Informed Consent for Treatment with Semaglutide Injections

Overview:

Human-based glucagon-like peptide-1 receptor agonists (GLP-1 RA) such as Semaglutide (compounded), Adlyxin®, Byetta®, Bydureon®, Ozempic®, Rybelsus®, Trulicity®, Victoza®, Wegovy®, Mounjaro® are prescribed as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) that is considered outside a healthy range. Other considerations for use of this drug class include fatty liver disease, metabolic syndrome, diabetes mellitus, among many other emerging applications.

These medicines work by slowing gastric emptying time and stimulating the satiety center in the brain to reduce hunger and appetite.

Treatment Considerations:

While using a GLP-1 RA it is highly recommended that you:

• Eat a fibrous diet. Focus on fruits and vegetables that are high in fiber.
• Eat small high protein meals as digestion is slowed down while on this medication.
• Avoid foods high in fat as they take longer to digest.
• Drink at least 32oz of water a day to avoid constipation.

Do not take this medicine if:

• You have a personal or family history of medullary thyroid carcinoma (Thyroid Cancer).
• You have a personal history of Multiple Endocrine Neoplasia syndrome type 2 (MEN2).
• You are pregnant or plan to become pregnant while taking this medicine.
• You are diabetic and/or taking any medications related to lowering your blood sugar levels without speaking with your endocrinologist or primary care medical provider. Specifically, if you are prescribed Insulin because the combination may increase your risk of hypoglycemia (low blood sugar). Dosage adjustments may be required by your medical provider.
• You are allergic to Semaglutide or any other GLP-1 agonist such as: Adlyxin®, Byetta®, Bydureon®, Ozempic®, Rybelsus®, Trulicity®, Victoza®, Wegovy®, Mounjaro® (THIS IS NOT AN ALL-INCLUSIVE LIST).

Precautions:

In rodents, semaglutide causes dose-dependent and treatment-duration dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether semaglutide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans.

Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists, including semaglutide.

Acute Gallbladder Disease: Treatment with semaglutide is associated with an increased occurrence of cholelithiasis and cholecystitis.

Acute Kidney Injury: There have been reports of acute kidney injury and worsening of chronic renal failure, which in some cases required hemodialysis, in patients treated with semaglutide. Patients with renal impairment may be at a greater risk of acute kidney injury, but some events have been reported in patients without known underlying renal disease. A majority of the events occurred in patients who experienced nausea, vomiting, or diarrhea, leading to volume depletion.

Diabetic Retinopathy Complications in Patients with Type 2 Diabetes: Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy.

Heart Rate Increase: Mean increases in resting heart rate of 1 to 4 beats per minute (bpm) were observed in semaglutide adult patients compared to placebo in clinical trials.

Common Side Effects (incidence ≥5%):

Nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distension, belching, hypoglycemia, flatulence, gastroenteritis, and gastroesophageal reflux disease.

Possible side effects of subcutaneous injections: itching, burning at the site of administration with or without thickening of the skin.