Important Safety Information for Compounded Semaglutide

What is semaglutide and how is it used?

Semaglutide is a GLP-1 receptor agonist. In its FDA-approved branded forms, it is prescribed along with a reduced-calorie diet and increased physical activity for chronic weight management, and to help manage type 2 diabetes. It is given as an injection under the skin, usually once a week.

The semaglutide provided through Zanason is compounded by a licensed pharmacy to your provider's prescription. Compounded medications are not FDA-approved and do not undergo the FDA's review for safety, effectiveness, or manufacturing quality. FDA-approved medicines containing semaglutide are available.

Ozempic® and Wegovy® are trademarks of Novo Nordisk A/S. Mounjaro® and Zepbound® are trademarks of Eli Lilly and Company. Zanason is not affiliated with the manufacturers of FDA-approved brand-name medications.

Who should NOT use semaglutide?

Do not use semaglutide if:

• You or a family member has had medullary thyroid carcinoma (MTC), or you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• You have had a serious allergic reaction to semaglutide or any of its ingredients
• You are pregnant, trying to become pregnant, or breastfeeding — semaglutide may harm an unborn baby. Stop at least 2 months before a planned pregnancy. Use effective contraception while taking it.

What should I tell my care team before starting semaglutide?

Tell your care team about all medications you take, including prescription and over-the-counter medicines, vitamins, and herbal or dietary supplements.

Share your full medical history. In particular, tell your care team if you have a history of:

• Pancreatitis, gallbladder disease, or kidney or liver problems
• Type 2 diabetes — especially if you take insulin or a sulfonylurea
• Diabetic retinopathy or other vision problems
• Depression, mood changes, or suicidal thoughts or behavior

Warnings and precautions

Pancreatitis

Acute pancreatitis, including fatal cases, has been reported in patients treated with GLP-1 receptor agonists. Stop taking semaglutide and contact your care team immediately if you have severe, lasting pain in your stomach or back, with or without vomiting.

Gallbladder disease

Treatment with semaglutide is associated with cholelithiasis and cholecystitis. Tell your care team about upper-stomach pain, fever, yellowing of the skin or eyes, or clay-colored stools.

Low blood sugar (hypoglycemia)

Semaglutide lowers blood glucose. The risk of hypoglycemia is higher if you also take insulin or an insulin secretagogue such as a sulfonylurea. Watch for dizziness, weakness, shakiness, headache, anxiety or mood changes, rapid heartbeat, confusion, slurred speech, sweating, or lightheadedness.

Kidney problems

Nausea, vomiting, and diarrhea can cause dehydration that may worsen kidney function, in some cases requiring hemodialysis. Stay well hydrated. Kidney problems are more likely in people with pre-existing kidney conditions.

Serious allergic reactions

Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported. Stop semaglutide and get medical help right away for swelling of the face, lips, tongue, or throat; trouble breathing or swallowing; severe rash or itching; fainting or dizziness; or very rapid heartbeat.

Diabetic retinopathy

Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. Patients with a history of diabetic retinopathy should be monitored for progression. Tell your care team about any vision changes.

Heart rate increase

Semaglutide was associated with increases in resting heart rate of 1–4 beats per minute on average. Tell your care team about palpitations or a racing heartbeat while at rest.

Mood changes

Suicidal behavior and ideation have been reported in clinical trials with other weight-management products. Monitor for new or worsening depression, suicidal thoughts or behavior, or unusual changes in mood or behavior. Tell your care team right away. Avoid semaglutide in patients with a history of suicidal attempts or active suicidal ideation.

Pulmonary aspiration during surgery

Semaglutide delays gastric emptying. There have been rare reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing surgery requiring general anesthesia or deep sedation who had residual gastric contents despite preoperative fasting. Tell your surgeon or proceduralist before any planned surgery if you are taking semaglutide.

Drug interactions

Semaglutide can interact with alcohol and certain prescription and non-prescription medications and herbal products:

• Insulin / sulfonylureas: increased risk of hypoglycemia — dose adjustments may be needed
• Oral medications: semaglutide delays gastric emptying and may change how oral medications are absorbed
• Thyroid hormone medication: review timing with the clinician who prescribes your thyroid medication, as it may need to be adjusted
• Medications with a narrow therapeutic window (for example, warfarin): drug levels should be monitored closely
• Alcohol: avoid alcohol while taking semaglutide — alcohol can worsen nausea and affect blood sugar

Common side effects

The side effects reported most often affect the stomach and digestion:

• Nausea
• Diarrhea
• Vomiting
• Constipation
• Stomach (abdominal) pain
• Decreased appetite
• Fatigue
• Headache
• Dyspepsia
• Dizziness
• Injection site reactions

These are not all of the possible side effects. Talk to your care team about any side effects that bother you or don't go away.

How to take semaglutide

Inject semaglutide under the skin once a week, on the same day each week, with or without food. Rotate injection sites — stomach, thigh, or upper arm.

Your care team will usually start you at a low dose and increase gradually to ease stomach-related side effects.

If you miss a dose and the next scheduled dose is more than 2 days away, take it as soon as possible. If less than 2 days away, skip the missed dose and resume on your regular day. Never take two doses at once.

Never share your semaglutide or injection device with anyone else, even if they have the same condition. Sharing may transmit infection and cause harm.

Pregnancy and breastfeeding

Do not use semaglutide if you are pregnant, trying to become pregnant, or breastfeeding. Semaglutide may cause fetal harm. Stop at least 2 months before a planned pregnancy. Use effective contraception while taking semaglutide. Tell your care team immediately if you become pregnant.