Important safety information

See important safety information, including boxed warnings for:

• Compounded semaglutide
• Compounded tirzepatide

Compounded semaglutide

While compounded drugs are legal under federal law, they haven’t been evaluated by the FDA for safety or effectiveness, and their manufacturing processes aren’t subject to FDA review. Based on your medical evaluation, your NiceRx-affiliated provider may recommend specific doses of compounded semaglutide.

Black Box Warning: Risk of Thyroid C-Cell Tumors

Semaglutide is contraindicated in individuals with a history or family history of medullary thyroid cancer (MTC), or individuals with multiple endocrine neoplasia syndrome type 2 (MEN2). Do not take semaglutide if you have ever had thyroid cancer.

The black box warning also warns of the risk of thyroid cancer. Studies in mice and rats showed that semaglutide (the active ingredient in Wegovy and Ozempic) caused thyroid tumors, including thyroid cancer. It’s not known if semaglutide will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. It’s important to tell your medical provider if you notice any lumps or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath, as these could be symptoms of thyroid cancer.

Who should not take semaglutide

You should NOT take semaglutide if you or anyone in your family has 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). Also, don’t take it if you’re allergic to semaglutide (the active ingredient in Wegovy and Ozempic) or its ingredients.

What is semaglutide used for?

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist medication for chronic weight management. It’s used along with a reduced-calorie diet and increased physical activity for people who are:

• Obese (BMI of 30 or greater)
• Overweight (BMI of 27 or greater) with weight-related health issues like high blood pressure, type 2 diabetes, dyslipidemia or high cholesterol.

Important limitations

• Don’t use semaglutide with other medications containing semaglutide or other GLP-1 receptor agonists.
• The efficacy and safety of using semaglutide with other weight loss products have not been established.
• It hasn’t been studied in people with a history of pancreatitis.
• It shouldn’t be used by people with type 1 diabetes mellitus.

How to administer semaglutide

You can take semaglutide with or without food. The injection is self-administered subcutaneously under the skin of your stomach, thigh, or upper arm once weekly on the same day every week. Your provider will give you detailed instructions and might gradually increase your dose every four weeks. Contact your NiceRx-affiliated provider if you have any questions. Don’t change your dose or stop taking semaglutide without talking to your medical provider first.

Before you start semaglutide

Semaglutide has certain drug interactions. Make sure to tell your NiceRx-affiliated medical provider doctor about ALL the medications you’re taking, including prescription and over-the-counter drugs, vitamins, and supplements. Some medications might interact with semaglutide, especially those used to treat type 1 or type 2 diabetes, including sulfonylureas or insulin (such as Glucotrol XL or Amaryl).

Since semaglutide can affect how your stomach empties (gastric emptying), it could also affect how your body absorbs other oral medications. Your doctor can help you schedule the best timing for your medications.

Make sure to tell your medical provider if you’re taking any other medications in the same drug class, including but not limited to Ozempic, Wegovy, Zepbound, Mounjaro, Saxenda, Trulicity, Victoza, Bydureon, or Byetta, or if you are using any other weight loss products including dietary supplements.

It’s important to share your full medical history with your medical provider, especially if you have or have a history of:

• Type 1 or type 2 diabetes
• Thyroid cancer
• Pancreatitis
• Kidney disease
• Eye problems related to diabetes (Diabetic retinopathy)
• Suicidal thoughts or related behavior
• Depression
• Problems with your intestines (Ileus)

Pregnancy and breastfeeding

Semaglutide shouldn’t be used during pregnancy or if you are planning to become pregnant. Studies in animals suggest there could be risks to the unborn baby from exposure to semaglutide while pregnant. There’s no benefit to trying to lose weight while pregnant, and it might even harm the baby.  Stop taking semaglutide at least 2 months before planning to become pregnant since the drug can stay in the bloodstream for a long period of time.

Do not take semaglutide if you are breastfeeding. It’s not yet known if semaglutide passes into human breast milk. If you’re breastfeeding, it’s important to discuss this with your NiceRx-affiliated healthcare provider before starting semaglutide.

Be honest with your doctor

It’s extremely important to be honest with your doctor about your health and medical history. Giving them inaccurate information could be harmful and, in some cases, even cause death.

Serious side effects to monitor

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

Semaglutide can cause serious side effects especially when starting treatment or changing doses. You or a caregiver should closely monitor these side effects. Some serious side effects to monitor include:

• Severe nausea and/or vomiting results in dehydration: Make sure to stay well hydrated and drink plenty of fluids while on semaglutide.
• Thyroid C-cell tumors: Lumps or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. (see black box warning)
• Pancreatitis (inflammation of the pancreas): Monitor for signs of acute pancreatitis, including severe abdominal pain that doesn’t go away, which may radiate to the back, with or without vomiting.
• Acute gallbladder disease (gallbladder problems): Tell your doctor if you have pain in your middle or right upper stomach, fever, yellowing of your skin or eyes, fever, or clay-colored stools. If inflammation of the gallbladder or gallstones is suspected, further studies are needed.
• Low blood sugar: Monitor for signs such as dizziness, weakness, shakiness, jitteriness, headache, mood/anxiety changes, confusion, rapid heartbeat, sweating, slurred speech, or lightheadedness. While rare with semaglutide, if this occurs, seek in-person care immediately.  This is more common if you have type 2 diabetes and take other medications for it – it’s best to speak with your healthcare provider about possibly lowering the dosage of these medications to lower the risk of hypoglycemia.
• Acute kidney injury (kidney problems): In individuals who have kidney problems, nausea, diarrhea, and vomiting may cause dehydration (loss of fluids) and may cause kidney problems to worsen. Make sure to drink plenty of water, especially if you already have kidney issues.
• Serious allergic reactions: Stop taking semaglutide and get medical help if you have swelling of your face, lips, tongue, or throat; a severe rash; a very fast heartbeat; trouble breathing; or if you faint or feel dizzy.
• Diabetic retinopathy complications (eye problems) in people with type 2 diabetes: If you have type 2 diabetes, tell your doctor about any changes in your vision.
• Increased heart rate: Let your doctor know if you have a racing heartbeat while at rest.
• Worsening depression or suicidal thoughts and behavior: Pay attention to any mental health changes changes, especially in your mood, feelings or thoughts, and tell your doctor right away if you have any mental changes that are new, worsen, or concern you.

Never share needles or syringes, as this can cause infections. Do not share semaglutide with other people.

Common side effects

Some common side effects of semaglutide include:

• Nausea
• Diarrhea
• Vomiting
• Constipation
• Stomach (abdominal) pain
• Headache
• Fatigue
• Dyspepsia

Drug interactions

It’s important to remember that semaglutide, like other medications, might interact with alcohol and other medications whether they’re prescription or over-the-counter) or herbal products you might be taking. If you’re taking insulin or medications that help your body release more insulin (like insulin secretagogues such as sulfonylureas), combining them with semaglutide can increase your risk of low blood sugar. Semaglutide can slow down how quickly your stomach empties (gastric emptying) and might affect how your body absorbs any other medications you take by mouth. If you’re taking thyroid or papillary hormone medication, it’s really important to talk to the doctor who prescribed it before you start taking semaglutide. They might need to adjust the timing of when you take your other medications. The drug levels of medications with a narrow therapeutic index (e.g. warfarin) should also be closely monitored while on semaglutide. Semaglutide should not be used with any other drugs in the same drug class.

Semaglutide may affect the efficacy of birth control pills. Speak with your provider before starting semaglutide if you are taking birth control. Your provider may recommend an alternative birth control for 4 weeks after you start taking semaglutide, and for 4 weeks after.

If you experience any negative side effects of prescription medications, please report them to the FDA. You can contact FDA MedWatch at 1-800-FDA-1088 or visit their website www.fda.gov/medwatch.

This information is not comprehensive. Always check the pharmaceutical packaging for a full list of warnings, side effects, interactions, and additional information, or talk to your healthcare provider for complete information and guidance.

Note: The above statements have not been reviewed or evaluated by the U.S. Food and Drug Administration (FDA). This product is not intended to diagnose, cure, treat or prevent any disease.

Compounded tirzepatide

While compounded drugs are legal under federal law, they haven’t been evaluated by the FDA for safety or effectiveness, and their manufacturing processes aren’t subject to FDA review. Based on your medical evaluation, your NiceRx-affiliated provider may recommend specific doses of compounded tirzepatide.

Black Box Warning: Risk of Thyroid C-Cell Tumors

Tirzepatide is contraindicated in individuals with a history or family history of medullary thyroid cancer (MTC), or individuals with multiple endocrine neoplasia syndrome type 2 (MEN2). Do not take semaglutide if you have ever had thyroid cancer.

The black box warning also warns of the risk of thyroid cancer. Studies in mice and rats showed that tirzepatide (the active ingredient in Zepbound and Mounjaro) caused thyroid tumors, including thyroid cancer. It’s not known if tirzepatide will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. It’s important to tell your medical provider if you notice any lumps or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath, as these could be symptoms of thyroid cancer.

Who should not take tirzepatide

You should NOT take tirzepatide if you or anyone in your family has 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). Also, don’t take it if you’re allergic to tirzepatide (the active ingredient in Zepbound and Mounjaro) or its ingredients.

What is tirzepatide used for?

Tirzepatide is a glucagon-like peptide-1 (GLP-1) receptor agonist medication for chronic weight management. It’s used along with a reduced-calorie diet and increased physical activity for people who are:

• Obese (BMI of 30 or greater)
• Overweight (BMI of 27 or greater) with weight-related health issues like high blood pressure, type 2 diabetes, dyslipidemia or high cholesterol.

Important limitations

• Don’t use tirzepatide with other medications containing tirzepatide or other GLP-1 receptor agonists.
• The efficacy and safety of using tirzepatide with other weight loss products have not been established.
• It hasn’t been studied in people with a history of pancreatitis.
• It shouldn’t be used by people with type 1 diabetes mellitus.

How to administer tirzepatide

You can take tirzepatide with or without food. The injection is self-administered subcutaneously under the skin of your stomach, thigh, or upper arm once weekly on the same day every week. Your provider will give you detailed instructions and might gradually increase your dose every four weeks. Contact your NiceRx-affiliated provider if you have any questions. Don’t change your dose or stop taking tirzepatide without talking to your medical provider first.

Before you start tirzepatide

tirzepatide has certain drug interactions. Make sure to tell your NiceRx-affiliated medical provider doctor about ALL the medications you’re taking, including prescription and over-the-counter drugs, vitamins, and supplements. Some medications might interact with tirzepatide, especially those used to treat type 1 or type 2 diabetes, including sulfonylureas or insulin (such as Glucotrol XL or Amaryl).

Since tirzepatide can affect how your stomach empties (gastric emptying), it could also affect how your body absorbs other oral medications. Your doctor can help you schedule the best timing for your medications.

Make sure to tell your medical provider if you’re taking any other medications in the same drug class, including but not limited to Ozempic, Wegovy, Zepbound, Mounjaro, Saxenda, Trulicity, Victoza, Bydureon, or Byetta, or if you are using any other weight loss products including dietary supplements.

It’s important to share your full medical history with your medical provider, especially if you have or have a history of:

• Type 1 or type 2 diabetes
• Thyroid cancer
• Pancreatitis
• Gastrointestinal disease
• Kidney disease
• Eye problems related to diabetes (Diabetic retionpathy)
• Suicidal thoughts or related behavior
• Depression

Pregnancy and breastfeeding

tirzepatide shouldn’t be used during pregnancy or if you are planning to become pregnant. Studies in animals suggest there could be risks to the unborn baby from exposure to tirzepatide while pregnant. There’s no benefit to trying to lose weight while pregnant, and it might even harm the baby.  Stop taking tirzepatide at least 2 months before planning to become pregnant since the drug can stay in the bloodstream for a long period of time.

Do not take tirzepatide if you are breastfeeding. It’s not yet known if tirzepatide passes into human breast milk. If you’re breastfeeding, it’s important to discuss this with your NiceRx-affiliated healthcare provider before starting tirzepatide.

Be honest with your doctor

It’s extremely important to be honest with your doctor about your health and medical history. Giving them inaccurate information could be harmful and, in some cases, even cause death.

Serious side effects to monitor

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

tirzepatide can cause serious side effects especially when starting treatment or changing doses. You or a caregiver should closely monitor these side effects. Some serious side effects to monitor include:

• Severe nausea and/or vomiting results in dehydration: Make sure to stay well hydrated and drink plenty of fluids while on semaglutide.
• Thyroid C-cell tumors: Lumps or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. (see black box warning)
• Severe gastrointestinal disease: Tirzepatide can cause some gastrointestinal side effects  like nausea, diarrhea, vomiting, constipation, and stomach pain. Sometimes these can be pretty intense. It’s important to know that Zepbound hasn’t been studied in people with severe gastrointestinal disease and isn’t recommended for these people. The majority of nausea, vomiting, and diarrhea typically occurred during dose increase and decreased over time.
• Pancreatitis (inflammation of the pancreas): Monitor for signs of acute pancreatitis, including severe abdominal pain that doesn’t go away, which may radiate to the back, with or without vomiting.
• Acute gallbladder disease (gallbladder problems): Tell your doctor if you have pain in your middle or right upper stomach, fever, yellowing of your skin or eyes, fever, or clay-colored stools. If inflammation of the gallbladder or gallstones is suspected, further studies are needed.
• Low blood sugar: Monitor for signs such as dizziness, weakness, shakiness, jitteriness, headache, mood/anxiety changes, confusion, rapid heartbeat, sweating, slurred speech, or lightheadedness. While rare with semaglutide, if this occurs, seek in-person care immediately.  This is more common if you have type 2 diabetes and take other medications for it – it’s best to speak with your healthcare provider about possibly lowering the dosage of these medications to lower the risk of hypoglycemia.
• Acute kidney injury (kidney problems): In individuals who have kidney problems, nausea, diarrhea, and vomiting may cause dehydration (loss of fluids) and may cause kidney problems to worsen. Make sure to drink plenty of water, especially if you already have kidney issues.
• Serious allergic reactions: Stop taking semaglutide and get medical help if you have swelling of your face, lips, tongue, or throat; a severe rash; a very fast heartbeat; trouble breathing; or if you faint or feel dizzy.
• Diabetic retinopathy complications (eye problems) in people with type 2 diabetes: If you have type 2 diabetes, tell your doctor about any changes in your vision.
• Increased heart rate: Let your doctor know if you have a racing heartbeat while at rest.
• Worsening depression or suicidal thoughts and behavior: Pay attention to any mental health changes changes, especially in your mood, feelings or thoughts, and tell your doctor right away if you have any mental changes that are new, worsen, or concern you.
• Pulmonary aspiration during general anesthesia or deep sedation: Tirzepatide can slow down how quickly your stomach empties. There have been some cases where people taking GLP-1 medications including tirzepatide have inhaled food or liquid from their stomach into their lungs during surgery that required them to be sedated. This happened even when they followed instructions not to eat or drink before the surgery. If you’re planning to have a major surgery that involves sedation, it’s important to talk to your doctor before major surgery requiring sedation for instructions.

Never share needles or syringes, as this can cause infections. Do not share tirzepatide with other people.

Common side effects

Some common side effects of tirzepatide include:

• Nausea
• Diarrhea
• Vomiting
• Constipation
• Stomach (abdominal) pain
• Indigestion
• Injection site reactions
• Fatigue
• Allergic reactions
• Belching
• Hair loss
• Gastroesophageal reflux disease (heartburn)

Drug interactions

It’s important to remember that compounded tirzepatide, like other medications, might interact with alcohol and other medications whether they’re prescription or over-the-counter) or herbal products you might be taking. If you’re taking insulin or medications that help your body release more insulin (like insulin secretagogues such as sulfonylureas), combining them with tirzepatide can increase your risk of low blood sugar. Tirzepatide can slow down how quickly your stomach empties (gastric emptying) and might affect how your body absorbs any other medications you take by mouth. If you’re taking thyroid or papillary hormone medication, it’s really important to talk to the doctor who prescribed it before you start taking tirzepatide. They might need to adjust the timing of when you take your other medications. The drug levels of medications with a narrow therapeutic index (e.g. warfarin) should also be closely monitored while on tirzepatide. Tirzepatide should not be used with any other drugs in the same drug class.

Tirzepatide may affect the efficacy of birth control pills. Speak with your provider before starting tirzepatide if you are taking birth control. Your provider may recommend an alternative birth control for 4 weeks after you start taking tirzepatide, and for 4 weeks after.

If you experience any negative side effects of prescription medications, please report them to the FDA. You can contact FDA MedWatch at 1-800-FDA-1088 or visit their website www.fda.gov/medwatch.

This information is not comprehensive. Always check the pharmaceutical packaging for a full list of warnings, side effects, interactions, and additional information, or talk to your healthcare provider for complete information and guidance.