Please take note of the following information:

Compounded drugs can be prescribed under federal regulations, but the FDA does not evaluate them for safety, effectiveness, or manufacturing. Your provider affiliated with Happy Care may suggest specific doses of compounded semaglutide based on your medical assessment.

Warning: Risk of Thyroid C-Cell Tumors

Studies with mice and rats have shown that semaglutide (the active component in Wegovy and Ozempic) caused thyroid tumors, including thyroid cancer. It is unknown whether semaglutide would cause thyroid tumors or a type of thyroid cancer known as medullary thyroid carcinoma (MTC) in humans. Inform your provider if you experience a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath, as these could be symptoms of thyroid cancer.

Do not use semaglutide if you or any of your family members have had a type of thyroid cancer called medullary thyroid carcinoma (MTC), or if you have a condition of the endocrine system called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

What is semaglutide used for?

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist used for chronic weight management, in combination with a reduced calorie diet and increased physical activity, for individuals 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 comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia).

Limitations of Use:

Semaglutide should not be used together with other semaglutide-containing products or any other GLP-1 receptor agonist.

The safety and effectiveness of combining it with other weight loss products have not been established.

Semaglutide has not been studied in patients with a history of pancreatitis.

Semaglutide should not be used in patients with type 1 diabetes mellitus.

Who should not use semaglutide?

Do not use semaglutide if:

You or any of your family members have had a type of thyroid cancer called medullary thyroid carcinoma (MTC), or if you have a condition of the endocrine system called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

You have a known allergic reaction to semaglutide (the active ingredient in Wegovy or Ozempic).

How should semaglutide be administered?

You can take semaglutide with or without food. The medication is self-administered through a subcutaneous injection in the stomach, thigh, or upper arm once a week on the same day every week. For detailed instructions on administering your dose, refer to your treatment plan or contact your Happy Care-affiliated provider. They will provide guidance on a treatment regimen that may involve increasing the dose every four weeks.

You should not change your dosing routine or stop taking semaglutide as prescribed without first consulting your provider.

What should I inform my Happy Care’s affiliated provider before using semaglutide?

Semaglutide has interactions with certain medications. It is important to disclose to your Happy Care-affiliated provider all the medications you are currently taking, including prescription drugs, over-the-counter medications, vitamins, and herbal and dietary supplements.

You should be cautious of the following medications:

Drugs used to treat type 1 or type 2 diabetes, including insulin or sulfonylureas (such as Amaryl or Glucotrol XL).

Semaglutide delays gastric emptying, potentially affecting the absorption of simultaneously taken oral medications. Your provider can advise you on how to schedule your medications.

Other medications in the same drug class, including Wegovy, Ozempic, Saxenda, Victoza, Trulicity, Byetta, or Bydureon.

If you are using other products for weight loss, including dietary supplements.

It is crucial to provide your entire medical history to your provider. In particular, inform your provider if you have or have had:

• Type 1 or type 2 diabetes
• Thyroid cancer
• Pancreatitis
• Kidney disease
• Diabetic retinopathy
• Depression
• Suicidal thoughts or behavior
• Ileus

Notify your provider if you are pregnant, planning to become pregnant, or breastfeeding.

If you are pregnant: Semaglutide should not be used during pregnancy, as animal studies suggest potential risks to the unborn baby from exposure to semaglutide during pregnancy. Weight loss during pregnancy offers no benefit and may harm the unborn baby.

If you are a female or male of reproductive potential: Discontinue semaglutide at least 2 months before planning a pregnancy since the drug may persist in the bloodstream for an extended period.

If you are breastfeeding: Semaglutide was found in the milk of lactating rats. Inform your Happy Care-affiliated provider if you are breastfeeding before starting semaglutide.

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, and in some cases, in death.

What are the most serious side effects that I or a caregiver should monitor for when taking semaglutide?

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

These are the serious side effects that can occur with semaglutide. You or a caregiver should carefully monitor for these side effects, especially at the beginning of treatment and with dose changes.

Thyroid C-Cell Tumors: In mice and rats, semaglutide (the active ingredient in Wegovy and Ozempic) caused an increase in thyroid C-cell tumors, including medullary thyroid carcinoma (MTC). It is unknown whether semaglutide causes thyroid C-cell tumors in humans. There were cases of MTC reported in patients who took liraglutide (the active ingredient in Victoza and Saxenda) after the drug was put on the market. Semaglutide should not be used if you have a family history of MTC or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Tell your provider right away if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.

Inflammation of Pancreas (Acute Pancreatitis): Monitor for signs of acute pancreatitis, including severe abdominal pain that does not go away, sometimes radiating to the back, with or without vomiting.

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

Low Blood Sugar (hypoglycemia): Semaglutide lowers blood glucose. It can cause too low blood sugar in patients with type 2 diabetes who also take another glucose control medication. Monitor your blood sugar and watch out for signs of too low blood sugar such as dizziness, blurred vision, mood changes, sweating, or fast heartbeat.

Acute Kidney Injury: In people with 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 plenty of water to help reduce your chance of dehydration.

Serious Allergic Reactions: Stop using semaglutide right away if you experience symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, severe rash or itching, very rapid heartbeat, problems breathing or swallowing, or fainting or feeling dizzy.

Diabetic Retinopathy Complications in Patients with Type 2 Diabetes: If you have type 2 diabetes, tell your provider right away if you experience changes in vision.

Increase in Heart Rate: Tell your provider immediately if you have a racing heartbeat while at rest.

Suicidal Behavior and Ideation: You should pay attention to any mental health 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.

Never Share Needles or Syringes: Sharing of needles or syringes poses a risk of infection.

What are the most common side effects of semaglutide?

• Nausea
• Diarrhea
• Vomiting
• Constipation
• Abdominal pain
• Headache
• Fatigue
• Dyspepsia
• Dizziness
• Abdominal distension
• Eructation
• Hypoglycemia in patients with type 2 diabetes
• Flatulence
• Gastroenteritis
• Gastroesophageal reflux disease

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

This information is not comprehensive. Please see the full Consumer Medical  Information for complete safety information.