Compounded drug notice
Compounded semaglutide is prepared for an individual patient by a U.S. pharmacy licensed in the state where it dispenses, under a prescription from a licensed provider. Federal law permits compounded drugs to be prescribed, but they are not FDA-approved, and the FDA does not review them for safety, effectiveness or manufacturing quality. Compounded semaglutide is not a generic version of, or equivalent to, any branded medication. Prescription required. Not everyone qualifies. Individual results vary.
Warning: risk of thyroid C-cell tumors
In rodent studies, semaglutide caused thyroid C-cell tumors, including thyroid cancer. It is not known whether semaglutide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in people. Do not use semaglutide if you or any of your family have ever had 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.
What is semaglutide used for?
Semaglutide is a GLP-1 receptor agonist. When prescribed for weight management it is used together with a reduced-calorie diet and increased physical activity in adults with obesity, or with overweight and at least one weight-related medical condition. Whether it is appropriate for you is decided by your licensed provider after reviewing your health history. It has not been studied in combination with other GLP-1 medicines and is not for people with type 1 diabetes.
Do not use semaglutide if you
- or any of your family have ever had medullary thyroid carcinoma (MTC);
- have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2);
- have had a serious allergic reaction to semaglutide or any of its ingredients;
- are pregnant, planning to become pregnant or breastfeeding;
- are already taking another GLP-1 receptor agonist medicine.
How is semaglutide taken?
Once a week, on the same day each week, as a subcutaneous injection under the skin of the abdomen, thigh or upper arm, with or without food. Your provider starts at a low dose and increases it gradually according to how you tolerate it. Use a new needle for every injection and never share vials, pens or needles with another person. Store and dispose of the medication as instructed by the dispensing pharmacy.
Before starting, tell your provider if you
- have or have had problems with your pancreas, kidneys or gallbladder;
- have type 2 diabetes or take insulin or a sulfonylurea;
- have a history of diabetic retinopathy;
- have severe stomach problems such as slowed emptying of the stomach (gastroparesis) or problems digesting food;
- have a history of depression, suicidal thoughts or mental health problems;
- are scheduled for surgery or a procedure with anesthesia;
- take any other prescription or over-the-counter medicines, vitamins or supplements, including oral medications whose absorption may be affected.
Pregnancy and breastfeeding
Semaglutide should not be used during pregnancy and may harm an unborn baby. If you plan to become pregnant, stop semaglutide at least two months beforehand, as it stays in the body for a long time. It is not known whether semaglutide passes into breast milk; discuss feeding options with your provider.
Serious side effects — get medical help right away
- Inflammation of the pancreas (pancreatitis). Stop using semaglutide and contact your provider right away if you have severe pain in your stomach area that will not go away, with or without vomiting.
- Gallbladder problems, including gallstones. Tell your provider if you get pain in the upper stomach, fever, yellowing of the skin or eyes, or clay-colored stools.
- Low blood sugar (hypoglycemia), especially if you also take insulin or a sulfonylurea. Signs include dizziness, sweating, confusion, shakiness, fast heartbeat and blurred vision.
- Kidney problems (kidney failure). Vomiting or diarrhea can cause dehydration, which may worsen kidney problems.
- Serious allergic reactions. Get medical help right away for swelling of the face, lips, tongue or throat, trouble breathing or swallowing, a severe rash or itching, or a very rapid heartbeat.
- Changes in vision in people with type 2 diabetes.
- Increased heart rate.
- Depression or thoughts of suicide. Pay attention to any sudden changes in mood, behavior, thoughts or feelings.
- Severe stomach problems, including stomach paralysis (gastroparesis) or intestinal blockage (ileus).
- Aspiration during surgery. Food may remain in the stomach longer; tell any provider planning a procedure with anesthesia that you use semaglutide.
Common side effects
Nausea, diarrhea, vomiting, constipation, stomach pain, headache, tiredness, upset stomach, dizziness, feeling bloated, belching, gas, heartburn, hair loss and injection-site reactions. Digestive symptoms are most common when starting or increasing the dose and often ease over time. These are not all the possible side effects. Contact your provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Prescription only. Compounded semaglutide is available only after an online visit with a licensed provider, who determines whether treatment is appropriate for you. This summary does not replace the full prescribing information and is not medical advice. Discuss every risk and benefit with your licensed provider before starting or changing treatment. If you experience a serious side effect, contact your provider; in an emergency, call 911. Individual results vary.
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