medical information

IMPORTANT COMPOUNDED SEMAGLUTIDE SAFETY INFORMATION

Compounded drugs can be prescribed under federal law, but they are not approved by the FDA and do not undergo reviews for safety, effectiveness, or manufacturing. Your provider may suggest specific doses of Compounded Semaglutide based on your medical evaluation.

MOST IMPORTANT SAFETY INFORMATION

  • Risk of thyroid C-Cell tumors: In rodent studies, semaglutide (the active ingredient in Wegovy and Ozempic) has been shown to cause thyroid C-Cell tumors, including thyroid cancer. It is not yet known whether compounded semaglutide can cause these tumors or a type of thyroid cancer known as medullary thyroid carcinoma (MTC) in humans. Inform your provider if you notice a lump or swelling in your neck, experience hoarseness, have trouble swallowing, or feel shortness of breath, as these could be signs of thyroid cancer.

  • Do not use compounded semaglutide if you or any family member have a history of medullary thyroid carcinoma (MTC) or if you have a condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

  • Avoid compounded semaglutide if you have ever had a severe allergic reaction to semaglutide or any ingredient in the compounded semaglutide injections.

WHAT IS COMPOUNDED SEMAGLUTIDE USED FOR?

Compounded semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist used for chronic weight management, alongside a reduced-calorie diet and increased physical activity, for adults with an initial body mass index (BMI) of 30 kg/m² or greater (obesity), or 27 kg/m² or greater (overweight) with at least one weight-related comorbidity (e.g., hypertension, type 2 diabetes, or dyslipidemia).

Limitations of Use:

    • Semaglutide should not be combined with other semaglutide-containing products or any other GLP-1 receptor agonists.
    • The safety and efficacy of using semaglutide with other weight loss medications have not been established.
    • Semaglutide has not been studied in individuals with a history of pancreatitis.
    • Semaglutide should not be used in patients with type 1 diabetes mellitus.

WHAT SHOULD MY PROVIDER BE TOLD BEFORE USING SEMAGLUTIDE?

Current medications: It’s essential to inform your provider about all the medications you are currently using, including prescription and over-the-counter medications, vitamins, and any herbal or dietary supplements.

Your complete medical history: Be sure to tell your provider if you have a history of:

  • Type 1 or type 2 diabetes
  • Medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
  • Pancreatitis
  • Gallbladder problems
  • Severe stomach issues, such as gastroparesis or difficulty digesting food
  • Kidney disease
  • Diabetic retinopathy
  • A history of eating disorders
  • Depression
  • Suicidal thoughts, behavior, or other mental health concerns
  • A history of suicide attempts

If you are pregnant: Semaglutide should not be used during pregnancy. Animal studies suggest potential risks to an unborn baby from exposure to semaglutide. There is no benefit to weight loss during pregnancy, and it may harm the baby.

If you are planning a pregnancy: Discontinue semaglutide at least 2 months before attempting to conceive, as the drug can remain in your system for an extended period.

If you are breastfeeding: Semaglutide has been found in the milk of lactating rats. Let your provider know if you are breastfeeding before starting semaglutide.

Failing to provide accurate information about your health or medical history in order to receive treatment can lead to serious harm, including, in some cases, death.

WILL SEMAGLUTIDE CAUSE ANY DRUG INTERACTIONS?

Be watchful for drug interactions while taking Semaglutide if also taking:

  • Insulin
  • Sulfonylureas: These may cause dangerously low blood sugar levels when combined with compounded semaglutide
  • Compounded semaglutide: delays gastric emptying, which could affect the absorption of other oral medications taken at the same time. Your provider can advise you on how to properly schedule your medications.
  • Other GLP-1 or GLP-1/GIP receptor agonists, such as liraglutide, dulaglutide, or tirzepatide
  • Other weight loss products, including dietary supplements

WHAT SERIOUS SIDE EFFECTS SHOULD BE MONITORED FOR WHEN TAKING SEMAGLUTIDE?

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

Serious side effects can occur with semaglutide. It is important for you or a caregiver to monitor for these effects, particularly at the beginning of treatment or after dose changes.

  • Thyroid C-Cell Tumors: In animal studies, semaglutide caused an increase in thyroid C-cell tumors, including medullary thyroid carcinoma (MTC). It is unknown if semaglutide causes thyroid C-cell tumors in humans. Cases of MTC were reported in patients who used liraglutide (the active ingredient in Victoza and Saxenda). Semaglutide is contraindicated in individuals with a family history of MTC or those with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). If you notice a lump or swelling in your neck, hoarseness, difficulty swallowing, or shortness of breath, contact your provider, as these could be symptoms of thyroid cancer.

  • Inflammation of the Pancreas (Acute Pancreatitis): Watch for signs of acute pancreatitis, such as severe abdominal pain that may radiate to the back, with or without vomiting.

  • Acute Gallbladder Disease: Semaglutide may cause gallbladder issues, including gallstones. Some gallbladder problems may require surgery. Contact your provider immediately if you experience upper stomach pain, yellowing of the skin or eyes (jaundice), fever, or clay-colored stools.

  • Low Blood Sugar (Hypoglycemia): Semaglutide lowers blood sugar and can cause dangerously low blood sugar in people with type 2 diabetes who are also taking other glucose-lowering medications. Monitor your blood sugar levels and watch for symptoms such as dizziness, blurred vision, mood changes, sweating, or a rapid heartbeat.

  • Acute Kidney Injury: In people with kidney problems, diarrhea, nausea, and vomiting can lead to dehydration, which may worsen kidney function. Drink plenty of water to reduce the risk of dehydration.

  • Serious Allergic Reactions: Stop using semaglutide immediately if you experience symptoms of a serious allergic reaction, such as swelling of the face, lips, tongue, or throat, severe rash or itching, rapid heartbeat, difficulty breathing or swallowing, or fainting or dizziness.

  • Diabetic Retinopathy Complications (in Type 2 Diabetes): If you have type 2 diabetes, notify your provider immediately if you experience changes in vision.

  • Increased Heart Rate: Contact your provider if you experience a racing heartbeat while at rest.

  • Suicidal Thoughts or Behavior: Pay attention to any changes in your mental health, especially sudden changes in mood, behavior, thoughts, or feelings. If you notice any concerning mental health changes, contact your healthcare provider right away.

  • Never Share a Needle: Needle-sharing increases the risk of infection.

Common side effects of semaglutide may include:

  • Nausea
  • Diarrhea
  • Vomiting
  • Constipation
  • Abdominal pain
  • Headache
  • Fatigue
  • Dyspepsia (indigestion)
  • Dizziness
  • Abdominal distension (bloating)
  • Eructation (belching)
  • Hypoglycemia in patients with type 2 diabetes
  • Flatulence (gas)
  • Gastroenteritis
  • Gastroesophageal reflux disease (GERD)

Reporting side effects:
You are encouraged to report any negative side effects to the FDA MedWatch program by calling 1-800-FDA-1088 or visiting fda.gov/medwatch.

This is not a comprehensive list of all possible side effects. Please refer to additional information provided by your pharmacy or speak with your prescriber or pharmacist.