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Important Safety Information

Important Safety Information Regarding Compounded Tirzepatide and Semaglutide Products
Please be aware that compounded drugs are not FDA-approved and do not undergo clinical studies to evaluate for safety and efficacy, similar to FDA-approved commercially available products. Compounded products may still be legally prescribed, and your healthcare provider may issue you a prescription for compounded tirzepatide based on your medical consultation.
Tirzepatide is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist used for chronic weight management, along with a reduced calorie diet and increased physical activity, for people with an initial body mass index (BMI) of:
30 kg/m2 or greater (obesity) or
27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, dyslipidemia, obstructive sleep apnea or cardiovascular disease).
Speak with your healthcare provider to see if tirzepatide may be right for you.
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 rodents, tirzepatide caused dose-dependent and treatment-duration-dependent thyroid C-cell tumors. It is unknown whether tirzepatide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans.
Who should not use tirzepatide:
Do not use tirzepatide if you or any family member 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).
Do not use tirzepatide if you have had a serious allergic reaction to tirzepatide in the past.
Before starting 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 severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.
Have a history of diabetic retinopathy.
Have or have had depression, suicidal thoughts, or mental health issues.
Are pregnant or plan to become pregnant. Tirzepatide should not be used during pregnancy and there may be potential risks to an unborn baby from exposure to tirzepatide during pregnancy. You should discuss with your healthcare provider whether and how you should stop using tirzepatide before you plan to become pregnant.
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. This includes prescription medications, 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. If you are taking medicines to treat diabetes, including insulin or sulfonylureas, please let your healthcare provider know as tirzepatide could increase your risk of low blood sugar.
Serious side effects can occur with tirzepatide. You or a caregiver should carefully monitor for these side effects, especially in the beginning of treatment and with dosage changes. Tirzepatide may cause serious side effects, including:
Thyroid C-Cell Tumors. 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, 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.
Paralysis of the stomach (gastroparesis). The symptoms of gastroparesis may include feeling full shortly after starting a meal, feeling full long after eating a meal, nausea, and vomiting. Contact your healthcare provider if you experience any of these symptoms. Tirzepatide has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients.
Inflammation of your pancreas (pancreatitis). Stop using tirzepatide and contact your healthcare provider immediately if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting.
Gallbladder problems. Tirzepatide may cause gallbladder problems, including gallstones. Some gallstones may need surgery. Contact 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. 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. 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 tirzepatide.
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 tirzepatide and seek medical attention 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 with tirzepatide.
Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use tirzepatide with medicines 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, mood changes, hunger, weakness or feeling jittery.
Depression or thoughts of suicide. You should pay attention to any mental changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Contact your healthcare provider immediately if you have any mental changes that are new, worse, or worry you.
The most common side effects of tirzepatide include: nausea, diarrhea, vomiting, constipation, stomach (abdominal) pain, indigestion, injection site reactions, feeling tired, allergic reactions, belching, hair loss, and heartburn. These are not all the possible side effects of tirzepatide. Talk to your healthcare provider about any side effect that bothers you or doesn’t go away.
If you are experiencing a medical emergency, call 911 or seek immediate medical attention.
You are encouraged to report negative side effects of prescription products:
Contact FDA MedWatch at 1-800-FDA-1088 or visit www.fda.gov/medwatch
Tirzepatide administration. The medication is self-administered as a subcutaneous injection in the stomach, thigh, or upper arm once a week on the same day every week. For detailed instructions on how to administer your dose, please speak with your healthcare provider. They will guide you on a treatment regimen and explain to self-administer the medication. You should not change your dosing regimen or stop taking tirzepatide as prescribed without first discussing with your healthcare provider.
This information is not comprehensive. Please discuss with your healthcare provider any questions or concerns you have regarding tirzepatide.
Important Safety Information
Mechanism of Action: Tirzepatide is both a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist. It selectively binds to and activates the GIP and GLP-1 receptors, the targets for native GIP and GLP-1 hormones. GIP and GIP-1 are hormones that are primarily released from the body’s small intestine that enhances the release of insulin following the consumption of food. Both of these hormones are known as incretins, with tirzepatide belonging to a class of drugs known as incretin mimetics. Tirzepatide works by directly activating GIP and GLP-1 pathways to help regulate blood sugar.
Adverse Reactions: 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. Please discuss with your physician the contraindications and other warnings and precautions before starting tirzepatide.

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 such as Glipizide, glimepiride, and glyburide) 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 semaglutide with other people

Drug Interactions

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

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

To report suspected adverse reactions to o semaglutide, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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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GLP-1 Rx Gummiesâ„¢

*Compounded medications may be prescribed by physicians but have not been FDA regulated for safety, effectiveness, or quality. FDA-approved medicines containing semaglutide are available.

 

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 such as Glipizide, glimepiride, and glyburide) 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 semaglutide with other people

Drug Interactions

 

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

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

To report suspected adverse reactions to o semaglutide, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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

 

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