SAFETY INFORMATION

GetWeightHealthy.com

Important Safety Information

Please see Important Safety Information below for intended use, potential risks and side effects, use in specific populations, and drug interactions of advertised prescription treatments.

Get Weight Healthy encourages the reporting of any adverse side effects of medications to the medical professional and the distributing pharmacy. Additionally, to report suspected adverse reactions to acarbose contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

In case of emergencies, please call 911 or go seek care at the nearest emergency room.

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Wegovy® and Zepbound® are FDA-approved for weight loss. GLP-1 receptor agonists—including Ozempic®, Mounjaro®, Compounded Semaglutide, and Compounded Tirzepatide—have been prescribed (on-and-off label) for weight management, including obesity, along with a reduced caloric diet and increased physical activity. Ozempic® and Mounjaro® are FDA-approved for type 2 diabetes treatment, but may be prescribed off-label for weight loss at a healthcare provider’s discretion. Take precaution with, and read all warnings concerning, GLP-1s, as they may cause serious side effects, including a risk of thyroid c-cell tumors. Do not use if you or your family have a history of a type of thyroid cancer called MTC (medullary thyroid carcinoma) or MEN 2 (multiple endocrine neoplasia syndrome). See important warnings & safety info about these medications. As an alternative to FDA-approved branded products, where appropriate, a provider may prescribe a GLP-1 compounded drug that is effective when prescribed off label for weight loss, which is prepared by a state-licensed sterile compounding pharmacy partner. Although GLP-1 compounded drugs are permitted to be prescribed under federal law, they are not FDA-approved and do not undergo safety, effectiveness, or manufacturing review. Thoroughly review all warnings and essential safety information regarding these drugs.Important safety information may be found below.

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Ozempic® (Semaglutide Injection)

Important Safety Information for Ozempic (semaglutide injection)

Last Updated: 27 September 2024

BLACK BOX WARNING

Warning: Risk of Thyroid C-Cell Tumors

See full prescribing information for complete boxed warning.

BLACK BOX WARNING:

GLP-1s are contraindicated in individuals with a history of medullary thyroid carcinoma, a family history of such, or in patients with multiple endocrine neoplasia syndrome type 2. Do not take them if you have ever had thyroid cancer. In studies with rodents, GLP-1s caused thyroid tumors, including thyroid cancer; it is not known if they will cause thyroid tumors or cancer in humans. Please notify your doctor ASAP if you develop trouble swallowing, hoarseness, a lump or swelling in your neck, or shortness of breath.

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

Tell your healthcare provider about your medical history prior to taking Ozempic®.

Avoid alcohol while taking this medication. If you’re taking diabetes medications, please discuss this with your prescribing doctor before starting Ozempic®, as your diabetes medications may need to be adjusted as you lose weight.

Use adequate contraception while taking this medication. Do not take this medication if pregnant, trying to get pregnant or breastfeeding. If you plan to become pregnant, this medication needs to be stopped at least 2 months before trying. This medication may cause fetal harm.

Notify your doctor if you have kidney, liver, or pancreas problems.

Stop using Ozempic® and call your healthcare provider immediately if you have severe stomach or abdomen pain that will not go away, with or without vomiting.

Stop using Ozempic® 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.

Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported. Discontinue Ozempic® if suspected and promptly seek medical advice.

WARNING

Please contact your doctor ASAP and seek in-person care immediately if a side effect becomes problematic or you experience:

Severe nausea and/or vomiting resulting in dehydration- it is important to stay well hydrated and drink plenty of fluids while on this medication
Kidney problems/kidney failure - vomiting, nausea, diarrhea can cause dehydration and kidney issues and make kidney problems worse in individuals who have pre-existing kidney conditions; may sometimes lead to the need for hemodialysis
Thyroid C-Cell Tumor: Trouble swallowing, hoarseness, a lump or swelling in your neck, or shortness of breath (see black box warning below)
Pancreatitis: Severe pain in your abdomen or back that will not go away
Acute gallbladder disease - Pain in the middle or right upper stomach, fever, white parts of your eyes turn yellow or skin turns yellow, nausea/vomiting. If gallstones or inflammation of the gallbladder is suspected further studies are needed.
Hepatitis/Elevated liver enzymes/Jaundice
Diabetic retinopathy problems: Changes in vision in those with type II diabetes, particularly vision problems may worsen in those with a history of diabetic retinopathy
Severe gastrointestinal disease - may cause gastrointestinal disease; do not use if you have a history of severe gastrointestinal disease
Signs of low blood sugar (for example, dizziness, weakness, shakiness, jitteriness, headache, anxiety/mood changes, rapid heartbeat, confusion, slurred speech, sweating, or lightheadedness). While this is rare with GLP-1s, if it occurs, please seek in-person care immediately. If you have these symptoms, try having liquid or food containing sugar (around 15-20 grams) —drinking juice, having regular soda, or eating some hard candies right away, as this will help raise your blood sugar quickly. If taken with insulin or an insulin secretagogue (ie sulfonylurea) it is best to talk to your healthcare provider about possibly lowering the dose of these medications to lower the risk of hypoglycemia.
Increasing heart rate
Worsening depression, behavior changes, or suicidality
Never share the Ozempic® pen with other people

SIDE EFFECTS

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

Nausea
Constipation
Vomiting
Diarrhea
Abdominal Pain
Headache
Indigestion
Injection site reactions
Dizziness
Back pain
Increased Lipase or Amylase
Altered taste
Nasopharyngitis (common cold)
Passing Gas
Bloating
Belching
Gastroenteritis
Decreased appetite
Fatigue
Gastroesophageal reflux disease
Low blood sugar (hypoglycemia) in those with type II diabetes
Upset stomach

These symptoms often subside as your body adjusts to the medications. Please notify your provider if side effects persist. For a complete list of side effects, review the medication packaging inserts.

DRUG INTERACTIONS

As with other medications, Ozempic® 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. Ozempic® delays gastric emptying and may impact the absorption of oral medications. If you are on thyroid hormone medication, prior to starting Ozempic®, 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 (ie warfarin) should be monitored closely while on Ozempic®.

Please consult the pharmaceutical packaging for a full list of side effects, warnings, interactions and additional information.

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

This information is not comprehensive. Please see the full Prescribing Information and Medication Guide for complete safety information for Ozempic®.

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Wegovy® (Semaglutide Injection)

Important Safety Information for Wegovy® (Semaglutide Injection)

Last Updated: 27 September 2024

BLACK BOX WARNING

Warning: Risk of Thyroid C-Cell Tumors

See full prescribing information for complete boxed warning.

Important Safety Information for Wegovy® (semaglutide) injection

BLACK BOX WARNING

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

Tell your healthcare provider about your medical history prior to taking Wegovy®.

Avoid alcohol while taking this medication. If you’re taking diabetes medications, please discuss this with your prescribing doctor before starting Wegovy®, as your diabetes medications may need to be adjusted as you lose weight.

Notify your doctor if you have kidney, liver, or pancreas problems.

Stop using Wegovy® and call your healthcare provider immediately if you have severe stomach or abdomen pain that will not go away, with or without vomiting.

Stop using Wegovy® 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.

Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported. Discontinue Wegovy® if suspected and promptly seek medical advice.

WARNING

Please contact your doctor ASAP and seek in-person care immediately if a side effect becomes problematic or you experience:

Severe nausea and/or vomiting resulting in dehydration- it is important to stay well hydrated and drink plenty of fluids while on this medication
Kidney problems/kidney failure - vomiting, nausea, diarrhea can cause dehydration and kidney issues and make kidney problems worse in individuals who have pre-existing kidney conditions; may sometimes lead to the need for hemodialysis
Thyroid C-Cell Tumor: Trouble swallowing, hoarseness, a lump or swelling in your neck, or shortness of breath (see black box warning below)
Pancreatitis: Severe pain in your abdomen or back that will not go away
Acute gallbladder disease - Pain in the middle or right upper stomach, fever, white parts of your eyes turn yellow or skin turns yellow, nausea/vomiting. If gallstones or inflammation of the gallbladder is suspected further studies are needed.
Hepatitis/Elevated liver enzymes/Jaundice
Diabetic retinopathy problems: Changes in vision in those with type II diabetes, particularly vision problems may worsen in those with a history of diabetic retinopathy
Severe gastrointestinal disease - may cause gastrointestinal disease; do not use if you have a history of severe gastrointestinal disease
Signs of low blood sugar (for example, dizziness, weakness, shakiness, jitteriness, headache, anxiety/mood changes, rapid heartbeat, confusion, slurred speech, sweating, or lightheadedness). While this is rare with GLP-1s, if it occurs, please seek in-person care immediately. If you have these symptoms, try having liquid or food containing sugar (around 15-20 grams) —drinking juice, having regular soda, or eating some hard candies right away, as this will help raise your blood sugar quickly. If taken with insulin or an insulin secretagogue (i.e., sulfonylurea) it is best to talk to your healthcare provider about possibly lowering the dose of these medications to lower the risk of hypoglycemia.
Increasing heart rate
Worsening depression, behavior changes, or suicidality
Never share the Wegovy® pen with other people

SIDE EFFECTS

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

DRUG INTERACTIONS

As with other medications, Wegovy® 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. Wegovy® delays gastric emptying and may impact the absorption of oral medications. If you are on thyroid hormone medication, prior to starting Wegovy®, 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 Wegovy®.

Please consult the pharmaceutical packaging for a full list of side effects, warnings, interactions and additional information.

This information is not comprehensive. Please see the full Prescribing Information and Medication Guide for Wegovy®

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Mounjaro® (Tirzepatide Injection)

Important Safety Information for Mounjaro® (Tirzepatide Injection)

Last Updated: 27 September 2024

BLACK BOX WARNING

Warning: Risk of Thyroid C-Cell Tumors

See full prescribing information for complete boxed warning.

BLACK BOX WARNING:

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

Tell your healthcare provider about your medical history prior to taking Mounjaro®.

Avoid alcohol while taking this medication. If you’re taking diabetes medications, please discuss this with your prescribing doctor before starting Mounjaro®, as your diabetes medications may need to be adjusted as you lose weight.

Females of reproductive potential should use adequate contraception while taking this medication. It is advised to use a non-oral contraceptive method (instead of oral contraceptive) or, if using oral contraception- add a barrier method of contraception 4 weeks after initiation and 4 weeks after dose escalation.

Do not take this medication if pregnant, trying to get pregnant or breastfeeding. If you plan to become pregnant, this medication needs to be stopped at least 2 months before trying. This medication may cause fetal harm.

Notify your doctor if you have kidney, liver, or pancreas problems.

Stop using Mounjaro® and call your healthcare provider immediately if you have severe stomach or abdomen pain that will not go away, with or without vomiting.

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; or very rapid heartbeat.

Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported. Discontinue Mounjaro® if suspected and promptly seek medical advice.

WARNING

Please contact your doctor ASAP and seek in-person care immediately if a side effect becomes problematic or you experience:

SIDE EFFECTS INFORMATION

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

DRUG INTERACTIONS

As with other medications, Mounjaro® 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. Mounjaro® delays gastric emptying and may impact the absorption of oral medications. If you are on thyroid hormone medication, prior to starting Mounjaro®, 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 (ie warfarin) should be monitored closely while on Mounjaro®.

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

Please consult the pharmaceutical packaging for a full list of side effects, warnings, interactions and additional information. This information is not comprehensive. Please see the full Prescribing Information, Instructions for Use, and Medication Guide for complete safety information for Mounjaro®.

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Zepbound® (Tirzepatide Injection)

Important Safety Information for Zepbound® (Tirzepatide Injection)

Last Updated: 27 September 2024

BLACK BOX WARNING

Warning: Risk of Thyroid C-Cell Tumors

See full prescribing information for complete boxed warning.

Important Safety Information for Zepbound® (tirzepatide) injection

BLACK BOX WARNING

Terzepatide is contraindicated in individuals with a history of medullary thyroid carcinoma, a family history of such, or in patients with multiple endocrine neoplasia syndrome type 2. Do not take it if you have ever had thyroid cancer. In studies with rodents, tirzepatide caused thyroid tumors, including thyroid cancer; it is not known if it will cause thyroid tumors or cancer in humans. Please notify your doctor ASAP if you develop trouble swallowing, hoarseness, a lump or swelling in your neck, or shortness of breath.

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

Tell your health care provider about your medical history prior to taking Zepbound.

Avoid alcohol while taking this medication. If you’re taking diabetes medications, please discuss this with your prescribing doctor before starting Zepbound, as your diabetes medications may need to be adjusted as you lose weight.

People of childbearing age should use reliable birth control while taking this medication. Use a non-oral contraceptive method (instead of an oral contraceptive). If you use oral contraception, add a barrier method of contraception during the first four weeks after initiation and for four weeks after dose escalation.

This medication may cause fetal harm. Do not take this medication if pregnant, trying to get pregnant, or breastfeeding. If you plan to become pregnant, this medication needs to be stopped at least two months before trying. Notify your doctor if you have kidney, liver, or pancreas problems.

Stop using Zepbound and call your health care provider immediately if you have severe stomach or abdomen pain that will not go away, with or without vomiting.

Stop using Zepbound 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 a very rapid heartbeat.

Severe hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported. Discontinue Zepbound if suspected and promptly seek medical advice.

WARNING

Please get in touch with your doctor ASAP and seek in-person care immediately if a side effect becomes problematic or you experience:

Severe nausea and/or vomiting resulting in dehydration; it is important to stay well hydrated and drink plenty of fluids while on this medication.
Kidney problems/kidney failure: vomiting, nausea, and diarrhea can cause dehydration and kidney issues and make kidney problems worse in individuals who have pre-existing kidney conditions; it may sometimes lead to the need for hemodialysis.
Severe stomach problems, including abdominal bloating or pain, acid reflux, a feeling of fullness after eating just a few bites of food, nausea, and vomiting, including vomiting undigested food eaten a few hours earlier. This may be a symptom of gastroparesis. Also tell your health care provider if you have stomach problems that will not go away.
An inability to pass gas or stool is a symptom of possible bowel obstruction. Other symptoms may include severe abdominal pain, nausea, and vomiting.
Thyroid C-cell tumor: Trouble swallowing, hoarseness, a lump or swelling in your neck, or shortness of breath (see black box warning below).
Pancreatitis: Severe pain in your abdomen or back that will not go away.
Acute gallbladder disease: Pain in the middle or right upper stomach, fever, white parts of your eyes or skin turning yellow or skin turns yellow, nausea/vomiting. If gallstones or inflammation of the gallbladder are suspected, further studies are needed.
Hepatitis, elevated liver enzymes/jaundice.
Diabetic retinopathy problems: Changes in vision in those with type 2 diabetes, particularly vision problems, may worsen in those with a history of diabetic retinopathy.
Severe gastrointestinal disease: may cause gastrointestinal disease; do not it use if you have a history of severe gastrointestinal disease.
Signs of low blood sugar (for example, dizziness, weakness, shakiness, jitteriness, headache, anxiety/mood changes, rapid heartbeat, confusion, slurred speech, sweating, or lightheadedness): While this is rare with GLP-1s, if it occurs, please seek in-person care immediately. If you have these symptoms, try having liquid or food containing sugar (around 15-20 grams)—drinking juice, having regular soda, or eating some hard candies right away, as this will help raise your blood sugar quickly. If taken with insulin or an insulin secretagogue (e.g., sulfonylurea), it is best to talk to your health care provider about possibly lowering the dose of these medications to lower the risk of hypoglycemia.
Increasing heart rate.
Worsening depression, behavior changes, or suicidality.
Note: Never share your Zepbound pen with other people.

SIDE EFFECTS

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

Nausea
Constipation
Vomiting
Diarrhea
Abdominal pain
Headache
Indigestion
Injection site reactions
Dizziness
Back pain
Increased lipase or amylase
Altered taste
Nasopharyngitis (common cold)
Passing gas
Bloating
Belching
Gastroenteritis
Decreased appetite
Fatigue
Gastroesophageal reflux disease
Low blood sugar (hypoglycemia) in those with type 2 diabetes
Upset stomach

DRUG INTERACTIONS

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

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. In case of emergencies, please call 911 or go to the nearest emergency room.

Please consult the pharmaceutical packaging for a full list of side effects, warnings, interactions and additional information.

This information is not comprehensive. Please see the full Prescribing Information and Medication Guide for Zepbound®.

Compounded Semaglutide (Injection)

Important Safety Information for Compounded Semaglutide (Injection)

Last Updated: 27 September 2024

BLACK BOX WARNING

Warning: Risk of Thyroid C-Cell Tumors

See full prescribing information for complete boxed warning.

* As an alternative to FDA-approved branded products, where appropriate, a provider may prescribe a compounded drug, which is prepared by a state-licensed sterile compounding pharmacy partner. 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. Your provider may recommend certain doses of compounded semaglutide based on your medical evaluation. FDA-approved medicines containing semaglutide are available.

Important Safety Information for Compounded Semaglutide (Injection)

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 people
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)

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 become pregnant
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.

What are the possible side effects of Semaglutide?

Semaglutide may cause serious side effects, including:

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, headache, tiredness (fatigue), upset stomach, dizziness, feeling bloated, belching, gas, stomach flu, heartburn, and runny nose or sore throat.

Semaglutide is a prescription medication.

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

This summary provides basic information about compounded semaglutide but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. 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 consult the pharmaceutical packaging for a full list of side effects, warnings, interactions and additional information.

You are encouraged to report negative side effects of compounded semaglutide to the FDA. Visit 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. This product is not intended to diagnose, treat, cure, or prevent any disease.

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Compounded Tirzepatide (Injection)

Important Safety Information for Compounded Tirzepatide (Injection)

Last Updated: 27 September 2024

BLACK BOX WARNING

Warning: Risk of Thyroid C-Cell Tumors

See full prescribing information for complete boxed warning.

* As an alternative to FDA-approved branded products, where appropriate, a provider may prescribe a compounded drug, which is prepared by a state-licensed sterile compounding pharmacy partner. 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. 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 people. Do not use Tirzepatide if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC), or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

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.

Common side effects
The most common side effects of Tirzepatide include nausea, diarrhea, decreased appetite, vomiting, constipation, indigestion, and 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. Read the information that comes with your prescription each time your prescription is filled. 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 consult the pharmaceutical packaging for a full list of side effects, warnings, interactions and additional information.

You are encouraged to report negative side effects of compounded Tirzepatide to the FDA. Visit 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. This product is not intended to diagnose, treat, cure, or prevent any disease.

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