Compounded Semaglutide (injection)

The safety information for this product was compiled by TrinityMeds and has not been reviewed by the FDA. This information is provided for your reference and may not address all potential risks or considerations that may apply to you. Please consult your healthcare provider regarding the risks associated with this medication and whether it is appropriate for you.

⚠️ WARNING: RISK OF THYROID C-CELL TUMORS

BLACK BOX WARNING:

Although compounded drugs are permitted to be prescribed under federal law, they are not FDA-approved and do not undergo safety, effectiveness, or manufacturing review. They are prepared by state-licensed pharmacies. Your provider may recommend certain doses of compounded semaglutide based on your medical evaluation. FDA-approved medicines containing semaglutide are available.

What is the most important information I should know about Semaglutide?

Semaglutide may cause serious side effects, including possible thyroid tumors, including cancer. Tell your healthcare 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. In studies with rodents, Semaglutide and medicines that work like Semaglutide 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 humans.

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 had a serious allergic reaction to semaglutide or any of the ingredients in Semaglutide.

Before using Semaglutide, tell your healthcare provider if you have any other medical conditions, including if you:

• Have or have had problems with your pancreas or kidneys.
• Have type 2 diabetes and a history of diabetic retinopathy.
• Have or have had depression, suicidal thoughts, or mental health issues.
• Are pregnant or plan to become pregnant. Semaglutide may harm your unborn baby. You should stop using Semaglutide 2 months before you plan to conceive.
• Are breastfeeding or plan to breastfeed. It is not known if Semaglutide passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Semaglutide may affect the way some medicines work and some medicines may affect the way Semaglutide works. Tell your healthcare provider if you are taking other medicines to treat diabetes, including sulfonylureas or insulin. Semaglutide slows stomach emptying and can affect medicines that need to pass through the stomach quickly.

Semaglutide may cause serious side effects, including:

If you experience a medical emergency, call 911 or go to the nearest emergency room.

Inflammation of your pancreas (pancreatitis): Stop using Semaglutide and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.

Gallbladder problems: Semaglutide may cause gallbladder problems, including gallstones. Some gallstones may need surgery. Call your healthcare provider if you have symptoms, such as pain in your upper stomach (abdomen), fever, yellowing of the skin or eyes (jaundice), or clay-colored stools.

Increased risk of low blood sugar (hypoglycemia) in patients with type 2 diabetes, especially those who also take medicines for type 2 diabetes such as sulfonylureas or insulin: This can be both a serious and common side effect. Talk to your healthcare provider about how to recognize and treat low blood sugar and check your blood sugar before you start and while you take Semaglutide. Signs and symptoms of low blood sugar may include dizziness or light-headedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, or feeling jittery.

Kidney problems (kidney failure): 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 fluids to help reduce your chance of dehydration.

Serious allergic reactions: Stop using Semaglutide and get medical help right away, if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat.

Change in vision in people with type 2 diabetes: Tell your healthcare provider if you have changes in vision during treatment with Semaglutide.

Increased heart rate: Semaglutide can increase your heart rate while you are at rest. Tell your healthcare provider if you feel your heart racing or pounding in your chest and it lasts for several minutes.

Depression or thoughts of suicide: You should pay attention to any mental 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.

The most common side effects of Semaglutide may include:

• Nausea
• Diarrhea
• Vomiting
• Constipation
• Stomach (Abdomen) Pain

These are not all the possible side effects of Semaglutide. Talk to your healthcare provider about any side effect that bothers you or doesn't go away.

Drug Interactions

As with other medications, compounded Semaglutide can interact with alcohol and certain prescription and non-prescription medications and herbal products. The risk of hypoglycemia is increased when combined with insulin or insulin secretagogues such as sulfonylureas. Semaglutide delays gastric emptying and may impact the absorption of oral medications. If you are on thyroid hormone medication, prior to starting Semaglutide, please review the timing of taking your thyroid hormone medication with the doctor who prescribes it as it may need to be adjusted. The drug levels of medications with narrow therapeutic windows (i.e., warfarin) should be monitored closely while on Semaglutide.

This summary provides basic information about compounded semaglutide but does not include all information known about this medicine. 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.

Please review all information provided by your compounding pharmacy and healthcare provider, including information about potential side effects, warnings, precautions, drug interactions, dosing instructions, and other important safety information. Contact your healthcare provider or pharmacist if you have any questions. Compounded medications are not FDA-approved and may not be accompanied by FDA-approved prescribing information.

You are encouraged to report negative side effects to the FDA. Visit https://www.fda.gov/medwatch or call 1-800-FDA-1088. In case of emergencies, please call 911 or go to the nearest emergency room.

Note: The above statements have not been evaluated by the Food and Drug Administration.