Important Safety Information for Compounded Semaglutide

Important Safety Information for Compounded Semaglutide

Your medical provider may recommend personalized dosages of compounded Semaglutide based on a medical review. Compounded drugs are not FDA approved and are not evaluated for safety, effectiveness, or quality standards.
This document is a summary of product information and does NOT have all possible information and potential side effects of the product. This is not medical advice and does not substitute advice from your health care provider.
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 provider may recommend certain doses of compounded Semaglutide based on your medical evaluation.

Indications and Use:

• Compounded Semaglutide is an injectable prescription medicine that may help adults and adolescents with obesity and excess weight (overweight) – who may 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 27 kg/m2 or higher.
• Compounded Semaglutide should not be used with other Semaglutide-containing products or any other GLP-1/GIP receptor agonist medicines. It is not known if compounded Semaglutide is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products. It is not known if compounded Semaglutide can be used in people who have had pancreatitis. It is not known if compounded 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 of 27 kg/m2 or higher

Limitations of Use:

• Compounded Semaglutide should not be used in combination with other Semaglutide-containing products or any other GLP-1/GIP receptor agonist medicines.
• 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.

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 vial is self-administered with a needle and syringe as a subcutaneous injection in the stomach, thigh, or upper arm once a week on the same day every week. Your 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 provider before using compounded Semaglutide?

Compounded Semaglutide has certain drug interactions. It’s important to tell your 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-/GIP 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 provider if you are breastfeeding before you start compounded Semaglutide. At this time, we do not recommend taking compounded Semaglutide if you are breastfeeding or bottle-feeding with breastmilk.

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?

The most common side effects are typically mild and usually resolve after the first several weeks of treatment. These can include nausea, vomiting, diarrhea, constipation, abdominal pain, upset stomach, abdominal distension, reflux, headache, fatigue, and dizziness. Swelling, redness, and itchiness at the injection site may occur. The FDA has issued its most serious warning (called a BOXED WARNING) that GLP-1s may be associated with a type of thyroid cancer called medullary thyroid carcinoma. So far, this side effect has primarily been seen in laboratory studies using rodents, so the risk to humans has not been determined.

SIDE EFFECTS:

Nausea, vomiting, stomach upset, diarrhea, tiredness, dizziness, or constipation may occur. Nausea usually lessens as you continue to use Semaglutide. If any of these effects last or get worse, tell your provider or pharmacist promptly. Remember that this medication has been prescribed because your provider has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Vomiting/diarrhea that doesn’t stop may result in dehydration. Contact your provider promptly if you notice any symptoms of dehydration, such as unusual dry mouth/thirst or dizziness/ lightheadedness. Tell your provider right away if you have any serious side effects, including: signs of kidney problems (such as change in the amount of urine), vision changes (such as decreased/blurred vision), fast heartbeat, mental/mood changes (such as depression, thoughts of suicide), signs of low blood sugar (sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, tingling hands/feet).

Get medical help right away if you have any very serious side effects, including: signs of pancreas or gallbladder disease (such as nausea/vomiting that doesn’t stop, severe stomach/abdominal pain). A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your provider or pharmacist.

In the US – Call your provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch

WARNING:

This medication has been found to cause a certain type of thyroid tumor (thyroid C-cell tumors) in rats and mice. It is unknown if this medication can cause similar tumors in humans. Talk with your provider about the benefits and risks of treatment with this medication. This medication should not be used by people with a personal/family history of a certain type of cancer (medullary thyroid carcinoma) or by people with a certain inherited disease (Multiple Endocrine Neoplasia syndrome type 2 or MEN 2). While using this medication, tell your provider right away if you notice any signs or symptoms of thyroid tumors, including unusual growth or lump in the neck, difficulty swallowing, shortness of breath, or unusual/lasting hoarseness

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 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 Vial/Needle/Syringe: Sharing poses a risk of infection.

Current/Recent Prescriptions

If you have any current/recent prescriptions for either compounded or brand name weight loss medications, do not take both medications. You will be asked to provide evidence of the current/recent prescription including dose specifics. Taking two or more GLP-1/GIP medications at the same time increases the risk of potentially serious side effects. Notify your provider immediately if you have any current or previous prescriptions for compounded or brand name weight loss medications.

Medical History

Failure to fully disclose your medical history to your provider may result in serious side effects, including death.

Before using Compounded Semaglutide

• Your healthcare provider will direct you to instructions on how to administer your GLP-1 therapy.
• 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 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 on the same day every week.
  • 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.

HOW IS COMPOUNDED SEMAGLUTIDE PRESCRIBED?

Compounded Semaglutide typically starts at a low dose that is gradually increased over time. The typical dosing schedule of compounded Semaglutide is:

• Weeks 1 – 4: 0.25 mg once a week
• Weeks 5 – 8: 0.5 mg once a week
• Weeks 9 – 12: 1 mg once a week
• Weeks 13 – 16: 1.7 mg once a week
• Weeks 17 – 20: 2.4 mg once a week

Depending on your specific situation, your maintenance dose could be lower than 2.4 mg once a week.

Follow the dosing instructions from your provider, as they may personalize your plan for your individual needs.

Legal Disclaimers:

Compounded Semaglutide is not approved by the FDA. The FDA does not evaluate compounded products for safety, effectiveness, or quality.

Zepbound and Mounjaro is a registered trademark of Eli Lilly and Company. Ozempic, Wegovy, Saxenda, and Victoza are registered trademarks of Novo Nordisk A/S. Byetta and Bydureon are registered trademarks of Amylin Pharmaceuticals, Inc..