Important Safety Information

The safety information for this product was compiled by NextMeds and has not been reviewed by the FDA. This information is provided for your reference and may not address all potential risks or considerations that may apply to you. Please consult your healthcare provider regarding the risks associated with this medication and whether it is appropriate for you.

⚠️ WARNING: RISK OF THYROID C-CELL TUMORS

BLACK BOX WARNING:

Although compounded drugs are permitted to be prescribed under federal law, they are not FDA-approved and do not undergo safety, effectiveness, or manufacturing review. They are prepared by state-licensed pharmacies. Your provider may recommend certain doses of compounded semaglutide based on your medical evaluation. FDA-approved medicines containing semaglutide are available.

What is the most important information I should know about Semaglutide?

Semaglutide 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, Semaglutide and medicines that work like Semaglutide caused thyroid tumors, including thyroid cancer. It is not known if Semaglutide will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in humans.

Do not use Semaglutide if:

• You or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• You have had a serious allergic reaction to semaglutide or any of the ingredients in Semaglutide.

Before using Semaglutide, tell your healthcare provider if you have any other medical conditions, including if you:

• Have or have had problems with your pancreas or kidneys.
• Have type 2 diabetes and a history of diabetic retinopathy.
• Have or have had depression, suicidal thoughts, or mental health issues.
• Are pregnant or plan to become pregnant. Semaglutide may harm your unborn baby. You should stop using Semaglutide 2 months before you plan to conceive.
• Are breastfeeding or plan to breastfeed. It is not known if Semaglutide passes into your breast milk.

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

Semaglutide may cause serious side effects, including:

If you experience a medical emergency, call 911 or go to the nearest emergency room.

Inflammation of your pancreas (pancreatitis): Stop using Semaglutide and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.

Gallbladder problems: Semaglutide may cause gallbladder problems, including gallstones. Some gallstones may need surgery. Call your healthcare provider if you have symptoms, such as pain in your upper stomach (abdomen), fever, yellowing of the skin or eyes (jaundice), or clay-colored stools.

Increased risk of low blood sugar (hypoglycemia) in patients with type 2 diabetes, especially those who also take medicines for type 2 diabetes such as sulfonylureas or insulin: This can be both a serious and common side effect. Talk to your healthcare provider about how to recognize and treat low blood sugar and check your blood sugar before you start and while you take Semaglutide. Signs and symptoms of low blood sugar may include dizziness or light-headedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, or feeling jittery.

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

Serious allergic reactions: Stop using Semaglutide and get medical help right away, if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat.

Change in vision in people with type 2 diabetes: Tell your healthcare provider if you have changes in vision during treatment with Semaglutide.

Increased heart rate: Semaglutide can increase your heart rate while you are at rest. Tell your healthcare provider if you feel your heart racing or pounding in your chest and it lasts for several minutes.

Depression or thoughts of suicide: You should pay attention to any mental changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.

The most common side effects of Semaglutide may include:

• Nausea
• Diarrhea
• Vomiting
• Constipation
• Stomach (Abdomen) Pain

These are not all the possible side effects of Semaglutide. Talk to your healthcare provider about any side effect that bothers you or doesn't go away.

Drug Interactions

As with other medications, compounded Semaglutide can interact with alcohol and certain prescription and non-prescription medications and herbal products. The risk of hypoglycemia is increased when combined with insulin or insulin secretagogues such as sulfonylureas. Semaglutide delays gastric emptying and may impact the absorption of oral medications. If you are on thyroid hormone medication, prior to starting Semaglutide, please review the timing of taking your thyroid hormone medication with the doctor who prescribes it as it may need to be adjusted. The drug levels of medications with narrow therapeutic windows (i.e., warfarin) should be monitored closely while on Semaglutide.

This summary provides basic information about compounded semaglutide but does not include all information known about this medicine. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about compounded semaglutide and how to take it. Your healthcare provider is the best person to help you decide if compounded semaglutide is right for you.

Please review all information provided by your compounding pharmacy and healthcare provider, including information about potential side effects, warnings, precautions, drug interactions, dosing instructions, and other important safety information. Contact your healthcare provider or pharmacist if you have any questions. Compounded medications are not FDA-approved and may not be accompanied by FDA-approved prescribing information.

You are encouraged to report negative side effects to the FDA. Visit https://www.fda.gov/medwatch or call 1-800-FDA-1088. In case of emergencies, please call 911 or go to the nearest emergency room.

Note: The above statements have not been evaluated by the Food and Drug Administration.

The safety information for this product was compiled by NextMeds and has not been reviewed by the FDA. This information is provided for your reference and may not address all potential risks or considerations that may apply to you. Please consult your healthcare provider regarding the risks associated with this medication and whether it is appropriate for you.

⚠️ WARNING: RISK OF THYROID C-CELL TUMORS

Although compounded drugs are permitted to be prescribed under federal law, they are not FDA-approved and do not undergo safety, effectiveness, or manufacturing review. They are prepared by state-licensed pharmacies. Your provider may recommend certain doses of compounded Tirzepatide based on your medical evaluation. FDA-approved medicines containing Tirzepatide are available.

What is the most important information I should know about compounded Tirzepatide?

Tirzepatide 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 rats, Tirzepatide and medicines that work like Tirzepatide caused thyroid tumors, including thyroid cancer. It is not known if Tirzepatide will cause thyroid tumors, or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in humans.

Do not use Tirzepatide if:

• You or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).
• You have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Before using Tirzepatide, tell your healthcare provider if you have any other medical conditions, including if you:

• Have or have had problems with your pancreas or kidneys.
• Have type 2 diabetes and a history of diabetic retinopathy.
• Have or have had depression, suicidal thoughts, or mental health issues.
• Are pregnant or plan to become pregnant. Tirzepatide may harm your unborn baby. You should stop using Tirzepatide 2 months before you plan to conceive.
• Are breastfeeding or plan to breastfeed. It is not known if Tirzepatide passes into your breast milk.

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

Tirzepatide may cause serious side effects, including:

Inflammation of the pancreas (pancreatitis): Stop using Tirzepatide and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.

Low blood sugar (hypoglycemia): Your risk for getting low blood sugar may be higher if you use Tirzepatide 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 Tirzepatide and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, and very rapid heartbeat.

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

Severe stomach problems: Stomach problems, sometimes severe, have been reported in people who use Tirzepatide. 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 Tirzepatide.

Gallbladder problems: Gallbladder problems have happened in some people who use Tirzepatide. 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.

Serious allergic reactions: Stop using Tirzepatide 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.

Side Effects

Many people experience no side effects. Some of the most common or potential side effects of Tirzepatide include:

• Nausea
• Diarrhea
• Decreased Appetite
• Vomiting
• Constipation
• Indigestion
• Stomach (Abdominal) Pain

These are not all the possible side effects of Tirzepatide. Talk to your healthcare provider about any side effect that bothers you or doesn't go away.

Drug Interactions

As with other medications, compounded Tirzepatide can interact with alcohol and certain prescription and non-prescription medications and herbal products. The risk of hypoglycemia is increased when combined with insulin or insulin secretagogues such as sulfonylureas. Tirzepatide delays gastric emptying and may impact the absorption of oral medications. If you are on thyroid hormone medication, prior to starting Tirzepatide, please review the timing of taking your thyroid hormone medication with the doctor who prescribes it as it may need to be adjusted. The drug levels of medications with narrow therapeutic windows (i.e., warfarin) should be monitored closely while on Tirzepatide.

This summary provides basic information about compounded Tirzepatide but does not include all information known about this medicine. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about compounded Tirzepatide and how to take it. Your healthcare provider is the best person to help you decide if compounded Tirzepatide is right for you.

Please review all information provided by your compounding pharmacy and healthcare provider, including information about potential side effects, warnings, precautions, drug interactions, dosing instructions, and other important safety information. Contact your healthcare provider or pharmacist if you have any questions. Compounded medications are not FDA-approved and may not be accompanied by FDA-approved prescribing information.

You are encouraged to report negative side effects of compounded Tirzepatide to the FDA. Visit https://www.fda.gov/medwatch or call 1-800-FDA-1088. In case of emergencies, please call 911 or go to the nearest emergency room.

Note: The above statements have not been evaluated by the Food and Drug Administration.

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.

IMPORTANT SAFETY INFORMATION

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

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 of reproductive potential: Discontinue OZEMPIC® at least 2 months before a planned pregnancy because of the long half-life of semaglutide.
• Pregnancy: May cause fetal harm. When pregnancy is recognized, discontinue OZEMPIC® immediately.
• Breastfeeding: Breastfeeding is not recommended during treatment with OZEMPIC®. Talk to your healthcare provider about the best way to feed your baby while using OZEMPIC®.
• Diabetic Retinopathy Complications in Patients with Type 2 Diabetes: Has been reported in trials with OZEMPIC®. Patients with a history of diabetic retinopathy should be monitored.
• Heart Rate Increase: Monitor heart rate at regular intervals.

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

For more information see the full Ozempic label here: Ozempic Label

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

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

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

Limitations of Use:

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

IMPORTANT SAFETY INFORMATION

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

Do not take WEGOVY® 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 WEGOVY®.
  • Injectable WEGOVY® inactive ingredients include: di-sodium phosphate dihydrate, sodium chloride, water for injection, and hydrochloric acid or sodium hydroxide may be added to adjust pH.
  • Oral WEGOVY® inactive ingredients include: magnesium stearate and Salcaprozate sodium.

WARNINGS AND PRECAUTIONS

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

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

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

DRUG INTERACTIONS WEGOVY® delays gastric emptying. 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 WEGOVY®
• Breastfeeding: Breastfeeding is not recommended during treatment with WEGOVY®. Talk to your healthcare provider about the best way to feed your baby while using WEGOVY®.
• Females of Reproductive Potential: Discontinue WEGOVY® at least 2 months before a planned pregnancy because of the long half-life of semaglutide.

For more information see the full Wegovy label here: Wegovy Label

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.

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®
• Breastfeeding: Breastfeeding is not recommended during treatment with ZEPBOUND®. Talk to your healthcare provider about the best way to feed your baby while using ZEPBOUND®.
• Diabetic Retinopathy Complications in Patients with Type 2 Diabetes: Has not been studied in patients with nonproliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy, or diabetic macular edema. Monitor patients with a history of diabetic retinopathy for progression
• Pulmonary Aspiration During General Anesthesia or Deep Sedation: Has been reported in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures. Instruct patients to inform healthcare providers of any planned surgeries or procedures.

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

For more information see the full Zepbound label here: Zepbound Label