Compounded medications are allowed for prescription under federal regulations, yet they aren't approved by the FDA and lack a review for safety, effectiveness, or manufacturing. Lumen-affiliated healthcare providers may suggest specific doses of compounded semaglutide based on your medical assessment.

Warning: Potential Risk of Thyroid C-Cell Tumors

• Research in rodents showed that semaglutide, the active ingredient in medications like Wegovy and Ozempic, can lead to thyroid tumors, including cancer. It's unclear if semaglutide has the same effect in humans. Notify your provider if you notice neck lumps, hoarseness, difficulty swallowing, or breathlessness, as these could be thyroid cancer symptoms.
• Semaglutide should not be used by individuals with a family history of medullary thyroid carcinoma (MTC) or those with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Uses of Semaglutide

• Semaglutide, a GLP-1 receptor agonist, is prescribed for chronic weight management, combined with a low-calorie diet and increased physical activity, for people with a BMI of 30 kg/m² or more (obesity) or 27 kg/m² or more (overweight) with at least one weight-related condition (e.g., hypertension, type 2 diabetes, dyslipidemia).

Limitations of use:

• Avoid using semaglutide with other semaglutide-based products or GLP-1 receptor agonists.
• The safety and efficacy of using it with other weight loss products are unestablished.
• Not studied in patients with a history of pancreatitis.
• Not for use in patients with type 1 diabetes.

Who Should Avoid Semaglutide

• Those with a personal or family history of MTC or MEN 2.
• Individuals allergic to semaglutide or its components.

Administration of Semaglutide

• Take semaglutide with or without food. Self-administer as a subcutaneous injection in the stomach, thigh, or arm weekly. Follow your Lumen-affiliated provider's instructions for dose administration.
• Consult your provider before changing or stopping the medication.

What should I tell my provider before using semaglutide?

Semaglutide has certain drug interactions. It’s important to tell your Ro-affiliated provider all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements.

Some medications to watch out for include:

• Medications used to treat type 1 or type 2 diabetes, including insulin or sulfonylureas (such as Amaryl or Glucotrol XL)
• Semaglutide causes a delay in gastric emptying, so it has the potential to impact the absorption of medications that are taken by mouth at the same time. Your provider can guide 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’re using other products for weight loss, including dietary supplements‍

It’s important to share your entire medical history with your provider. In particular, tell your provider if you have or have a past history of:

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

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

• If you are pregnant: Semaglutide should not be used during pregnancy. Based on animal studies, there may be potential risks to an unborn baby from exposure to semaglutide during pregnancy. There is no benefit to weight loss during pregnancy and it may cause harm to the unborn baby.
• If you are a female or male of reproductive potential: Discontinue semaglutide at least 2 months before a planned pregnancy since the drug can stay in the bloodstream for a long time.
• If you are breastfeeding: Semaglutide was found in the milk of lactating rats. Tell your Ro-affiliated provider if you are breastfeeding before you start semaglutide.

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

Serious Side Effects to Monitor

• Thyroid C-Cell Tumors: Watch for neck lumps or swelling, hoarseness, swallowing difficulties, or breathlessness.
• Acute Pancreatitis: Look out for severe abdominal pain, nausea, and vomiting.
• Gallbladder Disease: Be alert for upper stomach pain, jaundice, fever, or clay-colored stools.
• Low Blood Sugar: Monitor for symptoms like dizziness, blurred vision, mood changes, sweating, or fast heartbeat.
• Acute Kidney Injury: Stay hydrated to avoid dehydration.
• Allergic Reactions: Seek immediate help for symptoms like facial swelling, severe rash, rapid heartbeat, breathing difficulties, or fainting.
• Diabetic Retinopathy: Report any vision changes to your provider.‍
• Suicidal Behavior and Ideation: Be vigilant for mood or behavioral changes and consult your provider promptly. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.

Common Side Effects

• 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 review the latest consumer medical information from the FDA for complete safety information.