Safety Information

Compounded Tirzepatide

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

WARNING

Compounded tirzepatide usage has been associated with the potential development of thyroid tumors, including thyroid cancer. Watch for any potential symptoms, such as neck lumps or swelling, hoarseness, difficulty swallowing, or breathlessness. Should any of these symptoms arise, it is imperative to inform your healthcare provider promptly.

Avoid using compounded tirzepatide if you or any family members have a history of medullary thyroid carcinoma (MTC), a specific type of thyroid cancer. Similarly, refrain from its use if diagnosed with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), or if you’ve previously experienced a severe allergic reaction to tirzepatide or any of its components.

Serious Side Effects

Compounded tirzepatide carries the risk of severe side effects, which include:

• Gastrointestinal Issues: Reports indicate the possibility of severe stomach problems associated with compounded tirzepatide usage. Notify your healthcare provider if you experience persistent or severe stomach discomfort.
• Kidney Complications: Diarrhea, nausea, and vomiting may lead to dehydration, potentially resulting in kidney problems. Adequate fluid intake is crucial to mitigate this risk.
• Gallbladder Concerns: Some individuals may encounter gallbladder problems while using compounded tirzepatide. Seek immediate medical attention if symptoms such as upper abdominal pain, fever, jaundice, or changes in stool color occur.
• Pancreatitis: Discontinue use and contact your healthcare provider if you experience persistent abdominal pain, with or without vomiting, as it could indicate inflammation of the pancreas.
• Allergic Reactions: Cease compounded tirzepatide usage and seek urgent medical assistance if you develop symptoms of a severe allergic reaction, including facial swelling, breathing difficulties, rash, or rapid heartbeat.
• Hypoglycemia: The risk of low blood sugar may increase when using compounded tirzepatide alongside medications that lower blood sugar levels. Recognizable symptoms include dizziness, sweating, confusion, and rapid heartbeat.
• Vision Changes: Notify your healthcare provider of any alterations in vision observed during tirzepatide treatment.
• Depression or Suicidal Thoughts: Pay close attention to changes in mood or mental state while using tirzepatide, and promptly report any concerns to your healthcare provider.

Common Side Effects

The most frequently reported side effects of compounded tirzepatide include:

• Nausea
• Diarrhea
• Vomiting
• Constipation
• Abdominal pain
• Indigestion
• Injection site reactions
• Fatigue
• Allergic reactions
• Belching
• Hair loss
• Heartburn

These side effects are not exhaustive. Should you experience any persistent or bothersome side effects, discuss them with your healthcare provider for appropriate management.

Tell your healthcare provider if you have any side effects.

To report suspected severe side effects or adverse reactions to compounded trizepatide, 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.

Drug Interactions

As with other medications, compounded trizepatide 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. Compounded trizepatide delays gastric emptying and may impact the absorption of oral medications. If you are on papillary hormone medication, prior to starting compounded trizepatide, please review the timing of taking your papillary 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 compounded trizepatide.

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

Compounded Semaglutide

*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, 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. Compounded semaglutide delays gastric emptying and may impact the absorption of oral medications. If you are on papillary hormone medication, prior to starting compounded semaglutide, please review the timing of taking your papillary 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 compounded semaglutide.

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

To report suspected adverse reactions to compounded 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.

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 semaglutide.

Avoid alcohol while taking this medication. If you’re taking diabetes medications, please discuss this with your prescribing doctor before starting semaglutide, 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 semaglutide 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 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.

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

Tirzepatide may alter the efficacy of birth control pills. Talk with your doctor before starting tirzepatide if you are on birth control. Your healthcare provider may recommend another type of birth control for 4 weeks after you start tirzepatide and for 4 weeks after each increase in your dose.

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.