Compounded Semaglutide
GLP-1 receptor agonist
Compounded semaglutide is a compounded medication prepared by a state-licensed pharmacy for an individual prescription. Compounded drugs are not FDA-approved, and the FDA does not review them for safety, effectiveness, or quality before they are dispensed. FDA-approved medicines containing semaglutide (Wegovy®, Ozempic®) are available; ask your provider about them. The safety information below is based on the FDA-approved labeling for those products.
Do not use if
- You or a family member has had medullary thyroid carcinoma (MTC), or you have MEN 2.
- You have had a serious allergic reaction to semaglutide or any ingredient in the preparation.
- You are pregnant, planning to become pregnant, or breastfeeding. Semaglutide may harm an unborn baby; stop it at least 2 months before trying to conceive.
- You have type 1 diabetes or a history of diabetic ketoacidosis — semaglutide is not a substitute for insulin.
- You have a history of pancreatitis, severe stomach or bowel disease (including gastroparesis), or diabetic retinopathy — tell your provider so the risk can be weighed.
Serious risks — get medical help
- Pancreatitis — stop use and get medical help right away for severe pain in your stomach area that will not go away, with or without vomiting; the pain may spread to your back.
- Gallbladder problems (gallstones, inflammation) — 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 — dizziness, shakiness, sweating, confusion, fast heartbeat, or blurred vision.
- Kidney injury — vomiting, diarrhea, or nausea can cause dehydration that worsens kidney function, including in people without prior kidney disease. Drink fluids.
- Serious allergic reactions (anaphylaxis, angioedema) — swelling of the face, lips, tongue, or throat, trouble breathing or swallowing, severe rash, fainting, or very fast heartbeat. Stop use and call 911.
- Diabetic retinopathy complications — tell your provider about any change in vision, particularly if you have type 2 diabetes.
- Increased heart rate — report a racing or pounding heartbeat at rest.
- Depression or suicidal thoughts — pay attention to changes in mood or behavior and tell your provider promptly.
- Severe stomach or bowel problems, including slowed stomach emptying and, rarely, intestinal blockage (ileus). Not recommended if you have severe gastroparesis.
- Food or liquid getting into the lungs during surgery or a procedure — tell every clinician, especially your anesthesia team, that you take this medication before any procedure that uses anesthesia or deep sedation.
Common side effects
Nausea, diarrhea, vomiting, constipation, stomach pain, headache, tiredness, indigestion, dizziness, bloating, belching, gas, heartburn, and injection-site reactions. Stomach-related effects are most common when starting and after a dose increase, and usually ease over a few weeks.
Drug interactions
- Insulin and sulfonylureas (glipizide, glimepiride, glyburide) raise the risk of low blood sugar; doses may need adjusting.
- These medicines slow stomach emptying, which can change how oral medicines are absorbed. Medicines with a narrow margin (for example warfarin, levothyroxine, some seizure medicines) should be monitored more closely.
- Alcohol can worsen nausea and increase the chance of low blood sugar.
- Do not combine with other GLP-1 medicines or other prescription weight-loss drugs unless your provider directs it.
Missed dose
Based on FDA-approved semaglutide labeling: if you miss a dose and your next scheduled dose is more than 2 days (48 hours) away, take the missed dose as soon as possible. If the next dose is less than 2 days away, skip the missed dose and take your next dose on the usual day. If you miss two or more doses in a row, contact your provider before restarting — your dose may need to be lowered.
Also important
- Never share your vial, syringes, or needles with anyone, even if the needle is changed — you may give or get a serious infection.
- Tell your provider about every medical condition and every medicine, vitamin, and supplement you take.
- Losing weight can change how much of other medicines you need (for example blood pressure or diabetes medicines). Keep every prescriber informed.
Report side effects to your VIV RX care team at support@vivrx.com and to the FDA MedWatch program at 1-800-FDA-1088 or www.fda.gov/medwatch. If you think you are having a medical emergency, call 911 or go to the nearest emergency room.
