Important Safety Information for Compound Semaglutide Injection

Last updated October 18, 2024

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 OrderlyMeds provider may recommend certain doses of Compound Semaglutide based on your medical evaluation.

Indications and Use:

Compounded semaglutide is an injectable prescription medicine that may help adults with obesity, or with excess weight (overweight) who also have weight-related medical problems, lose weight and keep it off. It should be used with a reduced-calorie diet and increased physical activity.

Compounded semaglutide is a synthetic glucagon-like peptide-1 (GLP-1) receptor agonist used 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).

Compounded semaglutide should not be used with other semaglutide-containing products or any GLP-1 receptor agonist medicines. It is not known if semaglutide is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products. It is not known if semaglutide can be used in people who have had pancreatitis. It is not known if semaglutide is safe and effective for use in children under 18 years of age.

Important Safety Information for Compounded Semaglutide injection

Warning: Risk of Thyroid C-Cell Tumors

• In studies with mice and rats, semaglutide caused thyroid tumors, including thyroid cancer. It is not known if compounded 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  compounded 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).

Is Compounded Semaglutide FDA-approved?

Compounded semaglutide is not FDA approved and does not undergo the same rigorous efficacy and safety checks as do FDA-approved medications.  Compounded semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist which may be used 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:

• Compounded 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
• Compounded semaglutide has not been studied in patients with a history of pancreatitis

Note: Compounded medications are not FDA approved and do not have indications for treatment as an FDA approved medication would. The above are suggestions for use of compounded semaglutide while the FDA approved therapies remain on shortage.

Who should not use Compounded Semaglutide?

Do not use Compounded 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 compounded semaglutide

How should Compounded Semaglutide be administered? 

You can take compounded semaglutide with or without food. The pre-filled injector pen is self-administered as a subcutaneous injection in the stomach, thigh, or upper arm once a week on the same day every week. Your OrderlyMeds provider 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 compounded semaglutide as prescribed without discussing with your provider first.

What should I tell my OrderlyMeds provider before using Compounded Semaglutide?

• Compounded semaglutide has certain drug interactions. It’s important to tell your OrderlyMeds 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)
• Compounded 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 GLP-1 medications, including WeGovy® (semaglutide), Ozempic® (semaglutide), Saxenda® (liraglutide), Zepbound® (tirzepatide), Mounjaro® (tirzepatide), Victoza® (liraglutide), Byetta® (exenatide), or Bydureon® (exenatide).
• 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 a past history of:

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

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

• If you are pregnant: Compounded semaglutide should not be used during pregnancy. Based on animal studies, there may be potential risks to an unborn baby from exposure to Compounded 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 compounded 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: Compounded semaglutide was found in the milk of lactating rats. Tell your OrderlyMeds provider if you are breastfeeding before you start compounded 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 compounded semaglutide?

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

These serious side effects can occur with compounded 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 caused an increase in thyroid C-cell tumors, including medullary thyroid carcinoma (MTC). It is unknown whether compounded 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. Compounded semaglutide is contraindicated in patients with a family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). 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.
• 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:Compounded 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):Compounded 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 compounded 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 a Pen:Pen-sharing poses a risk of infection.

What are the most common side effects of compounded semaglutide?

• Nausea
• Diarrhea
• Vomiting
• Constipation
• Stomach pain
• Indigestion
• Injection site reactions
• Feeling tired
• Allergic reactions
• Belching
• Hair loss
• Gastroesophageal reflux disease (heartburn)

You are encouraged to report negative side effects of prescription products to the FDA. Visit <u>www.fda.gov/medwatch</u> or call 1-800-FDA-1088.

Before using Compounded Semaglutide

• Your healthcare provider should show you how to use compounded semaglutide before you use it for the first time.
• Tell your healthcare provider if you are taking medicines to treat diabetes including insulin or sulfonylureas which could increase your risk of low blood sugar. Talk to your healthcare provider about low blood sugar levels and how to manage them.
• If you take birth control pills by mouth, talk to your healthcare provider before you use compounded semaglutide. Birth control pills may not work as well while using compounded semaglutide. Your healthcare provider may recommend another type of birth control for 4 weeks after you start compounded semaglutide and for 4 weeks after each increase in your dose of compounded semaglutide.

Review these questions with your healthcare provider:

• Do you have other medical conditions, including problems with your pancreas or kidneys, or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?
• Do you take diabetes medicines, such as insulin or sulfonylureas?
• Do you have a history of diabetic retinopathy?
• Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements?
• Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? Compounded semaglutide may harm your unborn baby. Tell your healthcare provider if you become pregnant while using compounded semaglutide. It is not known if compounded semaglutide passes into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using compounded semaglutide.

How to take

• Read the Instructions for Use that come with compounded semaglutide.
• Use compounded semaglutide exactly as your healthcare provider says.
• Compounded semaglutide is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm.
• Use compounded semaglutide 1 time each week, at any time of the day.
• Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection.
• If you take too much compounded semaglutide, call your healthcare provider, seek medical advice promptly, or contact a Poison Center expert right away at 1-800-222-1222.

Learn more

Compounded semaglutide is a prescription medicine. For more information on semaglutide-containing products, please call 877-581-2210 to learn more or receive information regarding how to contact your pharmacy.

This summary provides basic information about compounded semaglutide but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about compounded semaglutide and how to take it. Your healthcare provider is the best person to help you decide if compounded semaglutide is right for you.

Disclaimer: Ozempic®, WeGovy®, Saxenda® and Victoza® are registered trademarks of Novo Nordisk.  Zepbound® and Mounjaro® are registered trademarks of Eli Lilly.    Byetta® and Bydureon® are registered trademarks of Amylin Pharmaceuticals.  OrderlyMeds has no affiliation with Novo Nordisk, Eli Lilly or Amylin Pharmaceuticals.  The compounded products available as part of OrderlyMeds’s Weight Loss Program are not made by Novo Nordisk, Eli Lilly or Amylin Pharmaceuticals or any company affiliated with Novo Nordisk, Eli Lilly or Amylin Pharmaceuticals.