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Important Safety Information for Compounded Semaglutide

Compounded drugs are permitted to be prescribed under federal law, but are not FDA-approved and do not undergo safety, effectiveness, or manufacturing review. Your Ro-affiliated provider may recommend certain doses of compounded semaglutide based on your medical evaluation.

Warning: Risk of Thyroid C-Cell Tumors

  • In studies with mice and rats, semaglutide (the active ingredient in Wegovy and Ozempic) caused thyroid tumors, including thyroid cancer. It is not known if semaglutide will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. Tell your 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. 

  • Do not use semaglutide if you or any of your family have 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).

What is semaglutide used for?

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist 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, or dyslipidemia).

Limitations of Use:

  • Semaglutide should not be used in combination with other semaglutide-containing products or any other GLP-1 receptor agonist

  • The safety and efficacy of coadministration with other products for weight loss 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 have 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).

  • 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 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, refer to your treatment plan or reach out to your Ro-affiliated provider. They will guide you on a treatment regimen that may include an increase in dose every four weeks.

You should not change your dosing regimen or stop taking semaglutide as prescribed without discussing with your provider first. 

What should I tell my Ro-affiliated 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.

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 serious side effects can occur with semaglutide. You or a caregiver should carefully monitor for these side effects, especially in 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 right away 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 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 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 right away 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:

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