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      GLP-1 Agonists (Semaglutide) at Portrait

      What to say to patients (verbally and/or over social media)

      • It is very important from a legal standpoint that we never say that we are offering Ozempic, Wegovy, or (the oral tablet form) Rybelsus
      • From the FDA’s perspective, patients should not use a compounded drug if an approved drug is available to treat a patient
        • Semaglutide compounding has been permitted due to the ongoing intermittent drug shortages
        • Here is a helpful FDA memo
      • Shipping compounded semaglutide in CA is not permitted
        • The company has sourced synthetic GLP-1, the peptide which semaglutide mimics in the body
        • Expected equitable clinical efficacy but without the higher price point for patients

      Background

      • Semaglutide is the generic name for branded Ozempic, Wegovy and Rybelsus
      • Rx was intended as an antidiabetic medication used for the treatment of type 2 diabetes, but has found its place as an anti-obesity medication used for long-term weight management

      Package Insert

      MOA

      • Semaglutide works as a glucagon-like peptide-1 (GLP-1) receptor agonist. The effect is to reduce food intake by lowering appetite and slowing down digestion in the stomach, ultimately helping to reduce body fat and weight.

      Side Effects

      • Mainly around GI effects
        • nausea, diarrhea, vomiting, constipation, abdominal pain, indigestion/heartburn, abdominal distension, belching, hypoglycemia (low blood glucose) in patients with type 2 diabetes, flatulence, gastroenteritis, and gastroesophageal reflux disease (GERD).
        • may also cause pancreatitis, gastroparesis, and bowel obstruction

      Contraindications

      • Black Box Warning
        • Personal or family history of multiple endocrine neoplasia syndrome type 2 (MEN 2)
      • Type 1 or type 2 diabetics who are insulin-dependent
      • History of thyroid cancer
      • History of pancreatitis
      • Rx to be discontinued 2 months before attempting pregnancy

      Monitoring

      • S/s depression or behavioral changes, suicidality
      • Glucose at baseline if the patient is a diabetic, then when dose is increased
      • Watch for gastric distress — increasing constipation, nausea, or heartburn
      • Regular (weekly) weight logs either in clinic or that patient performs at home

      How do we get our patient clear for use?

      • Record your patient’s height and weight into their chart (type into Internal Note section)
      • Confirm the following to ensure the patient is a candidate
        • No personal or family history of multiple endocrine neoplasia syndrome type 2 (MEN 2)
        • No type 1 or type 2 diabetics who are insulin-dependent
        • No history of thyroid cancer
        • No history of pancreatitis
        • Not pregnant or intending to become pregnant in the next two months
        • At Portrait, patients already on a hypoglycemic agent (e.g. metformin) are not candidates and should be managed by their primary care provider
      • Have your PCC notify that you need clearance for semaglutide
      • Patient will be evlauated for clearance by the on-staff provider

      Dosing Recommendations

      • 0.25 mg is injected under the skin once a week for 4 weeks
      • Increase by 0.25 mg every 4 weeks, until goal achieved OR
        • max dose of 2.5 mg once a week is reached

      Ongoing Monitoring/Documentation

      For patients already on semaglutide, document the following at each visit:

      Date Treatment Commenced:

      Current dose (if taking):

      Starting weight, current weight:

      Any active gastrointestinal symptoms?

      Any mood symptoms?

      Any change in intent for pregnancy?

      Please upload recent labs, if you have any

      *** IF THE PATIENT REPORTS SIGNIFICANT SIDE EFFECTS, RN’S NEED TO CONTACT THE GFE TEAM FOR NEXT STEPS. DO NOT MANAGE DOSING AS YOU MAY BE OUT OF PRACTICE SCOPE ***

      Outcome Expectations

      Most studies evaluated patients after week 68 of ongoing weekly use

      • Average was 15-20% of body weight loss over that time period
      • Study participants also enjoyed greater improvement in cardiometabolic risk factors and a greater increase in participant-reported physical functioning from baseline

      https://drive.google.com/drive/folders/1RXQJf6Zhv3Wp6_7XUHTbSJumwPEHT0V_?usp=sharing