Safety Information for Compounded Semaglutide

Important Notice: Compounded semaglutide is a customized medication prepared by a compounding pharmacy based on a healthcare provider’s prescription. Unlike FDA-approved semaglutide products (e.g., Ozempic®, Wegovy®, Rybelsus®), compounded semaglutide is not reviewed or approved by the FDA for safety, effectiveness, or quality. The preparation and dosage strength may vary, and individual responses to compounded medications can differ.

Before Starting Compounded Semaglutide, Talk to Your Healthcare Provider If You Have:

• Medical Conditions:

  • History of pancreatitis: Semaglutide may increase the risk of pancreatitis (inflammation of the pancreas). Inform your healthcare provider if you have a history of pancreatitis or any other pancreas-related issues.
  • Diabetic retinopathy: If you have or have had diabetic eye disease (retinopathy), you should inform your healthcare provider, as semaglutide may increase the risk of worsening eye problems.
  • Kidney or liver problems: Compounded semaglutide may affect kidney function, especially if you have kidney disease. Your healthcare provider will need to monitor your kidney function during treatment.
  • Gastrointestinal (GI) issues: Semaglutide can slow down gastric emptying and may lead to nausea, vomiting, or diarrhea. It may not be appropriate for people with certain GI conditions like gastroparesis.

• Allergies:

  • Hypersensitivity: If you are allergic to semaglutide or any of the ingredients in the compounded formulation, do not use this medication. Signs of an allergic reaction may include rash, itching, difficulty breathing, and swelling of the face, lips, or throat.

• Pregnancy and Breastfeeding:

  • Pregnancy: Semaglutide is classified as Category C for pregnancy, meaning it may cause harm to the fetus in some cases. It is not recommended during pregnancy unless the potential benefits outweigh the risks.
  • Breastfeeding: It is not known whether semaglutide passes into breast milk. You should discuss with your healthcare provider whether it is safe to use while breastfeeding.

• Other Medications:

  • Drug Interactions: Compounded semaglutide may interact with other medications, including insulin, oral diabetes medications, and drugs that affect blood pressure. Inform your healthcare provider of all medications, supplements, or herbal products you are taking.

*This is not a comprehensive list and you should always consult with a medical provider

Administration and Dosage

• Injection: Compounded semaglutide is typically administered subcutaneously (under the skin) once a week. Ensure you follow the instructions for injection provided by your healthcare provider or pharmacist to minimize the risk of infection or injury.
• Storage: Store compounded semaglutide as directed by your pharmacist. Typically, it should be refrigerated (between 36°F and 46°F or 2°C to 8°C) and should not be frozen.
• Disposal: Dispose of used needles and syringes properly in a designated sharps container.

Possible Side Effects

Common side effects of compounded semaglutide may include:

• Gastrointestinal symptoms: nausea, vomiting, diarrhea, constipation, stomach pain, or bloating. These are most common during the first few weeks of treatment and may subside over time.
• Low blood sugar (hypoglycemia): When used in combination with other diabetes medications, semaglutide may increase the risk of low blood sugar. Symptoms may include dizziness, confusion, sweating, or shaking.
• Injection site reactions: Redness, swelling, or irritation at the injection site may occur. Rotate injection sites to reduce the risk of these reactions.
• Headache and fatigue: Some individuals may experience headaches or feel more tired than usual.

Less common but more serious side effects may include:

• Pancreatitis (inflammation of the pancreas): Severe abdominal pain, nausea, and vomiting. Seek immediate medical attention if you experience these symptoms.
• Thyroid tumors: There have been reports of thyroid tumors in animal studies. While this has not been confirmed in humans, patients with a family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2) should avoid semaglutide.
• Kidney problems: Semaglutide can cause kidney injury, especially in people with pre-existing kidney conditions. Symptoms of kidney problems may include changes in urination, swelling of legs or ankles, or unusual fatigue.

This is not a comprehensive list and you should always consult with a medical provider

When to Seek Immediate Medical Attention

Please contact your doctor ASAP and seek in-person care immediately if a side effect becomes problematic or you experience:

• Severe abdominal pain, nausea, vomiting, or loss of appetite may indicate pancreatitis, a serious side effect.
• Signs of an allergic reaction, such as rash, difficulty breathing, or swelling of the face, lips, or throat.
• Signs of kidney problems, such as swelling in the legs or ankles, or changes in urination.
• Hepatitis/Elevated liver enzymes/Jaundice
• Signs of low blood sugar (for example, dizziness, weakness, shakiness, jitteriness, headache, anxiety/mood changes, rapid heartbeat, confusion, slurred speech, sweating, or lightheadedness)
• Increasing heart rate
• Worsening depression, behavior changes, or suicidality

Additional Considerations

• Monitoring: Regular monitoring of blood sugar levels, kidney function, and thyroid function is important while using semaglutide. Your healthcare provider will recommend periodic testing to ensure your health is being adequately managed.

• Lifestyle Factors: Compounded semaglutide is most effective when used as part of a comprehensive treatment plan, including dietary changes, exercise, and weight management. It is important to follow your healthcare provider’s guidance on lifestyle modifications to achieve the best outcomes.

Compounded semaglutide is not FDA-approved, and the safety, efficacy, and quality of compounded semaglutide may not have been reviewed by regulatory authorities. Always consult your healthcare provider to ensure that compounded semaglutide is appropriate for your condition, and follow their instructions for safe use.

If you experience any adverse reactions or side effects, contact your healthcare provider immediately.

Although this safety information provides an  outline of the potential risks, side effects, and precautions associated with compounded semaglutide, it is not a comprehensive list of risks associated with it. It is essential for individuals to have open communication with their healthcare providers to ensure safe and effective use of this medication.