Semaglutide:
Important
Safety Information

metaformin safety

Compounded Semaglutide refers to a formulation of the medication Semaglutide that is customized or prepared by a compounding pharmacy. Semaglutide itself is a glucagon-like peptide-1 (GLP-1) receptor agonist, a type of medication used in the management of type 2 diabetes mellitus.

Compounded drugs are permitted to be prescribed under federal law, providing healthcare providers with the flexibility to customize medications to meet the specific needs of individual patients. However, it’s essential to understand that compounded medications, including compounded Semaglutide, do not undergo the same level of scrutiny and regulation by the Food and Drug Administration (FDA) as commercially available medications.

As with any medication, it’s important to be aware of the potential risks and benefits associated with compounded Semaglutide and to use it under the guidance of a qualified healthcare provider. Regular monitoring and communication with your healthcare provider can help ensure the safe and effective use of compounded medications in your treatment regimen.

What is Semaglutide Used For?

Semaglutide is a medication classified as a glucagon-like peptide-1 (GLP-1) receptor agonist, prescribed for chronic weight management. It is recommended for individuals meeting the following criteria:

Body Mass Index (BMI) of 30 kg/m² or greater (classified as obesity) or BMI of 27 kg/m² or greater (classified as overweight), with at least one weight-related comorbid condition such as hypertension, type 2 diabetes mellitus, or dyslipidemia.

However, there are certain limitations to its use:

  • Semaglutide should not be used concurrently with other semaglutide-containing products or any other GLP-1 receptor agonists.
  • The safety and effectiveness of combining semaglutide with other weight-loss medications have not been established.
  • Semaglutide has not been studied in individuals with a history of pancreatitis.
  • It is contraindicated for use in patients with type 1 diabetes mellitus.

Warning: Risk of Thyroid C-Cell Tumors

Compounded semaglutide carries a warning regarding the potential risk of medullary thyroid carcinoma (MTC). MTC is a rare form of thyroid cancer that originates from the parafollicular C-cells of the thyroid gland. While the absolute risk of MTC with semaglutide is low, healthcare providers should carefully consider this risk before prescribing semaglutide, particularly in patients with a personal or family history of MTC or in patients with multiple endocrine neoplasia syndrome type 2 (MEN 2).

Who Should Not Take Semaglutide?

Semaglutide is contraindicated in certain individuals due to potential risks or medical conditions. Here’s a breakdown of who should not use Semaglutide:

  • Patients with a history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2) should not use semaglutide.
  • Individuals with a history of serious hypersensitivity reactions to semaglutide or any of its components should also avoid its use.
  • Pregnant or breastfeeding women should consult their healthcare provider before using Semaglutide.

How Should Semaglutide be Administered?

  • Compounded Semaglutide is typically administered once daily by subcutaneous injection.
  • The recommended starting dose and titration schedule may vary depending on individual patient factors, such as renal function and tolerability.
  • Injection sites may include the abdomen, thigh, or upper arm, and rotation of injection sites is recommended to minimize the risk of injection site reactions.

Foods to Avoid While Taking Semaglutide

  • Drinking alcohol excessively may increase the risk of lactic acidosis, a rare but serious complication associated with metformin use.
  • High-fat meals should also be avoided, as they may delay the absorption of Semaglutide and increase the risk of gastrointestinal side effects such as nausea and diarrhea.

Common Side Effects of Semaglutide

  • Nausea
  • Diarrhea
  • Vomiting
  • Constipation
  • Abdominal pain
  • Headache
  • Fatigue
  • Dyspepsia
  • Dizziness
  • Abdominal distension
  • Eructation
  • Hypoglycemia in patients with type 2 diabetes
  • Flatulence
  • Gastroenteritis
  • Gastroesophageal reflux disease

Most Serious Side Effects of Semaglutide

These serious side effects may occur with semaglutide. You or a caregiver must diligently monitor for these potential adverse reactions, especially when starting treatment or adjusting doses.


Thyroid C-Cell Tumors:
Semaglutide has been associated with an increased risk of thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in animal studies. While the risk in humans is uncertain, individuals with a family history of MTC or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) should avoid Semaglutide. Seek immediate medical attention if you notice a lump or swelling in your neck, experience hoarseness, have difficulty swallowing, or suffer from shortness of breath, as these could be signs of thyroid cancer.


Inflammation of Pancreas (Acute Pancreatitis):
Monitor for symptoms of acute pancreatitis, such as severe abdominal pain that persists, often radiating to the back, with or without vomiting.


Acute Gallbladder Disease:
Semaglutide may increase the risk of gallbladder problems, including the formation of gallstones. Some gallbladder issues may require surgical intervention. Contact your healthcare provider immediately if you experience upper stomach pain, jaundice (yellowing of the skin or eyes), fever, or pale-colored stools.


Low Blood Sugar (Hypoglycemia):
Semaglutide can lower blood sugar levels, potentially causing hypoglycemia in individuals with type 2 diabetes who are also taking other glucose-lowering medications. Monitor your blood sugar levels closely and be alert for signs of hypoglycemia, such as dizziness, blurred vision, mood changes, sweating, or rapid heartbeat.


Acute Kidney Injury:
Dehydration due to diarrhea, nausea, and vomiting associated with Semaglutide use may exacerbate kidney problems. Ensure adequate fluid intake to minimize the risk of dehydration.


Serious Allergic Reactions:
Discontinue Semaglutide immediately if you experience symptoms of a severe allergic reaction, such as swelling of the face, lips, tongue, or throat; severe rash or itching; rapid heartbeat; difficulty breathing or swallowing; or fainting.


Diabetic Retinopathy Complications:
Individuals with type 2 diabetes should promptly report any changes in vision to their healthcare provider.


Increase in Heart Rate:
Notify your healthcare provider if you experience a rapid heartbeat while at rest.


Suicidal Behavior and Ideation:
Monitor for changes in mood, behavior, thoughts, or feelings, and promptly report any concerning mental health changes to your healthcare provider.

Note

Please note that these warnings serve to highlight specific risks associated with compounded semaglutide and are not comprehensive. Healthcare providers should review the full prescribing information for semaglutide and consider individual patient factors before prescribing this medication. Patients should consult their healthcare provider for personalized guidance and recommendations regarding the use of semaglutide and the management of any potential risks.