Foundayo^®

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

Prescribing information

• black box warning

Common side effects

• Nausea
• Stomach (abdominal) pain
• Heartburn
• Constipation
• Headache
• Gas
• Diarrhea
• Swollen belly
• Hair loss
• Vomiting
• Feeling tired
• Indigestion
• Belching

Important safety information

FOUNDAYO is a prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off.

Limitations of Use:

• FOUNDAYO should not be used with other GLP-1 receptor agonist medicines.

• It is not known if FOUNDAYO is safe and effective for use in children.

WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning.

• It is not known if FOUNDAYO will cause thyroid tumors, or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
• Do not take FOUNDAYO if you or any of your family have ever had a type of thyroid cancer called MTC, or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

FOUNDAYO may cause serious side effects including:

Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, medicines that work like FOUNDAYO caused thyroid tumors, including thyroid cancer.

Do not use FOUNDAYO if:

• you or any of your family have ever had a type of thyroid cancer called MTC or if you have an endocrine system condition called MEN 2.
• you have had a serious allergic reaction to orforglipron or any of the ingredients in FOUNDAYO. Inactive ingredients include: Copovidone, crospovidone, magnesium stearate, microcrystalline cellulose, and sodium carbonate anhydrous. The film coating contains polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. The film coating of the 0.8 mg and 9 mg tablets also contains ferric oxide red and ferric oxide yellow, 2.5 mg and 14.5 mg tablets also contains ferric oxide yellow, and 5.5 mg and 17.2 mg tablets also contains ferrosoferric oxide and ferric oxide red.

Before taking FOUNDAYO, tell your healthcare provider about all of your medical conditions, including if you:

• have or have had problems with your pancreas or kidneys.
• have severe problems with your liver.
• have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.
• have a history of diabetic retinopathy.
• are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation).
• are pregnant or plan to become pregnant. FOUNDAYO may harm your unborn baby. Tell your healthcare provider if you become pregnant while taking FOUNDAYO.
• 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).
• Birth control pills by mouth may not work as well while taking FOUNDAYO. If you take birth control pills by mouth, your healthcare provider may recommend another type of birth control for 30 days after you start FOUNDAYO and for 30 days after each increase in your dose of FOUNDAYO. Talk to your healthcare provider about birth control methods that may be right for you while using FOUNDAYO.
• are breastfeeding or plan to breastfeed. Breastfeeding is not recommended during treatment with FOUNDAYO. Talk to your healthcare provider about the best way to feed your baby while using FOUNDAYO.

Before using FOUNDAYO, 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 an insulin or sulfonylurea. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. FOUNDAYO may affect the way some medicines work, and some medicines may affect the way FOUNDAYO works.

What are the possible side effects of FOUNDAYO?

• 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 an insulin or sulfonylurea. Signs and symptoms of low blood sugar may include:
  • dizziness or light-headedness
  • blurred vision
  • anxiety, irritability, or mood changes
  • sweating
  • slurred speech
  • hunger
  • confusion or drowsiness
  • shakiness
  • weakness
  • headache
  • fast heartbeat
  • feeling jittery
• serious allergic reactions. Stop taking 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
  • fainting or feeling dizzy
  • problems breathing or swallowing
  • very rapid heartbeat
  • severe rash or itching
• 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)
  • yellowing of skin or eyes (jaundice)
  • fever
  • 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 all your healthcare providers that you are taking FOUNDAYO before you are scheduled to have surgery or other procedures.

Talk to your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of FOUNDAYO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store FOUNDAYO?

• Store at room temperature between 68°F to 77°F (20°C to 25°C).

• FOUNDAYO is sensitive to light. Protect FOUNDAYO from light by keeping it in the original bottle and carton and replacing the cap each time after opening.

• If you no longer have the carton, store the bottle away from light. Keep FOUNDAYO and all medicines out of the reach of children.

Do not use FOUNDAYO for a condition for which it was not prescribed. Do not give FOUNDAYO to other people, even if they have the same condition you have. It may harm them. You can ask your pharmacist or healthcare provider for information about FOUNDAYO that is written for health professionals.

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Ozempic^®

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

Prescribing information

• black box warning

Common Side effects

• Nausea
• Diarrhea
• Vomiting

Important safety information

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 complete boxed warning.

• In rodents, semaglutide causes thyroid C-cell tumors in 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 symptoms of thyroid tumors.

Do not take OZEMPIC^® if you:

• Have a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN2).
• Have been diagnosed with Diabetes (Type 1)
• Have been diagnosed with pancreatitis or 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. and hydrochloric acid or sodium hydroxide may be added to adjust pH.
  • Oral OZEMPIC® inactive ingredients include: magnesium stearate and salcaprozate sodium
• Have a history of suicidal attempts or active suicidal ideation

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 insulin secretagogue or insulin may be necessary. Inform all patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.
• 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 and males 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
• 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.
• Suicidal Behavior and Ideation: Monitor for depression or suicidal thoughts. Discontinue OZEMPIC^® if symptoms develop.

Side Effects 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. May impact absorption of concomitantly administered oral medications. Use with caution.

USE IN SPECIFIC POPULATIONS

• Pregnancy: May cause fetal harm. When pregnancy is recognized, discontinue OZEMPIC^®.
• Females and Males of Reproductive Potential: Discontinue OZEMPIC^® at least 2 months before a planned pregnancy because of the long half-life of semaglutide.

Wegovy® Pill (semaglutide tablets): Important Safety Information

Wegovy® tablets are prescription GLP-1 medication used with a reduced-calorie diet and increased physical activity for long-term weight reduction in adults with obesity, or adults with overweight and at least one weight-related condition. They are also indicated to reduce the risk of major cardiovascular events in adults with established cardiovascular disease and either obesity or overweight. See the full Prescribing Information, including the boxed warning and the Medication Guide for complete details.

Boxed warning: Risk of thyroid C-cell tumors

Semaglutide causes thyroid C-cell tumors in rodents. It is unknown whether it causes such tumors, including medullary thyroid carcinoma (MTC), in humans. Do not use Wegovy® if you or a family member have had MTC, or if you have multiple endocrine neoplasia syndrome type 2 (MEN 2).

Who should not take Wegovy®

Do not take Wegovy® if you have had a serious allergic reaction to semaglutide or any of the tablet ingredients. Do not use Wegovy® with another semaglutide-containing product or another GLP-1 receptor agonist.

Warnings and precautions

Talk with your healthcare provider about your medical history and medicines, particularly a history of pancreatitis, gallbladder disease, kidney problems, severe stomach problems, diabetic eye disease, or use of insulin or medicines that increase insulin release. Wegovy® may cause pancreatitis, gallbladder problems, low blood sugar (particularly with certain diabetes medicines), dehydration-related kidney problems, severe gastrointestinal reactions, and serious allergic reactions. Wegovy® is not recommended for people with severe gastroparesis. Tell your healthcare team if you are scheduled for surgery or a procedure involving anesthesia or deep sedation.

Pregnancy and other medicines

Wegovy® may harm an unborn baby. Tell your healthcare provider if you are pregnant or plan to become pregnant; stop Wegovy® at least 2 months before a planned pregnancy. Wegovy® can delay stomach emptying and may affect absorption of medicines taken by mouth. Tell your provider about everything you take.

Common side effects

Common side effects include nausea, diarrhea, vomiting, constipation, abdominal pain, headache, tiredness, indigestion, dizziness, bloating, belching, and heartburn. Contact your healthcare provider if side effects bother you or do not go away.

Follow your own prescription label and the current Medication Guide. This summary does not replace the complete Wegovy® Prescribing Information.

Zepbound^®

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

Important safety information

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

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for 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 symptoms of thyroid tumors

Do not use ZEPBOUND^® if you:

• Have a personal or family history of medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN2).
• Have been diagnosed with Diabetes (Type 1)
• Have been diagnosed with pancreatitis or 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.
• Have a history of suicidal attempts or active suicidal ideation

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 insulin secretagogue or insulin may be necessary. Inform all patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia
• 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^®
• 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
• Suicidal Behavior and Ideation: Monitor for depression or suicidal thoughts. Discontinue ZEPBOUND^® if symptoms develop
• 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 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, 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^®
• 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 and Males of Reproductive Potential: Discontinue ZEPBOUND^® at least 2 months before a planned pregnancy because of the long half-life of ZEPBOUND^®

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Mounjaro^®

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

Prescribing information

• black box warning

Common Side effects

• Nausea
• Diarrhea
• Vomiting
• Decreased appetite
• Constipation
• Dyspepsia
• Abdominal pain

Important safety information

MOUNJARO^® (tirzepatide) is a glucose-dependent insulinotropic polypeptide (GIP) receptor and 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 tirzepatide-containing products or GLP-1 receptor agonist is not recommended.
• 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.

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning.

• Tirzepatide causes thyroid C-cell tumors in rats. It is unknown whether MOUNJARO^® 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.
• MOUNJARO^® 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 symptoms of thyroid tumors.

Do not use MOUNJARO^® if you:

• Have a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN2).
• Have been diagnosed with Diabetes (Type 1)
• Have been diagnosed with pancreatitis or 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 MOUNJARO^®. 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

WARNINGS AND PRECAUTIONS

• Pancreatitis: Has been reported in clinical trials. Discontinue promptly if pancreatitis is suspected
• 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 with Concomitant Use of Insulin Secretagogues or Insulin: Concomitant use with an insulin secretagogue or insulin may increase the risk of hypoglycemia. Reducing the dose of insulin secretagogue or insulin may be necessary
• Acute Kidney Injury: Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions
• Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported. Discontinue MOUNJARO^® if suspected and promptly seek medical advice
• 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 MOUNJARO^® at least 2 months before a planned pregnancy because of the long half-life of tirzepatide
• Pregnancy: Based on animal study, may cause fetal harm. When pregnancy is recognized, discontinue MOUNJARO^® immediately
• Diabetic Retinopathy Complications in Patients with a History of Diabetic Retinopathy: 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 Most common side effects (incidence ≥ 5%) of patients treated with MOUNJARO^®: nausea, diarrhea, vomiting, decreased appetite, constipation, dyspepsia, and abdominal pain

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

DRUG INTERACTIONS MOUNJARO^® delays gastric emptying. May impact absorption of concomitantly administered oral medications. Use with caution.

USE IN SPECIFIC POPULATIONS

• Pregnancy: May cause fetal harm. When pregnancy is recognized, discontinue MOUNJARO^®
• 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 and Males of Reproductive Potential: Discontinue MOUNJARO^® at least 2 months before a planned pregnancy because of the long half-life of MOUNJARO^®

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Warning: Risk of Thyroid C-Cell Tumors

• In studies with mice and rats, semaglutide (the active ingredient in Wegovy and Ozempic) caused thyroid tumors, including thyroid cancer. It is not known if Wegovy will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. 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 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).

What is the FDA-approved use of Wegovy?

• 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?

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 prescribing 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 prescribing provider before using Wegovy?

Wegovy has certain drug interactions. It’s important to tell your prescribing 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)
• 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 medications in the GLP-1 medication class, including Ozempic, 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: 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 or male 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: Wegovy was found in the milk of lactating rats. Tell your prescribing 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 (the active ingredient in Wegovy and Ozempic) during pregnancy. Pregnant women exposed to semaglutide and healthcare providers are encouraged to 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 that I or a caregiver should monitor for when taking Wegovy?

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

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 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 severe 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?

• Nausea
• Diarrhea
• Vomiting
• Constipation
• Dysesthesia (skin sensations)
• Stomach pain
• Headache
• Fatigue
• Upset stomach
• Dizziness
• Bloating
• Belching
• Low blood sugar in patients with type 2 diabetes
• Flatulence
• Gastroenteritis
• Heartburn
• Hair loss

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.

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