Important Safety Information

What is the FDA-approved use of Wegovy® relevant to this service?

Wegovy® is used along with a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity or with overweight plus a weight-related condition.

Wegovy® is also used to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with known cardiovascular disease and with either obesity or overweight.

Limitations of Use: Wegovy® should not be used in combination with other semaglutide-containing products or any other GLP-1 receptor agonist.

Who should not use Wegovy®?

• Anyone who, or whose family member, has ever had medullary thyroid carcinoma (MTC)
• Anyone with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• Anyone with a known allergic reaction to semaglutide or any ingredient in Wegovy®

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 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 provider before using Wegovy®?

Tell your provider about everything you take, including over-the-counter medicines, vitamins, and supplements. Take particular care with:

• Insulin or sulfonylureas — risk of low blood sugar
• Other oral medications — Wegovy® delays gastric emptying and can affect absorption
• Other GLP-1 receptor agonists

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

• Type 1 or type 2 diabetes
• Thyroid cancer
• Pancreatitis
• Kidney disease
• Diabetic retinopathy

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

• If you are pregnant: Wegovy® should not be used during pregnancy. Based on animal studies, there may be potential risks to an unborn baby from exposure to Wegovy® 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 of reproductive potential: Discontinue Wegovy® at least 2 months before a planned pregnancy since the drug can stay in the bloodstream for a long time.
• If you are breastfeeding: Breastfeeding is not recommended while you are taking Wegovy®. Tell your provider if you are breastfeeding before you start Wegovy®.
• Pregnancy registry: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to semaglutide during pregnancy. Contact Novo Nordisk at 1-877-390-2760 or www.wegovypregnancyregistry.com.

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 I should monitor for?

These serious side effects can occur with Wegovy. 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 (the active ingredient in Wegovy® and Ozempic) caused an increase in thyroid C-cell tumors, including medullary thyroid carcinoma (MTC). It is unknown whether Wegovy® 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. 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). 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: Wegovy® 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): Wegovy® lowers blood glucose. It can cause too low blood sugar in patients who take Wegovy® with another glucose control medication, including insulin. 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.
• Severe Gastrointestinal Adverse Reactions: Use of Wegovy® has been associated with gastrointestinal reactions that are sometimes severe.
• Serious Allergic Reactions: Stop using Wegovy® 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.
• Pulmonary Aspiration During General Anesthesia or Deep Sedation: Wegovy® causes a delay in gastric emptying. There have been reports of pulmonary aspiration (when food or liquid from the stomach enters the lungs) in people taking GLP-1 medications, including Wegovy, while undergoing surgery requiring sedation, even when instructed to fast before the surgery. If you have a planned major surgery requiring sedation, reach out to your provider for instructions.
• Never Share a Pen: Pen-sharing poses a risk of infection.

What are the most common side effects of Wegovy®?

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

Reporting and full information

You are encouraged to report negative side effects of prescription products:

• Contact Novo Nordisk Inc. at 1-833-934-6891
• Contact FDA MedWatch at 1-800-FDA-1088 or visit www.fda.gov/medwatch

This information is not comprehensive. Please see the full Prescribing Information for complete safety information.

• Prescribing Information

What is the FDA-approved use of Wegovy® relevant to this service?

Wegovy® is used along with a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity or with overweight plus a weight-related condition.

Wegovy® is also used to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with known cardiovascular disease and with either obesity or overweight.

Limitations of Use: Wegovy® should not be used in combination with other semaglutide-containing products or any other GLP-1 receptor agonist.

Who should not use Wegovy®?

• Anyone who, or whose family member, has ever had medullary thyroid carcinoma (MTC)
• Anyone with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• Anyone with a known allergic reaction to semaglutide or any ingredient in Wegovy®

How should Wegovy® pills be taken?

Take one Wegovy® pill by mouth once daily first thing in the morning before eating or drinking anything. The medication will only work if your stomach is completely empty. Swallow the pill whole with no more than 4 oz of water. Don’t cut, crush, or chew the pill. Remember to only take it with water – not coffee, juice, or any other liquids. After ingesting, avoid eating, drinking, or taking any other oral medications for at least 30 minutes so your body can fully absorb the medicine.

What should I tell my provider before using Wegovy®?

Tell your provider about everything you take, including over-the-counter medicines, vitamins, and supplements. Take particular care with:

• Insulin or sulfonylureas — risk of low blood sugar
• Other oral medications — Wegovy® delays gastric emptying and can affect absorption
• Other GLP-1 receptor agonists

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

• Type 1 or type 2 diabetes
• Thyroid cancer
• Pancreatitis
• Kidney disease
• Diabetic retinopathy

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

• If you are pregnant: Wegovy® should not be used during pregnancy. Based on animal studies, there may be potential risks to an unborn baby from exposure to Wegovy® 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 of reproductive potential: Discontinue Wegovy® at least 2 months before a planned pregnancy since the drug can stay in the bloodstream for a long time.
• If you are breastfeeding: Breastfeeding is not recommended while you are taking Wegovy®. Tell your provider if you are breastfeeding before you start Wegovy®.
• Pregnancy registry: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to semaglutide during pregnancy. Contact Novo Nordisk at 1-877-390-2760 or www.wegovypregnancyregistry.com.

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 I should monitor?

These serious side effects can occur with Wegovy. 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 (the active ingredient in Wegovy® and Ozempic) caused an increase in thyroid C-cell tumors, including medullary thyroid carcinoma (MTC). It is unknown whether Wegovy® 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. 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). 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: Wegovy® 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): Wegovy® lowers blood glucose. It can cause too low blood sugar in patients who take Wegovy® with another glucose control medication, including insulin. 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.
• Severe Gastrointestinal Adverse Reactions: Use of Wegovy® has been associated with gastrointestinal reactions that are sometimes severe
• Serious Allergic Reactions: Stop using Wegovy® 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.
• Pulmonary Aspiration During General Anesthesia or Deep Sedation: Wegovy® causes a delay in gastric emptying. There have been reports of pulmonary aspiration (when food or liquid from the stomach enters the lungs) in people taking GLP-1 medications, including Wegovy, while undergoing surgery requiring sedation, even when instructed to fast before the surgery. If you have a planned major surgery requiring sedation, reach out to your provider for instructions.

What are the most common side effects of Wegovy®?

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

Reporting and full information

You are encouraged to report negative side effects of prescription products:

• Contact Novo Nordisk Inc. at 1-833-934-6891
• Contact FDA MedWatch at 1-800-FDA-1088 or visit www.fda.gov/medwatch

This information is not comprehensive. Please see the full Prescribing Information for complete safety information.

• Prescribing Information

What is the FDA-approved use of Zepbound® relevant to this service?

Zepbound® is used along with a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity, or with overweight plus at least one weight-related condition.

Limitation of use: should not be used with other tirzepatide-containing products or any other GLP-1 receptor agonist.

Who should not use Zepbound®?

• Anyone who, or whose family member, has ever had MTC
• Anyone with MEN 2
• Anyone with a known allergic reaction to tirzepatide

How should Zepbound® be administered?

Zepbound® is available as a single-dose pre-filled autoinjector pen. Zepbound® is administered as a subcutaneous injection in the stomach, thigh, or upper arm once a week on the same day every week You can take Zepbound® with or without food. You should not change your dosing regimen or stop taking Zepbound® as prescribed without discussing with your provider first. Your provider will guide you on a treatment regimen that may include an increase in dose every four weeks.

What to tell your provider

Zepbound® 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 for diabetes: Medications used to treat type 1 or type 2 diabetes, including insulin or sulfonylureas (such as Amaryl or Glucotrol XL)
• Other oral medications: Zepbound® 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 Mounjaro, Wegovy, Ozempic, Saxenda, Victoza, Byetta, or Bydureon. These medications should not be taken with Zepbound.
• 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 or had a past history of:

• Type 1 or type 2 diabetes
• Thyroid cancer
• Gastrointestinal disease
• Pancreatitis
• Kidney disease
• Diabetic retinopathy

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

• If you are pregnant: Zepbound® should not be used during pregnancy. Based on animal studies, there may be potential risks to an unborn baby from exposure to Zepbound® 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 of reproductive potential: If you take birth control pills by mouth, talk to your healthcare provider before you take Zepbound®. Birth control pills may not work as well while taking Zepbound®. Your healthcare provider may recommend another type of birth control for 30 days after starting Zepbound® and for 30 days after each dose increase of Zepbound®.
• If you are breastfeeding: It is not known if Zepbound® passes into breast milk. Talk to your provider first about the benefits and risks of using Zepbound® while breastfeeding.
• Pregnancy registry: There will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Zepbound® during pregnancy. Pregnant patients exposed to Zepbound® and healthcare providers are encouraged to contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979).

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 should monitor for when taking Zepbound®?

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

• Thyroid C-Cell Tumors: In rats, Zepbound® caused a dose-dependent and treatment-duration-dependent increase in thyroid C-cell tumors. It is unknown whether Zepbound® causes thyroid C-cell tumors in humans. Zepbound® is contraindicated in patients with a personal or family history of medullary thyroid cancer (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.
• Severe Gastrointestinal Disease: Zepbound® is associated with gastrointestinal side effects, such as nausea, diarrhea, vomiting, constipation, and stomach pain, and can sometimes be severe. It hasn’t been studied in patients with severe gastrointestinal disease and isn’t recommended in these patients. The majority of nausea, vomiting, and/or diarrhea events occurred during a dose increase and decreased over time.
• Acute Kidney Injury: Gastrointestinal side effects of Zepbound® like diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems if dehydration is severe. It is important for you to drink plenty of water to help reduce your chance of dehydration.
• Acute Gallbladder Disease: Zepbound® along with other GLP-1 receptor agonists, and weight loss are associated with an increased chance of acute gallbladder disease. Tell your provider right away if you have pain in your upper stomach, yellowing of skin or eyes (jaundice), fever, or clay-colored stools.
• Inflammation of Pancreas (Acute Pancreatitis): Monitor for signs of acute pancreatitis, including severe abdominal pain that does not go away, sometimes radiating to the back, with or without vomiting.
• Allergic Reactions: Stop using Zepbound® right away if you experience symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, severe rash or itching, very rapid heartbeat, problems breathing or swallowing, or fainting or feeling dizzy.
• Low Blood Sugar (Hypoglycemia): Zepbound® lowers blood glucose. It can cause too low blood sugar in patients with type 2 diabetes who also take another glucose control medication. Monitor your blood sugar and watch out for signs of too low blood sugar such as dizziness, blurred vision, mood changes, sweating, or fast heartbeat.
• Diabetic Retinopathy Complications in Patients with a History of Diabetic Retinopathy: Rapid improvement of glucose control has been associated with temporary worsening of diabetic retinopathy. Tell your provider right away if you experience changes in vision.
• Pulmonary Aspiration During General Anesthesia or Deep Sedation: Zepbound® causes a delay in gastric emptying. There have been reports of pulmonary aspiration (when food or liquid from the stomach enters the lungs) in people taking GLP-1 medications, including Zepbound® while undergoing surgery requiring sedation, even when instructed to fast before the surgery. If you have a planned major surgery requiring sedation, reach out to your provider for instructions.
• Never Share a Pen or Needle: Sharing of pens or needles poses a risk of infection.

What are the most common side effects of Zepbound®?

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.

Reporting and full information

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

This information is not comprehensive. Please see full Prescribing Information for complete safety information.

• Prescribing Information

What is the FDA-approved use of Mounjaro® relevant to this service?

Mounjaro® is used along with diet and exercise to improve blood sugar control in adults with type 2 diabetes.

Use for weight management is off-label.

Tirzepatide is separately FDA-approved for chronic weight management under the brand name Zepbound®. A licensed provider may prescribe Mounjaro® off-label when clinically appropriate.

Limitation of use:

• Mounjaro® has not been studied in patients with a history of pancreatitis.
• Mounjaro® is not indicated for use in patients with type 1 diabetes mellitus

Who should not use Mounjaro®?

• 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.

What to tell your provider

Mounjaro® 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.

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

• Type 1 or type 2 diabetes
• Thyroid cancer
• Gastrointestinal disease
• Pancreatitis
• Kidney disease
• Diabetic retinopathy

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

• If you are pregnant: Mounjaro® should not be used during pregnancy. Based on animal studies, there may be potential risks to an unborn baby from exposure to Mounjaro® 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 of reproductive potential: If you take birth control pills by mouth, talk to your healthcare provider before you take Mounjaro®. Birth control pills may not work as well while taking Mounjaro®. Your healthcare provider may recommend another type of birth control for 30 days after starting Mounjaro®and for 30 days after each dose increase of Mounjaro®.
• If you are breastfeeding: It is not known if Mounjaro® passes into breast milk. Talk to your provider first about the benefits and risks of using Mounjaro® while breastfeeding.
• Pregnancy registry: There will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Mounjaro® during pregnancy. Pregnant patients exposed to Mounjaro® and healthcare providers are encouraged to contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979).

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.

How should Mounjaro® be administered?

You can take Mounjaro® 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 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 Mounjaro® as prescribed without discussing with your provider first.

What are the most serious side effects that I should monitor for when taking Mounjaro®?

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

• 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 nausea or vomiting. Sometimes 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.
• 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.
• 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.

What are the most common side effects of Mounjaro®?

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.

Reporting and full information

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

This information is not comprehensive. Please see full Prescribing Information for complete safety information.

• Prescribing Information

What is the FDA-approved use of Ozempic® relevant to this service?

Ozempic® is a GLP-1 receptor agonist used with diet and exercise to improve blood sugar control in adults with type 2 diabetes, and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease.

Limitations of use: Ozempic® has not been studied in patients with a history of pancreatitis. It is not for the treatment of type 1 diabetes.

Use for weight management is off-label.

Semaglutide is separately FDA-approved for chronic weight management under the brand name Wegovy®. A licensed provider may prescribe Ozempic® off-label when clinically appropriate.

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 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 Ozempic® as prescribed without discussing with your provider first.

What to tell your provider

Ozempic® 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)
• Ozempic® 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 Wegovy, Saxenda, Victoza, Byetta, or Bydureon
• 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

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

• If you are pregnant: Ozempic® should not be used during pregnancy. Based on animal studies, there may be potential risks to an unborn baby from exposure to Ozempic® 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 reproductive potential: Discontinue Ozempic® at least 2 months before a planned pregnancy since the drug can stay in the bloodstream for a long time.
• If you are breastfeeding: Ozempic® was found in the milk of lactating rats. Tell your provider if you are breastfeeding before you start Ozempic®
• Pregnancy registry: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to semaglutide (the active ingredient in Ozempic® and Wegovy®) during pregnancy. Pregnant women exposed to semaglutide and healthcare providers are encouraged to contact Novo Nordisk at 1-800-727-6500.

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 should monitor for when taking Ozempic®?

These serious side effects can occur with Ozempic® 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 (the active ingredient in Ozempic® and Wegovy®) caused an increase in thyroid C-cell tumors, including medullary thyroid carcinoma (MTC). It is unknown whether Ozempic® 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. 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). 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.
• 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.
• Never Share a Pen: Pen-sharing poses a risk of infection.
• Low Blood Sugar (hypoglycemia): Ozempic® lowers blood glucose. It can cause too low blood sugar in patients with type 2 diabetes who also take another glucose control medication. Monitor your blood sugar and watch out for signs of too low blood sugar such as dizziness, blurred vision, mood changes, sweating, or fast heartbeat.
• 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 Ozempic® 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.
• Acute Gallbladder Disease: Ozempic® 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.
• Increase in Heart Rate: Tell your provider right away if you have a racing heartbeat while at rest.

What are the most common side effects of Ozempic®?

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

Reporting and full information

You are encouraged to report negative side effects of prescription products:

• Contact Novo Nordisk Inc. at 1-833-934-6891
• Contact FDA MedWatch at 1-800-FDA-1088 or visit www.fda.gov/medwatch

This information is not comprehensive. Please see the full Prescribing Information for complete safety information.

• Prescribing Information

FDA-approved use

Foundayo™ is used along with a reduced-calorie diet and increased physical activity to reduce and maintain weight in adults with obesity or with overweight plus a weight-related condition.

Limitations of Use:

Foundayo™ should not be used in combination with other GLP-1 receptor agonists.

Who should not use Foundayo™?

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

How should I take Foundayo™?

• Take Foundayo™ exactly as your healthcare provider tells you to.
• Use Foundayo™ with a reduced-calorie diet and increased physical activity.
• Take Foundayo™ by mouth 1 time each day, with or without food.
• Swallow tablets whole. Do not break, crush, or chew the tablet.
• If you miss a dose, take it as soon as possible. Do not take 2 doses of Foundayo™ in the same day.
• Do not take more than 1 tablet per day.
• If you miss taking Foundayo™ for 7 or more days in a row, call your healthcare provider to talk about how to restart your treatment.
• If you take too much Foundayo, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

You should not change your dosing regimen or stop taking Foundayo™ as prescribed without discussing with your provider first. Your provider will guide you on a treatment regimen that may include an increase in dose every four weeks.

What to tell your provider

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

Some medications to watch out for include:

• Zocor (simvastatin): If you are taking Zocor while taking Foundayo, do not take more than 20 mg a day.
• Medications for diabetes: Medications used to treat type 1 or type 2 diabetes, including insulin or sulfonylureas (such as Amaryl or Glucotrol XL). Foundayo™ may increase the risk of low blood sugar if taken together.
• Other oral medications: Foundayo™ causes a delay in gastric emptying, so it has the potential to impact the absorption of medications.
• Other GLP-1 medications: Including Mounjaro, Zepbound, Wegovy, Ozempic, or Saxenda. These medications should not be taken with Foundayo™.
• 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 or have a past history of:

• Thyroid cancer
• Type 1 or type 2 diabetes
• Gastrointestinal disease
• Pancreatitis
• Liver disease
• Kidney disease
• Diabetic retinopathy

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

• If you are pregnant: Foundayo™ should not be used during pregnancy. Based on animal studies, there may be potential risks to the unborn baby from exposure to Foundayo™ during pregnancy. Intentional weight loss is not recommended during pregnancy and it may cause harm to the unborn baby.
• If you are a female of reproductive potential: If you take birth control pills by mouth, talk to your healthcare provider before you take Foundayo. Birth control pills may not work as well while taking Foundayo. Your healthcare provider may recommend another type of birth control for 30 days after starting Foundayo™ and for 30 days after each dose increase of Foundayo.
• If you are breastfeeding: Foundayo™ is not recommended for breastfeeding women. Talk to your provider first about the benefits and risks of using Foundayo™ while breastfeeding.
• Pregnancy Exposure Registry: There will be a pregnancy exposure registry for women who have taken Foundayo™ during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979).

Talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including insulin or sulfonylurea.

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 should monitor for when taking Foundayo™?

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

• Inflammation of the pancreas (pancreatitis). Stop taking Foundayo™ 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 nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back.
• Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Foundayo. Tell your healthcare provider if you have stomach problems that are severe or will not go away.
• 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 healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.
• Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Foundayo™ with medicines that can cause low blood sugar, such as insulin or sulfonylurea. 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.
• Serious allergic reactions. Stop using Foundayo™ 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.
• Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Foundayo.
• Gallbladder problems. Gallbladder problems have happened in some people who use Foundayo. 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.
• Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Foundayo™ may increase the chance of food getting into your lungs during surgery or other procedures. Tell your healthcare providers that you are taking Foundayo™ before you are scheduled to have surgery or other procedures.

What are the most common side effects of Foundayo™?

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

Reporting and full information

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

This information is not comprehensive. Please see full Prescribing Information for complete safety information.

• Prescribing Information

FDA-approved use

Metformin is FDA-approved, along with diet and exercise, to improve blood sugar control in adults with type 2 diabetes.

Use for healthy aging is off-label.

It is supported by observational data and remains under active study, but is not an FDA-approved use. A licensed provider may prescribe it off-label when clinically appropriate.

Who should not take metformin?

• Anyone with severe kidney impairment (eGFR below 30 mL/min/1.73 m²)
• Anyone with acute or chronic metabolic acidosis, including diabetic ketoacidosis
• Anyone with a known allergy to metformin

Starting metformin is not recommended when eGFR is between 30 and 45 mL/min/1.73 m². Your provider will check your kidney function before you start and periodically during treatment.

How should metformin be taken?

• Take metformin with a meal. This meaningfully reduces stomach upset, which is the most common reason people stop early.
• Swallow extended-release tablets whole. Do not split, crush, or chew them — doing so releases the full dose at once and makes side effects worse.
• Your provider will typically start you at a low dose and increase gradually, which also improves tolerability.
• If you miss a dose, take your next dose as prescribed. Do not take an extra dose to make up for it.
• You may occasionally notice something in your stool that looks like the tablet. With extended-release metformin this is the empty tablet shell and is not a cause for concern.

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

What to tell your provider

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:

• Insulin and insulin secretagogues (such as sulfonylureas) — taking these with metformin increases the risk of low blood sugar, and your provider may lower their dose
• Carbonic anhydrase inhibitors (such as topiramate) — may increase the risk of lactic acidosis
• Medicines that reduce how quickly your body clears metformin (such as ranolazine, vandetanib, dolutegravir, and cimetidine) — may cause metformin to build up
• Alcohol — potentiates metformin's effect on lactate metabolism; avoid excessive intake

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

• Kidney disease
• Liver disease
• Heart failure or any condition affecting oxygen delivery
• Type 1 diabetes or diabetic ketoacidosis
• Heavy or regular alcohol use

Tell your provider before any surgery or imaging procedure that uses contrast dye. Metformin usually needs to be stopped temporarily around these procedures, and your provider will tell you when to stop and when to restart.

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

• If you are pregnant: it is not known whether metformin will harm an unborn baby. Talk with your provider about the best way to manage your blood sugar during pregnancy.
• If you are a female of reproductive potential: metformin may cause ovulation to resume in some premenopausal women who were not ovulating, which can lead to an unintended pregnancy. Talk with your provider about contraception.
• If you are breastfeeding: it is not known whether metformin passes into breast milk. Talk with your provider first.

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 should monitor for when taking metformin?

• Lactic acidosis. Rare but serious, and a medical emergency. See the boxed warning above for symptoms. Stop metformin and seek care immediately.
• Vitamin B12 deficiency. Metformin can lower vitamin B12 levels over time, which may cause anemia. Your provider will monitor this and may recommend supplementation.
• Low blood sugar (hypoglycemia). Metformin rarely causes this on its own, but the risk increases if you also take insulin or a sulfonylurea, if you don't eat enough, or if you drink alcohol. Symptoms include dizziness, sweating, confusion, blurred vision, shakiness, and fast heartbeat.

What are the most common side effects of metformin?

Diarrhea, nausea, vomiting, gas, weakness, indigestion, abdominal discomfort, and headache. About 3 in 100 people notice a temporary metallic taste when starting.

These are most common early on and after a dose increase, and usually improve as your body adjusts. Taking metformin with food helps. If they aren't settling, contact your provider rather than stopping on your own.

Reporting and full information

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