergic Reactions: Stop using Wegovy right away if you experience swelling of your face, lips, tongue or throat, severe rash or itching, problems breathing or swallowing, or fainting.
• Diabetic Retinopathy Complications: Tell your provider right away if you experience changes in vision.
• Increase in Heart Rate: Tell your provider if you have a racing heartbeat while at rest.
• Suicidal Behavior and Ideation: Pay attention to any mental health changes, especially sudden changes in your mood, behaviors, thoughts, or feelings.
• Never Share a Pen: Pen-sharing poses a risk of infection.

What are the most common side effects?

Zepbound® (tirzepatide) injection

What is the FDA-approved use of Zepbound?

Zepbound is used along with a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:

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

Limitations of Use:

• Zepbound should not be used in combination with other tirzepatide-containing products or any other GLP-1 receptor agonist.
• The safety and efficacy of coadministration with other products for weight loss have not been established.
• Zepbound has not been studied in patients with a history of pancreatitis.

Who should not use Zepbound?

Do not use Zepbound 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 Zepbound.

How should Zepbound be administered?

You can take Zepbound with or without food. The pre-filled injector pen is self-administered as a subcutaneous injection in the stomach, thigh, or upper arm once a week on the same day every week. Your AmberHealth-affiliated 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 Zepbound as prescribed without discussing with your provider first.

What should I tell my AmberHealth-affiliated provider before using Zepbound?

Some medications to watch out for include:

• Medications for diabetes: Including insulin or sulfonylureas (such as Amaryl or Glucotrol XL)
• Other oral medications: Zepbound causes a delay in gastric emptying, so it has the potential to impact the absorption of medications taken by mouth at the same time.
• Other GLP-1 medications: Including Mounjaro, Wegovy, Ozempic, Saxenda, Victoza, Byetta, or Bydureon. These medications should not be taken with Zepbound.
• Hormonal birth control: If you are using an oral hormonal contraceptive, Zepbound may decrease its efficacy. Switch to a non-oral contraceptive method or use a barrier method for 4 weeks after starting Zepbound and for 4 weeks after each dose escalation.
• Other products for weight loss: Including dietary supplements

Tell your provider if you have a past history of:

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

What are the most serious side effects to monitor for?

• Thyroid C-Cell Tumors: Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath.
• Severe Gastrointestinal Disease: Nausea, diarrhea, vomiting, constipation, and stomach pain can sometimes be severe.
• Acute Kidney Injury: Drink plenty of water to reduce your chance of dehydration.
• Acute Gallbladder Disease: Tell your provider if you have pain in your upper stomach, jaundice, fever, or clay-colored stools.
• Inflammation of Pancreas (Acute Pancreatitis): Monitor for severe abdominal pain.
• Serious Allergic Reactions: Stop using immediately if you experience severe allergic symptoms.
• Low Blood Sugar (Hypoglycemia): Monitor blood sugar if you have type 2 diabetes.
• Diabetic Retinopathy Complications: Tell your provider if you experience changes in vision.
• Suicidal Behavior and Ideation: Pay attention to any mental health changes.
• Never Share a Pen: Pen-sharing poses a risk of infection.

What are the most common side effects?

Ozempic® (semaglutide) injection

What is the FDA-approved use of Ozempic?

Ozempic is a glucagon-like peptide-1 (GLP-1) receptor agonist that is used:

• With diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.
• To reduce the risk of major adverse cardiovascular events in patients with type 2 diabetes mellitus and established cardiovascular disease.

Limitations of Use:

• Ozempic is not for treatment of type 1 diabetes mellitus.
• Ozempic has not been studied in patients with a history of pancreatitis.

Who should not use Ozempic?

Do not use Ozempic 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 semaglutide (the active ingredient in Wegovy or Ozempic).

How should Ozempic be administered?

You can take Ozempic with or without food. The pre-filled injector pen is self-administered as a subcutaneous injection in the stomach, thigh, or upper arm once a week on the same day every week. Your AmberHealth-affiliated provider will guide you on a treatment regimen that may include an increase in dose every four weeks.

What are the most serious side effects to monitor for?

• Thyroid C-Cell Tumors: Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath.
• Inflammation of Pancreas (Acute Pancreatitis): Monitor for severe abdominal pain.
• Diabetic Retinopathy Complications: Tell your provider if you experience changes in vision.
• Low Blood Sugar (hypoglycemia): Monitor your blood sugar.
• Acute Kidney Injury: Drink plenty of water.
• Serious Allergic Reactions: Stop using immediately if you experience severe symptoms.
• Acute Gallbladder Disease: Tell your provider if you have upper stomach pain, jaundice, or fever.
• Increase in Heart Rate: Tell your provider if you have a racing heartbeat at rest.
• Suicidal Behavior and Ideation: Pay attention to mental health changes.
• Never Share a Pen: Pen-sharing poses a risk of infection.

What are the most common side effects?

Compound Semaglutide injection

Indications and Use

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

Compound Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist for chronic weight management for people with an initial body mass index (BMI) of:

• 30 kg/m² or greater (obesity)
• 27 kg/m² or greater (overweight) in the presence of at least one weight-related comorbid condition

Limitations of Use:

• Compound Semaglutide should not be used in combination with other semaglutide-containing products or any other GLP-1 receptor agonist.
• The safety and efficacy of coadministration with other products for weight loss have not been established.
• Compound Semaglutide has not been studied in patients with a history of pancreatitis.
• It is not known if Compound Semaglutide is safe and effective for use in children under 18 years of age.

Who should not use Compound Semaglutide?

• Those with a personal or family history of medullary thyroid carcinoma (MTC)
• Those with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• Those with a known allergic reaction to semaglutide

How should Semaglutide be administered?

You can take Semaglutide with or without food. The pre-filled injector pen is self-administered as a subcutaneous injection in the stomach, thigh, or upper arm once a week on the same day every week. Your AmberHealth provider will guide you on a treatment regimen that may include an increase in dose every four weeks.

Before using Compound Semaglutide

• Your healthcare provider should show you how to use Compound Semaglutide before you use it for the first time.
• Tell your healthcare provider if you are taking medicines to treat diabetes including insulin or sulfonylureas which could increase your risk of low blood sugar.
• If you take birth control pills by mouth, talk to your healthcare provider before you use Compound Semaglutide. Your healthcare provider may recommend another type of birth control for 4 weeks after you start and for 4 weeks after each dose increase.

What are the most serious side effects to monitor for?

• Thyroid C-Cell Tumors
• Inflammation of Pancreas (Acute Pancreatitis)
• Acute Gallbladder Disease
• Low Blood Sugar (hypoglycemia)
• Acute Kidney Injury
• Serious Allergic Reactions
• Diabetic Retinopathy Complications
• Increase in Heart Rate
• Suicidal Behavior and Ideation
• Never Share a Pen

What are the most common side effects?

How to take

• Read the Instructions for Use that come with Compound Semaglutide.
• Use Compound Semaglutide exactly as your healthcare provider says.
• Compound Semaglutide is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm.
• Use Compound Semaglutide 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 Compound Semaglutide, call your healthcare provider or contact a Poison Center at 1-800-222-1222.

Compound Tirzepatide injection

Indications and Use

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

Compound Tirzepatide is a synthetic, dual-acting glucagon-like peptide-1 (GLP-1) and GIP receptor agonist used for chronic weight management for people with an initial body mass index (BMI) of:

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

Limitations of Use:

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

Before using Compound Tirzepatide

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

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 gastroparesis?
• 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?

What are the most serious side effects to monitor for?

• Thyroid C-Cell Tumors: Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath.
• Severe Gastrointestinal Disease: Nausea, diarrhea, vomiting, constipation, and stomach pain.
• Acute Kidney Injury: Drink plenty of water.
• Acute Gallbladder Disease: Tell your provider if you have upper stomach pain, jaundice, or fever.
• Inflammation of Pancreas (Acute Pancreatitis): Monitor for severe abdominal pain.
• Serious Allergic Reactions: Stop using immediately if you experience severe symptoms.
• Low Blood Sugar (Hypoglycemia): Monitor blood sugar if you have type 2 diabetes.
• Diabetic Retinopathy Complications: Tell your provider if you experience changes in vision.
• Suicidal Behavior and Ideation: Pay attention to mental health changes.
• Never Share a Pen: Pen-sharing poses a risk of infection.

What are the most common side effects?

How to take

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